Pros and cons of using the novaring contraceptive ring

Bleeding from Novaring is one of the side effects of this drug. NovaRinga is a type of hormonal contraceptive. The mechanism of action of hormonal contraceptives is such that, interfering with the normal functioning of the endocrine system, they cause certain shifts. Some of these phenomena are what these drugs are trying to use. But any hormone in the human body does not do one thing. By acting on different points of metabolism, hormones cause such changes that a healthy woman becomes sterile. Such an effect can be achieved only with a very powerful effect on the female body. And of course, this impact does not go unnoticed.

Bleeding from Nuvaring - contraindications to the use of the drug

You should know that NovaRinga is contraindicated for such problems: venous thrombosis, a history of pulmonary embolism; arterial thrombi (myocardial infarction) or their harbinger - angina pectoris. Antithrombin III deficiency, migraine; diabetes; transferred pancreatitis, accompanied by hypertriglyceridemia; severe diseases, liver tumor, hormone-dependent malignant, vaginal bleeding of unknown etiology; diagnosed or possible pregnancy; the period of breastfeeding; hypersensitivity to any component of the drug.

Side effects - bleeding from Nuvaring

The side effects of Nuvaring are simply amazing. There is an increased risk of arterial (heart attack, stroke) and venous (possible pulmonary embolism) blood clots, which can manifest as sudden loss of vision, impaired speech, weakness or numbness on one side of the body, sudden pain in the chest or other part of the body. The use of this ring increases the risk of cervical and breast cancer. The chance of cancer decreases to normal levels 10 years after stopping the use of this drug. It also increases the risk of benign and malignant liver tumors, which can cause intra-abdominal bleeding. Other side effects should include an increase in the risk of pancreatitis, an increase in blood pressure numbers. In subsequent pregnancies, jaundice, gallstones, herpes of pregnancy, Sydenham's chorea, and hearing loss due to otosclerosis occur more often. Acute disturbances of work of a liver are possible. The use of hormonal contraceptives and Nuvaring worsens the course of Crohn's disease, ulcerative colitis. Often there is chloasma - spots on the face. Cases of ingrowth of the ring into the mucous membrane of the vagina have been noted - such a ring can only be removed promptly. There are cases when the ring gets into the urethra, and from there into the bladder, with the occurrence of cystitis.

During the use of Novaring, menstrual bleeding intensifies, in addition, bleeding from Novaring is possible just outside of menstruation. In this case, the doctor should examine whether there is a concomitant pathology that will be more difficult and it is necessary to weigh again whether there is a need to use hormones.

Using such a tool is akin to a dangerous attraction - it may blow over, or maybe not.

Name:

Novaring

Pharmacological
action:

Combined hormonal contraceptive drug containing etonogestrel and ethinylestradiol.
Etonogestrel is a progestogen (a derivative of 19-nortestosterone) that binds with high affinity to progesterone receptors in target organs. Ethinylestradiol is an estrogen and is widely used in the manufacture of contraceptives.
The contraceptive effect of NovaRing is due to a combination of various factors, the most important of which is the suppression of ovulation.

Efficiency
In clinical studies, it was found that the Pearl Index (an indicator that reflects the frequency of pregnancy in 100 women during 1 year of contraception) in women aged 18 to 40 years for NuvaRing was 0.96 (95% CI: 0.64-1.39) and 0.64 (95% CI: 0.35-1.07) in the statistical analysis of all randomized participants (ITT analysis) and the analysis of participants in studies that completed them according to the protocol (PP analysis), respectively. These values ​​were similar to Pearl Index values ​​obtained in comparative studies of combined oral contraceptives (COCs) containing levonorgestrel/ethinylestradiol (0.150/0.030 mg) or drospirenone/ethinylestradiol (3/0.30 mg).
Against the background of the use of the drug NovaRing, the cycle becomes more regular, the pain and intensity of menstrual-like bleeding decreases, which helps to reduce the incidence of iron deficiency. There is evidence of a reduced risk of endometrial and ovarian cancer with the use of the drug. In addition, high-dose COCs (0.05 mg ethinylestradiol) reduce the risk of developing ovarian cysts, inflammatory diseases of the pelvic organs, benign changes in the mammary glands and ectopic pregnancy. It is not entirely clear whether low-dose hormonal contraceptives offer similar benefits.

The nature of bleeding
A comparison of bleeding patterns over one year in 1000 women who used NovaRing and COCs containing levonorgestrel / ethinyl estradiol (0.150 / 0.030 mg) showed a significant reduction in the frequency of breakthrough bleeding or spotting when using NovaRing compared with COCs. In addition, the frequency of cases when bleeding occurred only during a break in the use of the drug was significantly higher among women who used NovaRing.
Effect on bone mineral density
A comparative two-year study of the effect of NovaRing (n=76) and a non-hormonal intrauterine device (n=31) showed no effect on bone mineral density in women.
Children
The safety and efficacy of NuvaRing in adolescents under 18 years of age have not been studied.

Pharmacokinetics
Etonogestrel
Suction
Etonogestrel, released from the NovaRing vaginal ring, is rapidly absorbed through the vaginal mucosa. Cmax of etonogestrel, which is about 1700 pg / ml, is achieved approximately 1 week after the introduction of the ring. Serum concentrations change in a small range and slowly decrease to about 1600 pg / ml after 1 week, 1500 pg / ml after 2 weeks and 1400 pg / ml after 3 weeks of use. Absolute bioavailability is about 100%, which exceeds the oral bioavailability of etonogestrel. According to the results of measuring the concentrations of etonogestrel in the cervix and inside the uterus in women using the drug NovaRing, and women
using oral contraceptives containing 0.150 mg of desogestrel and 0.020 mg of ethinylestradiol, the observed values ​​of etonogestrel concentrations were comparable.

Distribution
Etonogestrel binds to serum albumin and sex hormone-binding globulin (SHBG). Vd etonogestrel 2.3 l / kg.
Metabolism
Etonogestrel is metabolized in the liver to sulfate and glucuronide conjugates. Serum clearance is about 3.5 l / h. No direct interaction with ethinylestradiol has been identified.
breeding
The decrease in serum etonogestrel concentration is biphasic. T1 / 2 β-phase is about 29 hours. Etonogestrel and its metabolites are excreted in the urine and bile in a ratio of 1.7:1. T1 / 2 metabolites is approximately 6 days.

Ethinylestradiol
Suction
Ethinylestradiol released from NovaRing is rapidly absorbed through the vaginal mucosa. Cmax, which is about 35 pg / ml, is reached 3 days after the introduction of the ring and decreases to 19 pg / ml after 1 week, to 18 pg / ml after 2 weeks and 18 pg / ml after 3 weeks of use.
Absolute bioavailability is approximately 56% and is comparable to that of oral administration of ethinyl estradiol. According to the results of measuring the concentrations of ethinylestradiol in the cervical region and inside the uterus in women using the drug NovaRing, and women using oral contraceptives containing 0.150 mg of desogestrel and 0.020 mg of ethinylestradiol, the observed concentrations of ethinylestradiol were comparable.
The concentration of ethinylestradiol was studied in a comparative randomized study of NovaRing (daily release of ethinylestradiol in the vagina 0.015 mg), transdermal patch (norelgestromin / ethinylestradiol; daily release of ethinylestradiol 0.020 mg) and COCs (levonorgestrel / ethinylestradiol; daily release of these nilestradiol 0.030 mg) during one cycle in healthy women.
Monthly systemic exposure to ethinylestradiol (AUC0-∞) for NovaRing was statistically significantly lower than that of the patch and COC, and amounted to 10.9, 37.4 and 22.5 hh/ml, respectively.

Distribution
Ethinylestradiol binds to serum albumin. Vd is about 15 l/kg.
Metabolism
Ethinylestradiol is metabolized by aromatic hydroxylation followed by methylation to form a variety of hydroxylated and methoxylated metabolites, which are present both in the free state and as glucuronide and sulfate conjugates. Serum clearance is about 3.5 l / h.
breeding
The decrease in the concentration of ethinylestradiol in serum is biphasic. T1 / 2 of the β-phase is characterized by large individual differences, and, on average, is about 34 hours. Ethinylestradiol is not excreted unchanged; its metabolites are excreted in the urine and bile in a ratio of 1.3:1. T1 / 2 metabolites is about 1.5 days.

Special patient groups
Children
The pharmacokinetics of NuvaRing in healthy adolescent girls under the age of 18 years who have already begun menstruation has not been studied.
Impaired kidney function
The effect of kidney disease on the pharmacokinetics of NuvaRing has not been studied.
Impaired liver function
The effect of liver disease on the pharmacokinetics of NovaRing has not been studied.
However, in patients with impaired liver function, the metabolism of sex hormones may be impaired.
ethnic groups
The pharmacokinetics of the drug in representatives of ethnic groups has not been specifically studied.

Indications for
application:

Nuvaring is used as a contraceptive.

Mode of application:

The Nuvaring ring is intended for intravaginal use.
You can enter the ring yourself, for this you need to choose a comfortable position (sitting or standing, raising one leg, or lying down).
For insertion, the ring is compressed and inserted into the vagina.
The exact position of the ring in the vagina is not of great importance for the contraceptive effect, however, it must be conveniently placed so as not to cause discomfort or difficulty during intercourse.
After insertion, the ring must remain in the vagina for 3 weeks. If the ring is accidentally removed from the vagina (for example, when using a tampon), it should be rinsed with non-hot water and reinserted immediately.
After 3 weeks (on the same day of the week when the ring was inserted), the ring should be removed from the vagina. 7 days after the removal of the previous ring, if the woman still needs contraception, the next Novaring ring is introduced.
During the 7-day break, a woman should begin menstrual-like bleeding (as a rule, bleeding begins 2-3 days after the removal of the Novaring ring).
The next Nuvaring ring is administered regardless of whether the menstrual bleeding has ended or not.

If there is a risk of pregnancy, pregnancy should be excluded before using the Nuvaring ring.
If the woman did not use hormonal contraceptives in the previous cycle, the Nuvaring ring should be started during the first 5 days of the cycle (the first day of the cycle is the day the menstruation begins). During the first 7 days, in this case, you should additionally use a condom or other barrier method of contraception.
If the woman was taking oral contraceptives in the previous cycle, the Novaring ring should be started on the first day after the 7-day break or the next day after taking the last placebo tablet.

If the woman used mini-pills or other drugs in the previous cycle containing only progestogens (including progestogen intrauterine devices), the use of the Nuvaring ring should be started on the day when the last dose of progestogens was received (the day when the next progestogen injection would be given, or on the day the progestogen intrauterine device is removed).
When switching from contraceptives that contain only progestogens to the Novaring ring, a barrier method of contraception should be used for the first 7 days.
After the abortion carried out in the first trimester, the Novaring ring can be used immediately after an abortion (in this case, an additional method of contraception is not required).
After childbirth, miscarriage or abortion in the second trimester it is recommended to start using the Novaring ring within the fourth week after childbirth or abortion.
If the use of the Nuvaring ring is started later, a condom or other barrier method of contraception should be used additionally during the first 7 days.

If, after a 7-day break, a woman forgot to enter the Nuvaring ring, should be introduced as early as possible. During the first 7 days, in this case, you should additionally use a condom or other barrier method of contraception.
If the ring is accidentally removed, contraceptive effectiveness is reduced if the Nuvaring ring has been outside the vagina for more than 3 hours. The ring should be inserted back into the vagina as soon as possible, but if the break is more than 3 hours, additional barrier contraception should be used for the next 7 days.
If these 7 days fall on the third week of using Nuvaring, the ring must remain in the vagina for more than 3 weeks (the countdown starts from the moment the ring is first inserted), the next ring in this case is inserted one day after the removal of the previous one.

If a woman forgot to remove the Nuvaring ring in time, it should be borne in mind that its effectiveness persists for 4 weeks after administration.
If the ring was not removed in time, it should be removed as soon as the woman remembers about it. A new ring in this case is introduced 1 day after the removal of the previous one. If the Nuvaring ring has been in the vagina for more than 4 weeks, its effectiveness is reduced and pregnancy should be excluded before using a new one.
If during the 7-day interval between the use of the drug Novaring there is no development of menstrual-like bleeding, pregnancy should be excluded before the introduction of a new ring.
To delay menstrual bleeding a woman can enter the next ring without a 7-day break.
During the use of the second ring, in this case, the development of minor spotting is possible. In the following cycles, the rings should be administered as recommended, with 7-day breaks.

To change the timing of your menstrual bleeding a woman can shorten the interval between using Nuvaring by as many days as necessary to postpone her menstruation.
The shorter the break, the higher the chance that there will be no menstrual bleeding, however, minor spotting will appear during the cycle.
The used Novaring ring should be packed in a bag and disposed of with household waste, in such a way as to avoid accidental contact of the ring with other people.

Side effects:

Nuvaring is generally well tolerated by patients.
There are data on individual cases of the development of such undesirable effects due to the active components of the drug Nuvaring:
- from the nervous system: emotional lability, headache, migraine and migraine-like headache, depression, dizziness, causeless anxiety, increased fatigue;
-from the reproductive system: decreased libido, enlargement and tension of the mammary glands, dysmenorrhea, vaginal discharge, cervicitis, vaginitis, problems associated with sexual intercourse, which are due to the location of the ring;
- from the digestive system and liver: pain in the epigastric region, stool disorders, nausea, vomiting, change in body weight;
- allergic reactions: urticaria, pruritus, Quincke's edema;
-other: cystitis.

Contraindications:

Venous thrombosis (including history), including thromboembolism;
- arterial thrombosis (including history), including cerebrovascular accident, myocardial infarction and / or precursors of thrombosis, including angina pectoris, transient ischemic attack;
- heart defects with thrombogenic complications;
- predisposition to the development of venous or arterial thrombosis, including hereditary diseases: resistance to activated protein C, antithrombin III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia and antiphospholipid antibodies (cardiolipin antibodies, lupus anticoagulant);
- migraine with a history of focal neurological symptoms;
- diabetes mellitus with vascular damage;
- pronounced or multiple risk factors for venous or arterial thrombosis;
- pancreatitis (including history), in combination with severe hypertriglyceridemia;
- severe liver disease, until the normalization of its function;
- liver tumors, malignant or benign (including history);
- established or suspected hormone-dependent malignant tumors (for example, genital or breast);
- vaginal bleeding of unknown etiology;
- pregnancy (including intended);
- Hypersensitivity to any of the active or excipients of NovaRing.
In the event of any of the above conditions, you should immediately stop using the drug.

Caution should be given the drug in the presence of any of the diseases, conditions or risk factors listed below; in such cases, the doctor must carefully weigh the benefit-risk ratio of using NovaRing:
- the presence of diseases in the family history (venous thrombosis and embolism and / or arterial thrombosis in brothers / sisters at any age or in parents at a relatively early age);
- prolonged immobilization, major surgery, any surgery on the lower extremities or serious injury;

- thrombophlebitis of superficial veins;
- smoking (especially in women over 35);
- dyslipoproteinemia;
- heart valve disease;
- atrial fibrillation;
- arterial hypertension;
- diabetes;
- acute or chronic liver dysfunction;
- jaundice and / or itching caused by cholestasis;
- cholelithiasis;
- porphyria;
- systemic lupus erythematosus;
- hemolytic-uremic syndrome;
- Sydenham's chorea (small chorea);
- hearing loss due to otosclerosis;
- (hereditary) angioedema;
- chronic inflammatory bowel disease (Crohn's disease and ulcerative colitis);
- sickle cell anemia;
- chloasma;
- conditions that make it difficult to use the vaginal ring: cervical prolapse, bladder hernia, rectal hernia, severe chronic constipation.
In the event of an exacerbation of diseases, a deterioration in the condition, or the occurrence of any of the listed conditions for the first time, you should consult a doctor to decide on the possibility of further use of NovaRing.

If any of the diseases, conditions or risk factors listed below are present, the benefits of using NovaRing and the possible risks for each individual woman should be evaluated before she starts using NovaRing.
In the event of an exacerbation of diseases, a deterioration in the condition, or the occurrence of any of the conditions listed below for the first time, a woman should consult a doctor to decide on the possibility of further use of NovaRing.

Circulatory disorders
The use of hormonal contraceptives may be associated with the development of venous thrombosis (deep vein thrombosis and pulmonary embolism) and arterial thrombosis, as well as associated complications, sometimes with a fatal outcome.
The use of any COC increases the risk of developing venous thromboembolism (VTE) compared with the risk of developing VTE in patients not using COCs. The greatest risk of developing VTE occurs in the first year of COC use. Data from a large prospective cohort study of the safety of various COCs suggest that the greatest increase in risk, compared with the risk level in women who do not use COCs, occurs in the first 6 months after starting COC use or resuming their use after a break (4 weeks or more). In non-pregnant women not using oral contraceptives, the risk of developing VTE is 1 to 5 cases per 10,000 woman-years (WY).

In women using oral contraceptives, the risk of developing VTE is from 3 to 9 cases per 10,000 VL. The increased risk is less than in pregnancy, where the risk is 5-20/10,000 YL (pregnancy data based on actual length of pregnancy in standard studies; based on 9-month pregnancy, risk is 7 to 27 cases per 10,000 YL).
In women in the postpartum period, the risk of developing VTE is 40 to 65 cases per 10,000 VL. VTE is fatal in 1-2% of cases.
According to the results of studies, women using NuvaRing are at a greater risk of developing VTE, similar to that of women using COCs (adjusted risk ratio is presented in the table below).
The TASC (Transatlantic Active Cardiovascular Safety Study) was a large prospective observational study assessing the risk of VTE in women who started using NovaRing or COCs, switched to NovaRing or COCs from other contraceptives, or resumed using NovaRing or COC, in a population of typical users.

Women were followed up for 24-48 months.
The results showed a similar level of risk of developing VTE in women using NuvaRing (frequency 8.3 cases per 10,000 LL) and in women using COCs (frequency 9.2 cases per 10,000 LL).
For women using COCs, with the exception of desogestrel, gestodene and drospirenone, the incidence of VTE was 8.9 cases per 10,000 VL.
A retrospective cohort study initiated by the FDA (US Food and Drug Administration) showed that the incidence of VTE in women who started using NovaRing is 11.4 cases per 10,000 YL, while in women who started use COCs containing levonorgestrel, the incidence of VTE is 9.2 cases per 10,000 VL.

Extremely rare cases of thrombosis of other blood vessels (for example, arteries and veins of the liver, mesenteric vessels, kidneys, brain and retina) are known with the use of COCs. It is not known whether these cases are associated with the use of COCs.
Possible symptoms of venous or arterial thrombosis may include pain in one leg and/or swelling; sudden severe chest pain, possibly radiating to the left arm; an attack of shortness of breath, cough; any unusual, severe, prolonged headaches; sudden partial or complete loss of vision; double vision; slurred speech or aphasia; dizziness; collapse, with or without focal epileptic seizure; sudden weakness or severe numbness on one side of the body or any part of the body; movement disorders; "sharp" abdomen.

Risk factors for the development of venous thrombosis and embolism:
- age;
- the presence of diseases in the family history (venous thrombosis and embolism in brothers / sisters at any age or in parents at a relatively early age). If a hereditary predisposition is suspected, a woman should be referred to a specialist for advice before starting the use of any hormonal contraceptives;
- prolonged immobilization, major surgery, any surgery on the lower extremities, or serious trauma. In such situations, it is recommended to stop using the drug (in the case of a planned operation, at least 4 weeks in advance) with subsequent resumption of use no earlier than 2 weeks after the full restoration of motor activity;
- with obesity (body mass index over 30 kg/m2);
- possibly thrombophlebitis of superficial veins and varicose veins.

There is no consensus on the possible role of these conditions in the etiology of venous thrombosis.
Risk factors for the development of complications of arterial thromboembolism:
- age;
- smoking (with heavy smoking and with age, the risk increases even more, especially in women over 35 years old);
- dyslipoproteinemia;
- obesity (body mass index over 30 kg/m2);
- hypertension;
- migraine;
- heart valve disease;
- atrial fibrillation;
- the presence of diseases in a family history (arterial thrombosis in brothers / sisters at any age or in parents at a relatively early age). If a hereditary predisposition is suspected, a woman should be referred to a specialist for advice before starting the use of any hormonal contraceptives.

Biochemical factors that may indicate a hereditary or acquired predisposition to venous or arterial thrombosis include resistance to activated protein C, hyperhomocysteinemia, antithrombin III deficiency, protein C deficiency, protein S deficiency, antibodies to phospholipids (anti-cardiolipin antibodies, lupus anticoagulant).
Other conditions that can lead to unwanted circulatory problems include diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome and chronic inflammatory bowel disease (eg Crohn's disease or ulcerative colitis), and sickle cell anemia.
It is necessary to take into account the increased risk of thromboembolism in the postpartum period.
An increase in the frequency or severity of migraine (which may be a prodromal symptom of cerebrovascular accident) during the use of hormonal contraceptives may prompt immediate discontinuation of hormonal contraceptive use.
Women using CHCs should be advised to contact their doctor if symptoms of thrombosis appear. If thrombosis is suspected or confirmed, CHC use should be discontinued. In this case, it is necessary to use effective contraceptives, since anticoagulants (coumarins) have a teratogenic effect.

The risk of developing tumors
The most important risk factor for developing cervical cancer is infection with the human papillomavirus (HPV).
Epidemiological studies have shown that long-term use of COCs leads to an additional increase in this risk, but it remains unclear how much this is due to other factors, such as more frequent cervical smears and differences in sexual behavior, incl. use of barrier contraceptives. It remains unclear how this effect is associated with the use of NuvaRing.
A meta-analysis of the results of 54 epidemiological studies revealed a small increase (1.24) in the relative risk of developing breast cancer in women taking combined hormonal oral contraceptives.
The risk gradually decreases over 10 years after stopping the drugs.

Breast cancer rarely develops in women under the age of 40, so the additional incidence of breast cancer in women who take or have taken COCs is small compared to the overall risk of developing breast cancer.
Breast cancer diagnosed in women using COCs is clinically less pronounced than cancer detected in women who have never used COCs.
An increased risk of developing breast cancer may be
due to both the fact that in women taking COCs, the diagnosis of breast cancer is established earlier, and the biological effects of COCs, or a combination of both of these factors.
In rare cases, women taking COCs have experienced cases of benign, and even more rarely, malignant liver tumors. In some cases, these tumors have led to the development of life-threatening bleeding into the abdominal cavity. The doctor should consider the possibility of a liver tumor in the differential diagnosis of diseases in a woman taking NovaRing if the symptoms include acute pain in the upper abdomen, liver enlargement, or signs of intra-abdominal bleeding.

Other states
Women with hypertriglyceridemia or a family history of hypertriglyceridemia have an increased risk of developing pancreatitis when taking hormonal contraceptives.
Many women taking hormonal contraceptives there is a slight increase in blood pressure however, a clinically significant increase in blood pressure is rare.
A direct relationship between the use of hormonal contraceptives and the development of arterial hypertension has not been established.
If during the use of the drug NuvaRing there is a constant increase in blood pressure, you should contact your doctor to decide whether it is necessary to remove the vaginal ring and prescribe antihypertensive therapy. With adequate control of blood pressure with antihypertensive drugs, it is possible to resume the use of NovaRing.
During pregnancy and during the use of combined oral contraceptives, the development or worsening of the following conditions was noted, although their relationship with the use of contraceptives has not been fully established: jaundice and / or itching caused by cholestasis, formation of gallstones, porphyria, systemic lupus erythematosus, hemolytic - uremic syndrome, Sydenham's chorea (chorea minor), herpes of pregnancy, hearing loss due to otosclerosis, (hereditary) angioedema.

Acute or chronic liver dysfunction may serve as a basis for discontinuation of the drug NovaRing until the normalization of liver function tests.
Recurrence of cholestatic jaundice, observed earlier during pregnancy or when using sex steroid preparations, requires the withdrawal of NovaRing.
Although estrogens and progestogens may affect peripheral insulin resistance and tissue glucose tolerance, there is no evidence to support the need to change hypoglycemic therapy during the use of hormonal contraceptives. However, women with diabetes should be under constant medical supervision when using NuvaRing, especially in the first months of contraception.
There is evidence of worsening of the course of Crohn's disease and ulcerative colitis with the use of hormonal contraceptives.

In rare cases skin pigmentation may occur(chloasma), especially if it occurred earlier during pregnancy.
Women who are predisposed to the development of chloasma should avoid exposure to sunlight and ultraviolet radiation while using NuvaRing.
The following conditions may prevent proper insertion of the ring or cause it to fall out: cervical prolapse, bladder and/or rectal hernia, severe chronic constipation.
In very rare cases, women have inadvertently inserted the NuvaRing vaginal ring into the urethra and possibly into the bladder. When symptoms of cystitis appear, the possibility of incorrect insertion of the ring must be considered.
Cases of vaginitis during the use of the drug NuvaRing are described. There is no evidence that the treatment of vaginitis affects the effectiveness of the use of NovaRing, as well as evidence of the effect of the use of NovaRing on the effectiveness of the treatment of vaginitis.
Very rare cases of difficult removal of the ring have been described, requiring its removal by a healthcare professional.

Medical examination/consultation
Before prescribing NuvaRing or resuming its use, you should carefully review the medical history (including family history) of the woman and conduct a gynecological examination to exclude pregnancy.
It is necessary to measure blood pressure, conduct an examination of the mammary glands, pelvic organs, including a cytological examination of cervical smears and some laboratory tests, to exclude contraindications and reduce the risk of possible side effects of the drug.
The frequency and nature of medical examinations depend on the individual characteristics of each patient, but medical examinations are carried out at least once every 6 months.
A woman should read the instructions and follow all recommendations. The woman should be informed that NuvaRing does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
Reduced efficiency
The effectiveness of NuvaRing may be reduced if the regimen is not followed or if concomitant therapy is carried out.

Reduced cycle control
During the use of the drug NuvaRing, acyclic bleeding (spotting or sudden bleeding) may occur. If such bleeding is observed after regular cycles against the background of the correct use of the NuvaRing drug, you should contact your gynecologist for the necessary diagnostic tests, incl. to exclude organic pathology or pregnancy. Diagnostic curettage may be required.
Some women do not bleed after the ring is removed. If the drug NovaRing was used in accordance with the instructions, it is unlikely that the woman is pregnant. If the recommendations of the instructions are not followed and there is no bleeding after the removal of the ring, as well as in the absence of bleeding for two cycles in a row, pregnancy must be excluded.

Effects of ethinylestradiol and etonogestrel on the sexual partner
The degree of exposure and possible pharmacological effects of ethinylestradiol and etonogestrel on male sexual partners due to absorption through the tissues of the penis have not been studied.
Laboratory research
Use of contraceptive steroids may affect certain laboratory findings, including biochemical parameters of liver, thyroid, adrenal, and kidney function, plasma levels of transport proteins (eg, corticosteroid-binding globulin and sex hormone-binding globulin), lipid/lipoprotein fractions, and carbohydrate metabolism and indicators of coagulability and fibrinolysis. Indicators, as a rule, change within normal values.
Influence on the ability to drive vehicles and control mechanisms
Based on information about the pharmacodynamic properties of the drug NovaRing, it can be expected that it does not affect the ability to drive vehicles and work with mechanisms.
Given the pharmacodynamic properties of the drug NovaRing, it is not expected to affect the ability to drive a car and use complex equipment.

Interaction
other medicinal
by other means:

Interactions between hormonal contraceptives and other drugs may lead to the development of acyclic bleeding and / or contraceptive failure.
The following interactions with combined oral contraceptives are described in the literature in general.
Possible interaction with drugs that induce microsomal enzymes, which can lead to increased clearance of sex hormones.
Interaction with the following drugs has been established: phenytoin, barbiturates, primidone, carbamazepine, rifampicin, and possibly oxcarbazepine, topiramate, felbamate, ritonavir, griseofulvin and preparations containing St. John's wort.
When treating any of the listed drugs, you should temporarily use a barrier method of contraception (condom) in combination with Nuvaring, or choose another method of contraception.

During the concomitant use of drugs that cause the induction of microsomal liver enzymes, and within 28 days after their withdrawal, barrier methods of contraception should be used.
If concomitant therapy is to be continued after 3 weeks of ring use, then the next ring must be administered immediately without the usual interval.
Decreased effectiveness of oral contraceptives containing ethinylestradiol has been observed with concomitant use of antibiotics such as ampicillin and tetracyclines.
The mechanism of this effect has not been studied. In a pharmacokinetic interaction study, ingestion of amoxicillin (875 mg 2 times / day) or doxycycline (200 mg / day, and then 100 mg / day) for 10 days during the use of the drug Nuvaring slightly affected the pharmacokinetics of etonogestrel and ethinyl estradiol.

When using antibiotics (excluding amoxicillin and doxycycline), you should use a barrier method of contraception (condom) during treatment and for 7 days after stopping antibiotics.
If concomitant therapy is to be continued after 3 weeks of ring use, the next ring must be inserted immediately without the usual interval.
Pharmacokinetic studies have not revealed the effect of the simultaneous use of antifungal agents and spermicides on the contraceptive efficacy and safety of Novaring.
With the combined use of suppositories with antifungal drugs slightly increased risk of ring rupture.

Hormonal contraceptives can cause a violation of the metabolism of other drugs.
Accordingly, their plasma and tissue concentrations may increase (eg, cyclosporine) or decrease (eg, lamotrigine).
To exclude a possible interaction, it is necessary to study the instructions for use of other drugs.
Pharmacokinetic data show that the use of tampons does not affect the absorption of hormones released from the Novaring vaginal ring.
In rare cases, the ring may be accidentally removed when the tampon is removed.

Pregnancy:

NovaRing drug designed to prevent pregnancy.
If a woman wants to stop using the drug in order to become pregnant, it is recommended to wait for the restoration of the natural cycle to conceive, as this will help to correctly calculate the date of conception and delivery.
Pregnancy
The use of NuvaRing during pregnancy is contraindicated.
If pregnancy occurs, the ring should be removed.
Extensive epidemiological studies have not revealed an increased risk of congenital malformations in children born to women who took COCs before pregnancy, as well as teratogenic effects in cases where women took COCs in early pregnancy without knowing about it.
Although this applies to all COCs, it is not known if this also applies to NuvaRing. A clinical study in a small group of women showed that, despite the fact that NuvaRing is injected into the vagina, the concentrations of contraceptive hormones inside the uterus when using NuvaRing are similar to those when using COCs.
Pregnancy outcomes in women who used NuvaRing during a clinical study have not been described.
breastfeeding period
The use of the drug NovaRing during breastfeeding is not indicated.
The composition of the drug can affect lactation, reduce the amount and change the composition of breast milk.
Small amounts of contraceptive steroids and / or their metabolites can be excreted in milk, but there is no evidence of their negative effect on the health of children.

Overdose:

Serious consequences of an overdose of hormonal contraceptives are not described.
Symptoms: nausea, vomiting, slight vaginal bleeding in young girls.
Treatment: carry out symptomatic therapy. There are no antidotes.

Release form:

Vaginal ring Novaring smooth, transparent, colorless or almost colorless, without major visible damage, with a transparent or almost transparent area at the junction in waterproof aluminum foil bags of 1 or 3 pcs.

Storage conditions:

The drug should be stored out of the reach of children at a temperature of 2 ° to 8 ° C.
Shelf life - 3 years.

1 Nuvaring ring contains:
- active substance: ethinylestradiol - 2.7 mg, etonogestrel - 11.7 mg;
- Excipients: ethylene and vinyl acetate copolymer (28% vinyl acetate) - 1677 mg, ethylene and vinyl acetate copolymer (9% vinyl acetate) - 197 mg, magnesium stearate - 1.7 mg.

Last update of the description by the manufacturer 26.12.2014

Filterable List

Active substance:

ATX

Pharmacological group

Compound

Description of the dosage form

Smooth, transparent, colorless or almost colorless ring without much visible damage with a transparent or almost transparent area at the junction.

pharmachologic effect

Pharmacodynamics

Mechanism of action. NovaRing ® is a hormonal combined contraceptive containing etonogestrel and ethinyl estradiol. Etonogestrel is a progestogen (a derivative of 19-nortestosterone) that has a high affinity for progesterone receptors in target organs.

Ethinylestradiol is an estrogen and is widely used in the manufacture of contraceptives.

The contraceptive effect of NovaRing ® is due to a combination of various factors, the most important of which is the suppression of ovulation.

Efficiency. In clinical studies, it was found that the Pearl Index (an indicator that reflects the frequency of pregnancy in 100 women during 1 year of contraception) for the drug NovaRing ® in women aged 18 to 40 years was 0.96 (95% CI: 0.64 -1.39) and 0.64 (95% CI: 0.35-1.07) in the statistical analysis of all randomized participants (ITT analysis) and the analysis of participants in studies that completed them according to the protocol (PP analysis), respectively. These values ​​were similar to the Pearl Index values ​​obtained in comparative studies of combined oral contraceptives (COCs) containing levonorestrel/ethinylestradiol (0.15/0.03 mg) or drospirenone/ethinylestradiol (3/0.3 mg).

Against the background of the use of the drug NovaRing ®, the cycle becomes more regular, the pain and intensity of menstrual bleeding decreases, which helps to reduce the incidence of iron deficiency. There is evidence of a reduced risk of endometrial and ovarian cancer with the use of the drug.

The nature of the bleeding. Comparison of bleeding patterns over one year in 1000 women who used NovaRing ® and COCs containing levonorgestrel / ethinyl estradiol (0.15 / 0.03 mg) showed a significant reduction in the frequency of breakthrough bleeding or spotting when using NovaRing ® compared with COC. In addition, the frequency of cases when bleeding occurred only during a break in the use of the drug was significantly higher among women who used NovaRing®.

Effect on bone mineral density. A comparative 2-year study of the effect of NovaRing ® (n=76) and a non-hormonal intrauterine device (n=31) showed no effect on bone mineral density in women.

Children. The safety and efficacy of NovaRing ® for adolescents under the age of 18 have not been studied.

Pharmacokinetics

Etonogestrel

Suction. Etonogestrel, released from the NovaRing ® vaginal ring, is rapidly absorbed through the vaginal mucosa. C max etonogestrel in blood plasma, which is about 1700 pg / ml, is achieved approximately 1 week after the introduction of the ring. Plasma concentrations vary within a small range and slowly decrease to approximately 1600 pg / ml after 1 week, 1500 pg / ml after 2 weeks and 1400 pg / ml after 3 weeks of use. Absolute bioavailability is about 100%, which exceeds the oral bioavailability of etonogestrel. According to the results of measuring the concentrations of etonogestrel in the cervix and inside the uterus in women using the drug NovaRing ®, and women using oral contraceptives containing 0.15 mg of desogestrel and 0.02 mg of ethinyl estradiol, the observed values ​​of etonogestrel concentrations were comparable.

Distribution. Etonogestrel binds to plasma albumin and sex hormone-binding globulin (SHBG). The apparent V d of etonogestrel is 2.3 l / kg.

Metabolism. Biotransformation of etonogestrel occurs by known pathways of sex hormone metabolism. The apparent plasma clearance is about 3.5 l/h. Direct interaction with ethinyl estradiol, taken simultaneously, has not been identified.

Withdrawal. The concentration of etonogestrel in plasma decreases in 2 phases. In the terminal phase, T 1/2 is approximately 29 hours. Etonogestrel and its metabolites are excreted by the kidneys and through the intestines with bile in a ratio of about 1.7:1. T 1/2 metabolites is approximately 6 days.

Ethinylestradiol

Suction. Ethinyl estradiol, released from the NovaRing ® vaginal ring, is rapidly absorbed through the vaginal mucosa. C max in plasma, which is about 35 pg / ml, is achieved 3 days after the introduction of the ring and decreases to 19 pg / ml - after 1 week and to 18 pg / ml - after 3 weeks of use. Absolute bioavailability is approximately 56% and is comparable to that of oral administration of ethinyl estradiol. According to the results of measuring the concentrations of ethinylestradiol in the cervical region and inside the uterus in women using the drug NovaRing ®, and women using oral contraceptives containing 0.15 mg of desogestrel and 0.02 mg of ethinylestradiol, the observed values ​​of ethinylestradiol concentrations were comparable.

The concentration of ethinylestradiol was studied during a comparative randomized study of NovaRing ® (daily release of ethinylestradiol in the vagina - 0.015 mg), transdermal patch (norelgestromin / ethinylestradiol; daily release of ethinylestradiol - 0.02 mg) and COCs (levonorgestrel / ethinylestradiol; daily release ethinyl estradiol - 0 03 mg) during one cycle in healthy women. Monthly systemic exposure to ethinylestradiol (AUC 0-∞) for NovaRing ® was statistically significantly lower than that of the patch and COC, and amounted to 10.9 ng h / ml compared with 37.4 and 22.5 ng h /ml for the patch and COC, respectively.

Distribution. Ethinylestradiol binds nonspecifically to plasma albumin. The apparent V d is about 15 l/kg.

Metabolism. Ethinylestradiol is metabolized by aromatic hydroxylation. During its biotransformation, a large number of hydroxylated and methylated metabolites are formed. They circulate in free form or as sulfate and glucuronide conjugates. The apparent clearance is approximately 35 l / h.

Withdrawal. The concentration of ethinylestradiol in plasma decreases in 2 phases. T 1/2 in the terminal phase varies widely; the median is about 34 hours. Ethinylestradiol is not excreted unchanged. Metabolites of ethinylestradiol are excreted by the kidneys and through the intestines with bile in a ratio of 1.3:1. T 1/2 metabolites is about 1.5 days.

Special patient groups

Children. The pharmacokinetics of NovaRing ® in healthy adolescent girls under the age of 18 years who have already begun menstruation has not been studied.

Impaired kidney function. The effect of kidney disease on the pharmacokinetics of NovaRing® has not been studied.

Impaired liver function. The effect of liver disease on the pharmacokinetics of NovaRing® has not been studied. However, in patients with impaired liver function, the metabolism of sex hormones may be impaired.

ethnic groups. The pharmacokinetics of the drug in representatives of ethnic groups has not been specifically studied.

Indications for NovaRing ®

Contraception.

Contraindications

NovaRing ® is contraindicated in the presence of any of the conditions listed below. If any of these conditions occur during the period of use of the drug NovaRing ®, the use of the drug should be stopped immediately.

hypersensitivity to any of the active or auxiliary substances of the drug NovaRing ® ;

thrombosis (arterial or venous) and thromboembolism at present or in history (including deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disorders);

conditions preceding thrombosis (including transient ischemic attacks, angina pectoris) at present or in history;

predisposition to the development of venous or arterial thrombosis, including hereditary diseases: resistance to activated protein C, antithrombin III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia and antiphospholipid antibodies (antibodies to cardiolipin, lupus anticoagulant);

migraine with focal neurological symptoms at present or in history;

diabetes mellitus with vascular damage;

severe or multiple risk factors for venous or arterial thrombosis: hereditary predisposition to thrombosis (thrombosis, myocardial infarction or cerebrovascular accident at a young age in one of the closest relatives), hypertension, valvular heart disease, atrial fibrillation, extended surgery, prolonged immobilization, extensive trauma, obesity (body weight> 30 kg / m 2), smoking in women over 35 years of age (see "Special Instructions");

pancreatitis with severe hypertriglyceridemia at present or in history;

severe liver disease;

liver tumors (malignant or benign), incl. in history;

known or suspected hormone-dependent malignant tumors (for example, tumors of the genital organs or breast);

bleeding from the vagina of unknown etiology;

pregnancy, incl. supposed;

breastfeeding period;

The safety and efficacy of NovaRing® in adolescent girls under 18 years of age have not been studied.

Carefully

In the presence of any of the diseases, conditions or risk factors listed below, the benefits of using NovaRing ® and the possible risks for each individual woman should be evaluated before she starts using NovaRing ® (see section "Special Instructions"). In the event of an exacerbation of diseases, a deterioration in the condition, or the appearance of any of the conditions listed below for the first time, a woman should consult a doctor to decide on the possibility of further use of the drug NovaRing ®.

With caution, the drug NovaRing ® should be used in the following cases:

risk factors for the development of thrombosis and thromboembolism: hereditary predisposition to thrombosis (thrombosis, myocardial infarction or cerebrovascular accident at a young age in one of the closest relatives), smoking, obesity, dyslipoproteinemia, arterial hypertension, migraine without focal neurological symptoms, heart valve disease , cardiac arrhythmias, prolonged immobilization, major surgical interventions;

thrombophlebitis of superficial veins;

dyslipoproteinemia;

heart valve disease;

adequately controlled arterial hypertension;

diabetes mellitus without vascular complications;

acute or chronic liver disease;

jaundice and/or itching caused by cholestasis;

cholelithiasis;

porphyria;

systemic lupus erythematosus;

hemolytic-uremic syndrome;

Sydenham's chorea (small chorea);

hearing loss due to otosclerosis;

(hereditary) angioedema;

chronic inflammatory bowel disease (Crohn's disease and ulcerative colitis);

sickle cell anemia;

conditions that may make it difficult to use the vaginal ring: cervical prolapse, bladder hernia, rectal hernia, severe chronic constipation.

Use during pregnancy and lactation

NovaRing ® is intended to prevent pregnancy. If a woman wants to stop using the drug in order to become pregnant, it is recommended to conceive until the restoration of the natural cycle, because. this will help to correctly calculate the date of conception and childbirth.

The use of NovaRing ® during pregnancy is contraindicated. If pregnancy occurs, the ring should be removed. Extensive epidemiological studies have not revealed an increased risk of congenital malformations in children born to women who took COCs before pregnancy, as well as teratogenic effects in cases where women took COCs in early pregnancy without knowing about it. Although this applies to all COCs, it is not known if this also applies to NovaRing®. A clinical study in a small group of women showed that, despite the fact that NovaRing ® is administered into the vagina, the concentrations of contraceptive sex hormones inside the uterus when using NovaRing ® are similar to those when using COCs. Pregnancy outcomes in women who used the drug NovaRing ® during a clinical study are not described.

The use of the drug NovaRing ® during breastfeeding is contraindicated. The composition of the drug can affect lactation, reduce the amount and change the composition of breast milk. Small amounts of contraceptive sex hormones and / or their metabolites can be excreted in milk, but there is no evidence of their negative effect on the health of children.

Side effects

When using the drug, there may be side effects that occur with different frequencies: often (≥1 / 100); infrequently (≥1/1000,<1/100); редко (≥1/10000, <1/1000) см. табл. 1.

Table 1

1 The list of side effects is based on data obtained from spontaneous reports. It is not possible to accurately determine the frequency.

2 Observational cohort study data ≥1/10000 —<1/1000 женщино-лет.

3 Local partner reactions include reports of local penile reactions (e.g. pain, flushing, bruising, and abrasions).

Side effects that occurred when taking CHC are described in detail in the "Special Instructions" section: pancreatitis, cholecystitis, cerebrovascular disorders, benign and malignant liver tumors, chloasma, changes in insulin resistance.

In women with hereditary forms of angioedema, exogenous estrogens may cause or worsen the symptoms of angioedema.

Interaction

Interaction with other drugs

Interactions between hormonal contraceptives and other drugs may lead to the development of acyclic bleeding and / or contraceptive failure. The following interactions with combined oral contraceptives are described in the literature in general.

Hepatic metabolism: there may be interactions with drugs that induce microsomal liver enzymes, which can lead to an increase in the clearance of sex hormones. Interactions have been established, for example, with phenytoin, barbiturates, primidone, carbamazepine, rifampicin, and possibly also with oxcarbazepine, topiramate, felbamate, ritonavir, griseofulvin and preparations containing St. John's wort (Hypericum perforatum). When treating with any of the listed drugs, you should temporarily use a barrier method of contraception (condom) in combination with the use of the drug NovaRing ® or choose another method of contraception. During the concomitant use of drugs that induce microsomal enzymes, and within 28 days after their withdrawal, barrier methods of contraception should be used.

Antibiotics: a decrease in the effectiveness of oral contraceptives containing ethinyl estradiol has been observed with the concomitant use of antibiotics such as ampicillin and tetracyclines. The mechanism of this effect has not been studied. In a study of pharmacokinetic interactions, oral amoxicillin (875 mg 2 times a day) or doxycycline (200 mg / day, and then 100 mg / day) for 10 days during the use of the drug NuvaRing ® had little effect on the pharmacokinetics of etonogestrel and ethinyl estradiol. When using antibiotics (excluding amoxicillin and doxycycline), you should use a barrier method of contraception (condom) during treatment and for 7 days after stopping antibiotics.

If concomitant therapy is to be continued after 3 weeks of ring use, then the next ring must be inserted immediately, without the usual interval.

Pharmacokinetic studies have not revealed the effect of the simultaneous use of antifungal agents and spermicides on the contraceptive efficacy and safety of NovaRing®. With the combined use of suppositories with antifungal drugs, the risk of ring rupture slightly increases. Hormonal contraceptives can cause a violation of the metabolism of other drugs. Accordingly, their plasma and tissue concentrations may increase (eg cyclosporine) or decrease (eg lamotrigine).

To exclude possible interaction, it is necessary to read the instructions for use of other drugs.

Other types of interaction

Laboratory research. The use of contraceptive steroids may affect the results of certain laboratory tests, including biochemical parameters of liver, thyroid, adrenal and kidney function; on the plasma concentration of transport proteins, such as corticosteroid-binding globulin and SHBG in plasma; on lipid/lipoprotein fractions; on indicators of carbohydrate metabolism; as well as on indicators of blood clotting and fibrinolysis. Indicators, as a rule, change within normal values.

Combined use with tampons. Pharmacokinetic data show that the use of tampons does not affect the absorption of hormones released from the NovaRing ® vaginal ring. In rare cases, the ring may be accidentally removed when removing the tampon (see subsection in the section "Method of administration and dosage").

Dosage and administration

intravaginally. To achieve a contraceptive effect, NovaRing ® must be used according to the instructions.

A woman can independently insert the NovaRing ® vaginal ring into the vagina.

The doctor should inform the woman how to insert and remove the NovaRing ® vaginal ring (Fig. 1, 2).

To insert the ring, the woman should choose a comfortable position, such as standing with one leg raised, squatting or lying down. The NovaRing ® vaginal ring should be compressed and inserted into the vagina until the ring is in a comfortable position. The exact position of the ring in the vagina is not critical for the contraceptive effect (Fig. 3).

Insertion technique (see Figure 4a, 4b, 4c).

1. With one hand, insert the ring into the vagina, if necessary, spread the labia with the other hand (Fig. 4a).

2. Push the ring into the vagina until the ring is in a comfortable position (Fig. 4b).

3. Leave the ring in the vagina for 3 weeks (Figure 4c).

After the introduction (cf. ) the ring should be in the vagina constantly for 3 weeks. It is advisable for a woman to regularly check whether it remains in the vagina. If the ring was accidentally removed, then you must follow the instructions in subsection

The NovaRing ® vaginal ring should be removed after 3 weeks, on the same day of the week when the ring was inserted into the vagina. After a week break, a new ring is inserted (for example, if the NovaRing ® vaginal ring was installed on Wednesday at about 22.00, then it should be removed on Wednesday after 3 weeks at about 22.00. A new ring is inserted on the next Wednesday). To remove the ring, it must be picked up with the index finger or squeezed with the index and middle fingers and pulled out of the vagina (Fig. 5).

The used ring should be placed in a bag (keep out of the reach of children and pets) and discarded. Bleeding associated with the termination of the action of the drug NovaRing ® usually begins 2-3 days after the removal of the NovaRing ® vaginal ring and may not completely stop until the new ring is installed.

How to start using NovaRing ®

In the previous cycle, hormonal contraceptives were not used. NovaRing ® should be administered on the 1st day of the cycle (i.e. on the 1st day of menstruation). It is allowed to install the ring on the 2nd-5th days of the cycle, however, in the first cycle, in the first 7 days of using NovaRing ®, additional use of barrier methods of contraception is recommended.

Switching from combined hormonal contraceptives (CHCs). A woman should enter the NovaRing ® vaginal ring on the last day of the usual interval between cycles in taking CHC (tablets or patch). If a woman has taken CHC correctly and regularly and is sure that she is not pregnant, she can switch to the vaginal ring on any day of the cycle. In no case should the recommended hormone-free interval of the previous method be exceeded.

Switching from drugs containing only progestogen (mini-pill, progestin oral contraceptives, implants, injectable forms or hormone-containing intrauterine systems - IUDs). A woman taking mini-pills or progestin oral contraceptives can switch to NovaRing ® on any day. The ring is inserted on the day the implant or IUD is removed. If the woman received injections, then the use of the drug NovaRing ® begins on the day when the next injection should have been made. In all these cases, the woman must use a barrier method of contraception during the first 7 days after the introduction of the ring.

After an abortion in the first trimester. A woman can insert the ring immediately after an abortion. In this case, she does not need additional contraceptives. If the use of the drug NovaRing ® immediately after an abortion is undesirable, it is necessary to follow the recommendations given in subsection In the previous cycle, hormonal contraceptives were not used. At interval, the woman is recommended an alternative method of contraception.

After childbirth or after an abortion in the second trimester. A woman is recommended to enter the ring no earlier than the 4th week after childbirth (if she is not breastfeeding) or an abortion in the II trimester. If the ring is installed at a later date, then the use of an additional barrier method is recommended for the first 7 days. However, if sexual intercourse has already taken place, then before using the drug NovaRing ®, it is necessary to exclude pregnancy or wait for the first menstruation.

The contraceptive effect and cycle control may be impaired if the woman does not follow the recommended regimen. To avoid a decrease in the contraceptive effect, the following recommendations should be followed.

What to do in case of lengthening the break in the use of the ring. If during the break in the use of the ring there were sexual intercourse, pregnancy should be excluded. The longer the break, the higher the chance of pregnancy. If pregnancy is excluded, a woman should insert a new ring into the vagina as soon as possible. An additional barrier method of contraception, such as a condom, may be used for the next 7 days.

What to do if the ring has been temporarily removed from the vagina. The ring must be constantly in the vagina for 3 weeks. If the ring has been accidentally removed, it should be rinsed with cold or lukewarm (not hot) water and inserted into the vagina immediately.

If the ring remained outside the vagina for less than 3 hours, then its contraceptive effect is not reduced. A woman should insert the ring into the vagina as soon as possible (no later than 3 hours later).

If the ring was outside the vagina for more than 3 hours during the 1st or 2nd week of use, the contraceptive effect may decrease. The woman should insert the ring into the vagina as soon as possible. For the next 7 days, you must use a barrier method of contraception, such as a condom. The longer the ring has been out of the vagina and the closer this period is to the 7-day break in the use of the ring, the higher the likelihood of pregnancy.

If the ring was outside the vagina for more than 3 hours on the 3rd week of use, then the contraceptive effect may decrease. The woman should discard this ring and choose one of the following two methods:

1. Immediately install a new ring (a new ring can be used for the next 3 weeks. There may be no bleeding associated with the discontinuation of the drug. However, there may be spotting of blood or bleeding in the middle of the cycle).

2. Wait for bleeding associated with the cessation of the drug, and introduce a new ring no later than 7 days after the removal of the previous ring (this option should be selected only if the regimen of using the ring during the first 2 weeks was not violated).

What to do in case of prolonged use of the ring. If the drug NovaRing ® was used for no more than a maximum period of 4 weeks, then the contraceptive effect remains sufficient. A woman can take a week off from using the ring and then insert a new ring.

If the NovaRing ® vaginal ring has remained in the vagina for more than 4 weeks, then the contraceptive effect may worsen, so pregnancy must be excluded before the introduction of a new ring. If a woman does not adhere to the recommended regimen of application and bleeding does not occur after a week's break in the use of the ring, then pregnancy should be excluded before the introduction of a new ring.

How to move or delay the onset of menstrual bleeding. To delay menstrual-like withdrawal bleeding, a woman can insert a new ring without a week's break. The next ring must be applied within 3 weeks. This may cause spotting or bleeding. Further, after the usual week-long break, the woman returns to the regular use of the drug NovaRing ®.

To move the onset of bleeding to another day of the week, the woman may be advised to take a shorter break from the ring (for as many days as necessary). The shorter the break in the use of the ring, the higher the likelihood of the absence of bleeding that occurs after the removal of the ring, and the occurrence of bleeding or spotting during the period of application of the next ring.

Children

The safety and efficacy of NovaRing® in adolescent girls under 18 years of age have not been studied.

Overdose

Serious consequences of an overdose of hormonal contraceptives are not described. Possible symptoms include nausea, vomiting, and slight vaginal bleeding in young girls. There are no antidotes. Treatment is symptomatic.

special instructions

If any of the diseases, conditions or risk factors listed below are present, the benefits of using NovaRing ® and the possible risks for each individual woman should be evaluated before she starts using NovaRing ®. In the event of an exacerbation of diseases, a deterioration in the condition, or the occurrence of any of the conditions listed below for the first time, a woman should consult a doctor to decide on the possibility of further use of the drug NovaRing ®.

Circulatory disorders

The use of hormonal contraceptives may be associated with the development of venous thrombosis (deep vein thrombosis and pulmonary embolism) and arterial thrombosis, as well as associated complications, sometimes with a fatal outcome.

The use of any COC increases the risk of developing VTE compared with the risk of developing VTE in patients not using COCs. The greatest risk of developing VTE is observed in the 1st year of COC use. Data from a large prospective cohort study on the safety of various COCs suggest that the greatest increase in risk compared to the level of risk in women who do not use COCs occurs in the first 6 months after starting COC use or resuming their use after a break (4 weeks or more). In non-pregnant women not using oral contraceptives, the risk of developing VTE is 1 to 5 cases per 10,000 woman-years (WL). In women using oral contraceptives, the risk of developing VTE is from 3 to 9 cases per 10,000 VL. However, the risk increases to a lesser extent than during pregnancy, when it is 5-20 cases per 10,000 YL (pregnancy data are based on the actual duration of pregnancy in studies; when converted to a pregnancy of 9 months, the risk is from 7 to 27 cases per 10,000 JL). In women in the postpartum period, the risk of developing VTE is from 40 to 65 cases per 10,000 VL. VTE is fatal in 1-2% of cases.

According to the results of studies, the increased risk of developing VTE in women using NovaRing ® is similar to that in women using COCs (adjusted risk ratio, see table 2 below). In a large prospective observational study TASC (Transatlantic active safety study of the use of NovaRing ® for CCC), the risk of VTE was assessed in women who started using NovaRing ® or COCs, switched to NovaRing ® or COCs from other contraceptives, or resumed the use of NovaRing ® or COC, in a population of typical users. Women were observed for 24-48 months. The results showed a similar level of risk of developing VTE in women using NovaRing ® (8.3 cases per 10,000 VL) and women using COCs (9.2 cases per 10,000 VL). For women using COCs other than those containing desogestrel, gestodene and drospirenone, the incidence of VTE was 8.5 cases per 10,000 VL.

A retrospective cohort study initiated by the FDA (US Food and Drug Administration) showed that the incidence of VTE in women who started using NovaRing ® is 11.4 cases per 10,000 YL, while in women, those who started using COCs containing levonorgestrel, the incidence of VTE is 9.2 cases per 10,000 VL.

table 2

Assessment of the risk (risk ratio) of developing VTE in women using NovaRing ®, compared with the risk of developing VTE in women using COCs

1 Incl. low-dose COCs containing the following progestins: chlormadinone acetate, cyproterone acetate, desogestrel, dienogest, drospirenone, ethinodiol diacetate, gestodene, levonorgestrel, norethindrone, norgestimate or norgestrel.

2 Taking into account age, body mass index, duration of use, history of VTE.

3 Incl. low-dose COCs containing the following progestins: norgestimate, norethindrone, or levonorgestrel.

4 Taking into account age, place and year of inclusion in the study.

Extremely rare cases of thrombosis of other blood vessels (for example, arteries and veins of the liver, mesenteric vessels, kidneys, brain and retina) are known when using COCs. It is not known whether these cases are associated with the use of COCs. Possible symptoms of venous or arterial thrombosis may include unilateral edema and/or pain in the lower extremity, localized fever in the lower extremity, redness or discoloration of the skin on the lower extremity; sudden severe chest pain, possibly radiating to the left arm; an attack of shortness of breath, cough; any unusual, severe, prolonged headaches; sudden partial or complete loss of vision; double vision; slurred speech or aphasia; dizziness; collapse, with or without focal epileptic seizure; sudden weakness or severe numbness on one side of the body or any part of the body; movement disorders; acute abdomen.

Risk factors for the development of venous thrombosis and embolism:

Age;

The presence of diseases in the family history (venous thrombosis and embolism in brothers / sisters at any age or in parents at a young age). If a hereditary predisposition is suspected, a woman should be referred to a specialist for advice before starting the use of any hormonal contraceptives;

Prolonged immobilization, major surgery, any surgery to the lower extremities, or major trauma. In such situations, it is recommended to discontinue the use of the drug (in the case of a planned operation for at least 4 weeks) with subsequent resumption of use no earlier than 2 weeks after the full restoration of motor activity;

Perhaps thrombophlebitis of the superficial veins and varicose veins.

There is no consensus on the possible role of these conditions in the etiology of venous thrombosis.

Risk factors for the development of complications of arterial thromboembolism:

Age;

Smoking (with heavy smoking and with age, the risk increases even more, especially in women over 35 years old);

Dyslipoproteinemia;

Obesity (body mass index over 30 kg/m2);

Increased blood pressure;

Migraine;

valvular heart disease;

Atrial fibrillation;

The presence of diseases in the family history (arterial thrombosis in siblings at any age or parents at a relatively early age).

If a hereditary predisposition is suspected, a woman should be referred to a specialist for advice before starting the use of any hormonal contraceptives. Biochemical factors that may indicate a hereditary or acquired predisposition to venous or arterial thrombosis include resistance to activated protein C, hyperhomocysteinemia, antithrombin III deficiency, protein C deficiency, protein S deficiency, antibodies to phospholipids (anti-cardiolipin antibodies, lupus anticoagulant).

Other conditions that can lead to unwanted circulatory disorders include diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome and chronic inflammatory bowel disease (eg Crohn's disease or ulcerative colitis), as well as sickle cell anemia. It is necessary to take into account the increased risk of thromboembolism in the postpartum period.

An increase in the frequency or severity of migraine (which may be a prodromal symptom of cerebrovascular accident) during the use of hormonal contraceptives may prompt immediate discontinuation of hormonal contraceptive use.

Women using CHCs should be advised to contact their doctor if symptoms of thrombosis appear. If thrombosis is suspected or confirmed, CHC use should be discontinued. In this case, it is necessary to use effective contraceptives, since anticoagulants (coumarins) have a teratogenic effect.

The risk of developing tumors

The most important risk factor for developing cervical cancer is infection with the human papillomavirus. Epidemiological studies have shown that long-term use of COCs leads to an additional increase in this risk, but it remains unclear how much this is due to other factors, such as more frequent cervical smears and differences in sexual behavior, incl. use of barrier contraceptives. It remains unclear how this effect is associated with the use of NovaRing®.

According to a meta-analysis of the results of 54 epidemiological studies, there was a slight increase (1.24) in the relative risk of developing breast cancer in women taking COCs. The risk gradually decreases over 10 years after stopping the drugs. Breast cancer rarely develops in women under the age of 40, so the additional incidence of breast cancer in women who take or have taken COCs is small compared to the overall risk of developing breast cancer. Breast cancer diagnosed in women using COCs is clinically less pronounced than cancer detected in women who have never used COCs. An increased risk of developing breast cancer may be due to both the earlier detection of breast cancer in women taking COCs, the biological effects of COCs, or a combination of both.

In rare cases, women taking COCs have developed benign, and even more rarely, malignant liver tumors. In some cases, these tumors have led to the development of life-threatening bleeding into the abdominal cavity. The doctor should consider the possibility of a liver tumor in the differential diagnosis of diseases in a woman taking NovaRing ® if the symptoms include acute pain in the upper abdomen, liver enlargement, or signs of intra-abdominal bleeding.

Other states

Women with hypertriglyceridemia or a family history of hypertriglyceridemia have an increased risk of developing pancreatitis when taking hormonal contraceptives.

Many women taking hormonal contraceptives have a slight increase in blood pressure, but a clinically significant increase in blood pressure is rare. A direct relationship between the use of hormonal contraceptives and the development of arterial hypertension has not been established.

If during the use of the drug NovaRing ® there is a constant increase in blood pressure, you should contact your doctor to decide whether it is necessary to remove the vaginal ring and prescribe antihypertensive therapy. With adequate control of blood pressure with antihypertensive drugs, it is possible to resume the use of the drug NovaRing ®.

Against the background of pregnancy and during the use of COCs, the development or worsening of the following conditions was noted (although their relationship with the use of contraceptives has not been fully established): jaundice and / or itching caused by cholestasis, the formation of gallstones, porphyria, systemic lupus erythematosus, hemolytic- uremic syndrome, Sydenham's chorea (chorea minor), herpes of pregnancy, hearing loss due to otosclerosis, (hereditary) angioedema.

Acute or chronic violations of liver function may serve as a basis for discontinuation of the drug NovaRing ® until the normalization of liver function parameters. Recurrence of cholestatic jaundice, observed earlier during pregnancy or when using sex hormone preparations, requires discontinuation of the drug NovaRing ®.

Although estrogens and progestogens may affect peripheral insulin resistance and tissue glucose tolerance, there is no evidence to support the need to change hypoglycemic therapy during the use of hormonal contraceptives. However, women with diabetes should be under constant medical supervision when using NovaRing®, especially in the first months of contraception.

There is evidence of worsening of the course of Crohn's disease and ulcerative colitis with the use of hormonal contraceptives.

In rare cases, pigmentation of the skin of the face (chloasma) may occur, especially if it occurred earlier during pregnancy. Women predisposed to the development of chloasma should avoid exposure to sunlight and UV radiation while using NovaRing ®.

The following conditions may prevent proper insertion of the ring or cause it to fall out: cervical prolapse, bladder and/or rectal hernia, severe chronic constipation.

In very rare cases, women have inadvertently inserted the NovaRing ® vaginal ring into the urethra and possibly into the bladder. When symptoms of cystitis appear, the possibility of incorrect insertion of the ring must be considered.

Cases of vaginitis during the use of the drug NovaRing ® are described. There is no evidence that the treatment of vaginitis affects the effectiveness of the use of the drug NovaRing ®, as well as evidence of the effect of the use of the drug NovaRing ® on the effectiveness of the treatment of vaginitis.

Very rare cases of difficult removal of the ring have been described, requiring its removal by a healthcare professional.

Medical examination/consultation

Before you prescribe the drug NovaRing ® or resume its use, you should carefully review the medical history (including family history) of the woman and conduct a gynecological examination to exclude pregnancy. It is necessary to measure blood pressure, conduct an examination of the mammary glands, pelvic organs, including a cytological examination of cervical smears and some laboratory tests, to exclude contraindications and reduce the risk of possible side effects of the drug. The frequency and nature of medical examinations depend on the individual characteristics of each patient, but medical examinations are carried out at least once every 6 months. A woman should read the instructions and follow all recommendations. The woman should be informed that NovaRing ® does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Reduced efficiency

The effectiveness of the drug NovaRing ® may decrease if the regimen is not followed or if concomitant therapy is carried out.

Changing the nature of menstruation

During the use of the drug NovaRing ®, acyclic bleeding (spotting or sudden bleeding) may occur. If such bleeding is observed after regular cycles against the background of the correct use of the drug NovaRing ®, you should contact your gynecologist for the necessary diagnostic tests, incl. to exclude organic pathology or pregnancy. Diagnostic curettage may be required. Some women do not bleed after the ring is removed. If the drug NuvaRing ® was used in accordance with the instructions, it is unlikely that the woman is pregnant. If the recommendations of the instructions are not followed and there is no bleeding after the removal of the ring, as well as in the absence of bleeding for two cycles in a row, pregnancy must be excluded.

Effects of ethinylestradiol and etonogestrel on the sexual partner

The possible pharmacological effects and degree of exposure of ethinyl estradiol and etonogestrel to male sexual partners (due to absorption through the tissues of the penis) have not been studied.

Ring damage

In rare cases, when using the drug NovaRing ®, a rupture of the ring was observed.

The core of NovaRing ® is solid, so its contents remain intact, and the release of hormones does not change significantly. If the ring breaks, it usually falls out of the vagina (see recommendations in subsection What to do if the ring has been temporarily removed from the vagina in the section "Method of administration and dosage"). If the ring breaks, a new ring must be inserted.

Ring drop

Sometimes there was a prolapse of the NovaRing ® vaginal ring from the vagina, for example, when it was inserted incorrectly, the tampon was removed, during intercourse, or against the background of severe or chronic constipation. In this regard, it is advisable for a woman to regularly check the presence of the NovaRing ® vaginal ring in the vagina. In case of loss of the NovaRing ® vaginal ring from the vagina, it is necessary to follow the recommendations of subsection What to do if the ring has been temporarily removed from the vagina in the "Method of administration and dosage" section.

Ethinylestradiol (ethinylestradiol)
- etonogestrel (etonogestrel)

Composition and form of release of the drug

vaginal ring smooth, transparent, colorless or almost colorless, without much visible damage, with a transparent or almost transparent area at the junction.

Excipients: ethylene and vinyl acetate copolymer (28% vinyl acetate) - 1677 mg, ethylene and vinyl acetate copolymer (9% vinyl acetate) - 197 mg, magnesium stearate - 1.7 mg.

1 PC. - aluminum foil waterproof bags (1) - cardboard packs.
1 PC. - aluminum foil waterproof bags (3) - cardboard packs.

pharmachologic effect

Combined hormonal contraceptive drug containing etonogestrel and ethinyl estradiol.

Etonogestrel is a progestogen (a derivative of 19-nortestosterone) that binds with high affinity to receptors in target organs. Ethinylestradiol is an estrogen and is widely used in the manufacture of contraceptives.

The contraceptive effect is due to a combination of various factors, the most important of which is the suppression of ovulation.

In clinical studies, it was found that the Pearl Index (an indicator reflecting the frequency of pregnancy in 100 women during 1 year of contraception) in women aged 18 to 40 years was 0.96 (95% CI: 0.64-1.39) and 0.64 (95% CI: 0.35-1.07) in the statistical analysis of all randomized participants (ITT analysis) and the analysis of participants in studies that completed them according to the protocol (PP analysis), respectively. These values ​​were similar to Pearl Index values ​​obtained from comparative studies of combined oral contraceptives (COCs) containing levonorgestrel/ethinylestradiol (0.150/0.030 mg) or drospirenone/ethinylestradiol (3/0.30 mg).

Against the background of the use of the drug, the cycle becomes more regular, the pain and intensity of menstrual-like bleeding decreases, which helps to reduce the incidence of iron deficiency. There is evidence of a reduced risk of endometrial and ovarian cancer with the use of drugs containing this combination.

Pharmacokinetics

Ethinylestradiol

Based on the results of measuring the concentrations of ethinylestradiol in the cervical region and inside the uterus in women using and women using oral contraceptives containing 0.150 mg of desogestrel and 0.020 mg of ethinylestradiol, the observed values ​​of ethinylestradiol concentrations were comparable.

Ethinylestradiol binds to serum. The apparent V d is about 15 l/kg.

Ethinylestradiol is metabolized by aromatic hydroxylation. During its biotransformation, a large number of hydroxylated and methylated metabolites are formed, which circulate both in the free state and in the form of glucuronide and sulfate conjugates. The apparent clearance is approximately 3.5 l / h.

The concentration of ethinylestradiol in the blood decreases in two phases. T 1/2 in the terminal phase varies widely; the median is about 34 hours. Ethinylestradiol is not excreted unchanged; its metabolites are excreted by the kidneys and through the intestines in a ratio of 1.3:1. T 1/2 of metabolites is about 1.5 days.

Etonogestrel

According to the results of measuring the concentrations of etonogestrel in the cervical region and inside the uterus in women using the drug, and women using oral contraceptives containing 0.150 mg of desogestrel and 0.020 mg of ethinyl estradiol, the observed values ​​of etonogestrel concentrations were comparable. Etonogestrel binds to serum albumin and sex hormone-binding globulin (SHBG). The apparent V d of etonogestrel is 2.3 l / kg. Biotransformation of etonogestrel occurs by known pathways of sex hormone metabolism. The apparent plasma clearance is about 3.5 l/h. The plasma concentration of etonogestrel decreases in two phases. In the terminal phase, T 1/2 is about 29 hours. Etonogestrel and its metabolites are excreted by the kidneys and through the intestines with bile in a ratio of 1.7:1. T 1/2 metabolites is approximately 6 days.

In patients with impaired liver function, the metabolism of sex hormones may be impaired.

Indications

Contraception.

Contraindications

Thrombosis (arterial or venous) and thromboembolism at present or in history (including deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disorders); conditions preceding thrombosis (including transient ischemic attacks, angina pectoris) at present or in history; predisposition to the development of venous or arterial thrombosis, including hereditary diseases: resistance to activated protein C, antithrombin III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia and antiphospholipid antibodies (antibodies to cardiolipin, lupus); migraine with focal neurological symptoms at present or in history; diabetes mellitus with vascular damage; pronounced or multiple risk factors for venous or arterial thrombosis: hereditary predisposition to thrombosis (thrombosis, myocardial infarction or cerebrovascular accident at a young age in one of the closest relatives), arterial hypertension, lesions of the valvular apparatus of the heart, atrial fibrillation, extended surgery, prolonged immobilization, extensive trauma, obesity (BMI> 30 kg / m 2), smoking in women over 35 years of age; pancreatitis (including history) in combination with severe hypertriglyceridemia; severe liver disease; liver tumors, malignant or benign (including history); established or suspected hormone-dependent malignant tumors (for example, genital or breast); vaginal bleeding of unknown etiology; pregnancy (including intended); breastfeeding period; hypersensitivity to any of the active or excipients.

Carefully

The presence of risk factors for the development of thrombosis and thromboembolism: hereditary predisposition to thrombosis (thrombosis, myocardial infarction or cerebrovascular accident at a young age in one of the closest relatives), smoking, obesity, dyslipoproteinemia, arterial hypertension, migraine without focal neurological symptoms, valve disease heart, rhythm disturbances, prolonged immobilization, major surgical interventions; thrombophlebitis of superficial veins; dyslipoproteinemia; heart valve disease; adequately controlled arterial hypertension; diabetes mellitus without vascular complications; acute or chronic liver dysfunction; jaundice and/or itching caused by cholestasis; cholelithiasis; porphyria; systemic lupus erythematosus; hemolytic-uremic syndrome; chorea of ​​Sydenham (small chorea); hearing loss due to otosclerosis; angioedema (hereditary) edema; chronic inflammatory bowel disease (Crohn's disease and ulcerative colitis); sickle cell anemia; chloasma; conditions that make it difficult to use the vaginal ring: cervical prolapse, bladder hernia, rectal hernia, severe chronic constipation.

Dosage

This combination is used as part of a special dosage form for topical use.

Side effects

From the immune system: hypersensitivity.

From the side of metabolism and nutrition: increased appetite, weight gain.

From the nervous system: headache, migraine, dizziness, hypesthesia, depression, decreased libido, mood changes, fatigue, irritability.

From the urinary system: cervicitis, cystitis, urinary tract infections, dysuria, urge to urinate, pollakiuria-izuria, urge to urinate, pollakiuria.

From the digestive system: abdominal pain, nausea, bloating, diarrhea, vomiting, constipation.

From the reproductive system: vaginal infection, breast engorgement and tenderness, genital itching in women, painful menstrual bleeding, pelvic pain, vaginal discharge, no menstrual bleeding, breast discomfort, breast enlargement, breast lumps, cervical polyps uterus, contact (during intercourse) spotting (bleeding), pain during intercourse, ectropion of the cervix, fibrocystic mastopathy, heavy menstrual-like bleeding, acyclic bleeding, discomfort in the pelvic area, premenstrual-like syndrome, burning sensation in the vagina, vaginal odor, soreness in the vagina, discomfort and dryness of the vulva and vaginal mucosa.

From the musculoskeletal system: back pain, muscle spasms, pain in the extremities.

From the side of the skin and skin: acne, alopecia, eczema, pruritus, rash, urticaria.

From the side of the organ of vision: visual impairment.

From the side of the cardiovascular system: external thromboembolism, hot flashes, increased blood pressure.

Others: discomfort when using the vaginal ring, prolapse of the vaginal ring, malaise, swelling, sensation of a foreign body, difficulty in using a contraceptive, rupture (damage) of the ring.

drug interaction

Interaction between hormonal contraceptives and other drugs can lead to the development of acyclic bleeding and / or contraceptive failure.

Possible drug interactions inducing microsomal liver enzymes, which can lead to an increase in the clearance of sex hormones. Interaction with the following drugs has been established: phenytoin, barbiturates, primidone, rifampicin, and possibly oxcarbazepine, topiramate, felbamate, ritonavir, griseofulvin, and preparations containing St. John's wort.

When treating with any of the listed drugs, you should temporarily use a barrier method of contraception (condom) or choose another method of contraception. During concomitant use of drugs that cause induction of microsomal liver enzymes, and within 28 days after their cancellation, barrier methods of contraception should be used.

A decrease in the effectiveness of oral contraceptives containing ethinyl estradiol has been observed with concomitant use antibiotics such as ampicillin and tetracyclines. The mechanism of this effect has not been studied. In a pharmacokinetic interaction study, oral administration amoxicillin (875 mg 2 times / day) or doxycycline (200 mg / day, then 100 mg / day) within 10 days during the use of the drug had little effect on the pharmacokinetics of etonogestrel and ethinyl estradiol. When applied antibiotics (excluding amoxicillin and doxycycline) You should use a barrier method of contraception (condom) during treatment and for 7 days after stopping antibiotics. If concomitant therapy is to be continued after 3 weeks of ring use, then the next ring must be administered immediately without the usual interval.

Hormonal contraceptives can cause a violation of the metabolism of other drugs. Accordingly, their concentrations in plasma and tissues may increase. (eg, cyclosporine) or decrease (eg, lamotrigine).

special instructions

If any of the diseases, conditions or risk factors listed below are present, the benefits and possible risks for each individual woman should be assessed before she starts the use of the drug. In the event of an exacerbation of diseases, a deterioration in the condition, or the occurrence of any of the conditions listed below for the first time, a woman should consult a doctor.

The use of hormonal contraceptives may be associated with the development of venous thrombosis (deep vein thrombosis and pulmonary embolism) and arterial thrombosis, as well as associated complications, sometimes with a fatal outcome.

The use of any COC increases the risk of developing venous thromboembolism (VTE) compared with the risk of developing VTE in patients who do not use COCs. The greatest risk of developing VTE occurs in the first year of COC use. Data from a large prospective cohort study on the safety of various COCs suggest that the greatest increase in risk, compared with the level of risk in women who do not use COCs, occurs in the first 6 months after starting the use of COCs or resuming their use after a break (4 weeks or more) . In non-pregnant women not using oral contraceptives, the risk of developing VTE is 1 to 5 cases per 10,000 woman-years (WY). In women using oral contraceptives, the risk of developing VTE is from 3 to 9 cases per 10,000 VL. However, the risk increases to a lesser extent than during pregnancy, when it is 5-20 cases per 10,000 YL (pregnancy data are based on the actual duration of pregnancy in standard studies; when converted to a pregnancy of 9 months, the risk is from 7 to 27 cases per 10,000 YL). In women in the postpartum period, the risk of developing VTE is 40 to 65 cases per 10,000 VL. VTE is fatal in 1-2% of cases.

Women using COCs should be advised to consult a doctor if symptoms of thrombosis appear. If thrombosis is suspected or confirmed, COC use should be discontinued. In this case, it is necessary to use effective contraceptives, since anticoagulants (coumarins) have a teratogenic effect.

The most important risk factor for developing cervical cancer is infection with the human papillomavirus (HPV). Epidemiological studies have shown that long-term COC use leads to an additional increase in this risk, but it remains unclear how much this is due to other factors such as more frequent cervical smears and differences in sexual behavior, incl. use of barrier contraceptives.

Breast cancer diagnosed in women using COCs is clinically less pronounced than cancer detected in women who have never used COCs. The increased risk of developing breast cancer may be due to both the fact that in women taking COCs, the diagnosis of breast cancer is established earlier, and the biological effects of COCs, or a combination of both of these factors.

In rare cases, women who took COCs have experienced cases of benign, and even more rarely, malignant liver tumors. In some cases, these tumors have led to the development of life-threatening bleeding into the abdominal cavity. The physician should consider the possibility of a liver tumor in the differential diagnosis of diseases in a woman if the symptoms include acute pain in the upper abdomen, an enlarged liver, or signs of intra-abdominal bleeding.

Women with hypertriglyceridemia or a family history of hypertriglyceridemia have an increased risk of developing pancreatitis when taking hormonal contraceptives.

Many women taking hormonal contraceptives have a slight increase in blood pressure, but a clinically significant increase in blood pressure is rare. A direct relationship between the use of hormonal contraceptives and the development of arterial hypertension has not been established. If a persistent increase in blood pressure is noted during use, it is necessary to contact your doctor to decide whether it is necessary to remove the vaginal ring and prescribe antihypertensive therapy. With adequate control of blood pressure with the help, it is possible to resume the use of the drug.

During pregnancy and during the use of COCs, the development or worsening of the following conditions was noted, although their relationship with the use of contraceptives has not been fully established: jaundice and / or itching caused by cholestasis, formation of gallstones, porphyria, systemic lupus erythematosus, hemolytic-uremic syndrome, Sydenham's chorea (chorea minor), herpes of pregnancy, hearing loss due to otosclerosis, angioedema (hereditary) edema.

Acute or chronic liver dysfunction may warrant withdrawal until normalization of liver function tests. Recurrence of cholestatic jaundice, observed earlier during pregnancy or when using sex steroid preparations, requires discontinuation of the drug.

Women with diabetes should be under constant medical supervision, especially in the first months of contraception.

There is evidence of worsening of the course of Crohn's disease and ulcerative colitis with the use of hormonal contraceptives.

In rare cases, pigmentation of the skin of the face (chloasma) may occur, especially if it occurred earlier during pregnancy. Women who are prone to developing chloasma should avoid exposure to sunlight and ultraviolet radiation.

During use, acyclic bleeding (spotting or sudden bleeding) may occur. If such bleeding is observed after regular cycles against the background of proper use, you should contact your gynecologist for the necessary diagnostic tests, incl. to exclude organic pathology or pregnancy. Diagnostic curettage may be required.

The use of hormonal contraceptives may affect the results of certain laboratory tests, including biochemical parameters of liver, thyroid, adrenal and kidney function, plasma concentrations of transport proteins (for example, corticosteroid-binding globulin and sex hormone-binding globulin globulin), lipid/lipoprotein fractions, carbohydrate metabolism and indicators of coagulability and fibrinolysis. Indicators, as a rule, change within normal values.

Pregnancy and lactation

Contraindicated during pregnancy and lactation (breastfeeding).

For impaired liver function

Contraindicated in severe liver diseases (before the normalization of function indicators).

NovaRing Ring is a hormonal drug that has a high contraceptive effect and does not cause negative consequences for the body. Instructions for use characterize it as a reliable method of protection.

He is not whimsical in use, as he does not need the daily participation of a woman, acting independently. How exactly does it achieve this level of protection against unwanted conception, and in what situations should it be preferred?

Novaring ring, the instructions for use of which describe in detail the rules of use, is a highly effective new generation contraceptive. The artificial material from which the ring is made is also used for breast augmentation, in the manufacture of implants.

This is a translucent, almost colorless rim, 6 cm in diameter, reliably protecting the egg from fertilization by spermatozoa and the onset of conception. The material from which the drug is made is hypoallergenic, so a negative reaction to it occurs extremely rarely.

Composition and principle of action

The instructions for the NovaRing ring describe in detail the active substance and the mechanism of action. Inside the ring are ethinyl estradiol and etonogestrel, which are excreted from their shell every day in strictly limited doses. Due to the fact that there are many vessels in the vagina, the active substance quickly penetrates into the blood and begins to act.

Contraceptive pills work in the same way, when taken, the substance is absorbed through the stomach, and not through the walls of the vagina.

NuvaRing has the following effect on the female body:

1. Suppresses the onset of ovulation.
2. Does not allow the hormonal system to work.
3. Promotes the formation of thick mucus in the cervix, preventing sperm from getting inside and fertilizing the egg.

These processes can be reversed if you stop removing the ring from the body and wait for the normalization of the cycle.

Advantages of the method

In addition to the reliability of this type of contraception, the NovaRing ring has other positive aspects:

1. Low doses of hormones that a woman receives daily in the process of using the ring. According to researchers, it releases almost a third less ethinyl estradiol than oral contraceptives.
2. A woman does not need to think about taking contraceptives every day, since the drug works independently of her, releasing the required amount of the active substance.
3. With its help, it is easy to regulate your monthly cycle, namely, to delay or bring the onset of menstrual bleeding closer.
4. Like any hormonal remedy, NovaRing has a beneficial effect on appearance - it improves the skin, hair and nails, and reduces discomfort during menstruation and pain.

Disadvantages of the method

The main disadvantages of using a contraceptive ring are the presence of an impressive list of contraindications and side effects, as well as the need to strictly adhere to the regimen of using the drug.

But the disadvantages do not end there:

1. The NuvaRing cannot protect a woman from sexually transmitted diseases such as AIDS and syphilis. The same can be said about all hormonal contraceptives.
2. In addition, if a woman is susceptible to infection, the presence of a foreign object in the vagina can increase inflammation and increase the amount of discharge.
3. Due to the fact that the ring can move and even be removed from the vagina on its own, there is a need to periodically check its presence in order to prevent sperm from fertilizing the egg.
4. This method of contraception is psychologically unusual for women, therefore, it often causes distrust of its contraceptive properties.

Technique of use

You can use the NuvaRing ring only after fully reading the instructions and consulting with a gynecologist. It is not worth it to independently prescribe the use of this contraceptive, since it is difficult to take into account all the nuances known only to a professional.

At the onset of the first for menstruation, you can inject the drug into the vagina, while the procedure should be as follows:

1. To wash hands.
2. Take a comfortable position that opens up access to the vagina and makes it possible to completely relax, for example, lie down on the sofa.
3. Open the package and remove the ring from the aluminum wrap.
4. Flatten with two fingers and insert the ring deeply into the vagina, adhering to the back wall.

The whole process does not take much time and is very similar to inserting a tampon during menstruation. There should be no pain, therefore, if you feel discomfort, you must immediately remove the drug and consult a doctor. The elastic NuvaRing, if applied correctly, should adhere to the walls of the vagina and be fixed on them.

After three weeks of use, the contraceptive should be removed. This must be done correctly, although there is nothing complicated in the process.

You must again take a comfortable position and pick up the ring with your finger to gently remove it from the body. This item is no longer reusable, so it can be disposed of. Further, the girl can expect the appearance of bleeding, which should begin within the next 7 days. A new ring should be inserted 8 days after the previous one has been removed.

Use if hormonal contraceptives were not used in the previous cycle

The NuvaRing ring can be inserted already on the first day of the cycle at the initial signs of bleeding in order to protect yourself from conception as much as possible. If necessary, you can postpone the use of the ring for 2-5 days, if you turn to alternative methods of protection.

Switching from combined hormonal contraceptives

If desired, a woman can change the method of contraception, and instead of combined hormonal drugs, choose NovaRing ring. Instructions for use do not exclude this possibility if the woman followed the instructions of the gynecologist and did not miss taking the pills.

Switching from drugs containing only progestogen

Mini-pills are also easy to replace with NovaRing. Moreover, the transition can be made on any day of the cycle, instantly replacing the implant or IUD with the ring. When using injections to prevent conception, do not take breaks, but replace after the final injection.

After that, it is better to resort to the use of condoms for a week due to the possible decrease in the protective effect of the ring.

After an abortion in the first trimester

Using a NuvaRing ring after an early abortion, the instruction of which clearly describes this situation, you can not resort to alternative methods of protection against conception. An exception may be medical indications in which a woman is allowed to delay the introduction of the ring for up to 5 days.

After childbirth or after an abortion in the second trimester

A more serious surgical abortion for medical reasons or childbirth requires a more delicate approach in further contraception. NuvaRing should be used only after a month if the woman is not breastfeeding a newborn.

In case of delaying contraception and using the ring at a later date, it is worth resorting to condoms in order to protect yourself from conception as much as possible. In addition, you need to make sure that you are not pregnant. It is necessary to continue to use barrier methods of protection within 7 days after the introduction of the ring.

Use during pregnancy and lactation

Due to the fact that the NovaRing ring is a hormonal agent designed to prevent pregnancy, its use during this period is strictly prohibited. Although studies of the drug among women expecting a baby have not been conducted, it is not worth risking the health of the baby.

In addition, once the pregnancy has already occurred, the need for contraception disappears. What can not be said about the lactation period, which is also not recommended to be combined with the use of hormonal contraceptives. This is due to the fact that the active substance contained in the ring can change the composition of breast milk, or reduce its volume.

Break in application

Violation of the contraceptive regimen prescribed by a gynecologist can lead to conception. Before using the NovaRing ring after a break, the instructions provided by the manufacturer advise to make sure that there is no pregnancy.

If fertilization of the egg does not occur, the drug should be installed as soon as possible, while using alternative methods of contraception. But not always a break happens due to the fault of a woman who is simply lost in dates.

The NuvaRing ring tends to involuntarily move into the vagina and even be removed from it. Then you need to urgently return it to its place. If the contraceptive was absent in the vagina for no more than 3 hours, then you can not be afraid of conception. Otherwise, it is better to play it safe and resort to condoms or other barrier methods.

Extended use

If NuvaRing was used longer than the prescribed period, but not longer than a month, then the contraceptive effect will remain sufficient to prevent conception. A woman needs to take the prescribed weekly break and apply the following drug.

After 4 weeks of use, the contraceptive effect of NovaRing decreases, therefore, before introducing a new ring, you need to do a pregnancy test or consult a doctor to establish the fact that there is no pregnancy.

Periods and bleeding during use

Bleeding during contraception with this hormonal drug is considered normal. Most often, menstruation begins immediately after the removal of the ring, and stops with the introduction of a new contraceptive. Less commonly, bleeding does not start at all, and this is also not a deviation, subject to all recommendations.

The repeated absence of menstruation requires the intervention of a gynecologist, as this may mean pregnancy. However, using the NovaRing ring, the instruction requires strict monitoring of the state of the body, since severe bleeding should be observed by the attending gynecologist.

Cancellation of NovaRing

A woman can refuse NuvaRing protection at any time, since this process does not need special preparation. If necessary, the drug can be safely removed without waiting for 21 days of use.

Pregnancy after discontinuation of the contraceptive ring

Refusal of hormonal contraception leads to the cessation of exposure to the woman's body, and NovaRing is no exception. The onset of conception can occur as early as 4-5 weeks after the removal of the contraceptive ring.

drug interaction

The parallel use of the NovaRing ring with other medications may lead to a decrease in the contraceptive effect, as the instruction warns.

Medicines that should not be combined with hormonal contraception:

1. Drugs excreted in large quantities by the liver, leading to the occurrence of hepatic metabolism. This refers to drugs such as barbituria, carbamazepine, phenytoin, rifampicin, and some other drugs containing St. John's wort. While undergoing therapy with these drugs, it is better to resort to alternative methods of protection without removing the ring from the vagina.
2. Antibiotics also lead to a decrease in the contraceptive effect, as they have a great influence on the active substance of NovaRing. When taking these drugs, with the exception of doxycycline and amoxicillin, barrier contraceptives should be used during treatment and for a week after the end of the course.

Protection with a hormonal ring can also affect the biochemical parameters of some organs and change the composition of the blood. If during contraception a woman is required to undergo a medical commission, the attending physician should be aware of the reception of the NovaRing ring.

Side effects

A negative reaction to the drug is extremely rare, but not completely excluded. Side effects that occur in connection with the use of NovaRing rings usually do not require emergency medical attention, as they pass on their own.

Side effects include:

1. Intoxication - nausea, diarrhea, and sometimes vomiting.
2. Dizziness, constant anxiety, changeable mood, pain in the head, as a result of exposure to the nervous system.
3. Weight gain, breast hardening, decreased libido.
4. Cystitis.
5. Slight discharge, vaginitis.

In addition, a woman may be disturbed by the sensation of a foreign object in the vagina, as well as spontaneous removal of the ring.

Contraindications for use and use with caution

Not everyone is shown the use of the NuvaRing ring, since it has a lot of prohibitions and contraindications.

• Hormonally dependent malignant tumors.
• Vaginal bleeding that occurs for unknown reasons.
• Blood disorders such as thrombosis or bleeding disorders.
• Pregnancy and lactation.
• Severe liver pathologies, including tumors.
• Inflammatory processes in the vagina - vaginitis, colpitis.
• Allergies to contraceptive components.

It is possible to carefully use the product for:

• varicose veins;
• heart disease;
• autoimmune diseases;
• with the omission of the walls of the female genital organ or their loss;
• cholelithiasis;
• smoking.

It is necessary to stop protection with NuvaRing before the proposed surgical intervention.

Terms and conditions of storage

In order for the drug not to lose its contraceptive properties, it must be kept at 2-8 ° C, then the NovaRing ring will not lose its properties within 3 years from the date of release. The best place for this would be a regular refrigerator compartment, where the required temperature is maintained.

In addition, the contraceptive ring should be protected from children's attention, since, once in the body of a minor child, it can negatively affect the development of the baby. At the end of the expiration date, it is absolutely impossible to use the drug for its intended purpose.

Where to buy and price

The NuvaRing ring is freely available, so you can find it at any pharmacy. A large selection of the drug is offered by online portals for the sale of medicines. This makes it possible to resort to the use of NuvaRing in the most remote corners of the country, thanks to well-established logistics and courier delivery. On average, the price for one ring ranges from 600 to 1000 rubles.

NovaRing ring packages containing 3 contraceptives will cost from 1300 to 1800 rubles.

Each woman will find her positive aspects of this method of contraception, because the convenience and effectiveness of the NovaRing ring are obvious. Before deciding to use a hormonal drug, you should study the instructions, as well as consult with a gynecologist.

Video about the NovaRing ring, its effectiveness and rules of use

Instructions for using the NovaRing ring:

Expert opinion about the Nuvaring ring: