Novaring contraceptive ring instructions for use. NuvaRing - official * instructions for use

Another barrier method of contraception to protect against unwanted pregnancy, which can be purchased at the pharmacy, is the vaginal ring. This progressive tool is gaining more and more popularity among women. In this public way, you can exclude abortions from your life, reduce the risk of infections after surgery. Before introducing a vaginal device, you need to consult a gynecologist, to exclude the risk of contraindications, side effects. The hormonal ring is sold in a pharmacy, the instructions are attached.

Vaginal ring Nuvaring

This medicinal product is a hormonal contraceptive suitable for use at the age of reproductive activity. Nuvaring makes sexual intercourse safe, but there is a risk of penetration of a pathogenic infection with the subsequent course of the inflammatory process. Studying all existing methods of contraception, Novaring is the most productive, since the contraceptive effect is 97% with proper administration and installation.

Compound

This contraceptive ring has a hormonal basis, which reduces the activity of spermatozoa, the risk of unwanted pregnancy. Such a pharmacological appointment can only be made by a gynecologist, otherwise the method of protection at times loses its effectiveness in practice. The features of the chemical formula are detailed below in the form of a table:

Operating principle

This vaginal "device" has a diameter of 54 mm, a transparent and flexible structure, so that it can be installed correctly in order to avoid pregnancy. The ring is impregnated with the hormone estrogen, which provide contraceptive effectiveness. With direct contact, such a device is not felt by the sexual partner, does not interfere with the achievement of a natural orgasm. The predominant dose of hormones is enough to stop buying condoms, but not to exclude oral birth control pills (for greater effectiveness).

Among the additional pharmacological properties of the vaginal ring, doctors distinguish a reduction in the abundance of menstrual bleeding, the timeliness of the onset of menstruation, and the elimination of pain during uterine hemorrhages. When wearing such a device, the risk of developing cancer or ovarian cysts, ectopic pregnancy, and inflammatory processes in the urogenital area is reduced. In addition, it is possible to solve the problem with a disturbed menstrual cycle with the timely detection of the etiology of the pathology.

Indications for use

The vaginal ring is a progressive local contraceptive that significantly reduces and even minimizes the risk of an unwanted pregnancy. A high concentration of sex hormones suppresses the natural process of ovulation, while weakening the sexual activity of spermatozoa. With abnormal prolapse of the uterus and other physiological features of the reproductive organ, it is better not to use such a contraceptive device, choose an alternative.

Nuvaring ring - instructions for use

Before placing the ring in the vagina, it is important to study the instructions for use in detail, first visit a specialist. If there are no medical contraindications, the release of progesterone hormones will ensure safe sex and support the female health of the body. Features of the use of such a contraceptive are as follows:

• carefully remove the ring from the special packaging;
• choose a comfortable position - standing with one leg raised, sitting on a chair with a backrest or lying down;
• tightly squeeze the vaginal ring and insert his genitals;
• you can remove the vaginal device with your fingers according to this algorithm;
• dispose of the used ring, use the next ring in the same way.

If this method of contraception is chosen, it is important to remember: insert the ring into the vagina for 21 days, and after the specified time interval, continue protection against pregnancy with a week break. If the ring breaks, you can get pregnant, so it should be installed correctly. After carefully removing the characteristic device, doctors do not exclude the risk of uterine bleeding 2-3 days after the release of the vagina.

special instructions

When using a hormonal ring, the risk of developing arterial and venous thrombosis increases, therefore, when the first symptoms appear, the use of a contraceptive should be urgently stopped. Among the additional complications, doctors distinguish acyclic bleeding, chloasma, and frequent migraine attacks. Improper placement increases the risk of rupture of the vaginal ring.

Side effect

Topical application of the vaginal ring is not suitable for all women of reproductive age, since some during intensive care experience side effects associated not only with hormonal levels and sudden mood swings. Alternatively, these could be:

• a sharp increase in body weight;
• muscle and bone pain;
• decreased visual acuity;
• signs of dyspepsia;
• allergic, local reactions;
• frequent urination;
• decreased libido, symptoms of depression.

Contraindications

When choosing a contraceptive, it is important not only to take into account the reviews of friends, but also the recommendations of a specialist, information from the instructions. For example, vaginal rings have the following restrictions on use:

• diabetes;
• progressive pregnancy;
• uterine bleeding;
• malignant tumors;
• complicated thrombosis;
• obesity;
• arterial hypertension, myocardial pathology.

Nuvaring - analogues

A ring with a contraceptive effect may not be suitable for the patient, so the gynecologist recommends choosing an equally effective analogue. Alternatively, these may be the following pharmacological positions:

• Jeanine;
• Erotex;
• Logest;
• Benatex;
• Midian;
• Novinet;
• Yarina.

Nuvaring price

You can buy a ring with a contraceptive effect at a pharmacy, but it is cheaper to order it online. The purchase is not cheap, however, saving on the quality of pharmacological products is also not recommended, otherwise such protection may lead to unwanted childbirth. In addition to real reviews, it is recommended that you familiarize yourself with the prices:

Video

Combined hormonal contraceptive preparation containing etonogestrel and ethinyl estradiol.

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 the drug NovaRing ® was 0.96 (95% CI: 0.64-1.39) and 0.64 (95% CI: 0.35-1.07) in statistical analysis of all randomized participants (ITT analysis) and 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 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 bleeding

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.

The safety and efficacy of NovaRing ® for adolescent girls under the age of 18 has not been studied.

Pharmacokinetics

Etonogestrel

Suction

Etonogestrel, released from the NovaRing ® vaginal ring, is rapidly absorbed through the vaginal mucosa. C max etonogestrel in plasma, which is about 1700 pg / ml, is achieved approximately 1 week after the introduction of the ring. Plasma concentration varies in a small range and slowly decreases 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 ethinyl estradiol, the observed values ​​of etonogestrel concentrations were comparable.

Distribution

Etonogestrel binds to serum 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.

breeding

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.

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 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 NovaRing ® 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.

The concentration of ethinylestradiol was studied in a comparative randomized study of NovaRing ® (daily release of ethinylestradiol in the vagina 0.015 mg), a transdermal patch (norelgestromin / ethinylestradiol; daily release of ethinylestradiol 0.020 mg) and MDA (levonorgestrel / ethinylestradiol; daily release of ethinyl estradiol; daily release of ethinyl estradiol)0.00 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, 37.4 and 22.5 ngh/ml, respectively.

Distribution

Ethinylestradiol binds to serum 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, 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.

breeding

The concentration of ethinylestradiol in plasma 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.

Special patient groups

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.

Release form

The vaginal ring is smooth, transparent, colorless or almost colorless, without large 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.

Dosage

NovaRing ® is injected into the vagina once every 4 weeks. The ring is in the vagina for 3 weeks and then removed on the same day of the week that it was placed in the vagina; after a week break, a new ring is introduced. For example: if the NovaRing ® ring was installed on Wednesday at about 22.00, then it should be removed on Wednesday after 3 weeks at about 22.00; on the next Wednesday, a new ring is introduced.

Bleeding associated with the discontinuation of the effect of the drug usually begins 2-3 days after the removal of NovaRing ® and may not completely stop until a new ring is installed.

Hormonal contraceptives were not used in the previous menstrual cycle

NovaRing ® should be administered on the first day of the cycle (i.e. the first 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 taking combined oral contraceptives

NovaRing ® should be administered on the last day of the usual interval between cycles of combined hormonal contraceptives (tablets or patches). If a woman has been taking the combined hormonal contraceptive correctly and regularly and is sure that she is not pregnant, she can switch to using the vaginal ring on any day of the cycle.

Switching from progestogen-only drugs (mini-pill, progestin-only oral contraceptives, implants, injectable forms, or hormone-containing intrauterine systems - IUDs)

A woman taking mini-pills can switch to NovaRing ® 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 of pregnancy

The use of NuvaRing ® can be started immediately after an abortion. In this case, there is no need for additional use of other contraceptives. If the use of NovaRing ® immediately after an abortion is undesirable, the use of the ring should be carried out in the same way as if hormonal contraceptives were not used in the previous cycle. At interval, the woman is recommended an alternative method of contraception.

After childbirth or abortion in the second trimester of pregnancy

The use of NuvaRing ® should begin within the 4th week after childbirth (if the woman is not breastfeeding) or abortion in the second trimester. If the use of NovaRing ® is started at a later date, then additional use of barrier methods of contraception is necessary in the first 7 days of using NovaRing ® . However, if during this period 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 patient does not comply with the recommended regimen. To avoid the loss of the contraceptive effect in case of deviation from the regimen, the following recommendations must be followed.

Extension of 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 ruled out, 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.

If the ring has been temporarily removed from the vagina

If the ring was left outside the vagina for less than 3 hours, the contraceptive effect will not decrease. The ring should be reinserted 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 first or second week of use, then the contraceptive effect may be reduced. The ring should be placed in 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 during the third week of use, then the contraceptive effect may be reduced. The woman should discard this ring and choose one of the two following methods.

1. Immediately install a new ring. Keep in mind that a new ring can be used within the next 3 weeks. In this case, there may be no bleeding associated with the cessation of the drug. However, spotting of blood or bleeding in the middle of the cycle is possible.

2. Wait for bleeding associated with the termination of the drug, and introduce a new ring no later than 7 days after removing the previous ring. This option should only be selected if the ring has not been previously broken during the first 2 weeks.

Extended 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. You can take a week off from using the ring, and then introduce a new ring. If NovaRing ® 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.

How to move or delay the onset of menstrual bleeding

To delay menstrual-like withdrawal bleeding, a new ring can be inserted without a week break. The next ring must be used within 3 weeks. This may cause bleeding or spotting. Further, after the usual weekly break, you should return to the regular use of NovaRing ®.

To move the onset of bleeding to another day of the week, it may be recommended to take a shorter break from using the ring (for as many days as necessary). The shorter the break in ring use, the more likely it is that there will be no bleeding after ring removal and that bleeding or spotting will occur while the next ring is in use.

Ring damage

In rare cases, when using NuvaRing ®, a rupture of the ring was observed. The core of the NovaRing ® ring is solid, so its contents remain intact and hormone secretion does not change significantly. If the ring breaks, it usually falls out of the vagina. If the ring breaks, a new ring must be inserted (following the recommendations above "If the ring has been temporarily removed from the vagina").

Ring drop

Sometimes there was a loss of NovaRing ® from the vagina, for example, when it was inserted incorrectly, when a 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 ® ring in the vagina. If the ring falls out of the vagina, the above recommendations "If the ring was temporarily removed from the vagina" should be followed.

Rules for using NuvaRing ®

A woman can independently insert NovaRing ® into the vagina. To introduce the ring, a woman should choose the most comfortable position for her, for example, standing, raising one leg, squatting, or lying down. NuvaRing ® must be squeezed and passed into the vagina until the ring is in a comfortable position. The exact position of NovaRing ® in the vagina is not decisive for the contraceptive effect.

After insertion, the ring must remain in the vagina continuously for 3 weeks. If the ring is accidentally removed, it must be rinsed with warm (not hot) water and inserted into the vagina immediately.

To remove the ring, you can pick it up with your index finger or squeeze it between your index and middle fingers and pull it out of the vagina. The used ring should be placed in a bag (keep out of the reach of children and pets) and discarded.

Overdose

Serious consequences of an overdose of hormonal contraceptives are not described.

Suggested symptoms: nausea, vomiting, slight vaginal bleeding in young girls.

Treatment: carry out symptomatic therapy. There are no antidotes.

Interaction

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 liver enzymes, which can lead to an increase in the clearance of sex hormones. Interactions with the following drugs have 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 NovaRing ® 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.

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 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 NovaRing ® 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 administered 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 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.

Side effects

Determining the frequency of side effects: often (≥1 / 100), infrequently (<1/100, ≥1/1000), редко (<1/1000, ≥1/10 000).

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 data: ≥1/10,000 -<1/1000 женщин-лет.

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

Side effects that occurred when taking combined hormonal contraceptives: 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.

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 anticoagulant);
• 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 auxiliary substances of the drug NovaRing ®.

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

In the event of any of the above conditions, you should immediately stop using the drug.

With caution, the drug should be prescribed in the presence of any of the following diseases, conditions or risk factors; in such cases, the doctor must carefully weigh the benefit-risk ratio of using NovaRing®:

• 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, 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 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.

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 the drug NovaRing ®.

Application features

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 the drug 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 PDAs, 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 hormones inside the uterus when using NovaRing ® are similar to those when using PDA. 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 steroids and / or their metabolites can be excreted in breast milk, but there is no evidence of their negative effect on the health of children.

Application for violations of liver function

Use in children

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 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.

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 is presented in the table below). A large prospective observational study, TASC (Transatlantic Active Study on the Cardiovascular Safety of NovaRing ®), assessed the risk of VTE in women who started using NovaRing ® or COC, switched to NovaRing ® or COC from other contraceptives or resumed the use of the drug NovaRing ® or PDA, 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 NovaRing ® (frequency 8.3 cases per 10,000 LL) and in women using PDA (frequency 9.2 cases per 10,000 LL). For women using COCs, except 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 showed that the incidence of VTE in women who started using NovaRing ® is 11.4 cases per 10,000 VL, while in women who started using COCs containing levonorgestrel, the incidence of VTE is 9.2 cases per 10 000 JL.

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 progestogens: chlormadinone acetate, cyproterone acetate, desogestrel, dienogest, drospirenone, ethinodiol diacetate, gestodene, levonorgestrel, norethindrone, norgestimate, or norgestrel.

2 Based on age, BMI, duration of use, history of VTE.

3 Incl. low-dose COCs containing the following progestogens: 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 with the use of COCs. It is not known whether these cases are associated with the use of PDAs.

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 of 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; "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 any hormonal contraceptive;
• prolonged immobilization, major surgery, any surgery to the lower extremities, or major 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 (BMI over 30 kg / m 2);
• 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 (BMI over 30 kg/m2);
• arterial 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 disorders 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 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 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 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. It remains unclear how this effect is associated with the use of NovaRing®.

A meta-analysis of the results of 54 epidemiological studies revealed 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. 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 doctor should consider the possibility of a liver tumor in the differential diagnosis of diseases in a woman taking NuvaRing ® if 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 ®.

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 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 steroid 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 who are predisposed to the development of chloasma should avoid exposure to sunlight and ultraviolet 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.

Changes in 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.

Laboratory research

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.

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.

Of great importance among the methods of pregnancy planning is given to the prevention of unwanted conception. For this purpose, various means of contraception are used: condoms, pills, spirals. But there are also quite exotic pharmacological forms, for example, a vaginal contraceptive ring called NovaRing (or Nova Ring). Many women hear about this for the first time, so it is necessary to pay attention to the consideration of the features, method of application, indications and limitations of this remedy.

Characteristics

The pharmacological form is a flexible ring made of latex, which contains two active ingredients: estrogen and progestogen. Therefore, NovaRing refers to combined hormonal contraceptives with a predominantly local mechanism of action. The gestagen is etonogestrel, and the group of estrogens is ethinylestradiol, synthetic analogues of the natural hormones of the female body. The ring is 5.4 cm in diameter and only 4 mm thick. These sizes are suitable for most women, which is ensured by the flexibility of the form and its adjustment to the individual characteristics of the genitals.

The effects of the contraceptive ring are due to the action of the active substances that make up its composition.

Etonogestrel and ethinylestradiol bind to their respective receptors, thereby blocking the local effects of natural hormones - estrogens and progesterone. This is mainly manifested in the suppression of ovulation and the inhibition of the secretory transformation of the endometrium.

As soon as the ring is inserted into the vagina, its shell takes on the temperature of the human body, becoming permeable to the substances inside. Medicinal components are contained in low doses, they act mainly on the uterus and ovaries, without affecting other systems and organs. Based on the mechanism of action of etonogestrel and ethinylestradiol, the conception of a child becomes impossible. The egg does not mature and remains in the follicle, and the thin mucous membrane of the uterus prevents the implantation of the embryo.

Distribution in the body

Substances in the ring are actively released from it and absorbed through the vaginal mucosa. They enter the bloodstream, where they reach their maximum concentration after about three days (ethinylestradiol) and a week (etonogestrel) from the start of use. Bioavailability is high, comparable with the use of tableted contraceptives. Once in the blood plasma, the active substances bind to proteins (mainly albumin) and in this form are transferred to target organs. Metabolism occurs in the liver, the half-life of drugs ranges from 29 to 36 hours, and excretion from the body is carried out by the kidneys (with urine) and intestines (with bile).

Indications

The NovaRing ring is used as a planned contraceptive. But it also has medicinal properties, which makes it possible to use this pharmacological form for some gynecological diseases. We are talking about menstrual dysfunction, when the cycle is irregular, and menstruation is painful.

Using the ring to prevent unwanted conception, you can be sure of its reliability and high performance. The probability of pregnancy during the year of using a contraceptive does not exceed 0.9. This is a high rate, comparable to taking hormonal pills. But, in addition to this, the NuvaRing ring has other advantages:

• Ease of use (replacement is carried out once a month).
• Provides a predominantly local effect on the genitals.
• There is no chance of weight gain.
• The menstrual cycle is normalized.
• Reduces the risk of cancer of the uterus and ovaries.
• The ring does not affect the sensations during sexual intimacy.
• Rapid resumption of fertility (4 weeks after extraction).

A wide list of positive qualities should increase the adherence of patients to this method of protection. But, in comparison with other means of contraception, it has a number of disadvantages. Firstly, the use of the ring is quite unusual for a woman. Secondly, it does not protect against genital infections (unlike a condom). And thirdly, there are many contraindications and restrictions for using NovaRing.

As a contraceptive, the ring has many benefits. But there are certain disadvantages that limit its use.

Usage

Before using the ring, a woman should consult a gynecologist. The doctor will conduct an examination, based on the results of which he will say whether she can use such a contraceptive. The specialist should explain how and when it is better to introduce it and what can be expected in the long term.

Acting according to the instructions, a woman can put the NuvaRing ring herself. To do this, she must first choose a suitable position: lying on her back, squatting or standing with her leg elevated. Squeezing the contraceptive with two fingers, she introduces it. The position of the ring in the vagina should be comfortable, and the contraceptive effect does not depend on its accuracy.

The time when you start using the ring is important. The optimal timing of administration is determined by several factors:

• Other contraceptives were not used - on the first day of the menstrual cycle.
• After taking combined estrogen-gestagenic drugs (tablets or patches) - on the last day of the interval between their appointment.
• The transition from monocomponent progestogens - at any time of the cycle.
• With early abortion - immediately after the termination of pregnancy.
• In the postpartum period or during an abortion in the second trimester - after 1 month.

The ring is in the vagina for 3-4 weeks. Use beyond this period reduces the contraceptive effect. In case of spontaneous loss of NuvaRing, it is necessary to insert it back as soon as possible. If the ring was in the external environment for more than 3 hours, then its effect also decreases. In the intervals between the installation of a contraceptive, as well as in the first 7 days of its use, an additional condom should be used (this is not necessary after childbirth or abortion).

Side effects

The NovaRing contraceptive ring has a number of side effects. They occur with varying frequency and not in all women. Much depends on the individual characteristics of the organism. During the use of the ring, the following undesirable phenomena may occur:

• Gynecological: inflammatory processes (cervicitis), vaginal discharge, itching, burning and dryness in the vagina, scanty bleeding (including contact and acyclic), discomfort during intercourse, ectropion, cervical polyps; swelling and soreness of the mammary glands, mastopathy.
• Urological: cystitis, dysuric disorders (frequent urge).
• Digestive: nausea, decreased appetite, abdominal pain, flatulence, constipation.
• Neuropsychiatric: migraine headaches, visual disturbances, dizziness, weakness and fatigue, irritability, decreased sexual desire, depression.
• Skin-allergic: itching, punctate rash, urticaria, acne.
• Vascular: sensation of heat, thrombotic conditions.

In addition to the effects due to the content of the active components, the ring can simply fall out of the vagina, break or cause discomfort due to the form itself. But in order to minimize the risk of any side effects, it should be used only after consulting a doctor and an appropriate examination. Compliance with all the recommendations and requirements of the instructions will minimize adverse events.

The use of the NuvaRing ring may be associated with various unpleasant symptoms. But their probability can be reduced due to the strict observance of all conditions of use.

Restrictions and contraindications

Like any drug, the ring with etonogestrel and ethinyl estradiol has certain limitations that make the use of NovaRing impossible or highly undesirable. All such conditions must be taken into account by the doctor at the examination stage.

The considered contraceptive has a number of contraindications. In the NuvaRing contraceptive ring, the instructions indicate that it cannot be used in the following cases:

• Thrombotic conditions, including predisposition to them.
• Associated migraine (combined with neurological disorders).
• Diabetes complicated by angiopathy.
• Severe hepatic pathology (including oncology).
• Hormone-sensitive tumors of the gynecological sphere.
• Metrorrhagia with unknown cause.
• Pregnancy (confirmed and probable).
• Individual hypersensitivity to the components of the ring.

Caution should be taken in such conditions as hypertension, dyslipidemia, heart defects, systemic connective tissue diseases, inflammatory bowel disease, sickle cell anemia. Some restrictions relate to difficulties with the introduction of a contraceptive into the vagina, which can be observed with uterine prolapse, constipation, rectal diverticula, hernial protrusion of the bladder wall.

special instructions

If pregnancy develops during the use of NovaRing, the ring will have to be removed immediately. Studies confirming the safety of local combined contraceptives for the fetus are not enough to unequivocally speak about the absence of undesirable consequences. During breastfeeding, you should also not use this method. The effectiveness of the ring in adolescent girls is unknown.

In women who used combinations of estrogens and progestins as a contraceptive, there were cases of increased blood pressure, but a direct relationship between these events has not yet been established. With the correct intake of antihypertensive drugs, this effect is leveled. There are indications of the effect of the active substances that make up the ring on carbohydrate tolerance. But this does not require any changes in hypoglycemic therapy.

The components of NovaRing may have a certain effect on the results of some laboratory tests: liver tests, thyroid and adrenal hormones, indicators of kidney function, lipid spectrum, coagulogram. But all changes are within the reference values. The use of tampons does not affect the effectiveness of the ring in any way.

If, during the use of the remedy in question, a woman has any symptoms described as side effects or others that are alarming, you should immediately consult a doctor. Mild reactions do not require removal of the ring, but in some cases it should still be discontinued and switched to other contraceptives.

Every woman should be aware of contraindications and other restrictions that can become an obstacle to the use of NuvaRing.

Interaction

Estrogen-progestin contraceptives, including NovaRing, may interact with other medicines. The acceleration of metabolism, and hence the decrease in the contraceptive effect, can be observed with the parallel intake of inducers of microsomal oxidation in the liver. Such drugs include barbiturates, rifampicin, carbamazepine, ritonavir, St. John's wort-based preparations. The action of the ring is inhibited against the background of taking antibiotics from the group of ampicillin and tetracycline. Therefore, the patient should inform the doctor about all medications taken.

The NovaRing ring is a highly effective contraceptive of hormonal origin. Due to its shape, it has a predominantly local effect on the genitals. There are other positive qualities that contribute to the widespread use of the ring. But it can be used only in strict accordance with medical recommendations and instructions. This allows you to minimize the risk of adverse events and achieve a stable result.

In this article, you can read the instructions for using the drug Novaring. Reviews of site visitors - consumers of this medicine, as well as opinions of doctors of specialists on the use of Novaring in their practice are presented. We kindly ask you to actively add your reviews about the drug: the medicine helped or did not help get rid of the disease, what complications and side effects were observed, perhaps not declared by the manufacturer in the annotation. Nuvaring analogues in the presence of existing structural analogues. Use of a contraceptive hormonal ring to prevent pregnancy in women and during pregnancy and breastfeeding. The likelihood of conception after using the drug. Compound.

Novaring- combined hormonal contraceptive preparation for intravaginal use. Contains etonogestrel, which is a progestogen, a derivative of 19-nortestosterone, and ethinylestradiol, which is an estrogen.

The main mechanism of the contraceptive action of NovaRing is the inhibition of ovulation. The progestogen component (etonogestrel) inhibits the synthesis of LH and FSH by the pituitary gland and thus prevents the maturation of the follicle (blocks ovulation).

The Pearl Index, an indicator that reflects the frequency of pregnancy in 100 women during the year of contraception, when using the drug NuvaRing is 0.96.

Against the background of the use of the drug, the pain and intensity of menstrual-like bleeding decreases, the frequency of acyclic bleeding and the likelihood of developing iron deficiency conditions decrease. In addition, there is evidence of a reduced risk of endometrial and ovarian cancer with the use of the drug. NuvaRing does not reduce bone mineral density.

Compound

Ethinylestradiol + Etonogestrel + excipients.

Pharmacokinetics

Etonogestrel

Etonogestrel released from NovaRing is rapidly absorbed by the vaginal mucosa. Absolute bioavailability is about 100%. Etonogestrel binds to serum albumin and sex hormone-binding globulin (SHBG). 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

Ethinylestradiol released from NovaRing is rapidly absorbed by the vaginal mucosa. Absolute bioavailability is about 56%, which is comparable to oral bioavailability of ethinyl estradiol. Ethinylestradiol binds to serum albumin. Ethinylestradiol is not excreted unchanged; its metabolites are excreted in the urine and bile in a ratio of 1.3:1.

Indications

• contraception.

Release forms

Vaginal ring No. 1 and No. 3 (quantity in the package).

Instructions for use and method of use

NuvaRing is inserted into the vagina once every 4 weeks. The ring is in the vagina for 3 weeks and then removed on the same day of the week that it was placed in the vagina; after a week break, a new ring is introduced. For example: if the NuvaRing was inserted on Wednesday at about 10 pm, then it should be removed on Wednesday after 3 weeks at about 10 pm; on the next Wednesday, a new ring is introduced.

Bleeding associated with the cessation of the drug usually begins 2-3 days after removal of NovaRing and may not completely stop until a new ring is installed.

Hormonal contraceptives were not used in the previous menstrual cycle

NuvaRing should be administered on the first day of the cycle (i.e. the first day of menstruation). It is allowed to install the ring on the 2-5th day 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 taking combined oral contraceptives

NuvaRing should be administered on the last day of the free interval for combined hormonal contraceptives (tablets or patches). If a woman has been taking the combined hormonal contraceptive correctly and regularly and is sure that she is not pregnant, she can switch to using the vaginal ring on any day of the cycle.

The duration of the interval in taking hormonal contraceptives should not exceed the recommended period.

Switching from progestin-based contraception (mini-pill, implant, or injectable contraception) or progestogen-releasing intrauterine device (IUD)

A woman taking mini-pills can switch to the use of NuvaRing on any day (the ring is inserted on the day the implant or IUD is removed or on the day of the next injection). 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 1st trimester of pregnancy

NuvaRing can be used immediately after an abortion. In this case, there is no need for additional use of other contraceptives. If the use of NuvaRing immediately after an abortion is undesirable, the use of the ring should be done in the same way as if hormonal contraceptives were not used in the previous cycle. At interval, the woman is recommended an alternative method of contraception.

After childbirth or abortion in the 2nd trimester of pregnancy

The use of NuvaRing should begin within the 4th week after childbirth (if the woman is not breastfeeding) or abortion in the 2nd trimester. If the use of NovaRing is started at a later date, then additional use of barrier methods of contraception is necessary in the first 7 days of using NovaRing. However, if sexual intercourse has already taken place during this period, it is necessary to first exclude pregnancy or wait for the first menstruation before using NovaRing.

The contraceptive effect and cycle control may be impaired if the patient does not comply with the recommended regimen. To avoid losing the contraceptive effect in case of deviation from the regimen, the following recommendations should be followed.

Extension of 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 ruled out, 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.

If the ring has been temporarily removed from the vagina

If the ring was left outside the vagina for less than 3 hours, the contraceptive effect will not decrease. The ring should be reinserted into the vagina as soon as possible.

If the ring has been outside the vagina for more than 3 hours during the first or second week of use, the contraceptive effect may be reduced. The ring should be placed in 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 during the third week of its use, then the contraceptive effect may be reduced. The woman should discard this ring and choose one of two methods:

1. Immediately install a new ring. Keep in mind that a new ring can be used within the next 3 weeks. In this case, there may be no bleeding associated with the cessation of the drug. However, spotting of blood or bleeding in the middle of the cycle is possible.

2. Wait for bleeding associated with the termination of the drug, and introduce a new ring no later than 7 days after removing the previous ring. This option should only be selected if the ring has not been previously broken during the first 2 weeks.

Extended 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. You can take a week off from using the ring, and then introduce a new ring. If NuvaRing 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.

To change the time of onset of menstrual bleeding

To delay (prevent) menstrual-like withdrawal bleeding, you can insert a new ring without a week break. The next ring must be used within 3 weeks. This may cause bleeding or spotting. Further, after the usual weekly break, you should return to the regular use of NuvaRing.

To move the onset of bleeding to another day of the week, it may be recommended to take a shorter break from using the ring (for as many days as necessary). The shorter the break in ring use, the more likely it is that there will be no bleeding after ring removal and that bleeding or spotting will occur while the next ring is in use.

Ring damage

In rare cases, when using NovaRing, a ring rupture was observed. The core of the NovaRing ring 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. If the ring breaks, a new ring must be inserted.

Ring drop

Sometimes there was a prolapse of NovaRing from the vagina, for example, when it was inserted incorrectly, when a 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 NuvaRing ring in the vagina.

Incorrect insertion of the ring

In very rare cases, women have inadvertently injected NovaRing into the urethra. When symptoms of cystitis appear, the possibility of incorrect insertion of the ring must be considered.

Rules for using NovaRing

The patient can independently insert NovaRing into the vagina. To introduce the ring, a woman should choose the most comfortable position for her, for example, standing, raising one leg, squatting, or lying down. NuvaRing must be squeezed and passed into the vagina until the ring is in a comfortable position. The exact position of NuvaRing in the vagina is not decisive for the contraceptive effect.

After insertion, the ring must remain in the vagina continuously for 3 weeks. If the ring is accidentally removed, it must be rinsed with warm (not hot) water and inserted into the vagina immediately.

To remove the ring, you can pick it up with your index finger or squeeze it between your index and middle fingers and pull it out of the vagina.

Side effect

• vaginal infection (candidiasis, vaginitis);
• cystitis, cervicitis, urinary tract infections;
• weight gain;
• increased appetite;
• depression;
• decreased libido;
• mood change;
• headache;
• migraine;
• dizziness;
• visual impairment;
• hot flashes;
• abdominal pain;
• nausea, vomiting;
• bloating;
• diarrhea;
• constipation;
• acne
• alopecia;
• eczema;
• skin itching;
• skin rash;
• pain in the lumbar region;
• muscle spasms;
• pain in the limbs;
• dysuria;
• engorgement and soreness of the mammary glands;
• genital itching;
• pain in the pelvis;
• vaginal discharge;
• amenorrhea;
• ectropion of the uterus;
• menorrhagia, metrorrhagia;
• premenstrual syndrome;
• dysmenorrhea;
• spasm of the uterus;
• burning in the vagina;
• dryness of the vulva and vaginal mucosa;
• local reactions from the penis (sensation of a foreign body by a partner during intercourse, irritation of the penis with hypersensitivity to the components of the drug);
• prolapse of the vaginal ring;
• fatigue;
• malaise;
• stomach ache;
• swelling;
• sensation of a foreign body in the vagina.

Contraindications

• venous thrombosis (including history), including deep vein thrombosis, pulmonary embolism;
• arterial thrombosis (including history), including stroke, transient cerebrovascular accident, myocardial infarction and / or precursors of thrombosis, including angina pectoris, transient ischemic attack;
• heart defects with thrombogenic complications;
• changes in blood parameters that indicate a predisposition to the development of venous or arterial thrombosis, including resistance to activated protein C, antithrombin 3 deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia and antiphospholipid antibodies (cardiolipin antibodies, lupus anticoagulant);
• migraine with focal neurological symptoms;
• arterial hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg);
• diabetes mellitus with vascular damage;
• pancreatitis incl. in history, in combination with severe hypertriglyceridemia;
• severe liver disease, until the normalization of its function;
• liver tumors (including history);
• hormone-dependent malignant tumors (for example, breast cancer), established, suspected or in history;
• bleeding from the vagina of unknown etiology;
• pregnancy (including intended);
• lactation period;
• surgical interventions followed by prolonged immobilization;
• smoking (15 or more cigarettes per day) in women aged 35 and older;
• hypersensitivity to the components of the drug.

With caution, the drug should be prescribed in the presence of any of the following disease conditions or risk factors; in such cases, the doctor must carefully weigh the benefit-risk ratio of using NovaRing:

• venous or arterial thrombosis (in brothers and sisters and / or parents);
• obesity (body mass index over 30 kg/m2);
• dyslipoproteinemia;
• varicose veins (in combination with thrombophlebitis of superficial veins);
• atrial fibrillation;
• diabetes;
• systemic lupus erythematosus;
• hemolytic-uremic syndrome;
• epilepsy;
• chronic inflammatory bowel disease (Crohn's disease and ulcerative colitis);
• sickle cell anemia;
• congenital hyperbilirubinemia (Gilbert, Dubin-Johnson, Rotor syndromes);
• chloasma;
• fibromyoma of the uterus;
• fibrocystic mastopathy;
• conditions that make it difficult to use the vaginal ring: cervical prolapse, bladder hernia, rectal hernia, severe chronic constipation;
• adhesions in the vagina;
• smoking (less than 15 cigarettes per day) in women 35 years of age and older.

In case of exacerbation of diseases, deterioration of the condition, or the appearance of other risk factors, a woman should also consult a doctor and, possibly, stop the drug.

Use during pregnancy and lactation

The use of NovaRing during pregnancy, suspected pregnancy and lactation is contraindicated.

NovaRing is contraindicated during breastfeeding. NuvaRing is able to influence lactation, reduce the amount and change the composition of breast milk. Small amounts of contraceptive steroids and/or their metabolites may be excreted in milk.

special instructions

Before prescribing or resuming the use of NovaRing, a medical examination should be carried out: analyze the history (including family history) and exclude pregnancy; measure blood pressure; conduct an examination of the mammary glands, pelvic organs, including a cytological examination of smears from the cervix; conduct some laboratory tests to exclude contraindications and reduce the risk of possible side effects of the NovaRing drug. The frequency and nature of medical examinations are carried out by a specialist, taking into account the individual characteristics of each woman, but at least once every 6 months.

The patient should read the instructions for use of the NuvaRing drug and follow all recommendations.

It should be borne in mind that NovaRing does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Women aged 40 years and older, women with cervical intraepithelial neoplasia, and women who smoke at any age require additional consultation with a gynecologist before prescribing NovaRing.

The effectiveness of the drug NovaRing may decrease if the regimen is not followed.

During the use of NuvaRing, acyclic bleeding (spotting or sudden bleeding) may occur. If such bleeding is observed after regular cycles while using NovaRing in accordance with the instructions, you should contact your gynecologist for the necessary diagnostic tests, incl. to rule out cancer and pregnancy. Diagnostic curettage may be required.

Some women do not bleed after the ring is removed. If NuvaRing has been used as directed, 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 in two cycles in a row, pregnancy must be excluded.

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 combined hormonal contraceptives leads to an additional increase in the degree of this risk, but it remains unclear how much this is due to other factors. The positive role of regular examinations of a woman by a gynecologist and the use of barrier methods of contraception are obvious. There is no information on an increased risk of developing cervical cancer in HPV-infected women using NovaRing.

Studies have found a slight increase in the relative risk (1.24) of developing breast cancer in women taking combined hormonal oral contraceptives, but this risk gradually decreases over 10 years after drug withdrawal. Breast cancer is rare in women under 40 years of age, so the additional incidence of breast cancer in women who have taken or continue to use combined oral contraceptives is small compared to the overall risk of developing breast cancer. There is evidence that in women who took oral combined contraceptives, breast cancer is less common than in women who have never used such drugs. The possibility of the influence of the drug NovaRing on the incidence of breast cancer is being studied.

In rare cases, women taking combined oral contraceptives have observed benign liver tumors and, even more rarely, malignant ones. In some cases, these tumors have led to the development of life-threatening bleeding into the abdominal cavity. If there is severe pain in the upper abdomen, liver enlargement or signs of intra-abdominal bleeding in a woman using NovaRing, a liver tumor should be excluded.

Although many women taking hormonal contraceptives experience a slight increase in blood pressure, clinically significant hypertension is rare. A direct relationship between the use of hormonal contraceptives and the development of arterial hypertension has not been established. However, if a constant increase in blood pressure is noted during the use of NovaRing, the patient should contact the attending gynecologist; in such cases, the ring should be removed, antihypertensive therapy should be prescribed, and the issue of choosing the most appropriate method of contraception, incl. possible resumption of the use of the drug NovaRing.

Although estrogens and progestogens can 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.

Use of contraceptive steroids may interfere with 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.

Serious surgical intervention (including on the lower extremities) is a contraindication to the use of the drug. In the case of a planned operation, it is recommended to stop using the drug at least 4 weeks in advance, and resume it no earlier than 2 weeks after the full restoration of motor activity.

Women who are predisposed to the development of chloasma should avoid exposure to sunlight and ultraviolet radiation while using NuvaRing.

The degree of exposure and possible pharmacological effects of ethinyl estradiol and etonogestrel on the mucous membrane of the head and the skin of the penis have not been studied.

Influence on the ability to drive vehicles and control 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.

drug interaction

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

Possible interaction with drugs that induce microsomal enzymes, which can lead to increased clearance of sex hormones.

The effectiveness of NuvaRing may decrease with the simultaneous use of antiepileptic drugs (phenytoin, phenobarbital, primidone, carbamazepine, oxcarbazepine, topiramate, felbamate), anti-tuberculosis drugs (rifampicin), antimicrobial drugs (ampicillin, tetracycline, griseofulvin), possibly antiviral drugs (ritonavir) and medicines containing St. John's wort.

When treating any of the listed drugs, a woman should temporarily use a barrier method of contraception in combination with NuvaRing or choose another method of contraception. In the treatment of drugs that cause the induction of liver enzymes, the barrier method (condom) should be used during treatment and within 28 days after the withdrawal of such drugs.

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.

During treatment with antibiotics (excluding amoxicillin and doxycycline), it is necessary to use a barrier method of contraception (condom) during treatment and for 7 days after their withdrawal. 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.

As a result of studies of the pharmacokinetics of the effect on the contraceptive efficacy and safety of the NuvaRing drug, when it was used simultaneously with antifungal agents and spermicides, it was not revealed. With the combined use of suppositories with antifungal agents, 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 a possible interaction, it is necessary to study the instructions for use of other drugs.

The use of tampons does not affect the effectiveness of NuvaRing. In rare cases, the ring may be accidentally removed when the tampon is removed.

Analogues of the hormonal contraceptive Novaring

Novaring has no structural analogues for the active substance.

Analogues by pharmacological group (estrogens and gestagens in combinations):

• Angelique;
• Anteovin;
• Belara;
• Dailla;
• Desmoulins;
• Jess;
• Divina;
• Evra;
• Jeanine;
• Genetten;
• Zoely;
• indivina;
• Qlaira;
• Klimadinon;
• Klymen;
• Klimonorm;
• Cliogest;
• Lindinet 20;
• Lindinet 30;
• Logest;
• Marvelon;
• Mercilon;
• Midian;
• Microgynon;
• Novinet;
• Non-Owlon;
• Ovidon;
• Regulon;
• Rigevidon;
• Silest;
• Triaclim;
• Trigestrel;
• Triquilar;
• Trisequence;
• Femaflor;
• Femodene;
• Femoston;
• Evian;
• Egestrenol;
• Yarina;
• Yarina Plus.

In the absence of analogues of the drug for the active substance, you can follow the links below to the diseases that the corresponding drug helps with and see the available analogues for the therapeutic effect.