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There are quite a lot of types of contraception, the most popular of them today are barrier and hormonal methods.

One of the types of modern hormonal contraceptives is the NovaRing vaginal contraceptive ring.

What is the NovaRing vaginal ring?

NovaRing is a combined hormonal contraceptive drug, which includes microdoses of the hormones estrogen (ethinyl estradiol) and progestogen (etonogestrel).

The contraceptive is a flexible small ring (only 55 mm in diameter, 8.5 mm thick) made of hypoallergenic material. After insertion into the vagina, microdoses of hormones are released daily from the ring (this mechanism of action is achieved due to the complex system of membranes that make it up).

The contraceptive action, like that of other hormonal drugs, is carried out by suppressing ovulation. In addition, hormones increase the density of mucus in the cervix, thereby preventing the advancement of spermatozoa.

The main advantage of the NovaRing hormonal vaginal ring is the absence of primary passage through the gastrointestinal tract and liver, the intake of hormones into the body in microdoses, which significantly reduces the risk of side effects from its use compared to other hormonal drugs.

At the same time, the contraceptive effectiveness of the vaginal ring is high. The Pearl Index (an indicator reflecting the number of women out of a hundred who become pregnant while taking the drug during the year) when using a contraceptive ring is 0.96. For comparison, when taking combined oral contraceptives, the Pearl index is 0.1-0.9.

In addition to the contraceptive effect, the drug also has a positive effect on the menstrual cycle, making it more regular, and menstruation less painful and plentiful.

It is important to remember that the contraceptive ring is not protection against sexually transmitted diseases! Therefore, this method of contraception is suitable for women with one permanent sexual partner, as well as the absence of sexual infections in both partners.

Contraindications

Like any hormonal drug, NuvaRing has a fairly large list of contraindications.

There are also a number of diseases in which the use of the vaginal ring is possible with caution (obesity, heart defects, etc.).

A complete list of contraindications can be found in the instructions for the drug. Therefore, if a woman has any of these diseases or a predisposition to them (including diseases in relatives), then before using the drug, it is necessary to evaluate the possible risks and benefits of its use and possibly refuse to use it in favor of another method of contraception.

Use during pregnancy and lactation

If a woman wants to become pregnant, she should stop using the drug and wait for the restoration of the natural cycle. As a rule, pregnancy after the cancellation of NovaRing is possible after 1-2 months.

The use of a contraceptive ring for women during lactation is also undesirable. The composition of the drug can affect lactation, reduce the amount, and also change the composition of breast milk.

When a woman's pregnancy is established, the ring must be removed, since it is contraindicated during pregnancy.

Instructions for use

The NovaRing contraceptive ring is very convenient to use, because it does not require daily monitoring. After the introduction, the ring is in the vagina for exactly 3 weeks, then it must be removed, and on the same day on which it was introduced.

After removing the ring, a seven-day break is made, after which a new one is introduced. In fact, the principle is the same as when taking combined oral contraceptives, only in this case, the daily intake of hormones into the body occurs independently without the participation of a woman.

At the beginning of the use of the NuvaRing contraceptive ring, it is recommended to use additional barrier methods of contraception during the first seven days.

Before using the contraceptive ring for the first time, you must carefully read the instructions for use (it is better, of course, to consult a doctor), since the conditions for using the ring in individual cases may differ.

How to insert the NovaRing ring?

To insert the vaginal ring, a woman needs to choose a comfortable position, the ring can be inserted while standing, lying down or in a squatting position.

The ring must be compressed and inserted into the vagina, after which the ring will independently take the desired shape, depending on the individual structural features of the woman.

To remove the ring, squeeze it with two fingers (index and middle) and pull it out of the vagina.

Withdrawal bleeding usually begins 2 or 3 days after the removal of the vaginal ring and may not stop until a new ring is inserted.

Possible side effects

Despite the local release of hormones, side effects with the use of NovaRing are possible.

Women may experience headaches, dizziness, emotional instability (up to depression), weight gain, digestive disorders (nausea, vomiting, diarrhea), vaginal discharge, urinary tract infections, breast tenderness, etc.

Local reactions are also possible - the feeling of a foreign body in the vagina, discomfort during intercourse.

Estimated price

The NovaRing contraceptive ring is available in packs of 1 ring and 3. The average price of a pack with 1 ring is $30, a pack with 3 rings is $74.

The choice of contraceptive method is individual for each woman, it is influenced by a number of factors, ranging from health status and physiological characteristics, to personal preferences.

But in any case, this choice should be approached with all responsibility, and it is advisable to do this not on your own, but together with a competent specialist who can take into account not only your wishes, but also the capabilities of your body.

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 NuvaRing ® 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 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 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 using NovaRing ® and COC containing levonorgestrel / ethinylestradiol (0.150 / 0.030 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 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 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 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 during a comparative randomized study of the drug NovaRing ® (daily release of ethinylestradiol in the vagina 0.015 mg), transdermal patch (norelgestromin / ethinylestradiol; daily release of ethinylestradiol 0.020 mg) and COC (levonorgestrel / ethinylestradiol; daily release administration of ethinylestradiol 0.030 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, 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 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

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 NuvaRing ® from the vagina, for example, when it was inserted incorrectly, when a tampon was removed, during intercourse, or against a 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 immediate 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, you should first 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 the drug NovaRing ® is injected into the vagina, the concentrations of contraceptive hormones inside the uterus when using the drug 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 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 not using 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 NuvaRing ® 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 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 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 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 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.

NuvaRing, instructions for use of which are given below, is a contraceptive. The new millennium has come, and women in Russia are still poorly informed about the means of contraception from unwanted pregnancies. Most of them use coitus interruptus or a condom for this. Gynecologists continue to sound the alarm about the increase in the number of abortions, while a new generation of contraceptives appear on the pharmacological market every year.

There are a number of reasons why our women choose to take the risk of unwanted pregnancy and refuse new generation contraceptives:

1. The financial side of the issue. The more effective and safer the remedy, the higher its price. You can't argue with that. However, the modern arsenal of contraceptives includes dozens of items from which a woman with any income level can choose the option that suits herself. Better after consultation with a gynecologist.
2. Laziness. Many women do not want to pay attention to contraceptive issues, finding a lot of excuses. It is easier for them to hope that "maybe it will carry over", go for an abortion or give birth to an unwanted child, spoiling the life of themselves and him. Information about new contraceptives is now available, you can read about it on the Internet at any time of the day, but so far the situation has not changed.
3. Horror stories about contraception. Rumors circulate in society, which are overgrown with details and cases from life, such as: "one of my friends ...". It is believed that hormonal contraceptives can dramatically gain weight, and intrauterine devices cause cancer. It is easier for women to believe rumors than to come to a consultation with a gynecologist and get the opinion of a specialist.
4. Lack of culture of contraception. It was previously not customary to speak aloud about contraception in the USSR, and the arsenal of means was limited to 1-2 items. More than 20 years have passed, and there is still no culture of contraception in our society. This is not talked about in schools, universities and labor collectives. The situation needs change.

The modern business woman values ​​her health. She turns to a specialist who will help her choose a safe method of contraception, taking into account her individual characteristics and needs.

• Show all

  What are the methods of protection?

  The accumulated experience in this area allows us to talk about several basic methods of preventing unwanted pregnancy:

  Physiological methods of contraception. Despite a large share of errors, these methods continue to be practiced by our women. There are 2 main ones among them:

  1. 1. Temperature method. The physiology of a woman is such that she can become pregnant only during the period of ovulation, when the egg is released from the ovarian follicle. During ovulation, body temperature rises slightly. If you correctly use the temperature method, clearly keep a calendar of the menstrual cycle and measure the temperature in the rectum daily - in the morning and in the evening, then it works almost without errors. The advantage of the method is natural and free. This is the only church-approved way to protect yourself from unwanted pregnancy. Disadvantage: Takes time and requires concentration.
  2. 2. Calendar method. By counting, a woman schedules "safe" days and suitable for conception. On "dangerous" days, she does not practice unprotected sex. Advantage of the method: ease of use. Disadvantage: only suitable for women with a stable menstrual cycle, as it gives a lot of errors. Gynecologists strongly advise against using the calendar method for contraception.

  COC - combined oral contraceptives. Tablets are reliable contraceptives, their effectiveness is in the range of 98%. The composition of any oral contraceptive includes synthetic sex hormones, which:

  • inhibit the process of ovulation;
  • change the structure of the endometrium of the uterus, as a result of which the ovum cannot be fixed on its wall.

  Thus, a multi-stage protection is carried out. All stories about the dangers of oral contraceptives are greatly exaggerated. After the abolition of tablets, all functions of the female body are quickly restored. Experts believe that pregnancy on the effect of failure occurs faster and use this to stimulate conception. A small amount of hormones that are part of the tablets improves the condition of the skin, hair and nails, stabilizes the menstrual cycle, relieves the symptoms of premenstrual syndrome, and protects the body from iron deficiency anemia. In addition, according to WHO, women who take oral contraceptives have a reduced risk of developing cancer and osteoporosis.

  Like any pill, COCs have contraindications. Only a doctor should prescribe them, based on the data of the examination and diagnostic studies. Perhaps, when choosing a suitable remedy, you will have to change 2-3 drugs.

  Barrier means of protection against unwanted pregnancy. These include barrier agents that prevent the penetration of spermatozoa into the vagina - condoms and chemical barrier drugs.

  If sexual intercourse happened suddenly and the sexual partner turned out to be accidental, then a condom is the best method of contraception. Currently, they are made from high quality latex rubber, supplied with spermicidal and antibacterial lubricants for additional protection.

  

  For women who have regular sex with one partner, chemical barrier protection products are more suitable - gels, pastes, ointments, suppositories, vaginal rings and patches. All of them belong to the group of topical preparations.

  The composition of chemical barrier contraceptives includes special substances - spermicides, which:

  • destroy spermatozoa that have entered the vagina;
  • create a thin protective film on the walls of the vagina;
  • thicken the discharge from the cervical canal of the cervix, creating an additional barrier.

  Among the advantages of these contraceptives are efficiency, antiseptic, antifungal, antiviral and antibacterial action, ease of use. The substances included in their composition inhibit the pathogenic flora - chlamydia, herpes, gonococci, genital herpes virus. Barrier contraceptives are indicated for women during breastfeeding, as they are completely safe for the baby. The absence of contraindications makes them attractive to women over 40 years of age. Among the most popular drugs:

  • gramicidin ointment;
  • candles Patentex Oval;
  • cream, vaginal balls and tampons "Farmateks".

  The method of application for them is approximately the same - the introduction into the vagina 10-15 minutes before sexual intercourse.

  Barrier chemicals have a number of contraindications, they are not effective against venereal infections. Before use, it is necessary to consult a doctor.

  Intrauterine device. The IUD is a special flexible device that is inserted into the uterine cavity for a long time and prevents pregnancy. Spirals are divided according to the methods of exposure to drug and non-drug. Spirals made of copper, gold, silver, with the addition of progesterone have a medicinal effect.

  Navy functions:

  • causes thickening of the mucus of the cervical canal, creating a barrier in the cervix;
  • slows down the movement of the egg into the uterine cavity;
  • reduces the motor activity of spermatozoa;
  • causes changes in the structure of the endometrium, as a result of which the fetal egg cannot be implanted in the wall of the uterus.

  To date, the effectiveness of the IUD is 99%. Advantages of the product - reliable and durable protection against pregnancy, the best option for protection after childbirth, the ability to install on any day of the menstrual cycle. Disadvantages - not suitable for nulliparous women, after the expiration of the IUD, it is necessary to remove and take a break before the next installation for 3 months. The spiral does not protect against sexually transmitted diseases.

  Means of protection for men. Gone are the days when contraception was considered the prerogative of women. A man who respects himself and his woman will protect her from unwanted pregnancy and plan the birth of children. Among the known means of male contraception are:

  1. 1. Coitus interruptus. The method is not entirely effective, as a little lubricant containing spermatozoa is released on the glans penis. Also, a man must clearly control the onset of ejaculation, and this is not always possible.
  2. 2. Condom. A simple and convenient way for emergency situations when sex happened suddenly. It has no contraindications and, when used correctly, provides 98% protection.
  3. 3. Vasectomy. A simple and safe sterilization operation that lasts 10 minutes and makes a man incapable of conception. Currently, it is completely reversible, if desired, a man can always return his fertile function.

  There are no contraindications for male contraceptive methods.

  Methods of emergency contraception. In life, there are situations when unprotected sex has happened, or a woman has been abused and emergency measures are required to protect against unwanted pregnancy.

  The pharmaceutical industry offers a number of pills containing a loading dose of hormones that prevent conception and cause a rapid rejection of the endometrium from the walls of the uterus. These drugs include Escapel and Postinor, which are sold in pharmacies without a prescription.

  It is important to remember that these are emergency remedies, you cannot use them all the time, this can cause serious disruptions in the menstrual cycle. In the case of adolescents, the question of the use of the drug is decided by the doctor.

  

  The essence of the method

  Hormonal rings are a relatively new means of barrier contraception. Their popularity among the female population of the planet is growing. The main advantage of rings in comparison with tablets is a single injection every few weeks, while tablets should be taken daily, not forgetting about it.

  

  The contraceptive ring is made of plastic polymers. Its thickness is 8.4mm and its circumference is 55mm. The anatomical shape of the vagina is attached to the ring, so that the woman does not experience discomfort while wearing it. One ring is used during one menstrual cycle - it is installed on the 5th day of menstruation and removed after 21 days, before the onset of menstruation.

  The vaginal hormonal ring combines the advantages of barrier and hormonal contraceptives. The active ingredients of the drug are absorbed into the bloodstream under the influence of body temperature and suppress the process of ovulation.

  Ring Benefits:

  • use once a month;
  • easy introduction without the help of a doctor;
  • does not reduce libido and does not change the sensations during intercourse;
  • facilitates the course of premenstrual syndrome and menstruation;
  • reduces the risk of oncological diseases in the organs of the reproductive system and the colon;
  • minimizes the development of ovarian cysts, uterine fibroids and mastopathy of the mammary glands.

  

  Among the shortcomings, experts distinguish:

  • violation of lactation;
  • side effects;
  • soreness of the mammary glands;
  • lack of protection against sexually transmitted diseases.

  Since the composition of the vaginal ring includes hormonal preparations, it is necessary to consult a gynecologist before use.

  

  What is a product?

  The NovaRing vaginal hormonal ring is made of modern polymeric materials. It is smooth and colorless. The product contains 2 synthetic hormones:

  • an estradiol derivative;
  • nortosterone derivative.

  Polymers are used as auxiliary substances. Thus, NuvaRing is a combined remedy that consists of derivatives of female and male hormones. This combination provides suppression of ovulation and protects against possible pregnancy.

  

  NuvaRing is an effective modern contraceptive. Laboratory studies have shown that it protects in 96-97% of applications. In terms of effectiveness, the drug is not inferior to oral combined contraceptives, as it has an almost similar composition and mechanism of action.

  It has been proven that NuvaRing has the ability to reduce the soreness and profusion of menstrual bleeding, protecting a woman from a decrease in hemoglobin levels in the blood. Regular use of a contraceptive reduces the risk of developing malignant neoplasms of the reproductive organs.

  Compared to hormonal pills, the use of the ring does not cause increased menstrual bleeding or spotting. This effect is observed only during periods of abrupt withdrawal of the drug.

  

  Numerous studies have not recorded an increase in body weight with prolonged use of the NovaRing contraceptive.

  The effect of ring hormones has not been studied in adolescent girls (under 18 years of age).

  

  Mechanism of action

  The hormone, a derivative of nortestosterone, is released from the ring under the influence of body temperature and is quickly absorbed into the walls of the vagina. Its highest concentration in the blood is reached 1 week after the introduction of the ring. It is important that the bioavailability of the drug exceeds that of hormonal tablets.

  Once in the bloodstream, the substance binds to plasma proteins and affects the ovaries and all target organs that produce sex hormones. The main property of the hormone is to slow down the onset of ovulation.

  

  The second component of the vaginal ring, an estradiol derivative, reaches its maximum concentration on the 3rd day after installation. It affects the state of the endometrium, making it impossible for a possible fetal egg to implant on the uterine wall.

  The components of the vaginal ring are easily metabolized by the kidneys and excreted from the body.

  The cycle of application of the vaginal ring is as follows:

  1. 1. The ring is installed on the 5th-6th day of bleeding caused by the removal of the previous one.
  2. 2. Removed after 3 weeks, on the same day of the week when it was installed and preferably at the same hour (for example, Wednesday 21:00).
  3. 3. A break of 7-10 days is taken, then a new ring can be installed.

  Removing the vaginal ring can cause menstrual bleeding, which usually ends with the insertion of a new contraceptive.

  

  During the initial installation of the barrier ring, in the first days of use, it is recommended to protect yourself with other contraceptives, preferably barrier ones - pastes, gels, creams.

  How to make the transition from different types of contraceptives?

  Switching from oral contraceptives. If a woman decides to switch from using pills to using a vaginal ring, then she can do this on any day of the cycle, with full confidence that pregnancy has not occurred. Experts recommend doing this in the interval between pill cycles.

  

  Switching from drugs based on prostagens. These include progestogen pills, mini-pills, implants, intrauterine devices with hormones, contraceptive injections. The barrier ring can be inserted any day after the progestogen has ended. Immediately after the removal of the coil or on the day when the injection of the drug is prescribed. In the first week after installation, it is recommended to use other types of barrier contraceptives.

  After the operation of artificial termination of pregnancy, NuvaRing can be installed on the same day. Then there is no need to use other contraceptives. If this is not possible, then the procedure for using the vaginal ring is the same as in the previous case - use additional contraception in the first week.

  After the birth of the child and the period of feeding, such a ring can be inserted after the first menstruation.

  

  Violation of the mode of use

  During the period of using the vaginal ring, it sometimes becomes necessary to remove it. In such cases, the following rules apply:

  1. 1. If the ring was removed for a period of not more than 3 hours, then a sufficient concentration of hormones that prevent pregnancy will remain in the blood.
  2. 2. In the case when the ring was removed and there was sexual intercourse, it is necessary to make sure that pregnancy has not occurred. It is better to insert the vaginal ring after the onset of menstruation.
  3. 3. If the ring was removed in the first 2 weeks after insertion for more than 3 hours, this may reduce its contraceptive effect. The ring should be installed as soon as possible and additional contraceptives should be used in the first week.
  4. 4. If the ring was removed at 3 weeks of use, then you must either insert a new contraceptive, or wait for bleeding and insert it after a few days.
  5. 5. If the ring is used for more than 4 weeks, then its effect is reduced. The contraceptive should be removed from the vagina and replaced with a new one.

  

  A woman can avoid bleeding associated with contraceptive withdrawal. To do this, you must enter a new ring without interruption. In this case, spotting bleeding is considered normal.

  Thus, the woman herself can regulate the onset of bleeding and its duration. The shorter the period between the change of barrier rings, the shorter the period of bleeding, up to the absence.

  When the NuvaRing ring is installed correctly, then cases of its spontaneous loss are quite rare. The ring may fall out in the event of:

  • when the tampon is removed;
  • after sexual contact;
  • after a difficult act of defecation (with constipation).

  

  In such cases, you must either insert a new ring, or be guided by the installation rules after a break.

  How should the ring be inserted?

  A woman can insert a barrier ring herself, without resorting to the help of a gynecologist. To do this, she should take a comfortable position - standing, squatting, standing on one leg and lifting the other, lying on her back. Ring installation instructions are as follows:

  1. 1. Squeeze the ring between your fingers.
  2. 2. Insert your fingers deep into the vagina.
  3. 3. Release the ring.

  If NuvaRing is installed correctly, then the woman will not feel his presence when walking, sitting and lying down. The ring can interfere when it is not deeply inserted. In this case, it should be removed, washed well with warm water and reinstalled.

  

  To remove the ring, it is necessary to grab its rim between the fingers and carefully, so as not to damage the mucous membrane with nails, remove it from the vagina.

  Existing contraindications

  The barrier ring contains hormonal drugs, so you should consult a doctor before using it as a contraceptive. Only he can assess the degree of risk in the presence of concomitant diseases.

  

  Contraindications to the use of NovaRing:

  • diseases associated with the formation of blood clots in arteries and veins - blockage, impaired venous outflow, hereditary and genetic diseases associated with circulatory disorders;
  • diseases of the heart and blood vessels: malnutrition of the heart muscle, acute disorders of cerebral circulation, attacks of angina pectoris and ischemia, installation of artificial heart valves, hypertension;
  • frequent migraines with neurological syndrome;
  • diabetes mellitus type 1 and 2, when vascular damage occurs;
  • a history of severe injuries with a long period of rehabilitation;
  • obesity 3-4 degrees;
  • chronic pancreatitis;
  • conditions of liver failure or liver dysfunction;
  • existing or past hormone-dependent oncological diseases;
  • the period of pregnancy and breastfeeding;
  • hypersensitivity to the hormonal components of the contraceptive;
  • years of smoking.

  With caution, the NuvaRing vaginal contraceptive ring can be used for:

  • blockage of superficial veins;
  • heart defects;
  • controlled hypertension;
  • cholelithiasis;
  • jaundice caused by inflammation of the gallbladder;
  • mineralization in the gallbladder and kidneys;
  • manifestations of allergies;
  • diseases of the gastrointestinal tract;
  • iron deficiency anemia;
  • inflammatory processes in the cervix,
  • hernia of the rectum;
  • dyspeptic disorders.

  The specialist carefully weighs all the risks associated with the use of the NuvaRing ring and makes an appropriate conclusion.

  

  Side effects

  Side effects from the use of a hormonal ring:

  1. 1. Possible infection of the internal environment of the vagina and the development against this background of inflammatory processes in the cervix, in the walls of the bladder and urinary tract.
  2. 2. Reduced immunity.
  3. 3. Violation of metabolic processes, increased appetite.
  4. 4. Changes in mental reactions: irritability, mood swings, depression, decreased sexual desire.
  5. 5. The manifestation of nervous disorders - headaches, pre-syncope.
  6. 6. Violation of visual acuity.
  7. 7. Vascular reactions - hot flashes, thickening of the blood.
  8. 8. Indigestion - constipation, diarrhea, nausea, flatulence.
  9. 9. Muscular reactions - pain in the lower back and back, spasms, numbness of the extremities.
  10. 10. Increasing the sensitivity of the urinary tract - frequent urge to urinate.
  11. 11. Symptomatic disorders of the reproductive organs - swelling and soreness of the mammary glands, itching in the genital area, painful bleeding, similar to menstruation, discharge, pain in the lower abdomen, vaginal dryness.
  12. 12. Unpleasant sensations associated with the installation of the ring - ailments, swelling, and so on.

  Cases of side effects of the NovaRing vaginal ring are quite rare, but those women who decide to use this contraceptive should be aware of them.

  

  Exceeding the dosage and interaction with medicinal substances

  Cases of overdose when using a contraceptive were not observed. In some cases, hypersensitivity to active substances was recorded - dyspeptic disorders, minor bleeding in girls under 18 years of age. In these cases, it is recommended to remove the ring and carry out symptomatic treatment. Then you should contact your gynecologist for the selection of another contraceptive.

  The hormonal components of the NovaRing contraceptive may interact with drugs:

  1. 1. With enzyme preparations that improve liver function.
  2. 2. With preparations based on St. John's wort.
  3. 3. With antibiotics that reduce the effectiveness of contraceptives.

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

Active ingredients: ethinylestradiol 2.7 mg, etonogestrel 11.7 mg. Excipients: ethylene vinyl acetate copolymer (28% vinyl acetate), ethylene vinyl acetate copolymer (9% vinyl acetate), magnesium stearate.

pharmachologic effect

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.

Indications for use

• intravaginal contraception.

Mode of application

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.

Getting Started with Nuvaring

• 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 first 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 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 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 remained outside the vagina 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 was out of 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 has been outside the vagina for more than 3 hours during the third week of its use, 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 NuvaRing was used 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 more than 4 weeks, then the contraceptive effect may worsen, therefore, before the introduction of a new ring, pregnancy must be excluded.

To change the time of onset of menstrual bleeding

To postpone (prevent) menstrual-like withdrawal bleeding, you can enter 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 bear the onset of bleeding on 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

When using Nuvaring, the following side effects may occur:

Contraindications for use

• 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 III 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.

Carefully 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.

Although a causal relationship has not been conclusively proven, caution should be exercised when prescribing NuvaRing if, during the use of any other hormonal contraceptives or a previous pregnancy, the development or worsening of the following conditions / diseases was noted: jaundice and / or itching associated with cholestasis, formation of stones in the gallbladder, porphyria, Sydenham's chorea, herpes of pregnancy, otosclerosis with hearing loss, (hereditary) angioedema.

Recurrence of cholestatic jaundice and / or cholestasis with itching, which were observed during pregnancy or previous use of sex hormones, is the basis for discontinuing the use of NuvaRing.

The use of NuvaRing 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.

Application for violations of liver function

NuvaRing is contraindicated in severe liver disease (until normalization of function parameters).

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 NuvaRing, especially in the first months of contraception.

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.

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.

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.

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.