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NuvaRing®

N.V.Organon
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2019-09-19
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Clinical Pharmacology

Pharmacodynamics

Mechanism of action

Novara® is a hormonal combination contraceptive containing etonogestrel and ethinyl estradiol. Etonogestrel is a progestogen (a derivative of 19-nortestosterone), which binds to progesterone receptors in target organs with high affinity. Ethinyl estradiol is an estrogen and is widely used for the production of contraceptives.

The contraceptive effect of NuvaRing® 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 reflecting the pregnancy rate 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) with a statistical analysis of all randomized participants (ITT-analysis) and analysis of participants in the studies who completed them according to the protocol (PP-analysis), respectively. These values ​​were similar to the Pearl index values ​​obtained in comparative studies of combined oral contraceptives (COCs) containing levonorgestrel / ethinyl estradiol (0.150 / 0.030 mg) or drospirenone / ethinyl estradiol (3 / 0.30 mg).

Against the background of the use of the drug NuvaRing®, the cycle becomes more regular, the pain and intensity of menstrual-like bleeding decrease, which helps reduce the incidence of iron deficiency. There is evidence of a decrease in the risk of endometrial and ovarian cancer with the use of the drug.

The nature of the bleeding

Comparison of bleeding patterns over the course of one year in 1000 women who used Novara® and KOK containing levonorgestrel / ethinyl estradiol (0.150 / 0.030 mg) showed a significant decrease in the frequency of “breakthrough” bleeding or spotting bleeding when using Novara® compared to KOK. 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 the drug NuvaRing®.

Impact on bone mineral density

A comparative two-year study of the effect of the preparation NuvaRing® (n = 76) and the non-hormonal intrauterine device (n = 31) did not reveal any effect on the bone mineral density in women.

Children

The safety and efficacy of NuvaRing® for teenage girls under the age of 18 years has not been studied.

Pharmacokinetics

Etonogestrel

Suction

Etonogestrel, which is released from the vaginal ring NuvaRing®, is rapidly absorbed through the vaginal mucosa. The maximum concentration of etonogestrel in the blood plasma, which is about 1700 pg / ml, is reached approximately 1 week after the administration of the ring. Plasma concentrations vary in a small range and slowly decrease to approximately 1600 pg / ml after 1 week, 1500 pg / ml after 2 weeks and 1400 pg / ml after 3 weeks of use. The absolute bioavailability is about 100%, which exceeds the oral bioavailability of etonogestrel. According to the results of measurements of etonogestrel concentrations in the cervix and inside the uterus in women using NuvaRing® and women using oral contraceptives containing 0.150 mg of desogestrel and 0.020 mg of ethinyl estradiol, the observed values ​​of concentrations of etonogestrel were comparable.

Distribution

Etonogestrel binds to plasma albumin and sex hormone-binding globulin (SHBG). The apparent volume of distribution of etonogestrel is 2.3 L / kg.

Metabolism

Biotransformation of etonogestrel occurs by known ways of metabolism of sex hormones. The apparent clearance of blood plasma is about 3.5 l / h. Direct interaction with ethinyl estradiol, taken at the same time, is not revealed.

Removal

Plasma concentrations of etonogestrel are reduced in two phases. In the terminal phase, the half-life is approximately 29 hours. Etonogestrel and its metabolites are excreted by the kidneys and through the intestines with bile in a ratio of about 1.7: 1. The half-life of metabolites is approximately 6 days.

Ethinyl Estradiol

Suction

Ethinyl estradiol, which is released from the NuvaRing® vaginal ring, is rapidly absorbed through the vaginal mucosa. The maximum plasma concentration of about 35 pg / ml is reached 3 days after the ring is injected 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 oral ethinyl estradiol. According to the results of measurements of ethinyl estradiol concentrations in the cervix and inside the uterus in women using NuvaRing® and women using oral contraceptives containing 0.150 mg of desogestrel and 0.020 mg of ethinyl estradiol, the observed concentrations of ethinyl estradiol were comparable.

Concentration of ethinyl estradiol in the course of comparative random study of the preparation of Novairing® (daily ethinylestradiol) in the vagina. cycle in healthy women. Systemic exposure to ethinyl estradiol for a month (AUC 0-∞) for the preparation NuvaRing® was statistically significantly lower than that of the patch and KOK, and amounted to 10.9, 37.4 and 22.5 ng · h / ml, respectively.

Distribution

Ethinyl estradiol is not specifically bound to plasma albumin. The apparent volume of distribution is about 15 l / kg.

Metabolism

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

Removal

Plasma ethinyl estradiol concentrations are reduced in two phases. The elimination half-life in the terminal phase varies widely; the median is about 34 hours. Ethinyl estradiol is not displayed unchanged. Ethinyl estradiol metabolites are excreted by the kidneys and through the intestine with bile in a ratio of 1.3: 1. The half-life of metabolites is about 1.5 days.

Special patient groups

Children

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

Renal dysfunction

The effect of kidney disease on the pharmacokinetics of the preparation Novaraing® has not been studied.

Liver dysfunction

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

Ethnic groups

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

Indications

Contraception.

Composition

1 vaginal ring contains:

Active substances: etonogestrel - 11.7 mg, ethinyl estradiol - 2.7 mg.

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

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NuvaRing®

Dosage and Administration

To achieve a contraceptive effect, the preparation Novara® should be used according to the instructions.

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

The physician should inform the woman how to insert and remove the NovaRing® vaginal ring. For the introduction of the ring, a woman should choose a comfortable position, for example, standing, lifting one leg, squatting or lying down. The vaginal ring NovaRing® should be compressed and inserted into the vagina to a comfortable position of the ring. The exact position of the ring in the vagina is not critical to the contraceptive effect.

After insertion (see the subsection “How to start using the product NovaraRing®”), the ring should be constantly in the vagina for 3 weeks. It is advisable for a woman to regularly check whether it remains in the vagina. If the ring was accidentally removed, then you must follow the instructions in the subsection "What to do if the ring was temporarily removed from the vagina."

The vaginal ring NovaRing® should be removed after 3 weeks on the same day of the week when the ring was inserted into the vagina. After a week break, a new ring is introduced (for example, if the Novara® vaginal ring was installed on Wednesday at about 22.00, then it should be removed on Wednesday after 3 weeks at about 22.00. The new ring is introduced next Wednesday). To remove the ring, you need to pick it up with your index finger or squeeze it with your index and middle finger 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. Bleeding associated with the cessation of the action of the preparation NovaRing® usually begins 2-3 days after the removal of the vaginal ring NovaRing® and may not stop completely until the new ring is installed.

How to start the use of the drug Novairing®?

In the previous cycle, hormonal contraceptives were not used.

The preparation Novaring® should be administered on the first day of the cycle (ie, on the first day of menstruation). It is allowed to install the ring on the 2nd to 5th days of the cycle, however, in the first cycle in the first 7 days of the use of the preparation NovaRing®, the additional use of barrier methods of contraception is recommended.

Transition from combined hormonal contraceptives

A woman should be given the vaginal ring NovaRing® on the last day of the normal interval between cycles in taking combined hormonal contraceptives (pills or a patch).

If a woman correctly and regularly took a combined hormonal contraceptive and is sure that she is not pregnant, she can switch to the use of the vaginal ring on any day of the cycle. In no case should not exceed the recommended hormone interval of the previous method.

Transition from drugs containing only progestogen (mini-pilli, progestin oral contraceptives, implants, injection forms or hormone-containing intrauterine systems - IUD)

A woman taking mini-pili or progestin oral contraceptives can switch to the use of the drug Novara® on any given day. The ring is inserted on the day the implant or IUD is removed. If a woman received an injection, then the use of the drug Novairing® begins on the day when it was necessary to make the next injection. In all these cases, the woman should use a barrier method of contraception during the first 7 days after the introduction of the ring.

After abortion in the first trimester

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

After childbirth or after the second trimester abortion

A woman is recommended to enter the ring not earlier than 4 weeks after delivery (if she does not breastfeed) or abortion in the second trimester. If the ring is installed at a later date, then the use of an additional barrier method during the first 7 days is recommended. However, if sexual contact has already taken place, then before using the drug NovaRing®, it is necessary to exclude pregnancy or wait for the first menstruation.

Deviations from the recommended mode

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

What to do in case of lengthening the break in the application of the ring

If during a break in the use of the ring had sexual contact, pregnancy should be excluded. The longer the break, the higher the probability of pregnancy. If pregnancy is excluded, a woman should insert a new ring into the vagina as quickly as possible. Over the next 7 days, an additional barrier method of contraception should be used, for example, a condom.

What if the ring was temporarily removed from the vagina?

The ring must always be in the vagina for 3 weeks. If the ring was accidentally removed, it should be rinsed with cold or slightly warm (not hot) water and immediately inserted into the vagina.

  • If the ring remained outside the vagina for less than 3 hours, then its contraceptive effect does not decrease. A woman should insert the ring into the vagina as soon as possible (no later than 3 hours).
  • If the ring was out of the vagina for more than 3 hours during the first or second week of use, then the contraceptive effect may be reduced. A woman should insert the ring into the vagina as quickly as possible. Over the next 7 days, you must use a barrier method of contraception, for example, a condom. The longer the ring was outside the vagina and the closer this period is to the 7-day break in the use of the ring, the higher the probability of pregnancy.
  • If the ring was out of the vagina for more than 3 hours in the third week of use, then the contraceptive effect may be reduced. A woman should discard this ring and choose one of the following two methods.
  1. Immediately install a new ring. Note: A new ring can be applied within the next 3 weeks. At the same time there may be no bleeding associated with the termination of the drug. However, spotting or bleeding in the middle of the cycle is possible.
  2. Wait for bleeding associated with the termination of the drug, and enter a new ring no later than 7 days after the removal of the previous ring. Note: This option should be selected only if the mode of applying the ring during the first two weeks was not violated.

What to do in case of extended use of the ring?

If the preparation NovaRing® was used for no more than a maximum period of 4 weeks, then the contraceptive effect remains sufficient. A woman can take a week off using the ring and then introduce a new ring.

If the vaginal ring NovaRing® remains in the vagina for more than 4 weeks, then the contraceptive effect may worsen, therefore, before insertion of the new ring, pregnancy should be excluded.

If a woman does not adhere to the recommended regimen and after a week of interruption in the use of the ring, no bleeding occurs, then pregnancy should be excluded before the introduction of the new ring.

How to move or delay the onset of menstrual bleeding?

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

To transfer the onset of bleeding to another day of the week, a woman can be recommended to take a shorter break in the use of the ring (as many days as necessary). The shorter the break in the use of the ring, the higher the likelihood of no bleeding that occurs after removing the ring, and the occurrence of bleeding or spotting in the period of application of the next ring.

Children

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

Adverse reactions

When using the drug, there may be side effects that occur with varying frequency:

  • often (≥ 1/100);
  • infrequently (<1/100, ≥ 1/1 000);
  • rarely (<1/1 000, ≥ 1/10 000).

Infectious and parasitic diseases: often ≥1 / 100 - vaginal infection; infrequently <1/100, ≥1 / 1 000 - cervicitis, cystitis, urinary tract infections.

Immune system disorders: post-marketing application data1 - hypersensitivity.

Metabolic and nutritional disorders: infrequently <1/100, ≥1 / 1 000 - increase in appetite.

Mental Disorders: often ≥ 1/100 - depression, decreased libido; Infrequently <1/100, ≥ 1/1 000 - change in mood.

Nervous system disorders: often ≥ 1/100 - headache, migraine; infrequently <1/100, ≥ 1/1 000 - dizziness, hypoesthesia.

Violations by the organ of vision: infrequently <1/100, ≥ 1/1 000 - visual impairment.

Vascular disorders: infrequently <1/100, ≥ 1/1 000 - “Tides”; rarely <1/1 000, ≥ 1/10 000 - venous thromboembolism3.

Disorders of the gastrointestinal tract: often ≥ 1/100 - abdominal pain, nausea; infrequently <1/100, ≥ 1/1 000 - bloating, diarrhea, vomiting, constipation.

Violations of the skin and subcutaneous tissues: often ≥ 1/100 - acne; infrequently <1/100, ≥ 1/1 000 - alopecia, eczema, pruritus, rash; post-marketing application data1 - urticaria.

Disorders of the musculoskeletal and connective tissues: infrequently <1/100, ≥ 1/1 000 - pain in the back, muscle spasms, pain in the extremities.

Kidney and urinary tract disorders: infrequently <1/100, ≥ 1/1 000 - dysuria, imperative urination, pollakiuria.

Violations of the genital and breast organs: often ≥ 1/100 - engorgement and tenderness of the mammary glands, genital itching in women, painful menstrual bleeding, pain in the pelvic area, vaginal discharge; infrequently <1/100, ≥ 1/1 000 - absence of menstrual-like bleeding, discomfort in the mammary glands, enlargement of the mammary glands, induration in the mammary glands, cervical polyps, contact (during sexual intercourse) bleeding (bleeding), painful sensations during intercourse, cervical ectropion, fibrocystic mastopathy, heavy menstrual-like bleeding, acyclic bleeding, discomfort in the pelvic region, premenstrually-like syndrome, vaginal burning sensation, vaginal smell conductive, painful sensation in the vagina, discomfort and dryness of the vulva and vaginal mucosa; post-marketing application data1 - local reactions at the partner2.

General disorders and disorders at the site of administration: often ≥ 1/100 - discomfort when using the vaginal ring, loss of the vaginal ring; infrequently <1/100, ≥ 1/1 000 - fatigue, irritability, malaise, swelling, foreign body sensation, difficulty in using a contraceptive, ring rupture (damage).

Impact on the results of laboratory and instrumental studies: often ≥ 1/100 - weight gain; infrequently <1/100, ≥ 1/1 000 - increase in blood pressure.

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

2 - “local reactions at the partner” include reports of “local reactions by the penis” (eg, pain, flushing, bruising and abrasions).

3 - data from an observational cohort study: ≥ 1/10 000 - <1/1 000 women-years.

NovaRing® is contraindicated in the presence of any of the following conditions. In the event of any of these conditions in the period of use of the drug NovaRing®, you should immediately discontinue use of the drug.

  • Thrombosis (arterial or venous) and thromboembolism at present or in history (including deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disorders);
  • the conditions preceding thrombosis (including transient ischemic attacks, angina pectoris) now or in history;
  • susceptibility to the development of venous or arterial thrombosis, including inherited diseases: resistance to activated protein C, deficiency of antithrombin III, deficiency of protein C, deficiency of protein S, hyperhomocysteinemia and antiphospholipid antibodies (antibodies to cardiolipin, lupus anticoagulant);
  • migraine with focal neurological symptoms now or in history;
  • diabetes mellitus with vascular lesions;
  • severe or multiple risk factors for venous or arterial thrombosis: hereditary predisposition to thrombosis (thrombosis, myocardial infarction or cerebral circulation at a young age in one of the closest relatives), hypertension, valvular heart disease, atrial fibrillation, extended operative intervention immobilization, extensive trauma, obesity (body weight> 30 kg / m2), smoking in women over 35 years old (see the section "Special Instructions");
  • pancreatitis with severe hypertriglyceridemia now or in history.
  • severe liver disease;
  • liver tumors (malignant or benign), including a history;
  • known or suspected hormone-dependent malignant tumors (for example, of the reproductive organs or the mammary gland);
  • bleeding from the vagina of unknown etiology;
  • pregnancy, including the intended;
  • hypersensitivity to any of the active or auxiliary substances of the drug NovaRing®.

Carefully: If any of the following diseases, conditions, or risk factors are present, the benefits of using NovaRing® and the possible risks for each individual woman should be assessed before she starts using NovaRing® (see the Special Instructions section). In case of exacerbation of the disease, deterioration of the condition or the occurrence of any of the following conditions for the first time, a woman should consult a doctor to decide whether it is possible to continue using Novara®. With caution, NovaRing® should be used in the following cases: risk factors for thrombosis and thromboembolism: a hereditary predisposition to thrombosis (thrombosis, myocardial infarction or cerebral circulation at a young age in one of the closest relatives), smoking, obesity, dyslipoproteinemia, anesthesia, one of the closest relatives, smoking, obesity, dyslipoproteinemia, osteoma, someone from the next of kin, smoking, obesity, dislipoproteinemiemia, one of the closest relatives, smoking, obesity, dyslipoproteinemia, osteoma, one of the closest relatives, smoking, obesity, dyslipoproteinemia, osteoma, someone from the next of kin, smoking, obesity, dyslipoproteinemia, osteoporosis, someone from the next of kin, smoking, obesity, dislipoproteinemiemia, one of the closest relatives; hypertension, migraine without focal neurological symptoms, valvular disease, cardiac arrhythmias, prolonged immobilization, serious surgical interventions; thrombophlebitis of the superficial veins; dyslipoproteinemia; valvular disease; adequately controlled arterial hypertension; diabetes without vascular complications; acute or chronic liver disease; jaundice and / or itching caused by cholestasis; cholelithiasis; porphyria; systemic lupus erythematosus; hemolytic uremic syndrome; Chorea of ​​Sidengama (small chorea); hearing loss due to otosclerosis; (hereditary) angioedema; chronic inflammatory bowel disease (Crohn's disease and ulcerative colitis); sickle cell anemia; chloasma; conditions that may hinder the use of the vaginal ring: cervical prolapse, bladder hernia, rectal hernia, severe chronic constipation.

Drug interactions

Interaction with other drugs

The interaction between hormonal contraceptives and other drugs can lead to the development of acyclic bleeding and / or ineffective contraception.The literature describes the following interactions with combined oral contraceptives in general.

Hepatic metabolism: interactions may occur with drugs that induce liver microsomal enzymes, which may lead to an increase in the clearance of sex hormones. Interactions have been established, for example, with phenytoin, barbiturates, primidone, carbamazepine, rifampicin, and, possibly, with oxcarbazepine, topiramate, felbamate, ritonavir, griseofulvin, and preparations containing holed up Hypericum perforatum.

When treating with any of the listed remedies, it is necessary to temporarily use a barrier method of contraception (condom) in combination with the use of the drug NovaRing® or choose another method of contraception. During concomitant use of drugs that induce microsomal enzymes, and within 28 days after their withdrawal, barrier methods of contraception should be used.

If concomitant therapy is to be continued after a 3-week use of the ring, the next ring must be entered immediately without the usual interval.

Antibiotics: A decrease in the effectiveness of oral contraceptives containing ethinyl estradiol has been observed with the concomitant use of antibiotics such as ampicillin and tetracyclines. The mechanism of this effect has not been studied. In the study of pharmacokinetic interactions, ingestion of amoxicillin (875 mg, 2 times a day) or doxycycline (200 mg per day, and then 100 mg per day) for 10 days while using the preparation 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 discontinuation of antibiotics. If concomitant therapy is to be continued after a 3-week use of the ring, the next ring must be entered immediately without the usual interval. Pharmacokinetic studies did not reveal the effect of simultaneous use of antifungal agents and spermicides on the contraceptive efficacy and safety of the preparation NovaRing®. With the combined use of suppositories with antifungal drugs slightly increases the risk of ring rupture. Hormonal contraceptives can cause metabolic disorders of other drugs. Accordingly, their concentrations in plasma and tissues may increase (for example, cyclosporine) or decrease (for example, lamotrigine). To exclude possible interactions, you must read the instructions for use of other drugs.

Laboratory research

The use of hormonal contraceptive drugs can affect the results of certain laboratory tests, including biochemical indicators of liver, thyroid, adrenal gland and kidney function; plasma concentration of transport proteins, for example, corticosteroid-binding globulin (GHG) and SHBG; lipid / lipoprotein fractions; on carbohydrate metabolism; as well as on blood clotting and fibrinolysis. Indicators, as a rule, vary within normal values.

Combined use with tampons

Pharmacokinetic data show that the use of tampons does not affect the absorption of the hormones released from the NovaRing vaginal ring. In rare cases, the ring can be accidentally removed when removing the tampon (see the subsection "What to do if the ring was temporarily removed from the vagina" in the section "Dosage and administration").

Pregnancy and Lactation

The preparation NovaRing® is intended for the prevention of pregnancy. If a woman wants to stop using the drug to get pregnant, it is recommended that you wait for the natural cycle to restore its natural cycle, as this will help you correctly calculate the date of conception and childbirth.

Pregnancy

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 when women took COCs in the early stages of pregnancy without knowing it. Although this applies to all COCs, it is not known whether this also applies to NovaRing®. A clinical study in a small group of women showed that, despite the fact that the preparation NovaRing® is injected into the vagina, the concentrations of contraceptive sex hormones inside the uterus when using the drug NovaRing® are similar to those in the application of COCs. The outcomes of pregnancies in women who used the drug Novaraing® in the course of a clinical trial have not been described.

Breastfeeding period

Use of the drug NovaRing® during breastfeeding is not shown. The composition of the drug can affect lactation, reduce the amount and change the composition of breast milk. Small amounts of contraceptive sex hormones and / or their metabolites may be excreted in milk, but there is no evidence of their negative effect on children's health.

Special instructions

If you have any of the following diseases, conditions, or risk factors, you should evaluate the benefits of using NovaRing® and the possible risks for each individual woman before she starts using NovaRing®. In case of exacerbation of the disease, deterioration of the condition or the occurrence of any of the following conditions for the first time, a woman should consult a doctor to decide whether it is possible to continue using Novara®.

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 complications associated with them, sometimes with a fatal outcome.

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

According to research results, the increased risk of developing VTE in women using NovaRing® is similar to that in women applying COC (see the table below for the adjusted risk ratio). In a large prospective observational study TASC (Transatlantic Active Research on the Safety of the Cardiovascular Use of Novaring® for the Cardiovascular System), an assessment of the risk of developing VTE in women who started using Novara® or KOK who switched to Novaring® or KOC from other contraceptives or renewed use of the drug Novara® or KOK, in the population of typical users. Women were observed for 24-48 months. The results showed a similar risk level for the development of VTE in women using Novaring® (frequency 8.3 cases per 10,000 GF) and in women using COC (frequency 9.2 cases per 10,000 GH).For women using COCs, other than those containing desogestrel, gestodene, and drospirenone, the incidence of VTE was 8.5 cases per 10,000 LL.

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

Risk assessment (risk ratio) of VTE in women using NovaRing® compared with the risk of developing VTE in women using COC

Epidemiological study, population:

  1. TASC (Dinger, 2012) Women who began to use the drug (including again after the break) and transferred from other contraceptives.
  2. "FDA-initiated study" (Sydney, 2011) Women who began using combination hormonal contraceptives (CGCs) for the first time during the study period.

Drug (s) comparison:

  1. All available COCs throughout the study1. OP2: 0.8 (0.5-1.5) Available COCs, except those containing desogestrel, gestodene, drospirenone.
  2. COCs available during the study period3.

Risk ratio (RR) (95% CI):

  1. PR2: 0.8 (0.5-1.5); PR2: 0,9 (0,4-2,0).
  2. PR4: 1.09 (0.55-2.16); PR4: 0,96 (0,47-1,95).

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

2 - Taking into account age, BMI, duration of use, history of VTE.

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

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

Exceptionally rare cases of thrombosis of other blood vessels (for example, arteries and veins of the liver, mesenteric vessels, kidneys, brain and retina) with COC are known. It is not known whether these cases are related to the use of COCs.

Possible symptoms of venous or arterial thrombosis can be unilateral edema and / or pain in the lower limb, local temperature increase in the lower limb, hyperemia, or discoloration of the skin in the lower limb sudden severe chest pain, possibly radiating to the left hand; an attack of shortness of breath, coughing; any unusual, strong, prolonged headaches; sudden partial or complete loss of vision; double vision; slurred speech or aphasia; dizziness; collapse, accompanied or not accompanied by a focal epileptic seizure; sudden weakness or pronounced numbness on one side of the body or any part of the body; movement disorders; "Sharp" belly.

Risk factors for venous thrombosis and embolism:

  • age;
  • the presence of diseases in the family history (venous thrombosis and embolism in siblings at any age or in parents at a young age). If a hereditary predisposition is suspected, a woman should be referred to a specialist for consultation before starting to use any hormonal contraceptives;
  • prolonged immobilization, major surgery, any surgery on the lower limbs, or serious injury. In such situations, it is recommended to discontinue the use of the drug (in the case of a planned operation no less than 4 weeks) with the subsequent resumption of use no earlier than 2 weeks after the full recovery of motor activity;
  • obesity (body mass index more than 30 kg / m2);
  • possibly thrombophlebitis of superficial veins with varicose veins.

There is no consensus about 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 intensive smoking and with age, the risk increases even more, especially for women over 35 years old);
  • dyslipoproteinemia;
  • obesity (body mass index more than 30 kg / m2);
  • high blood pressure;
  • migraine;
  • valvular disease;
  • atrial fibrillation;
  • the presence of diseases in the family history (arterial thrombosis in siblings 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 consultation before starting to use any hormonal contraceptives. Biochemical factors that may indicate hereditary or acquired susceptibility to venous or arterial thrombosis include resistance to activated protein C, hyperhomocysteinemia, antithrombin III deficiency, protein C deficiency, deficiency of protein S, antibodies to phospholipids (cardiolipin antibodies, lupus anticoacid, anti-lactose anticoagulant, anti-antibacterial anti-inflammatory disease, anti-phospholipid deficiency (anti-cardiolipin antibodies, anti-lactation anticohistoma, anti-thrombin III, anti-thrombin, anti-thrombin, anti-thrombin, anti-thrombosis III, anti-phospholipid deficiency).

Other conditions that can lead to undesirable circulatory disorders include diabetes mellitus, systemic lupus erythematosus, hemolytic-uremic syndrome and chronic inflammatory bowel disease (for example, 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 a migraine (which may be a prodromal symptom of cerebral circulation) during the use of hormonal contraceptives may cause an immediate cessation of the use of hormonal contraceptives.

Women using KGC should be advised to consult a doctor if possible symptoms of thrombosis appear. With suspected or confirmed thrombosis, the use of CHC should be discontinued. At the same time 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 cervical cancer is infection with the human papillomavirus (HPV). Epidemiological studies have shown that prolonged use of COCs leads to an additional increase in the degree of this risk, but it remains unclear how much this is related to other factors, such as more frequent research on cervical smears and differences in sexual behavior, including the use of barrier contraceptives. It remains unclear how this effect is associated with the use of the drug NovaRing®.

According to a meta-analysis of the results of 54 epidemiological studies, a slight increase (1.24) in the relative risk of developing breast cancer in women taking combined hormonal oral contraceptives was revealed. The risk gradually decreases over 10 years after drug withdrawal. Breast cancer rarely develops in women under the age of 40 years, so the additional number of cases of breast cancer in women who take or have received COC is small compared with the overall risk of developing breast cancer. Cancer m

  • Brand name: NuvaRing®
  • Active ingredient: Ethinyl estradiol, Etonogestrel
  • Dosage form: Vaginal ring.
  • Manufacturer: N.V.Organon
  • Country of Origin: Netherlands

Studies and clinical trials of NuvaRing (Click to expand)

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