Or frequently asked questions about the NuvaRing hormonal ring, which the doctor hears at every appointment.

What is NuvaRing?

is an elastic ring that is inserted deep into the vagina. The system is installed in the first days of the menstrual cycle and remains in the genital tract for 21 days. The contraceptive ring contains the female sex hormones estrogen and progesterone. These substances are gradually released and enter the bloodstream, blocking ovulation and making pregnancy impossible. Hormones also make the cervical mucus viscous so that nimble sperm do not penetrate inside and fulfill their intended purpose.

Today, the NuvaRing vaginal ring is considered one of the most effective contraceptives with a minimal amount of hormones. This fact makes the system popular with both young and older women. What should you know about NuvaRing and how to use this contraceptive correctly?

Who is NuvaRing suitable for?

The contraceptive ring is a good choice for different categories of women:

• Young and nulliparous women with one sexual partner.
• After childbirth and completion of breastfeeding.
• In the premenopausal period (in the absence of chronic pathology that can become a contraindication).

Why is NuvaRing better than birth control pills?

The vaginal ring has three clear advantages over COCs with a similar composition:

• The dosage of estrogen is lower than in any hormonal pills.
• The drug does not pass through the gastrointestinal tract and does not affect digestion.
• You don’t need to remember to take the pills every day - just insert the ring once and forget about it for 21 days.

Can NuvaRing be given to nursing mothers?

The instructions for using the contraceptive ring do not recommend using NuvaRing during lactation. You should wait until breastfeeding is completed and only then insert the ring. Nursing mothers can use mini-pills (purely progestin preparations) as contraception. Don't forget about condoms.

Can a woman put on a contraceptive ring herself or should she go to a doctor?

NuvaRing is simple, convenient and affordable. Any woman can insert a ring on her own without any problems. To do this, you need to take a comfortable position - squatting, standing or lying - and insert the ring as deeply as possible. If any difficulties arise, you can make an appointment with a doctor. The doctor will insert the ring and then tell the patient in detail how to do it at home.

Can a man feel the ring during sex?

No, NuvaRing is not felt at all during sexual intercourse.

Can a woman feel the vaginal ring?

No, if the NuvaRing is installed correctly, it is not felt in the vagina.

Why doesn't the ring fall out?

NuvaRing, inserted deeply, is securely fixed into the vagina by muscles. In addition, the ring lies horizontally in the genital tract, like on a shelf, and the likelihood of it falling out is extremely low.

Can the ring fall out?

It's rare, but it happens. In this case, you need to wash the ring with warm or cool water and carefully insert it back into the vagina. The contraceptive effect does not suffer if less than 3 hours have passed since the ring fell out.

The ring fell out, but I didn’t have time to quickly put it back in place. What to do?

If more than 3 hours have passed since the ring fell out or was removed, you need to proceed according to the following scheme:

1. If such a problem occurs in the 1st or 2nd week of using the NuvaRing ring, you need to return it to its place as quickly as possible. The contraceptive effect of the drug is reduced, and for some time the woman will not be protected from unwanted pregnancy. It is recommended to additionally use a condom for the next 7 days.
2. If the ring falls out during the 3rd week of use, it should be thrown away and a new one should be inserted immediately. In this case, there will be no menstrual-like bleeding, but scanty spotting may be observed. This is normal, there is no need to panic. The ring is removed after the prescribed 21 days, then a break is taken for 7 days and a new drug is introduced.
3. If a woman does not want to get a new ring immediately, she can wait for the withdrawal bleeding and insert NuvaRing after 7 days. This option is only possible if the ring never falls out during the first two weeks. If the problem has occurred before, see point 2.

Is it possible to remove a vaginal ring during sex?

Yes, but this makes no sense, because NuvaRing does not feel like a woman or a man. If the ring is nevertheless removed, it must be returned within 2-3 hours and no later.

Can a NuvaRing sink in too deep?

No, the contraceptive ring is securely attached to the vagina. It will not fall into the uterus, since the entrance to the reproductive organ is blocked by a closed pharynx. The ring has nowhere to go from the woman's genital tract, and even during sex it will not penetrate too deeply.

Is it possible to leave the NuvaRing ring in the vagina for 4 weeks?

This is acceptable because the contraceptive effect of the system lasts up to 28 days. After 4 weeks, the ring must be removed: hormone levels drop, and the woman loses protection against unwanted pregnancy.

Is it possible to freeze a NuvaRing?

You can store the birth control ring in the refrigerator for up to 12 hours. It is not recommended to freeze the system in the freezer. If you need to take a contraceptive with you (for example, when traveling to another city), use a special cooler bag.

Is it possible to cancel periods?

Yes, you can insert a new ring without a week's break. Menstruation will not come, but spotting may occur in the middle of the cycle. The new ring can be left in the vagina for 21 days (as usual).

How to postpone the date of menstruation when using the NuvaRing ring?

It’s very simple: you just need to insert a new ring not after 7 days, but, for example, 5 or 6 after removing the previous one. It is important to know: the shorter the break, the higher the likelihood of spotting in the middle of the cycle.

Can girls under 18 years old use the birth control ring?

The safety of NuvaRing has not been studied in adolescents. An in-person consultation with a doctor is required.

Should I use a ring if I have uterine prolapse?

With this pathology, the NuvaRing may fall out. It is recommended to use other means of contraception.

Why can't you take antibiotics if you have a ring?

This is not entirely true. If the doctor has prescribed antibacterial drugs, they must be taken. The problem is that when using some antibiotics (in particular ampicillin and tetracycline), there is a decrease in the contraceptive effect. While a woman is taking antibiotics, she should additionally use condoms - for the entire period of treatment and for 7 days after completing the course of therapy.

Can a NuvaRing break?

Yes, this is possible. The risk of ring rupture increases with the simultaneous use of vaginal suppositories against a fungal infection (thrush). During treatment, you must additionally use condoms and monitor the condition of the NuvaRing.

Can I use a birth control ring with tampons?

Yes, the use of tampons does not affect the functionality of NuvaRing. In rare cases, the ring may fall out after removing the tampon.

Does NuvaRing cause cervical cancer?

It is believed that the main cause of malignant lesions of the cervix is ​​the human papillomavirus (HPV), but not the use of hormonal contraceptives. Statistics show that women who have used NuvaRing are more likely to develop cervical cancer, but gynecologists attribute this to regular examinations by a doctor and annual tests (smear for oncocytology). It is worth noting that in this situation, the disease is usually detected in the early stages, when it is much easier to cure.

How quickly can you get pregnant after removing the NuvaRing?

Fertility restoration occurs within 1-3 months after discontinuation of the drug. This means that a woman can become pregnant in the first cycle after removing the ring. In some cases, conception of a child occurs after 3-12 months.

How does the menstrual cycle change after the installation of a vaginal ring?

After the introduction of NuvaRing, the gradual release of hormones begins. The menstrual cycle becomes monotonous. The level of your own hormones remains stable. Menstruation, as a rule, becomes less abundant and its duration decreases. Menstrual-like bleeding due to NuvaRing occurs every 28 days strictly according to schedule.

How much does NuvaRing cost?

The average price for a contraceptive ring is about 1,000 rubles.

Thank you

The site provides reference information for informational purposes only. Diagnosis and treatment of diseases must be carried out under the supervision of a specialist. All drugs have contraindications. Consultation with a specialist is required!

Introduction

Doctors around the world are trying to create remedies contraception maximally convenient for women, safe, comfortable to use. Therefore, new, unfamiliar products appear in pharmacies from time to time. contraception; How to use them is not very clear. Currently in Russia, such contraceptives include the hormonal ring NuvaRing(although women all over the world have been using this remedy for more than a decade). We will try to give as complete an idea as possible about this method of contraception.

What is NuvaRing?

NuvaRing is a contraceptive in the form of an elastic, smooth, transparent ring that is inserted into a woman’s vagina and remains there for three weeks. Inside the female body, the ring changes its shape, occupying the optimal position in accordance with the individual characteristics of the physique. The flexible, soft ring does not cause any discomfort and does not remind you of yourself in any way.

With NuvaRing you don’t need to limit your physical activity: you can safely engage in any sport, including running, swimming, and horse riding. During sexual relations, the ring is not felt at all by the partners and does not create any inconvenience.

The dimensions of the ring are the same for everyone: thickness - 4 mm, diameter - 54 mm. This size is suitable for every woman, regardless of her height, weight and age, as it is able to mold to the individual contours of the body.

NuvaRing is produced in the Netherlands in one single form: in the form of a ring. There are no NuvaRing tablets. NuvaRing 1 and NuvaRing 3 differ in the number of rings in the package (one ring or three).

Composition and principle of action

Shell contraceptive ring consists of anti-allergic material. Under the shell, the NuvaRing ring contains a minimum dose of two female sex hormones (estrogen and progestogen). This dose is less than even that contained in any of the microdosed birth control pills.

When the NuvaRing ring is inserted into the vagina, its shell heats up to the temperature of the human body (34-42 o) and becomes permeable to the hormones contained inside the ring. Released from under the membrane, hormones act directly on the uterus and ovaries. Other organs remain outside the influence of hormones.

The dose of hormones contained in NuvaRing is enough to suppress the maturation of the egg and its release from the ovary. As a result, pregnancy becomes impossible.

Advantages of the method

• Reliability and high efficiency of contraceptive action.
• Ease of use: replacement only once a month.
• The body is minimally affected by hormones due to their low dosage.
• Hormones act only locally, without putting unnecessary stress on the liver, stomach and intestines.
• A woman’s weight does not increase when using NuvaRing.
• The regularity of the menstrual cycle is restored (if it was disrupted). Menstruation becomes less painful.
• The use of NuvaRing reduces the risk of ovarian and uterine cancer.
• Ensuring a full, natural, harmonious sex life.
• Rapid restoration of ovulation and fertility (within 4-5 weeks after removal of the hormonal ring).
• If desired, a woman can keep the use of NuvaRing secret: the partner will not feel the presence of the ring in the vagina.

Disadvantages of the method

There are only three disadvantages:

1. The method of contraception is psychologically unusual.
2. The presence of a fairly extensive list of contraindications.
3. NuvaRing, like other hormonal contraceptives, does not provide protection against sexually transmitted diseases, including AIDS (HIV infection).

Technique of use (how to insert NuvaRing)

The woman inserts the contraceptive ring into the vagina on her own, choosing a comfortable position for this: lying down, squatting, or standing, leaning her back against the wall and raising one leg. The ring is inserted during menstruation (on the 1st – 5th day). Hands must be washed clean. NuvaRing should be squeezed with your fingers, reducing its diameter, and inserted as deep as possible into the vagina. The smooth ring will slide inside the body without hindrance. If you feel uncomfortable after this, adjust the ring with your fingers. Once in the correct position, it will become imperceptible. It doesn’t matter where exactly the NuvaRing is fixed in the vagina: an indicator of correct insertion is the absence of discomfort.

After insertion of the contraceptive ring, it is not removed for three weeks. If NuvaRing is accidentally removed (for example, together with a tampon), it is washed with warm water and returned to its original place.

When the time comes to remove the hormonal ring, it is carefully pulled out by hooking it with the index finger or pinched between the middle and index fingers.

Application

The effect of one NuvaRing ring is designed for the duration of one menstrual cycle. The ring placed inside the vagina is removed on the 22nd day after insertion. In order not to lose your calculations, remember: remove the ring on the same day of the week on which it was inserted (introduced on Wednesday - remove it three weeks later on Wednesday; inserted on Friday - remove it three weeks later on Friday). It is better, of course, to mark the day of insertion and the day of removal on the calendar in advance.

After removing the ring, a 7-day break is required. On the 8th day, a new ring can be inserted.

If the patient has not previously used hormonal contraceptives, NuvaRing is administered, as mentioned above, between the 1st and 5th days of menstruation (no later than the 5th day).

If a woman switches to using NuvaRing after taking combined hormonal pills, the ring is inserted after a week-long break in contraception, on the day when she was supposed to start taking pills from the new package.

After taking the mini-pill, NuvaRing can be administered any day. After using intrauterine systems or implants - the next day after removing the IUD or implant. After injection contraception - on the day when the next injection is due.

In any case, during the first week of using NuvaRing it is recommended to additionally use a condom as a barrier method of contraception.

Use of NuvaRing after abortion or childbirth
If the abortion was performed in the first three months of pregnancy, NuvaRing can be administered immediately after the abortion. In this case, you do not need to use an additional condom.

If for some reason the hormonal ring was not inserted immediately after the abortion, you should wait until menstruation and insert NuvaRing from the 1st to the 5th day (plus using a condom for a week).

If the abortion took place in the second three weeks of pregnancy, then, just as after childbirth, you can start using NuvaRing only three weeks after the abortion. There is no need to use a condom.

If they want to introduce NuvaRing later than 21 days after childbirth or abortion, and during the intervening period there has been sexual intercourse, you need to wait until the first menstruation begins (to make sure there is no new pregnancy). Using a condom for a week is mandatory.

Break in use

If a woman, for any reason, violates the regimen of using NuvaRing and takes a break from using the contraceptive ring for more than 7 days, the contraceptive effect may be lost. The longer the break, the greater the risk of unwanted pregnancy. To prevent this from happening, you must follow these recommendations:
1. If there is an extended break in using NuvaRing, you need to insert a new ring into the vagina as soon as possible (plus using a condom for a week).
2. If the ring was removed accidentally, there are 2 possible scenarios:

• If NuvaRing was outside the vagina for less than three hours, the contraceptive effect of the hormones will not be interrupted. The ring should be returned to its place as soon as possible.
• If the hormonal ring is removed from the vagina for more than three hours, the contraceptive effect may be reduced. The ring, as in the previous case, must be immediately returned inside the vagina, and not removed from there for at least 7 days (plus the use of a condom for a week). Even if this episode occurred during the 3rd week of using NuvaRing, when the ring would soon have to be removed, you will have to extend the period of its use beyond 3 weeks (until 7 days have passed since the ring was returned to its place). Only then can the NuvaRing be removed and a new ring put in a week later.

Extended use

If a woman forgot to take out NuvaRing in time, and the ring was inside the vagina for 3 to 4 weeks, the contraceptive effect remains. The ring is removed as usual, and a new one is inserted a week later.

If NuvaRing remains in the vagina for more than 4 weeks, its contraceptive effect is reduced, and after removing the ring, a new one can be inserted only after making sure there is no pregnancy, i.e. waiting for the start of menstruation.

Menstruation and bleeding during and after NuvaRing use
cancellations

A break in the use of NuvaRing in most women causes bleeding associated with the cessation of hormonal effects. Bleeding begins 2-3 days after extraction
contraceptive ring, and may stop after the introduction of a new ring (but maybe earlier).

In some women, a break in the use of Nuvaring is not accompanied by bleeding. This option can be considered normal if the hormonal ring was used strictly according to the recommendations, and the absence of bleeding was noted once.

While NuvaRing is in the vagina, irregular, slight spotting may occur. It is also possible that there may be sudden onset of severe bleeding. Minor discharge does not require visiting a doctor, but with heavy bleeding you should urgently see a gynecologist.

Cancellation of NuvaRing

Cancellation of NuvaRing does not require any special preparation. The contraceptive ring is simply removed when you decide to stop using contraception.

Pregnancy after stopping the contraceptive ring

After removing the NuvaRing ring, the effect of hormones on the female body stops. The ovulation process is restored, i.e. maturation of a normal egg. Within 4-5 weeks after discontinuation of NuvaRing, conception and a full, normal pregnancy may occur. There are no consequences after using the vaginal ring.

Side effects

When using the NuvaRing hormonal ring, side effects are quite rare. Typically, these phenomena occur at the beginning of using the product, and soon go away on their own, without requiring treatment.

Side effects include the following symptoms:

• Reactions of the central nervous system - dizziness, headache, mood swings, anxiety.
• Reactions of the digestive system - nausea, sometimes abdominal pain, diarrhea, vomiting.
• Reactions of the endocrine system - changes in body weight (weight gain or loss may be noted), some increase and engorgement

Unwanted pregnancy is what worries most women. Everyone knows that abortions are harmful to health, and that is why birth control is the most pressing issue. Gynecologists, in turn, ring the bells, because taking some new generation contraceptives, unplanned pregnancies still end in abortions.

Medicine and pharmacology do not stand still. New modern drugs that protect against pregnancy are being developed and improved. This allows us to reduce the number of abortions and the consequences after them. Now there are not only hormonal pills, but also a whole group of topical medications.

How do modern contraceptives work?

Vaginal contraceptives work very simply - when a chemical enters the body, it kills sperm. Oral contraceptives prevent eggs from developing in the ovaries. They affect the uterine mucus, making it viscous and impenetrable for sperm. Birth control pills slow down or completely prevent the embryo from attaching to the cervix. All this prevents pregnancy from occurring.

Local medications, for example, suppositories, are a local and chemical method of preventing pregnancy. They contain nanoxynalone or benzalkonium. It is these active substances that affect spermatozoa and make them immobile by disrupting the integrity of the membrane.

The vaginal ring is one of the methods of contraception and belongs to the group of hormonal drugs. It is made of elastic material, which contains a small dose of progesterone and estrogen. The dosage is such that the release of a mature egg is prevented. There are other contraceptives that are highly effective and safe.

Are modern contraceptives harmful?

If the contraceptive is chosen incorrectly, it can harm the female body. For example, side effects will occur, weight will begin to gain, and hair growth will increase. This applies only to hormonal drugs, which are contraindicated for diseases of the cardiovascular system and diabetes. Even with problems in the liver and kidneys, such drugs are contraindicated. Women who smoke need to choose other contraceptives, since hormonal drugs put a powerful strain on the heart. There is also an increased risk of thrombosis.

According to medical indicators, if you regularly take hormonal drugs for a long time, sexual activity gradually decreases. This is explained by a decrease in testosterone production.

What types of contraceptives are there?

Contraceptives come in a variety of types and forms: hormonal pills, intrauterine devices, condoms, topical medications, injections.

"Jess" is a popular new generation of contraceptives. These are not only birth control pills, but also a drug that treats certain gynecological disorders and hormone dependence. This remedy treats acne and other facial skin imperfections. The contraceptive effect is achieved due to estrogens and gestagens included in the drug. They are the ones who block ovulation.

“Jess” affects health during menstruation. Its composition has an effect on reducing anemia and pain symptoms. Your periods are going faster. Very often, gynecologists prescribe this remedy for severe PMS symptoms. The advantage of these tablets over similar drugs is their low concentration of active substances. The drug is prescribed to women before menopause.

Jess Plus is an effective contraceptive. In addition to hormones that inhibit sperm passage and block ovulation, the drug contains folate (calcium levomefolate). This is a type of folic acid that is essential for a woman's normal health. B9 is quickly absorbed into the blood and has an effect on the nervous system. This drug is unique in that, unlike all contraceptive drugs, it provides the greatest guarantee. In addition, the composition of the product protects the woman from all troubles if pregnancy suddenly occurs. Her body will be prepared for this, and the active form of the drug will help eliminate deficiencies in the formation of the neural tube of the future fetus, that is, eliminate the development of disorders of the baby’s nervous system. This is a safe remedy for women of reproductive age. It can be used from the age of 18 until the onset of menopause.

Marvelon is a new generation of contraceptives for people over 35 years of age. Women who have already given birth and are of childbearing age should take low-dose hormonal medications. Marvelon can also be taken by women who have not given birth. It contains minimal hormone content. This drug belongs to the group of oral hormonal contraception. Intended for women with an active sex life. The composition of the tablets provides high-quality and complete protection against pregnancy. Medical indicators – 99% protection. Marvelon is safe for health, easy to use, and helps eliminate the problems of women during menstruation. If a woman experiences severe PMS syndrome, gynecologists often resort to prescribing this remedy. The low-dose drug contains ethinyl stradiol, gestodene, and norgistimate. These hormones are perfect for women after 35 years of age, as they improve the condition of facial skin, normalize hormonal balance and reduce the growth of unwanted hair. The drug is recommended for women over 25 years of age and before menopause.

Depo-Provera is a new generation of contraceptives for people over 40 years of age. It appeared on the pharmacological market not so long ago. This is a synthetic product of progesterone hormones. Currently, the drug is prescribed to women for contraception, treatment of a number of gynecological pathologies and even oncological pathologies. Women over 40 years of age can also take oral contraceptives, but doctors give preference to special injections. Depo-Provera is a suspension that contains medroxyprogesterone acetate. Once it is injected under the skin, it begins to act as a contraceptive and block ovulation. The injections are very effective, are administered intramuscularly, and have a number of positive therapeutic effects. Belongs to the group of safe drugs with minimal side effects. Recommended for use by women over 40 years of age and before menopause.

Pharmatex vaginal suppositories are excellent new generation contraceptives after 45 years. Since it is very difficult to choose contraceptives for women at this age, as there are various difficulties, Pharmatex is a reliable and safe option.

By this age, a bunch of acquired diseases are observed, and what could be taken in youth is not at all suitable for 45 years. Closer to menopause, gynecologists prescribe barrier contraceptives to women. It could also be condoms. But for those who are sexually active, the only way to avoid getting pregnant is to use vaginal suppositories. Pharmatex is such an effective remedy that it is compared to hormonal contraceptive ballet shoes and an intrauterine device. In addition to protecting against pregnancy, the active components protect a woman from various diseases because they destroy pathogenic microflora. Candles are recommended for use from the age of 45 until the full onset of menopause.

"Patentex Oval" - modern contraceptive suppositories. It contains chemical components nonoxynol and auxiliary substances that reduce the tension of the lipid membrane of sperm. Once in the vagina, suppositories paralyze the ability of sperm to move. The mechanical obstruction is caused by a spermatocidal substance, which, under the influence of body temperature, is distributed throughout the vagina. Thus, a stable barrier is formed. This prevents sperm from penetrating into the cervix.

The drug provides good prophylaxis against various infections. These suppositories can be used at any reproductive age, including after 45 years.

Nuvaring is a modern contraceptive. This is a ring made of a smooth and elastic material; it contains hormonal components that affect the movement of sperm and prevent them from moving into the uterus. A ring is inserted into the vagina. Since it is quite flexible, it takes the desired shape. This method of protection is convenient and safe. The ring does not interfere with leading a full life and engaging in sexual intercourse. There is no discomfort. The ring contains estrogen and progestogen. The ring is valid for one menstrual cycle. An excellent and effective remedy that treats a number of gynecological diseases. Prescribed to women aged 18 years and before menopause.

"Lactinet" is a contraceptive called a mini-pill. Each tablet contains synthetic analogues of female hormones. Progestin and estrogen interfere with the movement of sperm into the uterus. "Laktinent" is not more effective than combined contraceptives and has a number of contraindications, so these drugs should be prescribed only by gynecologists. Mini-pills are usually prescribed only to breastfeeding women or when combination drugs are contraindicated. These drugs are also prescribed to women over 45 years of age with varicose veins and diabetes mellitus. Suitable for women who smoke.

Contraceptive sponges are used more and more often. Some women do not want to be protected by contraceptives and barrier contraceptives help them save themselves from unwanted pregnancy. Contraceptive sponges do not allow sperm to penetrate into the cervix due to a mechanical obstacle and the release of a special spermicidal substance.

Modern contraceptive sponges are made of soft polyurethane. Contains benzalkonium chloride and nonoxynol. They are very easy to use. Prescribed to women of any reproductive age.

The most common method of protection against unwanted pregnancy is intrauterine contraception. The material used is polyethylene, which contains barium sulfate. Modern spirals differ in shape from those used 10 years ago. The spiral contains coating (copper or silver). The T-shaped intrauterine device is most often used.

This method of preventing unwanted pregnancy is not new, but, nevertheless, some forms and types of contraceptives belong to the means of the new generation. Some coils contain progestin or antibiotics. Inserted deep into the cervix.

Women who belong to the progesterone type, that is, have an angular figure, small breasts, who have skin problems and menstruation are accompanied by painful symptoms, should give preference to drugs with an antiandrogenic effect. These are: “Jess”, “Jess plus”, “Yarina”, etc.

If a woman has normal skin and her periods are painless, then you can choose the drugs Mercilon, Regulon, Femoden and others.

It is also important to know that hormonal drugs are addictive, so you should take a break, otherwise side effects may appear.

Catad_pgroup Local contraceptives

Indications for use
- Contraception
- Idiopathic menorrhagia
- Prevention of endometrial hyperplasia during HRT

INFORMATION IS PROVIDED STRICTLY
FOR HEALTH PROFESSIONALS

NuvaRing - official* instructions for use

*registered by the Ministry of Health of the Russian Federation (according to grls.rosminzdrav.ru)

INSTRUCTIONS
on the use of a medicinal product for medical use

Registration number:

Tradename:

NuvaRing ®

International nonproprietary name or generic name:

ethinyl estradiol + etonogestrel

Dosage form:

vaginal rings

Compound

1 vaginal ring contains:
active substances: etonogestrel – 11.7 mg, ethinyl estradiol – 2.7 mg;
Excipients: ethylene and vinyl acetate copolymer – 1677 mg, ethylene and vinyl acetate copolymer – 197 mg, magnesium stearate – 1.7 mg.

Description

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

Pharmacotherapeutic group:

combined contraceptive (estrogen + gestagen)

ATX code: G02BB01

Pharmacological properties

Pharmacodynamics

Mechanism of action
The drug NuvaRing ® is a hormonal combined contraceptive containing etonogestrel and ethinyl estradiol. Etonogestrel is a progestogen (19-nortestosterone derivative) that binds with high affinity to progesterone receptors in target organs. Ethinyl estradiol is an estrogen and is widely used in the production of contraceptives.
The contraceptive effect of the drug 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 incidence 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 the statistical analysis of all randomized participants (ITT analysis) and the analysis of study participants who completed the study 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).
With the use of the drug NuvaRing ®, the cycle becomes more regular, the pain and intensity of menstrual-like bleeding decreases, which helps reduce the incidence of iron deficiency conditions. There is evidence of a reduction in the risk of endometrial and ovarian cancer with the use of the drug.

Nature of bleeding
A comparison of bleeding patterns over one year in 1000 women using the drug NuvaRing ® and COCs containing levonorgestrel / ethinyl estradiol (0.150/0.030 mg) showed a significant reduction in the frequency of breakthrough bleeding or spotting when using the drug NuvaRing ® compared with COOK. In addition, the frequency of cases where bleeding occurred only during a break in the use of the drug was significantly higher among women using the drug NuvaRing ® .

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

Children
The safety and effectiveness of NuvaRing ® in adolescent girls under 18 years of age has not been studied.

Pharmacokinetics

Etonogestrel

Suction
Etonogestrel, released from the NuvaRing ® vaginal ring, is rapidly absorbed through the vaginal mucosa. The maximum concentration of etonogestrel in blood plasma, approximately 1700 pg/ml, is achieved approximately 1 week after insertion of the ring. Plasma concentrations vary within a small range and decrease slowly to approximately 1600 pg/ml after 1 week, 1500 pg/ml after 2 weeks and 1400 pg/ml after 3 weeks of use. Absolute bioavailability is about 100%, which exceeds the bioavailability of etonogestrel when taken orally. Based on the results of measurements of etonogestrel concentrations in the cervix and inside the uterus in women using the drug NuvaRing ® 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 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 through known pathways of sex hormone metabolism. The apparent clearance of blood plasma is about 3.5 l/h. No direct interaction with ethinyl estradiol taken concomitantly has been identified.

Removal
Plasma concentrations of etonogestrel decrease 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, released from the NuvaRing ® vaginal ring, is rapidly absorbed through the vaginal mucosa. The maximum plasma concentration of about 35 pg/ml is achieved 3 days after administration 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 ethinyl estradiol. Based on the results of measurements of ethinyl estradiol concentrations in the cervix and inside the uterus in women using the drug NuvaRing ® and women using oral contraceptives containing 0.150 mg of desogestrel and 0.020 mg of ethinyl estradiol, the observed values ​​of ethinyl estradiol concentrations were comparable.
Ethinyl estradiol concentrations were studied in a comparative randomized study of NovaRing ® (daily vaginal release of ethinyl estradiol 0.015 mg), transdermal patch (norelgestromin / ethinyl estradiol; daily release of ethinyl estradiol 0.020 mg) and COC (levonorgestrel / ethinyl estradiol; daily release of ethinyl estradiol ol 0.030 mg) during one cycle in healthy women. Systemic exposure to ethinyl estradiol over the course of a month (AUC0-?) for the drug NuvaRing ® was statistically significantly lower than for the patch and COCs, and amounted to 10.9, 37.4 and 22.5 ng h/ml, respectively.

Distribution
Ethinyl estradiol binds nonspecifically to plasma albumin. The apparent volume of distribution is approximately 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 freely or as sulfate and glucuronide conjugates. The apparent clearance is approximately 35 l/h.

Removal
Plasma ethinyl estradiol concentrations decrease in two phases. The half-life in the terminal phase varies widely; the median is about 34 hours. Ethinyl estradiol is not excreted unchanged. Ethinyl estradiol metabolites are excreted by the kidneys and through the intestines 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 NovaRing ® in healthy adolescent girls under 18 years of age who have already menstruated have not been studied.

Renal dysfunction
The effect of kidney disease on the pharmacokinetics of NovaRing ® has not been studied.

Liver dysfunction
The effect of liver diseases on the pharmacokinetics of NovaRing ® has not been studied. However, in patients with impaired liver function, the metabolism of sex hormones may deteriorate.

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

Indications for use

Contraception.

Contraindications

The drug NuvaRing ® is contraindicated in the presence of any of the conditions listed below. If any of these conditions occur during the use of the drug NuvaRing ®, you should immediately stop using the drug.

• Thrombosis (arterial or venous) and thromboembolism currently or in history (including deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disorders).
• Conditions preceding thrombosis (including transient ischemic attacks, angina) currently 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 (anticardiolipin antibodies, lupus anticoagulant).
• Migraine with focal neurological symptoms currently or in history.
• Diabetes mellitus with vascular damage.
• Severe or multiple risk factors for venous or arterial thrombosis: hereditary predisposition to thrombosis (thrombosis, myocardial infarction or cerebrovascular accident at a young age in one of the immediate family), hypertension, lesions of the valvular apparatus of the heart, atrial fibrillation, extended surgery, prolonged immobilization, extensive trauma, obesity (body weight >30 kg/m²), smoking in women over 35 years of age (see section “Special instructions”).
• Pancreatitis with severe hypertriglyceridemia, current or history.
• Severe liver diseases.
• Liver tumors (malignant or benign), including history.
• Known or suspected hormone-dependent malignant tumors (for example, genital or breast).
• Bleeding from the vagina of unknown etiology.
• Pregnancy, including suspected pregnancy.
• Hypersensitivity to any of the active or excipients of the drug NuvaRing ®.

Carefully

If any of the diseases, conditions or risk factors listed below are present, the benefits of using the drug NuvaRing ® and the possible risks for each individual woman should be assessed before she starts using the drug NuvaRing ® (see section “Special Instructions”). In case of exacerbation of diseases, deterioration of the condition, or the first occurrence of any of the conditions listed below, a woman should consult a doctor to decide on the possibility of further use of the drug NuvaRing ®.

The drug NuvaRing ® should be used with caution in the following cases:

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

Use during pregnancy and breastfeeding

The drug NuvaRing ® is intended to prevent pregnancy. If a woman wants to stop using the drug in order to become pregnant, it is recommended to wait for the restoration of the natural cycle to conceive, as this will help to correctly calculate the date of conception and birth.

Pregnancy

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

Breastfeeding period

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

Directions for use and doses

To achieve a contraceptive effect, the drug NuvaRing ® must be used according to the instructions.

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

The doctor should inform the woman how to insert and remove the NuvaRing ® vaginal ring. To insert the ring, the woman should choose a comfortable position, for example, standing, raising one leg, squatting or lying down. The NuvaRing ® vaginal ring should be squeezed and inserted into the vagina until the ring is in a comfortable position. The exact position of the ring in the vagina is not decisive for the contraceptive effect (Fig. 1-4).

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

The NuvaRing ® vaginal ring should be removed after 3 weeks on the same day of the week when the ring was inserted into the vagina. After a week's break, a new ring is inserted (for example, if the NuvaRing ® vaginal ring was installed on Wednesday at approximately 10:00 pm, it should be removed on Wednesday 3 weeks later at approximately 10:00 pm. A new ring is inserted on the next Wednesday). To remove the ring, you need to pick it up with your index finger or squeeze it with your index and middle fingers and pull it out of the vagina (Fig. 5). The used ring should be placed in a bag (keep out of the reach of children and pets) and discarded. Bleeding associated with the cessation of the action of the drug NuvaRing ® usually begins 2-3 days after removal of the NovaRing ® vaginal ring and may not completely stop until a new ring is installed.

How to start using the drug NuvaRing ®?

• No hormonal contraceptives were used in the previous cycle
  The drug NuvaRing ® should be administered on the first day of the cycle (i.e., on the first day of menstruation). It is possible to install a ring on days 2-5 of the cycle, however, in the first cycle in the first 7 days of using the drug NuvaRing ®, additional use of barrier methods of contraception is recommended.
• Switching from combined hormonal contraceptives
  A woman should insert the NuvaRing ® vaginal ring on the last day of the usual interval between cycles when taking combined hormonal contraceptives (pills or patch).
  If a woman has taken a combined hormonal contraceptive correctly and regularly and is sure that she is not pregnant, she can switch to using a vaginal ring on any day of the cycle.
  In no case should you exceed the recommended hormone-free interval of the previous method.
• Switching from progestogen-only medications (mini-pills, progestin-only oral contraceptives, implants, injectables, or hormone-containing intrauterine systems (IUDs))
  A woman taking mini-pills or progestin-only oral contraceptives can switch to using NuvaRing ® on any day. The ring is inserted on the day of removal of the implant or IUD. If a woman received injections, then use of the drug NuvaRing ® begins on the day when the next injection should have been given. In all these cases, the woman should use a barrier method of contraception for the first 7 days after insertion of the ring.
• After an abortion in the first trimester
  A woman can insert the ring immediately after an abortion. In this case, she does not need additional contraceptives. If the use of the drug NuvaRing ® immediately after an abortion is undesirable, it is necessary to follow the recommendations given in the subsection “In the previous cycle, hormonal contraceptives were not used.” In the interval, the woman is recommended an alternative method of contraception.
• After childbirth or after an abortion in the second trimester
  A woman is advised to have the ring inserted no earlier than 4 weeks after giving birth (if she is not breastfeeding) or having a second trimester abortion. If the ring is installed at a later date, it is recommended to use an additional barrier method for the first 7 days. However, if sexual intercourse has already taken place, then before using the drug NuvaRing ® it is necessary to exclude pregnancy or wait until the first menstruation.

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

• What to do if the break in using the ring is prolonged?
  If you had sexual intercourse during a break in using the ring, pregnancy should be ruled out. The longer the break, the higher the likelihood of pregnancy. If pregnancy is ruled out, the woman should insert a new ring into the vagina as quickly as possible. Over the next 7 days, an additional barrier method of contraception, such as a condom, should be used.
• What to do if the ring has been temporarily removed from the vagina?
  The ring must remain in the vagina continuously for 3 weeks. If the ring is accidentally removed, it should be washed with cold or slightly warm (not hot) water and immediately inserted into the vagina.
  • If the ring remains outside the vagina for less than 3 hours, its contraceptive effect is not reduced. The woman should insert the ring into the vagina as quickly as possible (no later than after 3 hours).
  • If the ring was outside the vagina for more than 3 hours during the first or second week of use, the contraceptive effect may be reduced. A woman should insert the ring into her vagina as quickly as possible. Over the next 7 days, you must use a barrier method of contraception, such as a condom. The longer the ring was outside the vagina and the closer this period is to the 7-day break in using the ring, the higher the likelihood of pregnancy.
  • If the ring was outside the vagina for more than 3 hours in the third week of use, the contraceptive effect may be reduced. The woman should throw away the ring and choose one of the following two methods.
    1. Immediately install a new ring.
       Note: the new ring can be used for the next 3 weeks. In this case, there may be no bleeding associated with the cessation of the drug. However, spotting or bleeding in the middle of the cycle is possible.
    2. Wait for bleeding associated with the cessation of the drug, and insert a new ring no later than 7 days after removing the previous ring.
       Note: This option should be chosen only if the ring application regimen has not been violated during the first two weeks.
• What to do in case of prolonged use of the ring?
  If the drug NuvaRing ® was used for no more than a maximum period of 4 weeks, then the contraceptive effect remains sufficient. A woman can take a week's break from using the ring and then insert a new ring.
  If the NuvaRing ® vaginal ring remains in the vagina for more than 4 weeks, the contraceptive effect may worsen, so pregnancy must be excluded before inserting a new ring.
  If a woman does not adhere to the recommended regimen and bleeding does not occur after a week's break in using the ring, then pregnancy should be ruled out before introducing a new ring.
• How to shift or delay the onset of menstrual bleeding?
  To delay menstrual-like withdrawal bleeding, a woman can insert a new ring without a week's break. The next ring must be used for 3 weeks. This may cause spotting or bleeding. Then, after the usual one-week break, the woman returns to regular use of the drug NuvaRing ® .
  To postpone the onset of bleeding to another day of the week, a woman may be advised to take a shorter break from using the ring (for as many days as necessary). The shorter the break in using the ring, the higher the likelihood of no bleeding occurring after the ring is removed and bleeding or spotting occurring during the use of the next ring.

Children

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

Side effect

When using the drug, side effects may occur, occurring with varying frequencies: often (?1/100), infrequently (<1/100, ?1/1 000), редко (<1/1 000, ?1/10 000).

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

Interaction with other drugs and other types of interactions

Interaction with other drugs

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

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 can lead to increased clearance of sex hormones. Interactions have been established, for example, with phenytoin, barbiturates, primidone, carbamazepine, rifampicin, and also possibly with oxcarbazepine, topiramate, felbamate, ritonavir, griseofulvin and preparations containing St. John's wort (Hypericum perforatum).

When treating with any of the listed drugs, you should temporarily use a barrier method of contraception (condom) in combination with the use of the drug NuvaRing ® or choose another method of contraception. During concomitant use of drugs that induce microsomal enzymes, and for 28 days after their discontinuation, barrier methods of contraception should be used.

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

Antibiotics: a decrease in the effectiveness of oral contraceptives containing ethinyl estradiol has been observed with concomitant use of antibiotics such as ampicillin and tetracyclines. The mechanism of this effect has not been studied. In a pharmacokinetic interaction study, oral administration 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 drug NuvaRing ® had little effect on the pharmacokinetics of etonogestrel and ethinyl estradiol. When using antibiotics (excluding amoxicillin and doxycycline), you should use a barrier method of contraception (condom) during treatment and for 7 days after stopping antibiotics. If concomitant therapy is to be continued after 3 weeks of ring use, the next ring should be administered immediately without the usual interval.

Pharmacokinetic studies did not reveal the effect of the simultaneous use of antifungal agents and spermicides on the contraceptive effectiveness and safety of the drug NuvaRing ®. When combined with suppositories and antifungal drugs, the risk of ring rupture slightly increases.

Hormonal contraceptives may interfere with the metabolism 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 should read the instructions for use of other drugs.

Laboratory research

The use of contraceptive hormonal drugs may affect the results of certain laboratory tests, including biochemical indicators of liver, thyroid, adrenal and kidney function; on the plasma concentration of transport proteins, for example, corticosteroid binding globulin (CBG) and SHBG; for lipid/lipoprotein fractions; on indicators of carbohydrate metabolism; as well as on indicators of 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 hormones released from the NovaRing ® vaginal ring. In rare cases, the ring may be accidentally removed when the tampon is removed (see the subsection “What to do if the ring has been temporarily removed from the vagina” in the “Dosage and Administration” section).

special instructions

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

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 fatal.

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

According to research results, the increased risk of developing VTE in women using the drug NuvaRing ® is similar to that in women using COCs (for adjusted risk ratio, see the table below). A large prospective observational study, TASC (Transatlantic Active Study of the Cardiovascular Safety of NuvaRing ®), assessed the risk of VTE in women who started using NuvaRing ® or COCs, switched to NuvaRing ® or COCs from other contraceptives, or resumed using NuvaRing ® or COCs. use of the drug NuvaRing ® or COCs in a population of typical users. The women were followed for 24-48 months. The results showed a similar level of risk of developing VTE in women using the drug NuvaRing ® (incidence of 8.3 cases per 10,000 YL) and in women using COCs (incidence of 9.2 cases per 10,000 YL). For women using COCs other than those containing desogestrel, gestodene and drospirenone, the incidence of VTE was 8.5 cases per 10,000 women.

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

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

Epidemiological study, population	Comparator(s)	Risk ratio (RR) (95% CI)
TASC (Dinger, 2012) Women who started using the drug (including again after a break) and switched from other means of contraception.	All available COCs during the study 1.	OR 2: 0.8 (0.5-1.5)
	Available COCs other than those containing desogestrel, gestodene, drospirenone.	OR 2: 0.9 (0.4-2.0)
"FDA Initiated Study" (Sydney, 2011) Women who started using combined hormonal contraceptives (CHCs) for the first time during the study period.	COCs available during the study period 3 .	OR 4: 1.09 (0.55-2.16)
	Levonorgestrel / 0.03 mg ethinyl estradiol.	OR 4: 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 age, place and year of inclusion in the study.

There are extremely rare cases of thrombosis of other blood vessels (for example, arteries and veins of the liver, mesenteric vessels, kidneys, brain and retina) with the use of COCs. It is unknown whether these cases are related to the use of COCs.

Possible symptoms of venous or arterial thrombosis may be unilateral swelling and/or pain in the lower extremity, local increase in temperature in the lower extremity, hyperemia or discoloration of the skin on the lower extremity; sudden severe chest pain, possibly radiating to the left arm; 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, accompanied or not accompanied by a focal epileptic seizure; sudden weakness or severe numbness on one side of the body or any part of the body; movement disorders; "acute" stomach.

Risk factors for the development of venous thrombosis and embolism:

• age;
• presence of diseases in the family history (venous thrombosis and embolism in brothers/sisters at any age or in parents at a young age). If a hereditary predisposition is suspected, before starting any hormonal contraceptives, the woman should be referred to a specialist for consultation;
• prolonged immobilization, major surgery, any surgery on the lower extremities or serious trauma. In such situations, it is recommended to stop using the drug (in the case of a planned operation, at least 4 weeks in advance) with subsequent resumption of use no earlier than 2 weeks after complete restoration of motor activity;
• possibly thrombophlebitis of the superficial veins with 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 significantly, especially in women over 35 years of age);
• dyslipoproteinemia;
• obesity (body mass index more than 30 kg/m²);
• increased blood pressure;
• migraine;
• heart valve disease;
• atrial fibrillation;
• presence of diseases in the family history (arterial thrombosis in brothers/sisters at any age or in parents at a relatively early age). If a hereditary predisposition is suspected, the woman should be referred to a specialist for consultation before starting any hormonal contraceptives.

Biochemical factors that may indicate hereditary or acquired predisposition to venous or arterial thrombosis include activated protein C resistance, hyperhomocysteinemia, antithrombin III deficiency, protein C deficiency, protein S deficiency, antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant).

Other conditions that can cause unwanted circulatory problems include diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome and chronic inflammatory bowel disease (such as Crohn's disease or ulcerative colitis), as well as sickle cell anemia.

It is necessary to take into account the increased risk of thromboembolism in the postpartum period.

An increase in the frequency or severity of migraine (which may be a prodromal symptom of cerebrovascular accidents) while using hormonal contraceptives may be a reason to immediately discontinue use of hormonal contraceptives.

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

Risk of developing tumors

The most important risk factor for developing cervical cancer is infection with the human papillomavirus (HPV). Epidemiological studies have shown that long-term use of COCs further increases this risk, but it is unclear how much of this is due to other factors, such as increased frequency of cervical smears and differences in sexual behavior, including the use of barrier contraceptives. It remains unclear how this effect is related to the use of the drug NuvaRing ®.

A meta-analysis of 54 epidemiological studies found a small increase (1.24) in the relative risk of breast cancer in women taking combined hormonal oral contraceptives. The risk gradually decreases over 10 years after stopping the drugs. Breast cancer rarely develops in women under 40 years of age, 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 who use COCs is clinically less severe than cancer diagnosed in women who have never used COCs. The increased risk of breast cancer may be due to the earlier diagnosis of breast cancer in women taking COCs, the biological effects of COCs, or a combination of both.

In rare cases, cases of development of benign, and even more rarely, malignant liver tumors have been observed in women taking COCs. In some cases, these tumors 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 corresponding family history have an increased risk of developing pancreatitis when taking hormonal contraceptives.
• Many women taking hormonal contraceptives experience a slight increase in blood pressure, but clinically significant increases in blood pressure are rare. A direct connection between the use of hormonal contraceptives and the development of arterial hypertension has not been established. If, when using the drug NuvaRing ®, there is a constant increase in blood pressure, you should contact your doctor to decide whether it is necessary to remove the vaginal ring and prescribe antihypertensive therapy. With adequate control of blood pressure using antihypertensive drugs, it is possible to resume use of the drug NuvaRing ®.
• During pregnancy and during the use of combined oral contraceptives, the development or worsening of the following conditions was noted, although their relationship with the use of contraceptives has not been definitively established: jaundice and/or itching caused by cholestasis, formation of gallstones, porphyria, systemic lupus erythematosus, hemolytic -uremic syndrome, Sydenham's chorea (minor chorea), herpes of pregnancy, hearing loss due to otosclerosis, (hereditary) angioedema.
• Acute or chronic liver diseases may serve as a reason to discontinue the drug NuvaRing ® until liver function indicators normalize. Recurrence of cholestatic jaundice, previously observed during pregnancy or during the use of sex hormones, requires discontinuation of the drug NuvaRing ® .
• Although estrogens and progestogens may influence 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 the drug NuvaRing ® , especially in the first months of contraception.
• There is evidence of a worsening of Crohn's disease and ulcerative colitis with the use of hormonal contraceptives.
• In rare cases, pigmentation of the facial skin (chloasma) may occur, especially if it occurred earlier during pregnancy. Women predisposed to the development of chloasma should avoid exposure to sunlight and ultraviolet radiation while using NuvaRing ®.
• The following conditions may prevent the ring from being inserted correctly or may cause it to fall out: cervical prolapse, bladder and/or rectal hernia, severe chronic constipation.
• In very rare cases, women have unintentionally inserted the NuvaRing ® vaginal ring into the urethra and possibly into the bladder. When symptoms of cystitis appear, it is necessary to consider the possibility of incorrect insertion of the ring.
• Cases of vaginitis have been described during use of the drug NuvaRing ® . There is no evidence that treatment of vaginitis affects the effectiveness of the use of the drug NuvaRing ® , as well as evidence of the influence of the use of the drug NuvaRing ® on the effectiveness of treatment of vaginitis.
• Very rare cases of difficult ring removal have been described that required removal by a medical professional.

Medical examination/consultation

Before prescribing the drug NuvaRing ® or resuming its use, you should carefully review the woman’s medical history (including family history) 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 for use and follow all recommendations. The woman should be informed that NuvaRing ® does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Reduced efficiency

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

Reduced cycle control

During use of the drug NuvaRing ®, acyclic bleeding (spotting or sudden bleeding) may occur. If such bleeding is observed after regular cycles while using the drug NuvaRing ® correctly, you should contact your gynecologist to conduct the necessary diagnostic studies, including to exclude organic pathology or pregnancy. A diagnostic curettage may be required.

Some women do not bleed after the ring is removed. If the drug NuvaRing ® was used according to 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 removing the ring, as well as if there is no bleeding for two cycles in a row, pregnancy must be excluded.

Effects of ethinyl estradiol and etonogestrel on a sexual partner

The possible pharmacological effects and extent of exposure of ethinyl estradiol and etonogestrel to male sexual partners (due to absorption through penile tissue) have not been studied.

Ring damage

In rare cases, when using the drug NuvaRing ®, ring rupture was observed. The core of the drug NuvaRing ® is solid, so its contents remain intact, and the release of hormones does not change significantly. If the ring ruptures, it usually falls out of the vagina (see the recommendations in the subsection “What to do if the ring has been temporarily removed from the vagina” in the “Dosage and Administration” section). If the ring ruptures, a new ring must be inserted.

Ring falling out

Sometimes the NuvaRing ® vaginal ring may fall out of the vagina, for example, if it is inserted incorrectly, when a tampon is removed, during sexual intercourse, or due to severe or chronic constipation. In this regard, it is advisable for a woman to regularly check the presence of the NuvaRing ® vaginal ring in the vagina. If the NuvaRing ® vaginal ring falls out of the vagina, you must follow the recommendations of the subsection “What to do if the ring has been temporarily removed from the vagina” in the “Method of administration and dosage” section.

Impact on the ability to drive vehicles and operate machinery

Based on information about the pharmacodynamic properties of the drug NuvaRing ®, it can be expected that it does not affect the ability to drive vehicles and operate machinery.

Release form

Vaginal rings 0.015 mg + 0.120 mg/day. 1 ring is packed in a waterproof aluminum foil bag, coated on the inside with a layer of low-density polyethylene and on the outside with a layer of polyethylene terephthalate (PET). 1 or 3 packets per cardboard box with instructions for use.

Storage conditions

Store at a temperature of 2 to 8 °C.
Keep out of the reach of children.

Best before date

3 years.
Do not use after the expiration date stated on the package.

Vacation conditions

On prescription.

Legal entity in whose name the registration certificate was issued

N.V. Organon, Netherlands

Manufacturer

Produced:
N.V. Organon, Netherlands

Release quality control:
N.V. Organon, Netherlands
N.V. Organon, Kloosterstraat 6, 5349 AB, Oss, the Netherlands
or
Organon (Ireland) Ltd., Ireland
Organon (Ireland) Ltd., P.O. Box 2857, Drynam Road, Swords, Co. Dublin, Ireland

Consumer complaints should be sent to:
MSD Pharmaceuticals LLC
st. Pavlovskaya, 7, building 1
Moscow, Russia, 115093