Nuvaring first use. Storage conditions and expiration date. Extended use of the ring

Combined hormonal contraceptive drug, 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 the combination 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 frequency of pregnancy in 100 women during 1 year of contraception) in women aged 18 to 40 years for the drug NuvaRing ® was 0.96 (95% CI: 0.64-1.39) and 0.64 (95 % CI: 0.35-1.07) in the statistical analysis of all randomized participants (ITT analysis) and the analysis of study participants 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).

Nature of bleeding

A comparison of bleeding patterns over a one-year period in 1000 women using NovaRing ® and COCs containing levonorgestrel/ethinyl estradiol (0.150/0.030 mg) showed a significant reduction in the incidence of breakthrough bleeding or spotting when using NovaRing ® compared to COCs. . 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 non-hormonal intrauterine device(n=31) showed no effect on mineral density bone tissue in women.

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 etonogestrel plasma Cmax of approximately 1700 pg/ml is achieved approximately 1 week after ring administration. Plasma concentrations vary over 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. 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 serum albumin and sex hormone binding globulin (SHBG). The apparent V d of etonogestrel is 2.3 l/kg.

Metabolism

Biotransformation of etonogestrel occurs known ways metabolism of sex hormones. Apparent plasma clearance is about 3.5 l/h. No direct interaction with ethinyl estradiol taken concomitantly has been identified.

Removal

The concentration of etonogestrel in the blood plasma decreases in two phases. In the terminal phase, T1/2 is about 29 hours. Etonogestrel and its metabolites are excreted by the kidneys and through the intestines with bile in a ratio of 1.7:1. 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. Plasma Cmax of approximately 35 pg/ml is achieved 3 days after ring administration 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 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 0.030 mg) during one cycle y healthy women. Systemic exposure to ethinyl estradiol over a month (AUC 0-∞) for the drug NuvaRing ® was statistically significantly lower than for the patch and COC, and amounted to 10.9, 37.4 and 22.5 ngch/ml, respectively.

Distribution

Ethinyl estradiol binds to serum albumin. The apparent Vd is about 15 l/kg.

Metabolism

Ethinyl estradiol is metabolized by aromatic hydroxylation. During its biotransformation, it forms large number hydroxylated and methylated metabolites that circulate both in the free state and in the form of glucuronide and sulfate conjugates. The apparent clearance is approximately 3.5 l/h.

Removal

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

Special patient groups

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.

Release form

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

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

1 piece - waterproof bags made of aluminum foil (1) - cardboard packs.
1 piece - waterproof bags made of aluminum foil (3) - cardboard packs.

Dosage

NuvaRing ® is inserted into the vagina once every 4 weeks. The ring is in the vagina for 3 weeks and then removed on the same day of the week on which it was placed in the vagina; after a week's break, a new ring is inserted. For example: if the NuvaRing ® ring was installed on Wednesday at approximately 10:00 pm, then it should be removed on Wednesday 3 weeks later at approximately 10:00 pm; on the following Wednesday a new ring is inserted.

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

Hormonal contraceptives were not used in the previous menstrual cycle

NuvaRing ® should be administered on the first day of the cycle (i.e., the first day of menstruation). It is 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 taking combined oral contraceptives

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

Switching from progestogen-only medications (mini-pills, progestin-only oral contraceptives, implants, injectables, or hormone-containing intrauterine systems (IUDs))

A woman taking the mini-pill 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 barrier method contraception during the first 7 days after insertion of the ring.

After an abortion performed in the first trimester of pregnancy

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

After childbirth or abortion performed in the second trimester of pregnancy

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

Extending the break from using the ring

If you had sexual intercourse during a break from using the ring, pregnancy should be ruled out. The longer the break, the higher the likelihood of pregnancy. If pregnancy is ruled out, a new ring should be inserted into the vagina as quickly as possible. Over the next 7 days, an additional barrier method of contraception, such as a condom, can be used.

If the ring has been temporarily removed from the vagina

If the ring remains outside the vagina for less than 3 hours, the contraceptive effect will not decrease. The ring should be reinserted into the vagina as soon as possible (no later than after 3 hours).

If the ring was left outside the vagina for more than 3 hours during the first or second week of use, the contraceptive effect may be reduced. You should place the ring in your vagina as soon 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 left outside the vagina for more than 3 hours during 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. Please note that 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's effect. However, spotting or bleeding in the middle of the cycle is possible.

2. Wait for bleeding associated with the cessation of the drug’s effect, and insert a new ring no later than 7 days after removing the previous ring. This option should only be chosen if the ring use regimen has not previously been violated during the first 2 weeks.

Extended use of the ring

If the drug NuvaRing ® was used no more than maximum term at 4 weeks, the contraceptive effect remains sufficient. You can take a week's break from using the ring and then insert a new ring. If NuvaRing ® remains in the vagina for more than 4 weeks, the contraceptive effect may deteriorate, so pregnancy must be excluded before inserting a new ring.

How to shift or delay the onset of menstrual bleeding

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

To postpone the onset of bleeding to another day of the week, it may be recommended to take a shorter break from using the ring (for as many days as necessary). The shorter the interval between ring use, the higher the likelihood that there will be no bleeding after ring removal and no bleeding or spotting will occur when the next ring is used.

Ring damage

IN in rare cases When using NuvaRing ®, ring rupture was observed. The core of the NuvaRing ® ring 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. If the ring ruptures, a new ring must be inserted (following the recommendations above "If the ring has been temporarily removed from the vagina").

Ring falling out

Sometimes NuvaRing ® fell out of the vagina, for example, when it was inserted incorrectly, when a tampon was removed, during sexual intercourse, or against the background of severe or chronic constipation. In this regard, it is advisable for a woman to regularly check the presence of the NuvaRing ® ring in the vagina. If the ring falls out of the vagina, you should follow the recommendations above "If the ring has been temporarily removed from the vagina."

Rules for using NuvaRing ®

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

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

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

Overdose

Serious consequences of an overdose of hormonal contraceptives have not been described.

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

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

Interaction

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

The literature describes following interactions with combined oral contraceptives in general.

Possible interaction with medicines, inducing microsomal liver enzymes, which can lead to increased clearance of sex hormones. Interactions have been established with the following drugs: phenytoin, barbiturates, primidone, carbamazepine, rifampicin, and possibly also oxcarbazepine, topiramate, felbamate, ritonavir, griseofulvin and preparations containing St. John's wort.

When treating any of the listed drugs, you should temporarily use a barrier method of contraception (condom) in combination with the drug NuvaRing ® or choose another method of contraception. During concomitant use of drugs that cause the induction of microsomal liver 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.

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 / day) or doxycycline (200 mg / day, and then 100 mg / 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 simultaneous use antifungal agents and spermicides on the contraceptive effectiveness and safety of the drug NuvaRing ®. When using suppositories in combination with antifungal drugs the risk of ring rupture increases slightly.

Hormonal contraceptives can cause metabolic disturbances in other medicines. Accordingly, their concentrations in plasma and tissues may increase (for example, cyclosporine) or decrease (for example, lamotrigine).

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

Pharmacokinetic data show that the use of tampons does not affect the absorption of hormones released from the NovaRing ® vaginal ring. In rare cases, the ring may be accidentally removed when removing the tampon.

Side effects

Frequency determination side effects: often (≥1/100), infrequently (<1/100, ≥1/1000), редко (<1/1000, ≥1/10 000).

Often	Uncommon	Rarely	Post-marketing data 1
Infections and infestations
Vaginal infection	Cervicitis, cystitis, urinary tract infections
From the immune system
			Hypersensitivity
Metabolism
Weight gain	Increased appetite
Mental disorders
Depression, decreased libido	Mood changes
From the nervous system
Headache, migraine	Dizziness, hypoesthesia
From the side of the organ of vision
	Visual impairment
From the cardiovascular system
	"Hot flashes", increased blood pressure	Venous thromboembolism 2
From the digestive system
Abdominal pain, nausea	Bloating, diarrhea, vomiting, constipation
From the skin
Acne	Alopecia, eczema, skin itching, rash		Hives
From the musculoskeletal system
	Back pain, muscle spasms, pain in limbs
From the urinary system
	Dysuria, urinary urgency, pollakiuria
From the genital organs and breast
engorgement and tenderness of the mammary glands, genital itching in women, painful menstrual-like bleeding, pain in the pelvic area, vaginal discharge	Absence of menstrual-like bleeding, discomfort in the mammary glands, enlarged mammary glands, lumps in the mammary glands, cervical polyps, contact (during intercourse) spotting (bleeding), pain during intercourse, ectropion of the cervix, fibrocystic mastopathy , heavy menstrual-like bleeding, acyclic bleeding, discomfort in the pelvic area, premenstrual-like syndrome, burning sensation in the vagina, vaginal odor, pain in the vagina, discomfort and dryness of the vulva and vaginal mucosa		Local reactions in partner 3 galactorrhea
From the body as a whole
	Fatigue, irritability, malaise, swelling
Others
Discomfort when using the vaginal ring, loss of the vaginal ring	Difficulty using a contraceptive, rupture (damage) of the ring, sensation of a foreign body in the vagina

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

2 Observational cohort study data: ≥1/10,000 -<1/1000 женщин-лет.

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

Side effects that occurred when taking combined hormonal contraceptives: pancreatitis, cholecystitis, cerebrovascular disorders, benign and malignant liver tumors, chloasma, changes in insulin resistance.

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

Indications

Contraception.

Contraindications

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;
pronounced or multiple risk factors for venous or arterial thrombosis: hereditary predisposition to thrombosis (thrombosis, myocardial infarction or cerebrovascular accident at a young age in one of the immediate family), arterial hypertension, lesions of the valvular apparatus of the heart, atrial fibrillation, extensive surgery, prolonged immobilization, extensive trauma, obesity (BMI>30 kg/m2), smoking in women over 35 years of age;
pancreatitis (including a history) in combination with severe hypertriglyceridemia;
severe liver disease;
liver tumors, malignant or benign (including history);
established or suspected hormone-dependent malignant tumors (for example, genital organs or breast);
vaginal bleeding of unknown etiology;
pregnancy (including suspected);
breastfeeding period;
hypersensitivity to any of the active or excipients of the drug NuvaRing ®.

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

If any of the above conditions occur, you should immediately stop using the drug.

The drug should be prescribed with caution if any of the following diseases, conditions or risk factors are present; in such cases, the doctor must carefully weigh the benefit-risk ratio of using the drug NuvaRing ®:

the presence of risk factors for the development of thrombosis and thromboembolism: hereditary predisposition to thrombosis (thrombosis, myocardial infarction or cerebrovascular accident at a young age in one of the immediate relatives), smoking, obesity, dyslipoproteinemia, arterial hypertension, migraine without focal neurological symptoms, valve diseases heart, 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 dysfunction;
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;
angioedema (hereditary) edema;
chronic inflammatory bowel diseases (Crohn's disease and ulcerative colitis);
sickle cell anemia;
chloasma;
conditions that make it difficult to use a vaginal ring: cervical prolapse, bladder hernia, rectal hernia, severe chronic constipation.

In case of exacerbation of diseases, deterioration of the condition, or the occurrence of any of the listed conditions, you should first consult a doctor to decide on the possibility of further use of the drug NuvaRing ® .

Features of application

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, because this will help to correctly calculate the date of conception and birth.

The use of NuvaRing ® during pregnancy is contraindicated. If pregnancy occurs, the ring should be removed. Extensive epidemiological studies have not found an increased risk of birth defects in children born to women who took COCs before pregnancy, nor have there been teratogenic effects in cases where women took COCs in early pregnancy without knowing about it. Although this applies to all COCs, it is unknown 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 hormones inside the uterus when using the drug NuvaRing ® are similar to those when using the COC. Pregnancy outcomes in women who used NuvaRing ® during a clinical trial have not been described.

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

Use for liver dysfunction

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

Use in children

The safety and effectiveness of NuvaRing ® for adolescents under 18 years of age has not been studied.

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 occurrence of any of the conditions listed below for the first time, a woman should consult a doctor to decide on the possibility of further use of the drug 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 with the risk of VTE in patients not using COCs. The greatest risk of developing VTE is observed in the first year of using COCs. 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. However, the risk increases to a lesser extent than during pregnancy, when it is 5-20 cases per 10,000 YL (pregnancy data are based on the actual duration of pregnancy in standard studies; when converted to a pregnancy duration of 9 months, the risk ranges from 7 to 27 cases per 10,000 JL). 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 NuvaRing ® is similar to that in women using COCs (the adjusted risk ratio is presented in the table below). A large prospective observational study, TASC (Transatlantic Active Study of the Cardiovascular Safety of NuvaRing ®), assessed the risk of developing VTE in women who started using NuvaRing ® or COCs, switched to NuvaRing ® or COCs from other contraceptives, or resumed use of the drug NuvaRing ® or PDA, in a population of typical users. The women were observed for 24-48 months. The results showed a similar level of risk of developing VTE in women using NuvaRing ® (incidence 8.3 cases per 10,000 YL) and in women using COCs (incidence 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 showed that the incidence of VTE in women who started using NuvaRing ® was 11.4 cases per 10,000 YL, while in women who started using COCs containing levonorgestrel, the incidence of VTE was 9.2 cases per 10,000 women. 10,000 JL.

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

Epidemiological study, population	Comparator(s)	Risk ratio (RR) (95% CI)
TAS (Dinger, 2012) Women who started using the drug (including again, after a break) and switched from other means of contraception.	All available PDAs during Study 1	OR 2: 0.8 (0.5-1.5)
	Available COCs, except 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.	PDAs available during 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 Incl. low-dose COCs containing the following gestagens: 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 Incl. low-dose COCs containing the following gestagens: 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 of 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; "sharp" 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 relatively early 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;
for obesity (BMI more than 30 kg/m2);
possibly thrombophlebitis of the superficial veins and varicose veins.

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

Risk factors for the development of complications of arterial thromboembolism:

age;
smoking (with heavy smoking and with age, the risk increases even more significantly, especially in women over 35 years of age);
dyslipoproteinemia;
obesity (BMI more than 30 kg/m2);
arterial hypertension;
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 lead to 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 migraines (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 COCs should be advised to consult a doctor if possible symptoms of thrombosis appear. If thrombosis is suspected or confirmed, use of the COC 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 leads to an additional increase in this risk, but it remains unclear to what extent this is due to other factors such as more frequent cervical smear examinations and differences in sexual behavior, including. use of barrier contraceptives. It remains unclear how this effect is related to the use of the drug NuvaRing ®.

A meta-analysis of the results of 54 epidemiological studies found a small increase (1.24) in the relative risk of developing breast cancer in women taking COCs. The risk gradually decreases over 10 years after stopping the drugs. Breast cancer rarely develops in women under 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. A physician 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 a constant increase in blood pressure is observed when using the drug NuvaRing ®, it is necessary to contact your doctor to decide whether it is necessary to remove the vaginal ring and prescribe antihypertensive therapy. With adequate blood pressure control using antihypertensive drugs, it is possible to resume use of the drug NuvaRing ® .

During pregnancy and during the use of COCs, the development or worsening of the following conditions was noted, although their relationship with the use of contraceptives has not been 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, angioedema (hereditary) edema.

Acute or chronic liver dysfunction 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 steroids, 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 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.

Changes in the nature of menstruation

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 tests, incl. 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.

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, plasma concentrations of transport proteins (for example, corticosteroid binding globulin and sex hormone binding globulin), lipid/lipoprotein fractions, carbohydrate metabolism and indicators of coagulation and fibrinolysis. Indicators, as a rule, vary within normal values.

Impact on the ability to drive vehicles and operate machinery

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

NuvaRing is a hormonal contraceptive, which is a vaginal ring. It is inserted intravaginally, independently, and also removed without the help of a doctor. Provides a high level of protection against unwanted pregnancy.

Description of the drug

NuvaRing is a thin ring of soft polymers containing small doses of ethinyl estradiol and etonogestrel. The product must be partially or completely transparent, made of a homogeneous, smooth material. The instructions for the NuvaRing contraceptive necessarily disclose the characteristic features of the product and the technique of its use.

Compound

The composition of hormonal substances includes ethinyl estradiol and etonogestrel - in amounts of 2.7 and 11.7 mg, respectively. The base is made of copolymers of ethylene and vinyl acetate. The composition also contains a small amount of magnesium stearate.

Method of action

The ring delivers hormonal substances directly to the uterus, they enter the bloodstream and are absorbed by the vaginal mucosa. The concentration of active hormones in the blood is the same as when using COCs. The drug prevents follicle development by inhibiting ovulation. There is also evidence that the contraceptive improves the general condition of a woman during menstrual bleeding.

Application

The price of the NuvaRing contraceptive is average compared to COCs, and in pharmacies it is sold both individually and three pieces in one package. It is installed on the first day of the cycle, and is removed exactly 21 days later. So that the woman does not forget about the time to remove the old ring, two stickers are placed in the box with the product. One sticker reminds you to remove the old product, and the other reminds you when to install a new one.

How to use:

Before administration, wash your hands with soap.
Take a comfortable position that allows access to the vagina.
Squeeze the product with two fingers and insert it inside as deeply as possible.
Make sure it is in a comfortable position.

It is convenient to perform the manipulation while squatting, lying, standing, bending one leg and moving it to the side. Its position inside is not important; the main guideline is the woman’s comfort. No lubricant, auxiliary substances or applicators are needed to perform these actions. It is removed with two fingers in the same convenient position.

Important! If the ring is inserted according to the instructions and retains its integrity, then the woman herself ceases to feel it immediately after insertion. Her sexual partner also does not feel the presence of the product during coitus.

After 21 days the ring is removed. After 1-2 days, menstrual bleeding occurs. The new product is installed in exactly one week. During this time, as a rule, the bleeding stops completely.

It is allowed to remove the product for up to three hours while maintaining its effectiveness. If a break was allowed beyond the specified time, additional barrier contraception will be required. If the product was removed accidentally, it should be immediately washed with running water at a temperature of 30-37 degrees and installed again.

Deviations in the normal use of NuvaRing

In case of unforeseen situations, there may be violations of the use of the product. To prevent this from causing undesirable consequences, you need to follow simple instructions. Possible violations of the regime:

the break between cycles is lengthened;
extended operation of one ring;
shortened break between two cycles.

If after removing one contraceptive ring the break lasts more than 7 days, then pregnancy must be excluded before installing a new one. If, as a result of violation of the regime, pregnancy does not occur, then a new remedy is installed immediately. In this case, for the next week after starting to use the new NuvaRing, you will need to use any barrier contraceptives.

If the ring was not removed on time, its contraceptive effect will begin to decline after the fourth week of use. It remains highly effective for 4 weeks, then additional means of protection against unwanted pregnancy are required. In this case, at the end of an extended cycle, spotting may occur.

After extended use, the standard break is 7 days. Before installing a new ring, if other contraceptives were not used at the end of the extended cycle of use, pregnancy must be excluded.

A shortened break between two cycles is possible if you need to complete the withdrawal bleeding faster and shift the next cycle by several days. However, in this case, slight bleeding may occur in the next period of use of the drug after the shortened period.

A woman may forget to remove or place the NuvaRing, or miss the seven-day rest period in between. In this case, it is important to rule out pregnancy before installing a new ring.

Changes in the timing of menstruation

If there is a need to shift the timing of menstruation, you can deliberately increase or decrease the break period between cycles. However, when increasing the rest period, you need to use barrier contraceptives together with NuvaRing.

Sometimes it is allowed not to take a break between two contraceptives. In this case, menstruation will begin only after the start of the next break, that is, 6 weeks after the last withdrawal bleeding.

Important! Any changes to the standard schedule for using the vaginal contraceptive NuvaRing are undesirable, so you need to especially carefully monitor the condition of the body, well-being, and the presence of untimely spotting and bleeding. As soon as a violation of the schedule is discovered, you need to return to standard use of the contraceptive.

Stopping contraception

Cancellation occurs upon completion of the full cycle of use. That is, after removing another ring, a new one is simply not installed after 7 days. As a result of withdrawal, the following phenomena may be observed in the period following the first cycle without the drug:

increased menstrual bleeding;
swelling, tenderness of the breast;
painful menstruation.

When starting to use NuvaRing, many women notice an improvement in their condition during menstruation. There is no premenstrual pain, bleeding is reduced. The effect of reducing the load of the menstrual cycle on the body lasts as long as the product is used. This is a good prevention of severe blood loss during menstruation. But after withdrawal, the body returns to its normal state.

Cancellation may be due to planning a pregnancy; in this case, it is recommended to wait until the normal menstrual cycle is established. This will make it easier for doctors to calculate the gestational age. Otherwise, conception immediately after cancellation is allowed and does not affect the course of pregnancy in any way.

Important! If pregnancy occurs as a result of a violation of the contraceptive schedule, the product must be removed immediately. This contraceptive is also contraindicated during breastfeeding, as it can reduce the level of milk production or lead to cessation of lactation.

Possible side effects

According to the instructions based on reviews from doctors, the NuvaRing contraceptive has a number of possible side effects. They appear rarely (less than 1/100, but more often 1/1000). These include:

vaginal infections;
vaginal discharge;
discomfort in the genital area (itching, pain, irritation);
pain, pulling sensations in the abdomen;
engorgement of the mammary glands;
headaches;
decreased libido;
weight gain;
skin rashes.

If side effects occur, it is better to consult a specialist. Depending on the situation, the doctor recommends either immediately removing the ring or ending the cycle. He may also prescribe medications to relieve unpleasant symptoms.

Very rarely there is an allergy to the product, or increased sensitivity and pain during sexual intercourse in a partner. According to reviews, men do not feel the presence of this contraceptive during sex.

Contraindications

Contraindications for using the ring are the same as for other hormonal contraceptives. These include:

venous or arterial thrombosis, location to it;
heart defects;
migraine (especially with focal symptoms);
hypertension;
gastrointestinal diseases (pancreatitis, liver tumors, chronic liver diseases);
hormone-dependent tumors;
vaginal bleeding with an unclear diagnosis;
rehabilitation after surgery;
diabetes mellitus with vascular damage;
pregnancy and lactation;
allergic reactions to the components of the drug;
smoking in women over 35 years of age.

Before using the drug, you should consult with an experienced gynecologist; using the drug and treatment without consultation may lead to unexpected side effects.

There is a great abundance of contraceptives in pharmacies. Every woman, man or married couple can choose the most comfortable one for themselves. All are guaranteed to be effective, but some can be dangerous, others need to be consumed regularly on a daily basis. These rules do not apply to the Nuvaring birth control ring.

How to use it? What is the mechanism of action? To whom is it shown, and for whom is it a forbidden fruit? - you will learn from this article.

Pharmacological action

Placement of the Nuvaring ring in the vagina

The contraceptive Nuvaring is a hormonal contraceptive.

The effect is provided by etonogestrel and ethinyl estradiol.

Thanks to the use of the Nuvaring vaginal ring, the menstrual cycle is adjusted. Pain during menstruation becomes less noticeable, and the amount of discharge decreases.

The possibility of iron deficiency anemia also decreases.

The main advantage of the Novaring hormone-based contraceptive ring is that its use prevents:

Ovarian cancer.
Endometrial oncology.
Ovarian cysts.
Ectopic pregnancy.
Inflammatory diseases of the genital organs.
Benign neoplasms in the mammary glands.

Composition and release form

The contraceptive Nuvaring is made in the form of a vaginal ring.

The concentration of ethinyl estradiol in it is 2.7 mg, and etonogestrel is 11.7 mg.

The composition also includes additional substances in the form of:

Ethylene copolymer.
Vinyl acetate copolymer.
Magnesium stearate.

Indications for use

The birth control contraceptive Nuvaring is primarily intended to protect against pregnancy.

Contraceptive effect of the hormonal ring

The Nuvaring vaginal ring is often prescribed by doctors for endometriosis. They also treat uterine fibroids when their size is small and surgery can be avoided.

Contraindications

The Nuvaring vaginal ring should not be used if you have:

Thrombosis/thromboembolism.
Heart defects.
Migraines.
Diabetes mellitus affecting the vascular system.
Severe liver diseases.
Neoplasms in the liver are benign/malignant.
Neoplasms with a location in the reproductive system that depend on hormones.
The period of gestation.
Intolerance to contraceptives.

Photo gallery of contraindications:

Thrombosis Migraine
Malignant neoplasms in the liver

Rarely and with great caution, the Nuvaring vaginal ring is recommended if:

Thrombosis in relatives.
Serious operations in general and on the legs as well.
Obesity.
Thrombophlebitis.
Arterial hypertension.
Smoking after 40 years.
Disorders of fat metabolism in the body.
Gallstone disease.
Hemolytic-uremic syndrome.
Choreas.
Otosclerosis with impaired auditory perception.
Systemic lupus erythematosus.
Angioedema.
Crohn's syndrome.
Ulcerative colitis.
Sickle cell anemia.
Porphyria.
Chronic constipation.
Hernia of the urethra.
Rectal hernia.
Uterine prolapse.

Side effects

Even the recommendations of gynecologists will not help avoid adverse reactions from the use of the Nuvaring contraceptive ring if the woman’s body does not accept it.

No.	Organ system	Adverse reactions from the Nuvaring hormonal ring
1	Reproductive and urinary systems	Thrush and other vaginal infections Cervicitis Cystitis Other ureteral infections Genital itching Breast engorgement and tenderness Dysmenorrhea Amenorrhea Heavy menstruation Uterine bleeding PMS Burning sensation in the vagina Pain and discomfort at the injection site
2	Immunity	Allergy
3	Metabolism	Increased appetite Weight gain
4	Mental disorders	Change in sex drive Mood variability Depressive state
5	Nervous system	Headaches Migraine Dizziness
6	Visual organs	Visual impairment
7	SSS	Increased blood pressure Tides
8	Digestive system	Nausea Flatulence Pain in the abdomen Diarrhea Constipation Vomit
9	Skin layer	Acne Itching Rashes
10	Muscles and bone tissue	Pain in the legs and back Spasmodic pain
11	Other	Fatigue Swelling

Patients also note discharge while using the Nuvaring vaginal ring. During intimacy, they may be bloody.

Sometimes the body can react to the contraceptive Nuvaring with a temperature of 37, which is an individual reaction of the female body.

Useful video:

Drug interactions

It is worth using additional methods of contraception together with the Nuvaring vaginal ring during the period of use of the following drugs and 30 days after treatment with them:

Barbiturates.
Oxcarbazepine.
Felbamate.
St. John's wort.

Photos of medicines:

If it is necessary to use intravaginal suppositories against candidiasis, it may occur damage or rupture Nuvaring vaginal ring.

Alcohol compatibility

alcohol should not be combined. This helps to reduce the contraceptive effect.

Dosage and overdose

The Nuvaring vaginal ring is not capable of causing serious overdose symptoms. Sometimes nausea or vomiting and bleeding may occur.

Instructions for use

The pros and cons of the Nuvaring contraceptive ring are clearly visible from the rules of use.

No.	Category	How to use the Nuvaring vaginal ring
1	How to insert?	Intravaginally, squeezing with fingers, in a squatting position, lying on your back or standing with your leg elevated. The diagram in the pictures will help you insert the ring correctly. This procedure is done once a month, preferably on the first day of menstruation. After 21 days, you need to remove the contraceptive for 7 days. On the 8th day, insert a new ring.
2	Switching from COC	Insert on the 7th day of the break after taking the tablets.
3	Switching from a mini-pill	According to the rules of the previous remedy / on any day.
4	Early abortion	Immediately after the procedure.
5	Late miscarriage/birth	3 weeks after the process.
6	Why does it fall out?	Most often this is due to damage to the contraceptive. In this case, you need to use a new ring.
7	Is it possible to place it in the middle of a cycle?	You can, but you must use condoms for the first week.
8	Is it possible to remove the ring ahead of time?	Not recommended, since such an action can provoke hormonal imbalance in the body.

Photo instructions:

1 2 3 4 5

Shelf life and storage of the drug

The Nuvaring vaginal ring should be stored under conditions 8 degree temperature during 3 year term.

Special instructions

If a woman is prone to pigmentation of the epidermis, it is better for her to avoid exposure to direct sunlight

Is it possible to get pregnant with a ring? None of the existing contraceptives absolutely protects against pregnancy.

The same applies to the Nuvaring vaginal ring. In certain cases they talk about counterfeiting.

Treatment of endometriosis with the contraceptive Nuvaring should be prescribed by a doctor and the process should be monitored regularly.

When using the Nuvaring vaginal ring, taking a bath is not prohibited.

Price

The cost of one contraceptive Nuvaring is about 1,200 rubles.

Conditions for dispensing from pharmacies

The Nuvaring vaginal ring is available at some pharmacies by prescription only. The hotline of any pharmacy chain will tell you this.

Analogues substitutes

You can replace the contraceptive Nuvaring with the following medications:

consists of ethinyl estradiol and dienogest in tablet form. Manufacturer: Bayer Pharma (Germany).
is made on the basis of drospirenone and ethinyl estradiol in tablet form. Manufacturer: Gedeon Richter (Hungary).
Available in tablet form with drospirenone and ethinyl estradiol. Manufacturer: Bayer Weimar (Germany).
is created in the form of an intrauterine device with levonorgestrel. Manufacturer: Bayer Schering Pharma (Germany/Finland).
Femoston It is produced in tablet form with estradiol and dydrogesterone. Manufacturer: Abbott Laboratories S.A. (USA), Solvay Pharmaceuticals (Netherlands).
Logest Available in the form of tablets with gestodene and ethinyl estradiol. Manufacturer: Bayer Pharma (Germany).

Photos of analogues:

Jess, Mirena, Yarina and Nuvaring

Jess and Yarina belong to combined oral contraceptives. Mirena is an intrauterine device.

All contraceptives are used for the same purpose, but they are suitable for each woman differently and the comfort/discomfort from them is also different.

Have you used the contraceptive Nuvaring and was it effective?

The Nuvaring vaginal ring allows women to protect themselves from unwanted pregnancy without the additional use of barrier contraceptive methods and pills.

The device has a large list of contraindications and sometimes causes adverse reactions.

Therefore, before use, you must carefully study the instructions, and it is better to consult a specialist.

The structure of the Nuvaring contraceptive ring is simple. Externally, it appears to be a silicone translucent rim that can be easily reshaped. The diameter of the protective agent is 5-6 cm.

Synthetic elastic material is used in pharmacology for the manufacture of various implants, therefore it is considered safe and proven.

Observations and studies show that the product is hypoallergenic. An allergic reaction to elastic material is a rare occurrence.

Inside the silicone rim there is a combination of drugs: etonogestrel.

Every day, a certain dose of active substances is released from the Nuvaring hormonal ring. They are absorbed into the vascular network of the vagina and penetrate into the bloodstream.

The effect of the drug begins immediately after installation and ends after removal. Using the ring has the following effect:

prevents their opening and release of the egg;
disrupts the process of endometrial proliferation, which creates unfavorable conditions for implantation;
organizes a special one that allows not only to protect against pregnancy, but also to obtain a therapeutic effect;
affects the secretory activity of the cervix, as a result of which the mucus thickens and reduces the activity of the sperm that enter it.

The mechanism of action of the ring is a reversible process.

Is it possible to get pregnant with a birth control ring?

The Nuvaring gynecological ring is intended to prevent unwanted pregnancy when maintaining an active sexual life without the use of others.

The mechanism of action of the silicone rim provides reliable protection against conception. When asked whether it is possible to get pregnant with a ring, gynecologists answer negatively.

However, there are exceptions to every rule. Medicine knows of cases where women became pregnant while using the hormonal system.

The reliability of the product is determined by the Pearl index, an indicator of the effectiveness of the contraceptive method. It is believed that the higher the value, the more dangerous the method.

The Pearl Index is determined from the number of random pregnancies involving 100 women of childbearing age during one year of use of the hormonal system.

For the Nuvaring ring, the rate is less than 1. This means that out of 100 representatives of the fairer sex who used the silicone device, only 1 became pregnant.

Nuvaring: instructions for use

The drug Nuvaring is recommended for use in the instructions for use for contraception. The hormonal agent is injected into.

It is permissible to start using Nuvaring on the 3rd or even 5th day. But only in this case will it be necessary to use additional means of protection against pregnancy throughout the entire month.

The product is approved for use after oral contraceptives, abortion, miscarriage and even childbirth (subject to refusal of breastfeeding).

For each case, an individual application scheme is provided.

How to insert the ring correctly?

The vaginal ring should only be inserted with clean hands. You must first open the package and remove the silicone rim.

To insert the system, you need to take a comfortable position: lying down, squatting, raising your leg on a chair. The ring is inserted in a similar way to sanitary tampons.

Use your thumb and index finger to flatten the elastic circle, insert it into the vagina and push it further away.

Over the next three weeks, the protective agent will remain in place. Its presence should be checked periodically, and in case of premature removal, the following measures should be taken:

take a break for a week, then use a new ring;
if the ring is not lost, then rinse it with water and reinsert it;
if the system is lost, introduce a new remedy immediately.

The effectiveness of the product after loss is not reduced if it is replaced no later than 3 hours later. If the gap is longer, then barrier protection must be used over the next few days.

How to take out Nuvaring?

Removal of the contraceptive ring is done with clean hands. You need to take a comfortable position, insert your finger into the vagina, pick up the system and pull it out.

Over the next week, menstrual-like withdrawal bleeding will begin.

The new device should be inserted exactly 7 days later at the same time as removal. During this period, bleeding may not yet be completed, but this does not affect the effectiveness of the hormonal ring.

If the break was more than 7 days, then the reliability of the protective agent decreases, which requires additional contraceptive measures.

Instructions for use after abortion

When used for the first time, Nuvaring is administered directly on the day of curettage.

If the use of vaginal products on the first day is undesirable, then you can start using the ring in the period from 2 to 5 days. This regimen requires additional contraception in the first week.

How to delay menstruation

To delay the onset of vaginal bleeding, you must remove the ring after 21 days and immediately insert a new one.

With this bleeding pattern, there will be no withdrawal, but some women experience spotting in the middle of the cycle.

Nuvaring should be removed after another 21 days or at the appropriate period for menstruation.

Using a ring for fibroids

The results of clinical studies show that the use of the Nuvaring ring for uterine fibroids has unexpected results.

In most patients, the tumor stopped growing under the influence of the new hormonal levels.

There are clinical cases showing the ineffectiveness of the silicone system for benign myometrial tumors. It is believed that today there are more effective ones than the Nuvaring ring.

Treatment of endometriosis

With endometriosis, focal spread of the functional layer of the uterus occurs. Under the influence of hormonal levels, they bleed, causing heavy menstruation.

The Nuvaring ring helps manage this condition by suppressing ovarian activity. The use of the hormonal system shows good results. Treatment is carried out in two ways:

The standard method is to use the ring with regular 7-day breaks;
Continuous use of the system for 3-6 months.

Use during pregnancy and pregnancy

The use of the Nuvaring ring is contraindicated during pregnancy. If conception occurs while using the device, the system should be removed immediately and consult a doctor.

The drug is intended to prevent unplanned pregnancy, so it is not advisable to use it while pregnant.

Nuvaring is not prescribed for breastfeeding. The medication is able to change a woman’s hormonal levels, reducing the amount of milk produced. Also, the substances that make up the ring are excreted in breast milk.

Modern pharmacology offers more effective and safe hormonal agents for preventing pregnancy during breastfeeding.

Contraindications to the use of Nuvaring

Thrombosis and varicose veins of the lower extremities. Any conditions accompanied by blood thickening.
Migraine accompanied by additional neurological symptoms. Including in the anamnesis.
Vascular lesions in diabetes mellitus.
Severe hypertriglyceridemia accompanied by pancreatitis.
Acute liver pathologies.
Malignant organ lesions with hormonal dependence.
Bloody vaginal discharge not associated with the menstrual cycle.
Hypersensitivity and high likelihood of an allergic reaction to the components.

If the described cases occur while using the ring, you should remove it immediately. The medication should be used with caution by women over 35 years of age and by smoking patients.

Advantages and disadvantages of the Nuvaring ring

The main advantage is the ability to realize reproductive function even after long-term use. Pregnancy after Nuvaring occurs in healthy women within 1-3 cycles.

The advantage of the drug can be called the method of its use. Vaginal administration eliminates problems with the digestive tract, as well as missed hormonal doses.

It is convenient to insert the ring and forget about contraceptive methods for 3 weeks. The advantages of the device are:

ease of use;
the ability to regulate the cycle;
reducing the intensity of bleeding.

The disadvantages include the price of Nuvaring. The cost of one ring is about 25 dollars. The triple system costs $55.

Like any medicine, Nuvaring can cause side effects.

They often manifest themselves in the form of spotting in the middle of the cycle, headaches, and decreased libido.

The drug affects the thickness of the blood, and therefore increases the risk of heart and vascular pathologies. Also, the disadvantages are listed:

Some patients find it difficult to insert and remove the system;
you can lose a ring and not notice it;
there may be increased secretion of vaginal mucus.

vaginal ring 2.7 mg+11.7 mg: pack. 1 or 3 pcs. Reg. No.: P N015411/01

Clinical and pharmacological group:

Hormonal contraceptive for intravaginal administration

Release form, composition and packaging

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

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

1 piece - waterproof bags made of aluminum foil (1) - cardboard packs.
1 piece - waterproof bags made of aluminum foil (3) - cardboard packs.

Description of the active components of the drug " Nuvaring ®»

Pharmacological action

A combined hormonal contraceptive drug containing etonogestrel and ethinyl estradiol.

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 frequency of pregnancy in 100 women during 1 year of contraception) in women aged 18 to 40 years for the drug NuvaRing ® was 0.96 (95% CI: 0.64-1.39) and 0.64 (95% CI: 0.35-1.07) in the statistical analysis of all randomized participants (ITT analysis) and the analysis of study participants 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).

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. In addition, high-dose COCs (0.05 mg ethinyl estradiol) reduce the risk of developing ovarian cysts, pelvic inflammatory diseases, benign changes in the mammary glands and ectopic pregnancy. It is not entirely clear whether low-dose hormonal contraceptives offer similar benefits.

Nature of bleeding

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

Indications

- contraception.

Dosage regimen

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

Hormonal contraceptives were not used in the previous menstrual cycle

Switching from taking combined oral contraceptives

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

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

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

A woman taking the mini-pill can switch to using NuvaRing ® on any day (the ring is inserted on the day the implant or IUD is removed or on the day of the next injection). In all these cases, the woman should use a barrier method of contraception for the first 7 days after insertion of the ring.

After an abortion performed in the first trimester of pregnancy

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

After childbirth or abortion performed in the second trimester of pregnancy

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

Extending the break from using the ring

If the ring has been temporarily removed from the vagina

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

If the ring was left outside the vagina for more than 3 hours during the first or second week of use, then the contraceptive effect may be reduced. You should place the ring in your vagina as soon 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 during the third week of use, then the contraceptive effect may be reduced. The woman should throw away this ring and choose one of two methods:

Extended use of the ring

If the drug NuvaRing ® was used no more than a maximum period of 4 weeks, then the contraceptive effect remains sufficient. You can take a week's break from using the ring and then insert a new ring. If NuvaRing ® remained in the vagina more than 4 weeks, then the contraceptive effect may worsen, so pregnancy must be ruled out before inserting a new ring.

To change the time of onset of menstrual bleeding

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

To postpone the onset of bleeding on another day of the week, it can be recommended to take a shorter break from using the ring (for as many days as necessary). The shorter the interval between ring use, the higher the likelihood that there will be no bleeding after ring removal and no bleeding or spotting will occur when the next ring is used.

Ring damage

In rare cases, when using NuvaRing ®, ring rupture has been observed. The core of the NuvaRing ® ring 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. If the ring ruptures, a new ring must be inserted.

Ring falling out

NuvaRing ® has sometimes been reported to fall out of the vagina, for example, when 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 ® ring in the vagina.

Incorrect insertion of the ring

In very rare cases, women have unintentionally inserted NuvaRing ® into the urethra. When symptoms of cystitis appear, it is necessary to consider the possibility of incorrect insertion of the ring.

Safety and effectiveness of the drug NuvaRing for teenagers under 18 years of age have not been studied.

Rules for using NuvaRing ®

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

Side effect

When using the drug, side effects may occur, occurring with varying frequencies: often (≥1/100), infrequently (<1/100, ≥1/1 000), редко (<1/1000, ≥1/10 000).

Often	Uncommon	Rarely	Post-marketing data 1
Infections and infestations
Vaginal infection	Cervicitis, cystitis, urinary tract infections
From the immune system
			Hypersensitivity
Metabolism
Weight gain	Increased appetite
Mental disorders
Depression, decreased libido	Mood changes
From the nervous system
Headache, migraine	Dizziness, hypoesthesia
From the side of the organ of vision
	Visual impairment
From the cardiovascular system
	"Hot flashes", increased blood pressure	Venous thromboembolism 3
From the digestive system
Abdominal pain, nausea	Bloating, diarrhea, vomiting, constipation
From the skin
Acne	Alopecia, eczema, skin itching, rash		Hives
From the musculoskeletal system
	Back pain, muscle spasms, pain in limbs
From the urinary system
	Dysuria, urinary urgency, pollakiuria
From the genital organs and breast
Engorgement and tenderness of the mammary glands, genital itching in women, dysmenorrhea, pain in the pelvic area, vaginal discharge	Amenorrhea, discomfort in the mammary glands, enlarged mammary glands, lumps in the mammary glands, cervical polyps, contact (during sexual intercourse) spotting (bleeding), dyspareunia, ectropion of the uterus, fibrocystic mastopathy, menorrhagia, metrorrhagia, discomfort in the pelvic area, premenstrual syndrome, uterine spasm, burning sensation in the vagina, vaginal odor, painful sensations in the vagina, discomfort and dryness of the vulva and vaginal mucosa		Local reactions in partner 2
From the body as a whole
	Fatigue, irritability, malaise, swelling
Others
Discomfort when using the vaginal ring, loss of the vaginal ring	Difficulty using a contraceptive, rupture (damage) of the ring, sensation of a foreign body in the vagina

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

2 Local reactions in a partner include reports of local reactions on the penis.

3 Observational cohort study data: ≥1/10,000 -<1/1000 женщин-лет.

Contraindications

- venous thrombosis (including a history), including thromboembolism;

- arterial thrombosis (including a history), including cerebrovascular accidents, myocardial infarction and/or precursors of thrombosis, including angina pectoris, transient ischemic attack;

— heart defects with thrombogenic complications;

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

— migraine with focal neurological symptoms in the anamnesis;

- diabetes mellitus with vascular damage;

- pronounced or multiple risk factors for venous or arterial thrombosis;

- pancreatitis (including a history), in combination with severe hypertriglyceridemia;

- severe liver diseases, until normalization of liver function indicators;

- liver tumors, malignant or benign (including in history);

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

- vaginal bleeding of unknown etiology;

— pregnancy (including suspected);

- hypersensitivity to any of the active or excipients of the drug NuvaRing ®.

If any of the above conditions occur, you should immediately stop using the drug.

WITH caution the drug should be prescribed if any of the following diseases, conditions or risk factors are present; in such cases, the doctor must carefully weigh the benefit-risk ratio of using the drug NuvaRing ®:

- presence of diseases in the family history (venous thrombosis and embolism and/or arterial thrombosis in brothers/sisters at any age or in parents at a relatively early age;

- prolonged immobilization, major surgical interventions, any surgical interventions on the lower extremities or serious trauma;

— obesity (body mass index more than 30 kg/m2);

— thrombophlebitis of superficial veins;

- smoking (especially in women over 35 years old);

- dislipoproteinemia;

- heart valve disease;

- atrial fibrillation;

- arterial hypertension;

- diabetes mellitus;

- acute or chronic liver dysfunction;

- 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 make it difficult to use a vaginal ring: cervical prolapse, bladder hernia, rectal hernia, severe chronic constipation.

Pregnancy and lactation

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 inserted into the vagina, the concentrations of contraceptive 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 steroids and/or their metabolites may be excreted in milk, but there is no evidence of their negative effects on the health of children.

Use for liver dysfunction

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

Application for children

The safety and effectiveness of NuvaRing ® for adolescents under 18 years of age has not been studied.

Special instructions

Circulatory disorders

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, women using the drug NuvaRing ® are at greater risk of developing VTE, similar to that of women using COCs (adjusted risk ratio is presented in the table below). A large prospective observational study, TASC (Transatlantic Active Study of the Safety of 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 use the drug NuvaRing ® or COCs, in the population of typical users. The women were observed 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, excluding desogestrel, gestodene and drospirenone, the incidence of VTE was 8.9 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 women of those who started using COCs containing levonorgestrel, the incidence of VTE is 9.2 cases per 10,000 YL.

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)
TAS (Dinger, 2012) Women who started using the drug (including again, after a break) and switched from other means of contraception.	All available COCs during Study 1	OR 2: 0.8 (0.5-1.5)
	Available COCs, except 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 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 Incl. 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 Incl. low-dose COCs containing the following progestins: norgestimate, norethindrone or levonorgestrel.

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

Possible symptoms of venous or arterial thrombosis may include pain in one leg and/or swelling; sudden severe chest pain, possibly radiating to the left arm; 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; "sharp" 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 relatively early 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 surgical interventions, any surgical interventions 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;

— for obesity (body mass index more than 30 kg/m2);

— possibly thrombophlebitis of the superficial veins and varicose veins.

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

Risk factors for the development of complications of arterial thromboembolism:

— age;

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

— dyslipoproteinemia;

— obesity (body mass index more than 30 kg/m2);

— hypertension;

— 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.

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

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

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. An increased risk of developing breast cancer may be
due to both the fact that women taking COCs are diagnosed with breast cancer earlier and the biological effects of COCs, or a combination of both of these factors.

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.

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.

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

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.

Very rare cases of difficult ring removal have been described that required removal by a medical professional.

Medical examination/consultation

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

Effects of ethinyl estradiol and etonogestrel on a sexual partner

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

Laboratory research

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

Impact on the ability to drive vehicles and operate machinery

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

Considering the pharmacodynamic properties of the drug NuvaRing ®, its effect on the ability to drive a car and use complex equipment is not expected.

Overdose

Serious consequences of an overdose of hormonal contraceptives have not been described.

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

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

Drug interactions

Conditions for dispensing from pharmacies

The drug is available with a prescription.

Storage conditions and periods

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

Drug interactions

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.

There may be an interaction with drugs that induce microsomal enzymes, which can lead to increased clearance of sex hormones. Interactions have been established with the following drugs: phenytoin, barbiturates, primidone, carbamazepine, rifampicin, and possibly also oxcarbazepine, topiramate, felbamate, ritonavir, griseofulvin and preparations containing St. John's wort.

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

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 / day) or doxycycline (200 mg / day, and then 100 mg / day) for 10 days while using the drug NuvaRing ® had little effect on the pharmacokinetics of etonogestrel and ethinyl estradiol. When using antibiotics (except 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 can cause disruption of 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, it is necessary to study the instructions for use of other drugs.