Novairing - Instructions For Using The Ring, Reviews, Price, Analogues

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Novairing

NuvaRing: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Drug interactions
11. 11. Analogs
12. 12. Terms and conditions of storage
13. 13. Terms of dispensing from pharmacies
14. 14. Reviews
15. 15. Price in pharmacies

Latin name: NovaRing

ATX code: G02BB01

Active ingredient: etonogestrel + ethinylestradiol (etonogestrel + ethinylestradiol)

Manufacturer: Organon (Netherlands)

Description and photo update: 2019-19-08

Prices in pharmacies: from 1242 rubles.

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Novairing is a combined hormonal contraceptive for intravaginal use.

Release form and composition

NovaRing's dosage form is a vaginal ring: transparent, smooth, almost colorless or colorless, without visible significant damage, at the junction there is a transparent or almost transparent area (1 pc. In sealed aluminum foil bags, in a cardboard box 1 or 3 bags) …

Content of active substances in 1 ring:

• Etonogestrel - 11.7 mg;
• Ethinylestradiol - 2.7 mg.

Auxiliary components: ethylene and vinyl acetate copolymer (28% vinyl acetate), magnesium stearate, ethylene and vinyl acetate copolymer (9% vinyl acetate).

Pharmacological properties

Pharmacodynamics

Novairing is a hormonal combined contraceptive that contains ethinyl estradiol and etonogestrel. Etonogestrel is a progestogen (19-nortestosterone derivative) that binds with high affinity to progesterone receptors localized in target organs. Ethinylestradiol belongs to estrogens and is widely used in the production of contraceptive drugs.

The contraceptive effect of NovaRing is due to a combination of various factors, the most important of which is the suppression of ovulation.

The results of clinical studies indicate that the Pearl index (a parameter showing the frequency of pregnancy when 100 women were observed for 1 year during the use of contraception) in patients aged 18-40 years for this drug was 0.96 [95% CI (confidence interval) ranged from 0.64 to 1.39] in the statistical analysis of all randomized participants (PT analysis) and 0.64 (95% CI ranged from 0.35 to 1.07) in the analysis of participants who completed them in according to the protocol (PP-analysis). These results were similar to the values of Pearl indices, determined during comparative studies of combined oral contraceptives (COCs), which included drospirenone / ethinylestradiol (3 / 0.3 mg) or levonorgestrel / ethinyl estradiol (0.15 / 0.03 mg) …

Against the background of the use of NovaRing rings, the cycle normalizes (it becomes more regular), and the intensity and soreness of menstrual bleeding weakens, which reduces the frequency of development of iron deficiency states. There is evidence that the use of this drug reduces the risk of ovarian and endometrial cancer.

For 1 year, 1000 women who used Novaring and COCs, which include levonorgestrel / ethinylestradiol (0.15 / 0.03 mg), were compared with the characteristics of the nature of bleeding. The results of the study confirmed that when NovaRing was used, the frequency of spotting bleeding or breakthrough bleeding was significantly reduced compared with COCs. Also, cases in which bleeding was observed only during a break in the use of a contraceptive, occurred much more often in women who used vaginal rings.

A comparative study of the effects of NuvaRing and a non-hormonal intrauterine device, carried out for 2 years, did not reveal a clinically significant effect on bone mineral density in women.

Pharmacokinetics

Etonogestrel

Etonogestrel, which is released from the vaginal ring, is rapidly absorbed through the vaginal mucosa. Its maximum plasma concentration is approximately 1700 pg / ml and is reached on average 1 week after the ring is inserted. The level of the substance in the blood plasma changes in a small range and gradually decreases to about 1600 pg / ml after 1 week, 1500 pg / ml after 2 weeks and 1400 pg / ml after 3 weeks after starting the drug. The absolute bioavailability reaches 100%, which exceeds the bioavailability when taking etonogestrel orally. The results of measuring the concentrations of this active substance inside the uterus and in the cervical region confirm that the determined values of the concentrations of etonogestrel in patients using NuvaRing and patients taking COCs, which contain 0.02 mg of ethinylestradiol and 0,15 mg of desogestrel were found to be comparable.

Etonogestrel binds to sex hormone binding globulin (SHBG) and plasma albumin. The apparent volume of distribution of the substance is 2.3 l / kg.

The biotransformation of etonogestrel is carried out through the known pathways of sex hormone metabolism. The apparent plasma clearance is approximately 3.5 L / h. There is no direct interaction of etonogestrel with ethinyl estradiol taken simultaneously.

The plasma level of etonogestrel decreases in two phases. The terminal phase is characterized by a half-life of approximately 29 hours. Etonogestrel and its metabolites are excreted through the kidneys and intestines with bile in a quantitative ratio of approximately 1.7: 1. For metabolites, the elimination half-life is about 6 days.

Ethinylestradiol

When released from the vaginal ring, ethinyl estradiol is rapidly absorbed through the vaginal mucosa. Its peak plasma concentration is approximately 35 pg / ml and is reached 3 days after the ring is inserted, after which it gradually decreases to 19 pg / ml after 1 week and 18 pg / ml after 2-3 weeks after the start of use. The absolute bioavailability is approximately 56% and is comparable to that when ethinyl estradiol is taken orally. In accordance with the results of determining the concentrations of this active substance inside the uterus and in the cervical region, the measured values of the concentrations of ethinylestradiol were comparable in patients taking oral contraceptives containing 0.02 mg of ethinyl estradiol and 0.15 mg of desogestrel, and patients using NovaRing. The content of ethinyl estradiol in the body was investigated during a comparative randomized study of the drug NovaRing (when the ring is inserted into the vagina per day, 0.015 mg of ethinyl estradiol is released into the vagina), COC (levonorgestrel / ethinyl estradiol; 0.03 mg of ethinyl estradiol is released per day) and a transdermal patch (ethinyl estradiol); 0.02 mg of ethinyl estradiol is released per day) during one cycle in healthy women. It was found that the systemic exposure of ethinylestradiol for a month for the Novaring vaginal rings was statistically significantly weaker than that of the COC and the patch: the AUC indicator was 10.9 ng h / ml compared to 22.5 and 37.4 ng h / ml for COC and patch, respectively.

Ethinyl estradiol is characterized by non-specific binding to albumin in blood plasma. The apparent volume of distribution is approximately 15 l / kg.

Ethinylestradiol is metabolized by aromatic hydroxylation. Its biotransformation leads to the formation of a large number of methylated and hydroxylated metabolites. In the blood, they circulate either in free form or in the form of glucuronide and sulfate conjugates. The apparent ground clearance is approximately 35 l / h.

The concentration of ethinyl estradiol in the blood plasma decreases in a biphasic manner. In the terminal phase, the half-life varies widely, and the median is approximately 34 hours. Ethinylestradiol is not excreted unchanged. Its metabolites are excreted through the kidneys and intestines with bile in an approximate ratio of 1.3: 1. For metabolites, the half-life is 1.5 days on average.

The pharmacokinetics of NuvaRing rings when used in healthy adolescent girls who have not reached the age of 18 and who have already started menstruating have not been studied. The effect of liver and kidney diseases on the pharmacokinetic parameters of the drug has not been sufficiently studied, however, in patients with liver dysfunctions, a deterioration in the metabolism of sex hormones is allowed. The pharmacokinetics of NovaRing in representatives of various ethnic groups has not been specifically studied.

Indications for use

According to the instructions, NuvaRinga is indicated for intravaginal contraception.

Contraindications

• Multiple or severe risk factors for arterial or venous thrombosis: hereditary predisposition (presence of thrombosis, cerebrovascular accident or myocardial infarction in close relatives at a young age), lesions of the valvular apparatus of the heart, arterial hypertension, atrial fibrillation, obesity (body mass index more than 30 kg per 1 m ²), extensive trauma and / or surgery, smoking over the age of 35, prolonged immobilization;
• Arterial and venous thrombosis, thromboembolism, including pulmonary thromboembolism, deep vein thrombosis, cerebrovascular disorders, myocardial infarction (including a history);
• A tendency to develop arterial or venous thrombosis, including such hereditary diseases as antithrombin III deficiency, resistance to activated protein C, protein C deficiency, protein S deficiency, antiphospholipid antibodies (lupus anticoagulant, antibodies to cardiolipin) and hyperhomocysteinemia;
• Transient ischemic attacks, angina pectoris and other pathologies preceding thrombosis (including a history);
• Migraine with focal neurological symptoms (including history);
• Pancreatitis (including history) with concomitant severe hypertriglyceridemia;
• Benign or malignant neoplasms of the liver (including history);
• Severe liver pathology;
• Diabetes mellitus with vascular lesions;
• Suspected or diagnosed malignant hormone-dependent tumors (including genitals, mammary glands);
• The period of pregnancy or suspicion of it;
• Vaginal bleeding of unknown etiology;
• Breastfeeding period;
• Hypersensitivity to drug substances.

The efficacy and safety of NovaRing's use by patients under the age of 18 has not been established.

If symptoms of any of the above conditions occur, the drug should be discontinued immediately.

The appointment of Novairing should be done with extreme caution (after a careful assessment of the balance of benefits and risks of contraception): in the presence of risk factors for the development of thromboembolism and thrombosis, including cardiac arrhythmias, arterial hypertension, heart valve disease, a hereditary predisposition (presence of thrombosis, myocardial infarction or cerebral circulation in the closest relatives at a young age), obesity, smoking, dyslipoproteinemia, migraine without focal neurological symptoms, serious surgical interventions, prolonged immobilization; patients with dyslipoproteinemia, superficial vein thrombophlebitis, controlled arterial hypertension, valvular heart disease, diabetes mellitus without vascular complications, cholelithiasis, acute or chronic liver dysfunction,porphyria, hemolytic uremic syndrome, systemic lupus erythematosus, hearing loss on the background of otosclerosis, chorea minor (Sydenham's chorea), angioedema (hereditary) edema, sickle cell anemia, chronic inflammatory bowel pathologies (ulcerative colitis, Crohn's disease), chloasma; with pathologies that make it difficult to use the vaginal ring (hernia of the bladder and / or rectum, prolapse of the cervix, chronic severe constipation), with itchy skin and / or jaundice against the background of cholestasis.complicating the use of the vaginal ring (hernia of the bladder and / or rectum, prolapse of the cervix, chronic severe constipation), with pruritus and / or jaundice against the background of cholestasis.complicating the use of the vaginal ring (hernia of the bladder and / or rectum, prolapse of the cervix, chronic severe constipation), with pruritus and / or jaundice against the background of cholestasis.

In case of appearance / exacerbation of any of these conditions or deterioration of health, you should consult a doctor.

Instructions for the use of NovaRing: method and dosage

The NovaRing contraceptive ring is used by insertion into the vagina. The procedure is performed 1 time in 4 weeks, in a prone position, standing (lifting the leg bent at the knee) or squatting. Squeezing the ring, it is inserted into the vagina and placed in a comfortable position, the accuracy of the location does not affect the effectiveness of contraception.

In the absence of hormonal contraception in the previous menstrual cycle, the ring is inserted on the first day of menstrual bleeding. After 3 weeks, on the day of the week and at about the same time the ring was installed, it is removed. During the absence of the ring, menstrual bleeding occurs, which occurs 2-3 days after removal. The new ring is injected after one week off on the set day of the week, even if the withdrawal bleeding has not ended.

If the use of NovaRing is started from the second to the fifth day of the menstrual cycle, during the first 7 days it is necessary to additionally use barrier contraceptives.

When switching from combined oral contraceptives, the ring is recommended to be inserted on the last day of the break between cycles of use or on any day of the cycle, but subject to regular intake of the previous combined hormonal drug and complete confidence in the absence of pregnancy.

The period of the recommended break in the use of hormonal contraceptives must not be exceeded.

When switching from progestogenic contraceptives, the contraceptive ring can be inserted on the day the implant or the hormone-containing intrauterine system is removed, the next injection, or on any day after using the mini-pill. In each of these cases, during the first 7 days of use, the use of additional barrier methods of contraception is required.

After an abortion in the first trimester of pregnancy, the NuvaRing ring can be inserted immediately after the operation without resorting to additional contraceptives.

The introduction of the ring is recommended within the fourth week after an abortion in the second trimester of pregnancy or childbirth (in the absence of breastfeeding). At a later period of start of use, it is recommended to use additional condoms during sexual intercourse during the first 7 days of hormonal contraception.

If a woman has had sexual intercourse after childbirth or abortion, then before inserting the ring, it is necessary to confirm the absence of pregnancy or insert the ring at the beginning of the menstrual cycle.

After insertion, the ring must remain in the vagina for 3 weeks. If accidentally removed, so as not to interfere with the contraceptive effect, it should be rinsed with warm water and placed in the vagina within the next 3 hours.

If the period of absence of the ring in the established place exceeds 3 hours in the first or second week of use, then it is recommended to use additional barrier contraceptives after inserting it into the vagina for the next 7 days.

If accidental removal occurred in the third week of use, and the ring was missing for more than 3 hours, then the risk of violation of the contraceptive effect is very high. In this case, the dropped ring should be discarded and one of the following actions should be chosen.

A new ring can be inserted immediately and must be worn for the next 3 weeks. Menstrual bleeding may not occur, the risk of spotting bleeding or breakthrough bleeding in the middle of a new cycle increases.

The next option can be selected only if there are no violations in the mode of using the ring during the first 2 weeks. He suggests waiting for withdrawal bleeding and inserting a new ring no later than 1 week after removing the previous ring.

If a woman had sexual intercourse during the week's break, then pregnancy must be excluded before the introduction of a new ring. In the absence of pregnancy and after the introduction of NuvaRing, it is necessary to use additional barrier contraceptives during the first 7 days.

The contraceptive property of the ring remains sufficient for up to 4 weeks. If the ring is not removed for more than 4 weeks, then there is a risk of pregnancy, since the contraceptive effect has been exhausted. Therefore, you need to make sure that there is no pregnancy before the next introduction of NuvaRing.

To delay withdrawal bleeding, the next ring should be inserted on the first day of the intended break and used within 3 weeks. During this period, the appearance of spotting and breakthrough bleeding is possible. Then you should follow the usual regimen of regular use of the ring.

To postpone the onset of withdrawal bleeding to another day of the week, the ring should be removed not on the set day of the week, but later, reducing the interruption in use. It should be borne in mind that the shorter the break, the greater the risk of the absence of menstrual bleeding and the appearance of spotting in the next cycle of using the ring.

If the ring is damaged (broken), it should be replaced with a new one.

It is recommended to regularly check the presence of the ring in the vagina, since it may fall out, for example, in women with chronic constipation, if inserted incorrectly, after intercourse.

To remove the ring, it should be hooked with the index finger and pulled out of the vagina, then discarded, previously placed in a bag.

Side effects

• Genitals and mammary glands: often - itching of the external genital organs, painful withdrawal bleeding, vaginal discharge, pain in the pelvic region, tenderness and engorgement of the mammary glands; infrequently - absence of menstrual bleeding, enlargement of the mammary glands, discomfort in the mammary glands and / or in the pelvic region, lumps in the mammary glands, spotting (bleeding) during intercourse, painful intercourse, cervical polyps, ectropion of the cervix, acyclic bleeding, profuse withdrawal bleeding, fibrocystic breast disease, burning sensation and / or soreness inside the vagina, premenstrual syndrome, vaginal odor, dryness and discomfort of the vulva and vaginal mucosa; frequency unknown - galactorrhea, local reactions in the partner's penis such as pain,bruising, hyperemia, abrasions;
• Immune system: frequency unknown - hypersensitivity;
• Infections and invasions: often - vaginal infection; infrequently - cystitis, cervicitis, urinary tract infections;
• Metabolism: often - an increase in body weight; infrequently - increased appetite;
• Digestive system: often - nausea, abdominal pain; infrequently - vomiting, bloating, constipation, diarrhea;
• Mental disorders: often - decreased libido, depression; infrequently - mood changes;
• Organ of vision: infrequently - visual impairment;
• Nervous system: often - headache, migraine; infrequently - hypesthesia, dizziness;
• Cardiovascular system: infrequently - hot flashes, increased blood pressure (BP); rarely - venous thromboembolism;
• Skin: often - acne; infrequently - itching, alopecia, rash, eczema; frequency unknown - urticaria;
• Urinary system: infrequently - pollakiuria, dysuria, urge to urinate;
• Musculoskeletal system: infrequently - muscle spasms, pain in the back and / or limbs;
• General ailments: infrequently - irritability, fatigue, painful condition, edema;
• Others: often - discomfort during the use of the vaginal ring, prolapse of the vaginal ring; infrequently - difficulties in use, damage (rupture) of the ring, sensation of a foreign body.

In addition, against the background of the use of NovaRing, it is possible to develop cholecystitis, pancreatitis, cerebrovascular disorders, chloasma, benign and malignant liver tumors, and a change in insulin resistance.

In hereditary forms of angioedema, combined hormonal contraceptives can cause or aggravate the symptoms of angioedema.

Overdose

Cases of complications leading to serious health consequences and associated with an overdose of NuvaRing have not been described. Potential symptoms include minor vaginal bleeding in young women, nausea, and vomiting. There are no specific antidotes. In this case, symptomatic therapy is prescribed.

special instructions

The appointment of NovaRing is indicated only after excluding pregnancy and a complete gynecological examination (including mammary glands, pelvic organs, cytological examination of cervical smears), measuring blood pressure, carrying out some laboratory tests that exclude contraindications. During the period of using the contraceptive ring, a woman should undergo a medical examination at least once every six months.

In case of exacerbation or the appearance of symptoms of diseases, deterioration of health, a woman should consult a doctor for advice.

The use of NovaRing can cause circulatory disorders and, as a consequence, cause the development of deep vein thrombosis, pulmonary embolism, arterial thrombosis and complications associated with these pathologies, sometimes with a risk of death.

In extremely rare cases, women taking complex hormonal contraceptives develop thrombosis of the veins and arteries of the liver, mesenteric vessels, cerebral vessels, retina, kidneys and other blood vessels, although the connection with the use of NovaRing has not been precisely established.

Symptoms of arterial or venous thrombosis can be: severe sudden chest pain with possible return to the left arm, prolonged and intense headaches, an attack of coughing or shortness of breath, acute abdomen, sudden weakness or severe numbness of one side or any part of the body, movement disorders, double vision, sudden loss of vision (partial or complete), aphasia, dizziness, the appearance of unilateral edema and / or pain in the lower limb, local fever, skin discoloration or hyperemia, collapse with or without a focal epileptic seizure.

Risk factors that can cause venous thrombosis and embolism include: age, a family history of thrombosis, obesity (body weight index more than 30 kg per 1 m ²), prolonged immobilization, major surgical interventions, any leg surgery, serious injuries, possibly varicose veins and thrombophlebitis of superficial veins.

The use of NuvaRing should be discontinued 4 weeks before the planned operation and resumed only when motor activity is fully restored after 2 weeks.

In addition to age, obesity and heredity, factors for the possible occurrence of complications of arterial thromboembolism can be: heavy smoking (especially in women after 35 years), dyslipoproteinemia, migraine, atrial fibrillation, arterial hypertension, heart valve disease.

If in a family history (close relatives of the patient: parents in their youth, brothers, sisters) there is a predisposition to thrombosis, it is impossible to start using any hormonal contraceptives without consulting a specialist.

Unwanted circulatory disorders can occur with biochemical factors of predisposition to venous or arterial thrombosis (hyperhomocysteinemia, resistance to activated protein C, protein C deficiency, antithrombin III deficiency, antibodies to phospholipids, protein S deficiency), diabetes mellitus, hemolytic systemic uremic syndrome lupus erythematosus, chronic inflammatory bowel disease, sickle cell anemia, in the postpartum period.

An increase in the frequency or severity of migraines while taking hormonal contraceptives may cause their cancellation.

According to epidemiological studies, the risk of developing tumors with prolonged use of hormonal oral contraceptives increases. How much this is associated with the use of NuvaRing has not been established, since the diagnosis of a tumor in this category of patients may be associated with more frequent observations with a doctor.

While using the drug, it is possible to develop benign or malignant liver tumors, which can cause life-threatening bleeding into the abdominal cavity. Therefore, in the differential diagnosis of diseases in women taking hormonal contraceptives, it is necessary to take into account the possibility of a liver tumor with existing signs of intra-abdominal bleeding, acute pain in the upper abdomen or an enlarged liver.

The use of NuvaRing can cause a slight increase in blood pressure, with a pronounced constancy of this pathology, one should consider the feasibility of further hormonal contraception.

In case of recurrence of cholestatic jaundice, which first appeared during pregnancy or previously taken sex steroids, the development of acute or chronic liver dysfunctions, Novairing must be canceled.

If a woman has diabetes mellitus, constant medical supervision is necessary, especially in the first cycles of using the drug.

The cause of incorrect insertion or frequent prolapse of the ring may be existing pathologies: a hernia of the bladder and / or rectum, prolapse of the cervix, severe chronic constipation.

In case of an unexpected appearance of symptoms of cystitis, the correct insertion of the ring should be checked.

The effectiveness of NovaRing may decrease if the regimen of use is violated or the simultaneous use of other drugs.

If acyclic bleeding occurs during the use of the ring, you should consult a gynecologist to exclude pregnancy or organic pathology.

If there is no withdrawal bleeding after removing the ring two cycles in a row, you should consult a doctor.

When conducting laboratory tests, the health worker should be informed about the use of contraceptive hormonal drugs.

The contraceptive ring does not protect against sexually transmitted diseases, including HIV infection (AIDS).

The effect of NuvaRing on the ability to drive vehicles and mechanisms has not been established.

Application during pregnancy and lactation

NuvaRing is designed to prevent pregnancy. If a woman wants to stop using the ring in order to become pregnant, conception should be postponed until the natural cycle is restored, as this will help to determine the date of conception and childbirth as correctly as possible.

Installation of a vaginal ring during pregnancy is contraindicated. In the event of a diagnosed pregnancy, it must be removed immediately. Extensive epidemiological studies do not confirm the presence of 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 contraceptives in early pregnancy without knowing about it. However, at the moment it is not known whether this applies to the drug Novairing. A clinical study conducted in a small group of patients showed that, despite the introduction of a ring into the vagina, the level of sex hormones that have a contraceptive effect when using Novairing is similar to that when taking other COCs. Pregnancy outcomes in womenwho used the drug during a clinical trial are not described.

The use of NovaRing rings during lactation is contraindicated. The active components of the contraceptive can affect the production of breast milk, changing its composition and reducing its amount. Contraceptive sex hormones and / or their metabolites can be excreted in breast milk in small concentrations, but there is no evidence of their negative impact on the health of children.

Drug interactions

If necessary, concomitant therapy with the use of a contraceptive ring, it is necessary to consult a doctor in order to avoid the development of unwanted adverse reactions.

Analogs

NovaRing's analogues are: Janine, Logest, Midiana, Novinet, Yarina.

Terms and conditions of storage

Store at 2-8 ° C. Keep out of the reach of children.

The shelf life is 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about NovaRing

Experts leave mostly positive reviews about NovaRing, referring to it as a reliable and effective contraceptive with a minimum number of adverse reactions. Almost nowhere is the onset of unwanted pregnancy mentioned during the use of the drug. Gynecologists often recommend a hormone ring for endometriosis, indicating that it can prevent the disease from progressing. However, some patients still mention such side effects of NuvaRing as headache, weight gain and vaginal discomfort.

The price of NovaRing in pharmacies

The approximate price for Novaring in pharmacy chains is 1259-1695 rubles (for 1 ring) or 3226-3830 rubles (for 3 rings).

NuvaRing: prices in online pharmacies

Drug name Price Pharmacy

Novairing 15 mcg + 120 mcg / 24 h vaginal rings 1 pc. 1242 RUB Buy

Novaring vaginal ring 1429 RUB Buy

Novairing 15 mcg + 120 mcg / 24 h vaginal rings 3 pcs. RUB 3110 Buy

Novaring vaginal ring 15mkg + 120mkg / day 3 pcs. 3594 RUB Buy

Anna Kozlova Medical journalist About the author

Education: Rostov State Medical University, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!