Annovera is a vaginal ring containing two female hormones: estrogen and progestin. It is a microdose, monophasic ring able to prevent an unwanted pregnancy.
Contents:
Indications
Hormonal contraception
Mechanism of action
Annovera is a hormonal combined contraceptive containing segesterone acetate and ethinyl estradiol. Segesterone acetate is a progestogen, which has a high affinity for progesterone receptors in target organs. Ethinyl estradiol is an estrogen. The contraceptive effect is achieved due to a combination of various factors, the most important of which is the ovulation suppression.
Mode of application and dosage
Intravaginal route of administration. To achieve a contraceptive effect, the ring must be used according to the instructions. Annovera vaginal ring should be removed after 3 weeks on the same day of the week when the ring was set up. After a week-long break, a new ring is introduced (for example, if the vaginal ring was set up on Wednesday at about 10 pm, then it should be removed on Wednesday after 3 weeks at about 10 pm). A new ring is introduced on the next Wednesday.
Contraindications
- Hypersensitivity to segesterone, ethinyl estradiol and/or to any of the excipients;
- Venous thrombosis or thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (pulmonary embolism), currently or in history;
- Arterial thrombosis or arterial thromboembolism (ATE), including myocardial infarction and stroke, or prodromal conditions (transient ischemic attack, angina pectoris) now or in history;
- Diagnosed hereditary or acquired predisposition to venous or arterial thromboembolism;
- The presence of multiple high-risk factors for the development of venous or arterial thromboembolism or the presence of one such severe risk factor as diabetes mellitus with diabetic angiopathy, uncontrolled arterial hypertension, severe dyslipoproteinemia;
- Surgical interventions with prolonged immobilization or extensive trauma;
- Pancreatitis with severe hypertriglyceridemia at present or in history;
- Acute or chronic liver disease of a severe degree;
- The presence of liver tumors (malignant or benign) at present or in history;
- The presence of hormone-dependent malignant diseases;
- Migraine with focal neurological symptoms at present or in history;
- Vaginal bleeding of unknown etiology;
- Combined use with direct-acting antiviral drugs containing ombitasvir/paritaprevir/ritonavir and dasabuvir;
- Pregnancy;
- Period of breastfeeding;
- Age up to 18 years.
Side effects
| System organ class | Often – 1/100 | Not often – 1/100, 1/1000 | Rare – 1/1000, 1/10000 | Postmarketing data1 |
| Infectious and parasitic diseases | Vaginal infection | Cervicitis, cystitis, genitourinary infections | – | – |
| Immune system disorders | – | – | – | Hypersensitivity |
| Metabolic and nutritional disorders | – | Increase in appetite | – | – |
| Mental diseases | Depression, decrease in libido | Change in mood | – | – |
| Nervous system disorder | Headache, migraine | Dizziness, hypesthesia | – | – |
| Vision impairments | – | Vision disorders | – | – |
| Cardiovascular system disorder | – | Hot flashes | Venous thromboembolism2 | – |
| Gastrointestinal system disorders | Stomach ache, nausea | Bloating, diarrhea, nausea, constipation | – | – |
| Skin system disorder | Acne | Alopecia, eczema, itching, rash | – | Hay fever |
| Musculoskeletal and connective tissue disorders | – | Bacjpain, convultions, pain in limbs | – | – |
| Kidney disorders | – | Dysuria, frequent urination, pollakiuria | – | – |
| Violations of the genitals and mammary gland | tenderness of mammary glands, genital itching, painful menstrual-like secretions, pelvic pain, vaginal secretions | absence of menstruation, unpleasant feelings in mammary glands, increase in mammary glands, cervical polyps, painful feeling during intercourse, fibrocystic mastopathy, ample menstrual-like bleedings, premenstrual syndrome | – | Local reactions in a partner3, galactorrhea |
| Laboratory tests | Increase in weight | Hypertension | – | – |
Interactions
To determine the possible interaction, you must read the instructions for the use of concomitant drugs. The interaction of hormonal contraceptives with other drugs can result in breakthrough bleeding and/or a decrease in the effectiveness of contraception. Consult your doctor to get to know more about possible interactions.
What if I miss a dose?
The ring should be present in the vagina for 3 weeks. If the ring was accidentally removed, it should be washed with cold or slightly warm (not hot) water and immediately inserted into the vagina.
If the ring remained outside the vagina for less than 3 hours, then its contraceptive effect does not decrease. A woman should insert the ring into the vagina as soon as possible (no later than 3 hours).
If the ring was outside the vagina for more than 3 hours during the 1st or 2nd week of use, the contraceptive effect may decrease. A woman should insert a ring into the vagina as soon as possible. Over the next 7 days, it is necessary to use a barrier method of contraception, for example, a condom. The longer the ring was outside the vagina and the closer this period to a 7-day break in the ring use, the higher the likelihood of pregnancy.
Annovera and pregnancy
Annovera is intended to prevent pregnancy. If a woman wants to discontinue the drug in order to become pregnant, it is recommended to wait for the restoration of the natural menstrual cycle to conceive, because this will help to correctly calculate the date of conception and childbirth.
The use of the vaginal ring during pregnancy is contraindicated. In case of pregnancy, the ring should be removed. Extensive epidemiological studies did not reveal the risk of developmental defects in children born to women who received sex hormones before pregnancy, or the presence of teratogenic effects with the accidental use of COCs in early pregnancy.