ANNOVERA Vaginal Ring - Yearly Hormonal Contraceptive by Mayne Pharma

ANNOVERA is a flexible vaginal contraceptive ring containing segesterone acetate and ethinyl estradiol. It provides reversible, hormonal birth control for females of reproductive potential through a once-yearly regimen, offering contraception over 13 cycles with a single vaginal system.

ANNOVERA is indicated to prevent pregnancy in females of reproductive potential. It is designed for use as a combination hormonal contraceptive vaginal ring worn for 21 days followed by a 7-day ring-free interval, repeated for up to 13 cycles (one year).

Limitations: It has not been adequately studied in females with a body mass index (BMI) greater than 29 kg/m2.

segesterone acetate and ethinyl estradiol

ANNOVERA releases two hormones, segesterone acetate (a progestin) and ethinyl estradiol (an estrogen), which work together to prevent ovulation. By maintaining steady hormone levels through vaginal absorption, ANNOVERA inhibits egg release and causes changes in cervical mucus and the uterine lining, reducing the chance of fertilization or implantation.

Method of use: One ANNOVERA vaginal system is inserted into the vagina and worn continuously for 21 days (3 weeks). After removal, it remains out for a 7-day ring-free interval during which withdrawal bleeding typically occurs. The vaginal system is then cleaned and reinserted for another 21-day cycle. This 21-days-in, 7-days-out cycle continues for 13 cycles (one year).

Insertion and removal can be done by the user, pressing the ring sides together for insertion and hooking a finger to gently remove it. The ring should be positioned fully inside the vagina and behind the pelvic bone.

Starting instructions:

• No hormonal contraceptive use previously or after copper IUD removal: Insert between days 2 and 5 of menstrual bleeding with no back-up contraception needed. If cycles are irregular or insertion is later than day 5, use additional barrier methods for the first 7 days.
• Switching from combination hormonal contraceptives (CHCs): Can switch on any day of previous CHC cycle without back-up contraception, provided the CHC was used properly and no more than 7 hormone-free days have passed.
• Switching from progestin-only methods (pills, injections, implants, or IUS): Start ANNOVERA when next dose or implant/IUS removal occurs. Use additional barrier contraception for the first 7 days.
• After first trimester abortion or miscarriage: Start within 5 days without back-up contraception. If more than 5 days have passed, use barrier methods for 7 days after insertion.
• After second trimester abortion, miscarriage, or childbirth: Start no sooner than 4 weeks postpartum and only if not breastfeeding due to thromboembolism risk. Use barrier contraception for 7 days if no period occurred before starting.

Missed dose or expulsion:

• If the ring is accidentally expelled during the 21-day period, it must be washed with mild soap and warm water, rinsed, dried, and reinserted within 2 hours to maintain effectiveness without need for back-up contraception.
• If the ring is out of the vagina for more than 2 continuous hours (or cumulative 2 hours during the 21 days), additional contraception like condoms or spermicide should be used until the ring has been in place for 7 consecutive days.
• If the 7-day ring-free interval is extended, consider possible pregnancy and use back-up contraception until the ring is in place for 7 consecutive days.
• If ANNOVERA is left in for more than 21 days, it should be removed for 7 days before reinsertion to continue the 21/7 cycle.

The use of tampons does not affect hormone absorption from ANNOVERA.

• Females over 35 years who smoke.
• Current or history of deep vein thrombosis, pulmonary embolism, cerebrovascular disease, coronary artery disease, thrombogenic valvular or rhythm heart disease.
• Inherited or acquired hypercoagulopathies.
• Uncontrolled hypertension or hypertension with vascular disease.
• Diabetes mellitus in females over 35, or diabetes with hypertension, vascular disease, end-organ damage, or duration over 20 years.
• Migraine with aura, or any migraine in females over 35.
• Current or history of breast cancer, especially hormone-sensitive.
• Benign or malignant liver tumors, acute hepatitis, severe (decompensated) cirrhosis.
• Undiagnosed abnormal uterine bleeding.
• Hypersensitivity to any ANNOVERA components.
• Use with hepatitis C drug combinations including ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.

Cardiovascular risk: Cigarette smoking increases the risk of serious cardiovascular events (such as blood clots, stroke, and heart attack) in combination hormonal contraceptive users. This risk rises with age and cigarette consumption. ANNOVERA should not be used by females over 35 years old who smoke.

Thrombotic disorders: Use is contraindicated in females with a history or high risk of arterial or venous thrombosis (deep vein thrombosis, pulmonary embolism), cerebrovascular or coronary artery disease, thrombogenic heart valve or rhythm disorders, or hypercoagulopathies.

Hypertension: ANNOVERA is contraindicated in uncontrolled hypertension or hypertension with vascular disease. Blood pressure should be monitored during use, and development of significant hypertension requires discontinuation.

Liver disease and tumors: Contraindicated in acute hepatitis, severe cirrhosis, or benign/malignant liver tumors. Discontinue if jaundice develops. Use is contraindicated with certain hepatitis C drugs (ombitasvir/paritaprevir/ritonavir combinations) due to hepatotoxicity risk.

Diabetes and metabolic effects: Use with caution in diabetes, especially over age 35 or with vascular complications. Monitor blood glucose. Consider alternative contraception with uncontrolled dyslipidemia.

Headaches: Discontinue if new migraines or neurological symptoms develop, particularly if migraine with aura or age over 35.

Bleeding irregularities: May cause irregular bleeding or absence of menstruation. Persistent abnormal bleeding should be evaluated.

Toxic shock syndrome: Rare risk; evaluate patients presenting with fever and symptoms of TSS promptly.

Perioperative use: Stop ANNOVERA at least 4 weeks before and through 2 weeks after major surgery or prolonged immobilization due to increased VTE risk.

Postpartum use: Avoid during first 4 weeks postpartum unless fully weaned from breastfeeding due to elevated thromboembolism risk.

Common side effects associated with ANNOVERA include irregular vaginal bleeding patterns, amenorrhea, headaches, and possible breast tenderness. Serious hypersensitivity reactions such as throat constriction, facial swelling, hives and wheezing have been reported. Signs of thrombotic events (such as leg pain, chest pain, sudden vision loss) require immediate medical attention.

ANNOVERA should not be used concomitantly with hepatitis C treatment regimens containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to risk of elevated liver enzymes. Discontinue ANNOVERA prior to starting such therapy and wait approximately 2 weeks after completion before restarting.

Pregnancy: ANNOVERA is intended to prevent pregnancy and should not be used if pregnancy is suspected or confirmed.

Lactation: ANNOVERA should not be initiated before weaning; use is contraindicated during breastfeeding.

No specific overdose information provided.

No specific storage instructions provided.