Annovera

Contraception

Annovera is a prescription birth control method used to prevent pregnancy. It is a flexible, reusable silicone ring that is inserted into the vagina. It is designed to be used for one year, covering 13 consecutive menstrual cycles.

How It Works

The ring contains two hormones: segesterone acetate (a progestin) and ethinyl estradiol (an estrogen). These hormones are released into the body to prevent pregnancy primarily by stopping ovulation, which is the release of an egg from the ovaries. The hormones also cause changes in the cervical mucus and the lining of the uterus to further reduce the chance of conception.

Important Considerations for Use

• Body Mass Index (BMI): Annovera has not been adequately studied in females with a BMI greater than 29 kg/m². Because of this, its effectiveness in individuals with a higher BMI is not fully known.
• STI Protection: This medication is used strictly for the prevention of pregnancy. It does not provide protection against HIV infection or other sexually transmitted infections (STIs).
• Reversibility: Annovera is a reversible form of birth control. If a person decides they want to become pregnant, they can stop using the ring at any time.

Hormone Release

Annovera contains two active hormones: segesterone acetate (a progestin) and ethinyl estradiol (an estrogen). Once the ring is inserted into the vagina, it continuously releases a low dose of these hormones, which are absorbed through the vaginal wall and into the bloodstream.

Preventing Ovulation

The main way Annovera works is by suppressing the hormones responsible for ovulation. By maintaining steady levels of progestin and estrogen, the medication signals the body to prevent the ovaries from releasing a mature egg each month. If no egg is released, there is nothing for sperm to fertilize.

Secondary Mechanisms

In addition to stopping ovulation, Annovera provides other layers of protection against pregnancy:

• Thickening cervical mucus: The hormones cause the mucus in the cervix to become thicker and stickier. This acts as a physical barrier that makes it difficult for sperm to swim into the uterus.
• Thinning the uterine lining: The medication changes the lining of the uterus (the endometrium), making it thinner. This change makes the environment less suitable for a fertilized egg to implant and develop.

Common Side Effects

Many people using Annovera experience mild side effects as their bodies adjust to the hormones. These may include:

• Headache or migraine
• Nausea and vomiting
• Vaginal yeast infections or increased discharge
• Abdominal or pelvic pain
• Painful menstrual cramps
• Breast tenderness or pain
• Irregular bleeding or spotting between periods
• Diarrhea
• Genital itching

Some users may also experience discomfort while the ring is in place or notice the ring during sexual intercourse.

Serious Side Effects

While rare, Annovera can cause serious and potentially life-threatening side effects. Seek immediate medical care if you experience symptoms of the following:

• Blood clots: Pain, swelling, or warmth in the leg; sudden shortness of breath; or sharp chest pain.
• Heart attack or stroke: Sudden numbness or weakness, especially on one side of the body; severe headache; vision changes; or difficulty speaking.
• Liver problems: Yellowing of the skin or eyes (jaundice), dark-colored urine, or pain in the upper right abdomen.
• Gallbladder disease: Severe stomach pain, fever, and nausea.
• Toxic Shock Syndrome (TSS): High fever, a sunburn-like rash, muscle aches, or dizziness.
• High blood pressure: New or worsening hypertension.

Boxed Warning: Smoking and Cardiovascular Risk

Cigarette smoking increases the risk of serious cardiovascular side effects from combination hormonal contraceptives. This risk increases with age, particularly in those over 35 years old, and with the number of cigarettes smoked. People using this medication are strongly advised not to smoke.

Blood Clotting and Cardiovascular Events

The use of this vaginal system is associated with an increased risk of serious blood clotting conditions, including:

• Deep vein thrombosis (clots in the legs)
• Pulmonary embolism (clots in the lungs)
• Heart attack
• Stroke

The risk of developing a blood clot is highest during the first year of use or when restarting the medication after a break of four weeks or longer. Use should be discontinued if a blood clot occurs or if there is a planned surgery that involves long periods of inactivity.

Contraindications

This medication should not be used by individuals with certain health conditions, including:

• A high risk of arterial or venous blood clots.
• Current or past breast cancer or other estrogen-sensitive cancers.
• Liver tumors or active liver disease.
• Undiagnosed abnormal uterine bleeding.
• Use of certain Hepatitis C drug combinations.

Other Precautions

Toxic Shock Syndrome (TSS): Cases of TSS have been reported with the use of vaginal rings. Symptoms may include sudden high fever, vomiting, diarrhea, a sunburn-like rash, and low blood pressure. Medical attention should be sought immediately if these symptoms occur.

Liver and Gallbladder Issues: Estrogen may increase the risk of gallbladder disease. If jaundice (yellowing of the skin or eyes) develops, the medication should be removed and medical advice sought.

Blood Pressure and Diabetes: Blood pressure should be monitored regularly, as some users may experience significant increases. People with pre-diabetes or diabetes should be monitored closely because hormonal contraceptives can affect glucose tolerance and lipid levels.

Headaches: The onset of new or worsening migraine headaches, or the development of headaches with a new pattern, may require discontinuation of the medication.

Pregnancy

Annovera is used to prevent pregnancy and should not be used by anyone who is already pregnant. If pregnancy is confirmed while the vaginal ring is in use, the ring should be removed immediately. Current evidence suggests that the accidental use of hormonal contraceptives during early pregnancy does not significantly increase the risk of birth defects.

Breastfeeding

The hormones in Annovera can affect nursing in the following ways:

• Milk production: Estrogen-containing contraceptives can decrease the quantity and quality of breast milk. This is more likely to happen if the medication is started before breastfeeding is well-established.
• Hormone transfer: Small amounts of the hormones in the ring pass into breast milk. While the impact on the infant is generally considered low, healthcare providers typically recommend using other forms of birth control until the child is weaned.

Dosage Form

Annovera is supplied as a vaginal system, which is a soft, flexible, silicone-based ring. It is opaque white in color and non-biodegradable.

Strengths

The system contains a combination of two hormones:

• Segesterone acetate
• Ethinyl estradiol

A single vaginal ring is designed to be used for one full year, covering 13 menstrual cycles. It releases a continuous dose of medication while inserted. The typical schedule involves keeping the ring in place for 21 days, followed by a 7-day period where the ring is removed, cleaned, and stored.

FDA Approval and Indication

Annovera (segesterone acetate and ethinyl estradiol vaginal system) was approved by the U.S. Food and Drug Administration (FDA) in August 2018. It is indicated for use by females of reproductive potential to prevent pregnancy. It is the first long-acting, reusable vaginal ring contraceptive designed to be used for 13 cycles (one year).

Boxed Warning

The FDA-approved labeling for Annovera includes a boxed warning concerning cigarette smoking and serious cardiovascular events. Regulatory safety information includes the following:

• Cigarette smoking increases the risk of serious cardiovascular side effects from combination hormonal contraceptives.
• This risk increases with age, particularly in women over 35 years old.
• The risk also increases with the number of cigarettes smoked.
• Annovera is contraindicated in women over 35 years old who smoke.

Contraindications and Safety Status

In addition to the boxed warning, the FDA identifies several contraindications where Annovera should not be used, including:

• A high risk of arterial or venous thrombotic diseases.
• Current or history of breast cancer or other estrogen- or progestin-sensitive cancer.
• Liver tumors or liver disease.
• Undiagnosed abnormal uterine bleeding.
• Hypersensitivity to any of the components in the system.

Annovera is a prescription-only medication. It is not approved for protection against HIV infection or other sexually transmitted diseases.

Insurance Coverage

Many health insurance plans cover Annovera at no cost under the Affordable Care Act. Because it is an FDA-approved contraceptive, it is often included in the list of preventive services that do not require a copayment or coinsurance. It is important to verify coverage with a specific insurance provider, as some plans may require a prior authorization or have specific formulary requirements.

Out-of-Pocket Costs

For those without insurance coverage, the initial cost of Annovera may be higher than other birth control methods. This is because a single ring is designed to last for an entire year, or 13 cycles. When comparing costs, it is helpful to consider that one purchase replaces the need for monthly prescriptions or multiple rings throughout the year.

Savings and Assistance

The manufacturer may provide financial assistance options, such as savings cards, for eligible patients. These programs can reduce the out-of-pocket expense for people with commercial insurance. Additionally, some community health clinics or family planning clinics may offer the ring at a reduced cost based on a person's income level.