Segesterone Acetate; Ethinyl Estradiol Vaginal Ring

What is this medication?

SEGESTERONE ACETATE; ETHINYL ESTRADIOL (se JES ter one; ETH in il es tra DYE ole) prevents ovulation and pregnancy. It belongs to a group of medications called contraceptives. It is a combination of the hormones estrogen and progestin.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Annovera

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Abnormal vaginal bleeding
• Blood vessel disease or blood clots
• Breast, cervical, endometrial, ovarian, liver, or uterine cancer
• Diabetes
• Gallbladder disease
• Having surgery
• Heart disease or recent heart attack
• High blood pressure
• High cholesterol or triglycerides
• History of irregular heartbeat or heart valve problems
• Kidney disease
• Liver disease
• Migraine headaches
• Protein C/S deficiency
• Recently had a baby, miscarriage, or abortion
• Stroke
• Systemic lupus erythematosus (SLE)
• Tobacco use
• An unusual or allergic reaction to estrogens, progestins, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Insert the ring into your vagina as directed. Follow the directions on the prescription label. Leave the ring in place for 3 weeks (21 days). Often check to make sure the ring is still in place. After 3 weeks, remove it for a 1-week break (7 full days). Clean the ring as directed. After the 1-week break is over, reinsert the ring. Follow the same directions each month. The ring is reusable for up to 1 year (13 cycles). Do not use more often than directed.

A patient package insert for the product will be given with each prescription and refill. Read this sheet carefully each time. The sheet may change frequently.

This medication comes with INSTRUCTIONS FOR USE. Ask your pharmacist for directions on how to use this medication. Read the information carefully. Talk to your pharmacist or care team if you have questions.

Contact your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

You will need to use the ring exactly as directed. It is very important to follow the schedule every cycle. If you do not use the ring as directed, you may not be protected from pregnancy. If the ring should slip out, is lost, or if you leave it in longer or shorter than you should, contact your care team for advice.

What may interact with this medication?

Do not take this medication with the following:

• Dasabuvir, ombitasvir, paritaprevir, ritonavir
• Ombitasvir, paritaprevir, ritonavir
• Vaginal lubricants or other vaginal products that are oil-based or silicone-based

This medication may also interact with the following:

• Acetaminophen
• Antibiotics or medications for infections, such as rifampin, rifabutin, rifapentine, and griseofulvin
• Aprepitant or fosaprepitant
• Armodafinil
• Ascorbic acid (vitamin C)
• Barbiturate medications, such as phenobarbital or primidone
• Bosentan
• Certain antiviral medications for hepatitis, HIV or AIDS
• Certain medications for cancer treatment
• Certain medications for seizures, such as carbamazepine, clobazam, felbamate, lamotrigine, oxcarbazepine, phenytoin, rufinamide, topiramate
• Certain medications for treating high cholesterol
• Cyclosporine
• Dantrolene
• Elagolix
• Flibanserin
• Grapefruit juice
• Lesinurad
• Medications for diabetes
• Medications to treat fungal infections, such as griseofulvin, miconazole, fluconazole, ketoconazole, itraconazole, posaconazole, voriconazole
• Mifepristone
• Mitotane
• Modafinil
• Morphine
• Mycophenolate
• St. John's Wort
• Tamoxifen
• Temazepam
• Theophylline or aminophylline
• Thyroid hormones
• Tizanidine
• Tranexamic acid
• Ulipristal
• Warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. You will need a regular breast and pelvic exam and Pap smear while on this medication.

Check with your care team to see if you need an additional method of contraception during the first cycle that you use this ring. External condoms made with natural rubber latex, polyisoprene, and polyurethane and spermicides may be used. Do not use a diaphragm, cervical cap, or internal condom, as it is unknown if this ring can interfere with these contraceptive methods and their proper placement.

If you have any reason to think you are pregnant, stop using this medication right away and contact your care team.

If you are taking this medication for hormone-related problems, it may take several cycles of use to see improvement in your condition.

Talk to your care team if you use tobacco products. Changes to your treatment plan may be needed. Tobacco increases the risk of getting a blood clot or having a stroke while you are taking this medication. The risk is higher if you are over the age of 35 years.

You may get dark patches on your face (chloasma) while taking this medication. If you noticed dark patches on your face during a pregnancy, your risk of getting it is higher. Keep out of the sun. If you cannot avoid the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning booths.

This medication can make your body retain fluid, making your fingers, hands, or ankles swell. Your blood pressure can go up. Contact your care team if you feel you are retaining fluid.

If you are going to have elective surgery, you may need to stop using this medication before the surgery. Consult your care team for advice.

This medication does not protect you against HIV infection (AIDS) or any other sexually transmitted infections.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Blood clot—pain, swelling, or warmth in the leg, shortness of breath, chest pain
• Gallbladder problems—severe stomach pain, nausea, vomiting, fever
• Increase in blood pressure
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• New or worsening migraines or headaches
• Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision
• Unusual vaginal discharge, itching, or odor
• Vaginal pain, irritation, or sores
• Worsening mood, feelings of depression

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Breast pain or tenderness
• Dark patches of skin on the face or other sun-exposed areas
• Irregular menstrual cycles or spotting
• Nausea
• Stomach pain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Protect from light. Between each cycle of use, wash and dry the ring as directed and store in the case. Get rid of any medication after the expiration date. The ring should be placed in the case after 13 cycles (1 year) of use and discarded via a medication take-back option, if available. If not, then discard in the trash out of reach of children and pets. Do NOT flush down the toilet.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.