Ethinyl Estradiol (ETH-i-nil es-tra-DYE-ol), Segesterone Acetate (se-JES-ter-one AS-e-tate)

Prevents pregnancy.

Brand Name(s):

Annovera

When This Medicine Should Not Be Used:

How to Use This Medicine:

Insert

• This medicine is inside a vaginal system that is put into your vagina. Your doctor or nurse will show you how to put in the vaginal system. The ring should be left in place for 3 weeks. It will then be removed and cleaned with mild soap and warm water, patted dry, then will be inserted 1 week later. During the week without the vaginal system, you will usually have your menstrual period.
• If you have an irregular menstrual cycle or if you start using this vaginal system more than 5 days from your last menstrual bleeding, you should also use a second form of birth control (including condom or spermicide) during the first 7 days to avoid pregnancy.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Once the vaginal system is in place, you should not be able to feel it. If you feel uncomfortable, the vaginal system may not be inserted far enough. Gently push it farther into your vagina. If you feel pain, talk to your doctor.
• The vaginal system may move down accidently. This can happen if you remove a tampon, during sex, or strain to have a bowel movement. Gently push it back into place. If the vaginal system comes all the way out, wash it with mild soap and warm water, pat it dry with a clean cloth towel or paper towel, and put it back inside. Call your doctor if the vaginal system comes out several times.
• Missed dose:
  • If the vaginal system has slipped out and it has been out for 2 hours or less, wash it with mild soap and warm water, pat it dry with a clean cloth towel or paper towel, and reinsert it. You should still be protected from pregnancy. If the vaginal system has been out for more than 2 hours (including multiple removals), use an additional form of birth control (including condoms or spermicide) until the vaginal system has been in the vagina for 7 days in a row.
  • If you forget to reinsert the vaginal system after the vaginal system-free week, use an additional form of birth control (including condoms or spermicide) until the vaginal system has been in the vagina for 7 days in a row.
  • If you leave the vaginal system inside the vagina for more than 21 days, remove it for 7 days and then reinsert it for 21 days to go back to the regular schedule.
• Do not use the vaginal system for more than 13 cycles (1 year). Place the used vaginal system inside the case that comes with it. Throw it in the trash. Do not flush the vaginal system down the toilet.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine together with medicine to treat hepatitis C virus infection, including ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.
• Some foods and medicines can affect how segesterone acetate/ethinyl estradiol works. Tell your doctor if you are using any of the following:
  • Acetaminophen, aprepitant, ascorbic acid, bosentan, cyclosporine, efavirenz, prednisolone, St John's wort, theophylline, tizanidine
  • Medicine to treat an infection (including fluconazole, griseofulvin, itraconazole, ketoconazole, rifabutin, rifampin, voriconazole)
  • Medicine to treat HIV infection (including amprenavir/ritonavir, atazanavir/ritonavir, boceprevir, darunavir/ritonavir, fosamprenavir/ritonavir, indinavir, lopinavir/ritonavir, nelfinavir, nevirapine, ritonavir, telaprevir, tipranavir/ritonavir)
  • Medicine to treat seizures (including carbamazepine, felbamate, lamotrigine, oxcarbazepine, phenobarbital, phenytoin, rufinamide, topiramate)
  • Thyroid medicine
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.
• Do not use this medicine together with oil-based vaginal creams, gels, lubricants, or suppositories. Ask your doctor before you use other products or medicines into your vagina.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant.
• Tell your doctor if you are breastfeeding, or if you recently had a baby, miscarriage, or abortion. Tell your doctor if you have kidney disease, cervical cancer, diabetes, migraines, heart or blood vessel disease, obesity, high cholesterol, high blood pressure, or a history of depression or chloasma (skin discoloration on the face). Tell your doctor if you smoke or if you are having a surgery that requires inactivity for a long time.
• This medicine may cause the following problems:
  • Increased risk of heart attack, stroke, or blood clots
  • Liver problems
  • High blood pressure
  • Gallbladder disease
  • High cholesterol or fats in the blood
  • Increased risk of cervical cancer
  • Toxic shock syndrome
• This medicine may cause skin discoloration. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.
• This medicine will not protect you from HIV/AIDS or other sexually transmitted diseases.
• You might have spotting or irregular bleeding when you first start using this medicine. You might have unplanned bleeding if you miss a dose or are late taking it. However, if you have heavy bleeding, call your doctor.
• Tell any doctor or dentist who treats you that you are using this medicine. You may need to stop using this medicine several days before you have surgery or medical tests.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Breast lumps, tenderness, pain, swelling, or discharge
• Chest pain that may spread, trouble breathing, coughing up blood
• Dark urine or pale stools, loss of appetite, yellow skin or eyes
• Fast, slow, or pounding heartbeat
• Numbness or weakness on one side of your body, pain in your lower leg, sudden or severe headache, problems with vision, speech, or walking
• Redness, pain, itching, or burning sensation inside your vagina
• Sudden and severe stomach pain, nausea, vomiting, lightheadedness
• Sudden high fever, diarrhea, dizziness, fainting, muscle aches, sunburn-like rash
• Unusual or unexpected vaginal bleeding or heavy bleeding
• Vision loss, double vision

If you notice these less serious side effects, talk with your doctor:

• Darkened skin on your face
• Depression, mood changes
• Headaches

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088