Segesterone acetate and ethinyl estradiol (Vaginal)

Segesterone acetate and ethinyl estradiol combination is used to prevent pregnancy. It is a flexible birth control vaginal system (in the shape of a ring) that contains two types of hormones, segesterone acetate and ethinyl estradiol. It works by stopping a woman's egg from fully developing each month. The egg can no longer accept a sperm, and fertilization (pregnancy) is prevented.

No contraceptive method is 100 percent effective. Birth control methods such as having surgery to become sterile or not having sex are more effective than vaginal systems. Discuss your options for birth control with your doctor.

This medicine will not prevent HIV infection or other sexually transmitted diseases. It will not help as emergency contraception, such as after unprotected sexual contact.

This medicine is available only with your doctor's prescription.

It is very important for your doctor to check your progress at regular annual visits to ensure this medicine is working properly. Blood tests may be needed to check for unwanted effects. Your doctor may also want to check your blood pressure while you are using this medicine.

Even though you are using this medicine to prevent pregnancy, using it while you are pregnant could harm your unborn baby. If you think you may be pregnant while using this medicine, tell your doctor right away. You can start using this medicine 4 weeks after giving birth if you are not breastfeeding.

Vaginal bleeding of different amounts may happen between your regular menstrual periods during the first month of use. This is sometimes called spotting when it is lighter, or breakthrough bleeding when it is heavier.

• If this happens, continue using Annovera™.
• The bleeding usually stops within 1 week. Check with your doctor if the bleeding lasts more than 1 week.
• If the bleeding continues after you have been taking hormonal contraceptives on schedule, check with your doctor.

Do not use this medicine with medicines that treat hepatitis C virus infection, including ombitasvir/paritaprevir/ritonavir, with or without dasabuvir (Technivie®, Viekira Pak®).

Do not use this medicine if you smoke cigarettes or if you are over 35 years old. If you smoke while using Annovera™, you increase your risk of having a blood clot, heart attack, or stroke. Your risk is even higher if you are over age 35, have diabetes, high blood pressure, high cholesterol, or are overweight. Talk with your doctor about ways to stop smoking. Keep your diabetes under control. Ask your doctor about diet and exercise to manage your weight and blood cholesterol level.

Using this medicine may increase your risk of having blood clotting problems. Check with your doctor right away if you have pain in the chest, groin, or legs, especially the calves, trouble breathing, a sudden severe headache, slurred speech, sudden unexplained shortness of breath, sudden loss of coordination, or vision changes while using this medicine.

Check with your doctor immediately if you experience blurred vision, difficulty reading, or any other change in vision during or after treatment. Your doctor may want an eye doctor (ophthalmologist) to examine your eyes.

Check with your doctor right away if you have pain or tenderness in the upper stomach, dark urine, pale stools, loss of appetite, nausea, vomiting, or yellowing of the eyes or skin. These could be signs of a serious liver problem.

Your blood pressure might become too high while you are using this medicine. This may cause headaches, dizziness, or blurred vision. You may need to measure your blood pressure at home. If you think your blood pressure is too high, call your doctor right away.

This medicine may increase your risk of gallbladder disease. Check with your doctor if you start to have stomach pain, nausea, and vomiting.

Using this medicine may increase your risk of cervical cancer. Talk with your doctor about this risk. Check with your doctor immediately if you experience abnormal vaginal bleeding.

This medicine may cause skin discoloration. Use sunscreen when you are outdoors. Avoid sunlamps and tanning beds.

Toxic shock syndrome (TSS) may occur while using this medicine. Call your doctor right away if you have any of the following symptoms: sudden high fever, diarrhea, dizziness, fainting, vomiting, muscle aches, or a sunburn-like rash.

Check with your doctor before refilling an old prescription, especially after a pregnancy. You will need another physical examination, and your doctor may change your prescription.

Make sure any doctor or dentist who treats you knows that you are using this medicine. The results of some medical tests may be affected by this medicine. You may also need to stop using this medicine at least 4 weeks before and 2 weeks after having major surgery.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (e.g., St. John's wort) or vitamin supplements.

In deciding to use a medicine, you need to consider the risks of taking it compared to the benefits it may provide. This is a choice you will make with your doctor. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There have not been appropriate studies on how segesterone acetate and ethinyl estradiol combination affects children. However, there are no specific problems expected that would limit the use of this medicine in teenagers. This medicine may be used for birth control in teenage females, but it should not be used before menstruation begins.

Geriatric

There have not been appropriate studies on how segesterone acetate and ethinyl estradiol combination affects elderly people. This medicine is not recommended for elderly women.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medicine during breastfeeding. Weigh the potential benefits against the potential risks before taking this medicine while breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while in other cases, two different medicines can be used together even if an interaction might happen. In these situations, your doctor may adjust the dose or take other precautions. When taking this medicine, it is very important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions are significant but not necessarily exhaustive.

Using this medicine with any of the following medicines is not recommended. Your doctor may choose not to prescribe this medicine or may change some of the other medicines you take.

• Dasabuvir
• Ombitasvir
• Paritaprevir
• Ritonavir
• Tranexamic Acid

Using this medicine with any of the following medicines is generally not recommended, but may be needed in some cases. If both medicines are prescribed, your doctor may change the dose or how often you take one or both of the medicines.

• Amifampridine
• Amobarbital
• Amoxicillin
• Ampicillin
• Amprenavir
• Anagrelide
• Apalutamide
• Aprepitant
• Armodafinil
• Artemether
• Bacampicillin
• Belzutifan
• Betamethasone
• Bexarotene
• Boceprevir
• Bosentan
• Bupropion
• Butabarbital
• Butalbital
• Carbamazepine
• Carbenicillin
• Cefaclor
• Cefadroxil
• Cefdinir
• Cefditoren
• Cefixime
• Cefpodoxime
• Cefprozil
• Ceftazidime
• Ceftibuten
• Cefuroxime
• Cenobamate
• Ceritinib
• Clobazam
• Cloxacillin
• Cobicistat
• Colesevelam
• Cyclacillin
• Cyclosporine
• Dabrafenib
• Darunavir
• Dexamethasone
• Dicloxacillin
• Dipyrone
• Donepezil
• Doxycycline
• Efavirenz
• Elagolix
• Elvitegravir
• Encorafenib
• Enzalutamide
• Etravirine
• Felbamate
• Fosamprenavir
• Fosaprepitant
• Fosphenytoin
• Fostemsavir
• Glecaprevir
• Grazoprevir
• Griseofulvin
• Guar Gum
• Indinavir
• Isotretinoin
• Ivosidenib
• Lesinurad
• Lixisenatide
• Lopinavir
• Lorlatinib
• Lumacaftor
• Mavacamten
• Mephobarbital
• Meropenem
• Methohexital
• Minocycline
• Mitapivat
• Mitotane
• Mobocertinib
• Modafinil
• Mycophenolate Mofetil
• Mycophenolic Acid
• Nafcillin
• Nelfinavir
• Nevirapine
• Nirmatrelvir
• Octreotide
• Oxacillin
• Oxcarbazepine
• Oxytetracycline
• Paclitaxel
• Paclitaxel Protein-Bound
• Penicillin G
• Penicillin G Procaine
• Penicillin V
• Pentobarbital
• Phenobarbital
• Phenylbutazone
• Phenytoin
• Pibrentasvir
• Piperaquine
• Pitolisant
• Prednisolone
• Prednisone
• Primidone
• Red Clover
• Rifabutin
• Rifampin
• Rifapentine
• Rilpivirine
• Rufinamide
• Saquinavir
• Secobarbital
• Simeprevir
• Somatrogon-ghla
• St John's Wort
• Sugammadex
• Sultamicillin
• Tazemetostat
• Telaprevir
• Telotristat Ethyl
• Tetracycline
• Theophylline
• Thiopental
• Thioridazine
• Ticarcillin
• Tigecycline
• Tirzepatide
• Tizanidine
• Topiramate
• Troglitazone
• Ulipristal
• Valproic Acid
• Voxilaprevir

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both may be the best treatment for you. If both medicines are prescribed, your doctor may change the dose or how often you take one or both of the medicines.

• Amitriptyline
• Atazanavir
• Atorvastatin
• Clomipramine
• Diazepam
• Doxepin
• Etoricoxib
• Ginseng
• Imipramine
• Lamotrigine
• Levothyroxine
• Licorice
• Liothyronine
• Lorazepam
• Parecoxib
• Roflumilast
• Selegiline
• Temazepam
• Tipranavir
• Triazolam
• Troleandomycin
• Valdecoxib
• Voriconazole
• Warfarin

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used around meal times or with certain foods because interactions may happen. Mixing alcohol or tobacco with certain medicines may also cause interactions. The following interactions are significant but not necessarily exhaustive.

Using this medicine with any of the following may increase the risk of certain side effects, but using both may be necessary in some cases. If used together, your doctor may change the dose or how often you take this medicine or give you special instructions about food, alcohol, or tobacco use.

• Caffeine

Other Medical Problems

Having other medical issues may affect the use of this medicine. Make sure to inform your doctor if you have any other medical problems, especially:

• Abnormal or unusual vaginal bleeding or
• Blood clots (e.g., deep vein thrombosis, pulmonary embolism), or history of or
• Blood disorder (e.g., hypercoagulopathy), acquired or inherited or
• Breast cancer, or history of or
• Diabetes with kidney, eye, nerve, or blood vessel damage or
• Heart attack, history of or
• Heart or blood vessel disease (e.g., coronary artery disease, heart valve problems), or history of or
• Hypertension (high blood pressure), uncontrolled or
• Jaundice during pregnancy or from using hormonal therapy in the past or
• Liver disease (e.g., cirrhosis, hepatitis), including tumors or cancer or
• Major surgery coming up, with long periods of not being able to move or
• Migraine headache or
• Stroke, history of or
• Tumors (estrogen-dependent), known or suspected—Should not be used in patients with these conditions.

• Angioedema (swelling of the face, tongue, or throat), inherited or
• Chloasma gravidarum (skin disorder during pregnancy), history of or
• Cholestasis (bile problem) during pregnancy, history of or
• Cervical cancer or
• Depression, history of or
• Gallbladder disease or
• Hypertension (high blood pressure) or
• Toxic shock syndrome, history of or
• Vaginal or cervical erosion or ulcers—Use with caution. May worsen these conditions.

• Diabetes or
• Hyperlipidemia (high cholesterol or fats in the blood), or family history of or
• Kidney disease or
• Obesity, or history of—Use with caution. These conditions may increase the risk for more serious side effects.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Bladder pain
• Bloody or cloudy urine
• Chills
• Difficult, burning, or painful urination
• Fever
• Frequent or painful urination
• Severe and throbbing headache
• Itching of the vagina or outside the genitals
• Lower back or side pain
• Pain during sexual intercourse
• Stomach pain
• Thick, white curd-like vaginal discharge without odor or with mild odor
• Upper or lower abdominal pain

Less common

• Anxiety
• Back pain
• Chest pain
• Confusion
• Cough
• Dizziness or lightheadedness
• Expulsion of tissue with clots from your vagina
• Fainting
• Fast heartbeat
• Hives, itching, skin rash
• Hoarseness
• Irritation
• Joint pain, stiffness or swelling
• Mental depression
• Mood or other mental changes
• Numbness of the hands
• Pain, redness, or swelling in the arm or leg
• Redness of the skin
• Severe stomach pain
• Swelling of the eyelids, face, lips, hands, or feet
• Tightness in the chest
• Troubled breathing or swallowing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Cramps
• Diarrhea
• Heavy bleeding
• Nausea
• Normal menstrual bleeding occurring earlier, possibly lasting longer than expected
• Vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

In the U.S.

• Annovera

Available Dosage Forms:

• Insert, Extended Release

Therapeutic Class: Contraceptive

Pharmacologic Class: Segesterone

Use this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects.

This medicine is to be used only in the vagina. This combination medicine is contained in a vaginal system that is placed into your vagina. The vaginal system will slowly release small amounts of the medicine for your body to absorb.

This medicine comes with a patient information leaflet and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.

This medicine is used in a 4 week cycle for 13 cycles (1 year). You may start using the vaginal system between the second and fifth day of your menstrual period, keeping it in place for 3 weeks.

Once the vaginal system is in place inside your vagina, you should not be able to feel it. If you feel uncomfortable, it may not be inserted far enough. Gently push the vaginal system 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.

Remove the vaginal system after 3 weeks on the same day of the week and time it was inserted. During the 1-week break, you will usually have your menstrual period. Wash the vaginal system with mild soap and warm water, pat it dry with a clean cloth towel or paper towel, and keep it inside the case that comes with it. Reinsert it after a week.

While using this medicine, you may need to use an additional form of birth control method (eg, condom, spermicide) during the first 7 days to prevent pregnancy, especially if you have an irregular menstrual cycle or if you start using this vaginal system more than 5 days from your last menstrual bleeding.

If you need to remove the vaginal system, hook your finger through it and pull it out.

If you are switching from a combination hormonal method (eg, pills, patch) to Annovera™, start using this medicine on any day. Do not use this medicine after more than 7 hormone-free days.

If you are switching from a progestin-only method (eg, progestin-only implant, injection, intrauterine system, pill) to Annovera™, start using it on the day after you used your last progestin-only pill, or on the day your implant or IUD is removed, or on the day you would have your next injection. You must also use an additional barrier method of birth control (eg, male condom with spermicide) for the first 7 days.

Do not eat grapefruit or drink grapefruit juice while you are using this medicine. Grapefruit and grapefruit juice may change the amount of this medicine that is absorbed in the body.

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.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For vaginal dosage form (vaginal system):For contraception (to prevent pregnancy): Adults—One vaginal system inserted into the vagina for 21 days (3 weeks), followed by a 1 week vaginal system-free interval. It is then reinserted 1 week after. Children—Use and dose must be determined by your doctor.

Missed Dose

Call your doctor or pharmacist for instructions.

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.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

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.

• How do you use Annovera for birth control?