Oteseconazole

Oteseconazole is used to lower the chances of getting repeated vaginal yeast infections.

Oteseconazole should only be taken by women who are not pregnant and who cannot get pregnant.

Oteseconazole may also be used for reasons that are not mentioned in this medication guide.

Follow all instructions on your prescription label and read all medication guides or instruction sheets. Your doctor may change your dose from time to time.

Oteseconazole can be taken by itself or with another medicine called fluconazole. Your doctor will decide the right treatment for you. Use the medicine exactly as instructed.

Take it with food.

Swallow the capsule whole and do not crush, chew, break, or open it.

Store at room temperature, away from moisture, heat, and light.

Do not use if you are pregnant or plan to get pregnant, or breastfeeding or plan to breastfeed.

You should not use oteseconazole if you are allergic to it, or if you:

• are able to get pregnant;
• are pregnant or plan to get pregnant; or
• are breastfeeding or plan to breastfeed.

Tell your doctor if you have ever had:

• liver or kidney disease.

May harm an unborn baby. Tell your doctor if you are pregnant, think you might be pregnant, or plan to get pregnant.

Do not breastfeed while using oteseconazole.

Not approved for use in females who have not had their first menstrual period.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Common side effects of oteseconazole may include:

• headache; or
• nausea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Vaginal Candidiasis:

There are 2 recommended dosage regimens, and only one should be used:Oteseconazole-Only Dosage Regimen:-Day 1: 600 mg orally as a single dose-Day 2: 450 mg orally as a single dose-Beginning on Day 14: 150 mg orally once a week (every 7 days) for 11 weeks (weeks 2 through 12)-Duration of therapy: 12 weeksOteseconazole and Fluconazole Dosage Regimen:-Day 1, Day 4 and Day 7: Administer Fluconazole orally (should be prescribed separately)-Day 14 to 20: Administer Oteseconazole 150 mg orally once a day for 7 days-Beginning of Day 28: Administer Oteseconazole 150 mg once a week (every 7 days) for 11 weeks (weeks 4 to 14)-Duration of therapy: 14 weeksUse: Recurrent Vulvovaginal Candidiasis (RVVC) in females with a history of RVVC who are NOT of reproductive potential

Take the medicine as soon as you remember, but skip the missed dose if it's nearly time for your next dose. Do not take two doses at once.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Other drugs may impact oteseconazole, including prescription and over-the-counter medicines, vitamins, and herbal products. Inform your doctor about all other medicines you are using.