Drug Database: Oteseconazole

What is oteseconazole? What is oteseconazole?

What is oteseconazole?

Oteseconazole is an antifungal prescription medicine approved by the U.S. Food and Drug Administration (FDA) to reduce the frequency of vulvovaginal candidiasis that keeps coming back (recurrent vulvovaginal candidiasis) in females who are not pregnant and who are not able to become pregnant.

Vulvovaginal candidiasis can be an opportunistic infection (OI) of HIV. An OI is an infection that occurs more frequently or is more severe in people with weakened immune systems—such as people with HIV—than in people with healthy immune systems. To learn more about OIs, read the HIVinfo What is an Opportunistic Infection? fact sheet.

How is oteseconazole used in people with HIV? How is oteseconazole used in people with HIV?

How is oteseconazole used in people with HIV?

The Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents With HIV include recommendations on the use of oteseconazole in people with HIV to treat recurrent vulvovaginal candidiasis and reduce the frequency of recurrent vulvovaginal candidiasis.

The recommended uses may not always be consistent with FDA-approved uses of oteseconazole. See the Guidelines for complete information on recommended uses of oteseconazole in adults with HIV. Oteseconazole may have other recommended uses not listed above.

What should I tell my health care provider before taking oteseconazole? What should I tell my health care provider before taking oteseconazole?

What should I tell my health care provider before taking oteseconazole?

Before taking oteseconazole, tell your health care provider:

• If you are allergic to oteseconazole or any other medicines.
• About any medical conditions you have or have had, including kidney or liver problems.
• About anything that could affect your ability to take medicines, such as difficulty swallowing or remembering to take pills.
• If you are pregnant or plan to become pregnant. Oteseconazole may harm an unborn baby and should not be used in women who are pregnant, plan to become pregnant, or are able to become pregnant. Talk to your health care provider about the risks of taking oteseconazole during pregnancy.
• If you are breastfeeding or plan to breastfeed. For mothers with HIV in the United States, the Guideline recommends speaking with your health care provider to discuss options for feeding your baby. Mothers with suppressed viral load have a less than 1% chance of transmitting HIV to their baby via their own milk. Although most medicines are safe to use while breastfeeding, some medicines should be avoided. Always let your health care provider know about all the medicines and supplements you are taking before you start breastfeeding.
• About other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Oteseconazole may interact with other medicines or supplements. For a list of medicines and supplements that may interact with oteseconazole, see the drug label, or ask your health care provider or pharmacist.

How should I take oteseconazole? How should I take oteseconazole?

How should I take oteseconazole?

Take oteseconazole according to your health care provider’s instructions. Your health care provider will tell you how much oteseconazole to take and when to take it.

It is important to complete the full prescribed course of treatment with oteseconazole, even if you begin to feel better. If you stop using oteseconazole too soon or skip doses, your infection may not be fully treated, and the fungus may become harder to treat (resistant).

Before you start oteseconazole and each time you get a refill, read any printed information that comes with your medicine.

What side effects can oteseconazole casue? What side effects can oteseconazole cause?

What side effects can oteseconazole cause?

Oteseconazole may cause side effects that can be mild or serious. To learn about possible side effects of oteseconazole, see the FDA drug label or talk to your health care provider or pharmacist. Tell your health care professional if you have any side effect that bothers you or that does not go away. Your health care professional may be able to tell you about ways to prevent or reduce some side effects.

You may report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088) or online.

How should oteseconazole be stored?How should oteseconazole be stored?

How should oteseconazole be stored?

• Store oteseconazole at room temperature, 68°F to 77°F (20°C to 25°C). Protect oteseconazole from light when removed from the outer carton.
• Keep oteseconazole in the original blister package and wallet that it came in until you are ready to take it.
• Do not use oteseconazole if the original seal over the blister package is broken or missing.
• Throw away oteseconazole that is no longer needed or expired (out of date). Follow FDA guidelines on how to safely dispose of unused medicine.
• Keep oteseconazole and all medicines out of reach of children.

Where can I find more information about oteseconazole? Where can I find more information about oteseconazole?

Where can I find more information about oteseconazole?

• Recommendations on the HIV-related uses of oteseconazole, from the Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents With HIV.
• This Patient Version drug summary is based on the following FDA label(s): Capsule. The Patient Package Insert includes information for people taking oteseconazole.
• The American Hospital Formulary Service (AHFS) Patient Medication Information for oteseconazole available from MedlinePlus.
• Oteseconazole-related research studies, from ClinicalTrials.gov. (The ClinicalTrials.gov search can be modified so that you can get results that better match your interests.)