Drug Database: Podofilox

What is podofilox? What is podofilox?

What is podofilox?

Podofilox is a prescription medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of external genital warts and perianal warts. Podofilox gel and solution are for topical cutaneous use only.

External genital and perianal warts are caused by the human papillomavirus (HPV). HPV 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 podofilox used in people with HIV? How is podofilox used in people with HIV?

How is podofilox used in people with HIV?

The Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents With HIV and/or the Guidelines for the Prevention and Treatment of Opportunistic Infections in Children With and Exposed to HIV include recommendations on the use of podofilox in people with HIV to treat external genital warts, including perianal warts, caused by HPV.

The recommended uses may not always be consistent with FDA-approved uses of podofilox. See the Adult and Pediatric Opportunistic Infection Guidelines for complete information on recommended uses of podofilox in adults and children with HIV. Podofilox may have other recommended uses not listed above.

What should I tell my health care provider before using podofilox? What should I tell my health care provider before using podofilox?

What should I tell my health care provider before using podofilox?

Before using podofilox, tell your health care provider:

• If you are allergic to podofilox or any other medicines.
• About any medical conditions you have or have had.
• About anything that could affect your ability to use podofilox, such as difficulty with applying a topical gel or solution to the affected area or trouble with remembering a scheduled dose.
• If you are pregnant or plan to become pregnant. Podofilox should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus. Talk to your health care provider about the risks and benefits of using podofilox during pregnancy. The Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents With HIV may include other recommendations on the use of podofilox during pregnancy. Please refer to these guidelines for additional information.
• 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 using before you start breastfeeding.
• About other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Podofilox may affect the way other medicines or products work, and other medicines or products may affect how podofilox works. Ask your health care provider if there are interactions between podofilox and the other medicines you take.

How should I use podofilox? How should I use podofilox?

How should I use podofilox?

Use podofilox according to your health care provider’s instructions. Your health care provider will tell you how much podofilox to use and when to use it. Before you start using podofilox and each time you get a refill, read any printed information that comes with your medicine.

What side effects can podofilox cause? What side effects can podofilox cause?

What side effects can podofilox cause?

Podofilox may cause side effects that can be mild or serious. To learn about possible side effects of podofilox, see the FDA drug labels for podofilox gel and solution 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 podofilox be stored? How should podofilox be stored?

How should podofilox be stored?

• Store podofilox gel and solution at room temperature, 68°F to 77°F (20°C to 25°C). Keep the gel and solution away from excessive heat and do not freeze.
• Keep podofilox in the container that it came in and keep the container tightly closed.
• Do not use podofilox if the original seal over the container opening is broken or missing.
• Throw away podofilox that is no longer needed or expired (out of date). Follow FDA guidelines on how to safely dispose of unused medicine.
• Keep podofilox and all medicines out of reach of children.

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

Where can I find more information about podofilox?

• Recommendations on the HIV-related uses of podofilox, from the Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents With HIV and the Guidelines for the Prevention and Treatment of Opportunistic Infections in Children With and Exposed to HIV.
• This Patient Version drug summary is based on the following FDA label(s): Gel; Solution. The Patient Package Insert and Patient Information section of the label include information for people using podofilox.
• Research studies related to podofilox, from ClinicalTrials.gov. (The ClinicalTrials.gov search can be modified so that you can get results that better match your interests.)