Drug Database: 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?

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 include recommendations on the use of podofilox to treat external genital warts, including perianal warts, caused by HPV infection.

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?

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 breast/chestfeeding or plan to breast/chestfeed. For people with HIV in the United States, the Guideline recommends speaking with your health care provider to discuss options for feeding your baby. People with suppressed viral load have a less than 1% chance of transmitting HIV to their baby via their own milk.
• 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.

Ask your health care provider about possible side effects from podofilox. Your health care provider will tell you what to do if you have side effects.

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.

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?

• 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. To learn more about the ClinicalTrials.gov search features, please see How to Search.)