Drug Database: Imiquimod

What is imiquimod?

Imiquimod is a prescription medicine approved by the U.S. Food and Drug Administration (FDA). It is a cream for topical use only. Imiquimod is FDA-approved for the treatment of certain skin conditions, including:

• Actinic keratosis (a skin condition that may develop into skin cancer)
• External genital warts (warts on the outside of the genitals) and perianal warts (warts around the outside of the anus)

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 imiquimod 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 uses of imiquimod in people with HIV to:

Treat:

• HPV disease, including:
  • External genital warts
  • Vulvar intraepithelial neoplasia (VIN) (a precancerous skin condition affecting the vulva in females)
  • Anal intraepithelial neoplasia (AIN) (a precancerous skin condition affecting the anal area)
• Herpes simplex virus (HSV) disease, including external genital lesions, in people for whom the medicine acyclovir will not effectively treat HSV (also known as acyclovir-resistant HSV)

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

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

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

Before using imiquimod, tell your health care provider:

• If you are allergic to imiquimod or any other medicines.
• About any medical conditions you have or have had, for example, skin or immune system problems.
• If you are being treated or have been treated for external genital warts, perianal warts, or actinic keratosis with other medicines or surgery.
• About anything that could affect your ability to use imiquimod, such as difficulty with applying a cream to the affected area or trouble with remembering a scheduled dose.
• If you are pregnant or plan to become pregnant. Imiquimod should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Talk to your health care provider about the risks and benefits of using imiquimod 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 imiquimod 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. Imiquimod may affect the way other medicines or products work, and other medicines or products may affect how imiquimod works. Ask your health care provider if there are interactions between imiquimod and the other medicines you take.

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

How should I use imiquimod?

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

How should imiquimod be stored?

• Store imiquimod cream 5% at 39°F to 77°F (4°C to 25°C). Do not freeze.
• Keep imiquimod in the container that it came in and keep the container tightly closed.
• Do not use imiquimod if the original seal over the container opening is broken or missing.
• Throw away imiquimod that is no longer needed or expired (out of date). Follow FDA guidelines on how to safely dispose of unused medicine.
• Keep imiquimod and all medicines out of reach of children.

Where can I find more information about imiquimod?

• Recommendations on the HIV-related uses of imiquimod, 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): Cream (5%). The Patient Information section of the label and Patient Package Insert include information for people using imiquimod.
• The American Hospital Formulary Service (AHFS) Patient Medication Information for imiquimod topical available from MedlinePlus.
• Imiquimod-related research studies, 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.)