In the U.S.—

• Aldara

• Biological response modifier

Imiquimod (i-MI-kwi-mod) is used to treat external warts around the genital and rectal areas called condyloma acuminatum. It is not used on warts inside the vagina, penis, or rectum.

It works by aiding the immune system to help protect the body from viruses that cause warts. The medicine does not fight the viruses that cause warts directly. It does help to relieve and control wart production.

This medicine is available only with your doctor's prescription, in the following dosage form:

• Topical
• Cream (U.S. and Canada)

In deciding to use a medicine, the risks of using the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For imiquimod, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to imiquimod. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Imiquimod has not been shown to cause birth defects or other problems in humans. However, studies in animals using doses higher than recommended for humans have shown that imiquimod causes bone problems or low birth weight in pregnancies. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—It is not known whether imiquimod passes into breast milk. However, this medicine has not been reported to cause problems in nursing babies.

Children—Studies of this medicine have been done only in adult patients, and there is no specific information comparing use of imiquimod in children up to 18 years of age with use in other age groups.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of imiquimod in the elderly with use in other age groups.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your doctor and pharmacist if you are using any other topical prescription or nonprescription (over-the counter [OTC]) medicine that is to be applied to the same area of the skin.

Other medical problems—The presence of other medical problems may affect the use of imiquimod. Make sure you tell your doctor if you have any other medical problems, especially:

• Skin problems, genital or
• Surgery, genital (recent)—Imiquimod may cause skin irritation and redness of skin for these conditions

To apply the medicine:

• Wash your hands before and after using the medicine . Avoid getting the medicine into your eyes.
• Use the medicine only as directed by your doctor . Do not use more of it, do not use it more often, and do not use it longer than directed.
• Allow medicine to stay on skin for 6 to 10 hours, then wash area thoroughly with soap and water.
• Throw out any unused cream from the single-dose packet.
• Do not apply an occlusive dressing (airtight covering, such as kitchen plastic wrap) over the medicine, unless told to do so by your doctor. To do so may cause irritation of the skin. Other materials that are not airtight, such as cotton gauze or cotton underclothes, may be used.

Dosing—The dose of imiquimod will be different for different patients. Follow your doctor's orders or the directions on the label . The following information includes only the average doses of imiquimod. If your dose is different, do not change it unless your doctor tells you to do so.

• For topical dosage form (cream):
  • For warts on the skin outside of the genital or rectal areas (condyloma acuminatum):
    • Adults—Apply a thin film to wart once every other day (three times a week) before normal sleeping hours. Rub in well and leave on for six to ten hours. Remove medicine from wart by washing with mild soap and water. Continue treatment until wart is gone or for up to sixteen weeks.
    • Children—Use and dose must be determined by doctor.

Missed dose—If you miss a dose of this medicine, wait until the next evening to apply it. Then go back to your regular dosing schedule.

Storage—To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Keep the medicine from freezing. Do not refrigerate.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

If you notice severe skin irritation or flu-like symptoms (diarrhea, fatigue, fever, headache, or muscle pain), check with your doctor . It may be necessary for you to reduce the number of times a day that you use the medicine or to stop using the medicine for a short time until your skin is less irritated or your flu-like symptoms disappear.

Avoid having genital, oral, or anal sex while the medicine is on your skin. Make sure you wash the cream off your skin before you engage in any sexual activity . Also, the medicine contains oils that can weaken latex (rubber) condoms, diaphragms, or cervical caps causing them not to work properly to prevent pregnancy.

Do not use any other skin product on the same skin area on which you use this medicine, unless directed otherwise by your doctor.

Do not share your medicine with others , even if you think that they have the same condition you have.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.