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    What is the most important information I should know about Aldara?

• Do not get the treated area wet, bathe or shower, or go swimming until the prescribed amount of time for treatment has passed.
• Aldara may increase the sensitivity of the skin to sunlight. Avoid prolonged exposure to sunlight and artificial UV rays (e.g., sunlamps). A sunscreen should be applied and protective clothing (e.g., hat, long sleeves) should be worn when exposure to the sun is unavoidable. Individuals with sunburn should not use Aldara until the sunburn is fully healed.
• Aldara is not a cure for genital or perianal warts. New warts may develop during treatment with Aldara. It is not known whether Aldara can stop the spread of genital or perianal warts to other people.
• Do not have sexual contact including genital, anal, or oral sex when the cream is on the genital or perianal skin. Aldara may weaken condoms and vaginal diaphragms. This means they may not work as well to prevent pregnancy. Talk to your healthcare provider about the use of effective birth control and about safer sex methods.

    What is Aldara?

• Imiquimod is an immune response modifier. The exact way that Aldara works is not known.
• Aldara is used in the treatment of external genital and perianal warts, actinic keratosis (warty overgrowths of skin) on the face and scalp and for treating superficial basal cell carcinoma.
• Imiquimod may also be used for purposes other than those listed in this medication guide.

    What should I discuss with my healthcare provider before using Aldara?

• Do not use Aldara on areas of broken, wounded, or burned skin. Wait until these conditions have healed before using Aldara.
• Before using Aldara, tell your doctor if you have any other medical conditions or if you use any other medications. You may not be able to use Aldara, or you may require a dosage adjustment or special monitoring during treatment.
• Aldara is in the FDA pregnancy category C which means that it is not known whether Aldara will be harmful to an unborn baby. Do not use Aldara without first talking to your doctor if you are pregnant or could become pregnant during treatment.
• It is not known whether Aldara passes into breast milk. Do not use Aldara without first talking to your doctor if you are breast feeding a baby.

    How should I apply Aldara?

• Use imiquimod exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.
• Aldara is intended for external use only. Do not take Aldara by mouth. Avoid getting this medication in the eyes, on the lips, or in the nose. Do not apply Aldara in the vagina or anus.
• Do not use Aldara on areas of broken, wounded, or burned skin. Wait until these conditions have healed before using Aldara.
• Aldara should be applied before bed, and left on the skin for approximately 8 hours for the treatment of actinic keratosis and 6 to 10 hours for the treatment of genital or perianal warts. After the prescribed amount of time passes, the cream should be removed by washing the area with mild soap and water.
• To use Aldara:
• Before applying Aldara, wash the area to be treated with mild soap and water and allow the area to dry thoroughly (at least 10 minutes).
• Uncircumcised males treating genital warts under the foreskin must pull back the foreskin and clean before treatment. The area under the foreskin should be cleaned daily during treatment.
• Wash your hands before and after application of Aldara cream.
• Open a new packet of imiquimod cream just before use. Apply up to, but not more than, one package of the cream to the treatment area at each application.
• Female patients applying Aldara to genital warts around the vaginal opening should take special care to avoid getting the cream on the skin surrounding the genital wart. Also, do not apply the cream inside the vagina. Because the vaginal skin is delicate, pain or swelling may occur, possibly resulting in difficulty urinating.
• Rub the cream into the skin until the cream is no longer visible.
• For the treatment of actinic keratosis, the treated area should be no larger than approximately 2 inches by 2 inches (about the size of the forehead or one cheek).
• Do not cover the area with an airtight bandage or tight clothing. A cotton gauze dressing may be used if needed. Cotton underwear may be worn after application of the cream to the genital or perianal area .
• Use each packet of cream for one application only. Throw away any unused cream in the packet, out of the reach of children and pets. Do not save unused cream for later use.
• Do not get the treated area wet, bathe or shower, or go swimming until the prescribed amount of time for treatment has passed.
• Aldara is usually used once a day, 2 days a week, 3 to 4 days apart in the treatment of actinic keratosis. Use Aldara for the full amount of time as prescribed by your doctor. Treatment with Aldara should continue for 16 weeks, even if all actinic keratoses appear to be gone, unless you are told otherwise by your healthcare provider.
• Aldara is usually used once a day, 3 days a week in the treatment of genital warts. Use Aldara for the full amount of time as prescribed by your doctor. Treatment with Aldara should continue for 16 weeks, even if all actinic keratoses appear to be gone, unless you are told otherwise by your healthcare provider.
• Do not use Aldara for longer than is prescribed. Using too much Aldara cream, using it too often, or for too long, can increase the risk of having a severe skin reaction or other side effect. Talk to your healthcare provider if you symptoms do not improve or if they worsen.
• Use Aldara only on the areas of skin for which it is prescribed. Do not use it to treat other skin conditions.
• Do not have sexual contact including genital, anal, or oral sex when the cream is on the genital or perianal skin. Aldara may weaken condoms and vaginal diaphragms. This means they may not work as well to prevent pregnancy. Talk to your healthcare provider about the use of effective birth control and about safer sex methods.
• Store Aldara at room temperature away from moisture and heat.

    What happens if I miss a dose?

• If you miss a dose of Aldara, apply the missed dose as soon as you remember then resume the regular treatment schedule.

    What happens if I overdose?

• Seek emergency medical attention if an overdose is suspected.
• Symptoms of an Aldara overdose may include severe skin reactions and possibly systemic reactions including low blood pressure.

    What should I avoid while using Aldara?

• Do not get the treated area wet, bathe or shower, or go swimming until the prescribed amount of time for treatment has passed.
• Aldara may increase the sensitivity of the skin to sunlight. Avoid prolonged exposure to sunlight and artificial UV rays (e.g., sunlamps). A sunscreen should be applied and protective clothing (e.g., hat, long sleeves) should be worn when exposure to the sun is unavoidable. Individuals with sunburn should not use Aldara until the sunburn is fully healed.
• Aldara is not a cure for genital or perianal warts. New warts may develop during treatment with Aldara. It is not known whether Aldara can stop the spread of genital or perianal warts to other people.
• Do not have sexual contact including genital, anal, or oral sex when the cream is on the genital or perianal skin. Aldara may weaken condoms and vaginal diaphragms. This means they may not work as well to prevent pregnancy. Talk to your healthcare provider about the use of effective birth control and about safer sex methods.

    What are the possible side effects of Aldara?

• Stop using Aldara and seek emergency medical attention if you experience a rare but serious allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives).
• Other less serious side effects are more likely to occur. Continue to use Aldara and talk to your healthcare provider if you experience any of the following:
• treatment site reactions such as redness; swelling; sores, blisters, or ulcers; hardened or thickened skin; peeling skin; scabbing or crusting; itching; burning; and changes in skin color that do not always go away;
• headache;
• muscle aches;
• tiredness; or
• diarrhea.
• During treatment with Aldara and until after the skin is healed, the skin of the treatment area is likely to appear noticeably different from the normal surrounding skin. If a skin reaction becomes severe, affects your daily activities, or does not go away, contact your healthcare provider right away. Sometimes, treatment with Aldara must be stopped for a while to allow the skin to heal.
• Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

    What other drugs will affect Aldara?

• Aldara is not likely to interact with medications taken orally during treatment. Tell your doctor and pharmacist about all other medicines you are using, especially other topical preparations, and talk to your doctor and pharmacist before using any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.

    Where can I get more information?

• Your pharmacist has additional information about Aldara written for health professionals that you may read.