Aldara

Generic Name: Imiquimod
Typical Brand Name(s): Aldara

What Is It Used For?

IMIQUIMOD (Aldara™) cream is used to treat skin conditions external genital or anal warts. Because imiquimod does not kill the virus (HPV virus) that causes genital or anal warts, new warts may appear during or after treatment. This drug is also effective at treating other skin conditions such as actinic keratosis and superficial basal cell cancers. Generic imiquimod skin cream is not yet available.

How Is It Used?
Apply imiquimod cream to the affected areas as directed on the prescription label. Wash hands before and after applying cream. Imiquimod cream should be applied just before bedtime. A thin layer of the cream should be applied topically with the fingers; the cream should be massaged gently into the affected areas until no longer visible. Avoid contact with lips, eyes, or nose. Use imiquimod cream only on the affected area as directed by your health care provider. Do not use imiquimod cream longer than prescribed. Using too much imiquimod cream or using it too often, or for too long can increase your chances for having a severe skin reaction or other side effect. Discard packet after applying to affected area; partial packets should not be saved or reused.

• For treatment of genital or anal warts: You will usually apply this cream every other day (3 times a week) until the warts are gone, for a maximum of 16 weeks. Do not use the cream inside the vagina or rectum. Avoid getting imiquimod cream in your eyes. Uncircumcised men treating warts under the foreskin of the penis should pull back the foreskin and clean the area daily. Women should take special care if applying the cream at the opening of the vagina because local skin reactions on the delicate moist surfaces can cause pain and swelling, and may cause problems passing urine. Do not bandage or wrap the treated area. The treated area should be washed with mild soap and water 6-10 hours after applying the cream (usually upon waking).
• For the treatment of actinic keratosis: You will apply the cream to the affected area twice weekly, 3-4 days apart, for 16 weeks. Leave on skin for about 8 hours as directed, after which time the cream should be washed off using mild soap and water usually upon waking. The area you treat with imiquimod cream should be no larger than the size of your forehead or one cheek (for example, 2 inches by 2 inches).
• For the treatment of superficial basal cell cancer: You will apply the cream to the affected area 5-times per week for 6 weeks (such as Monday through Friday before going to bed). Leave the cream on your skin for about 8 hours, as directed, after which time the cream should be washed off using mild soap and water.

Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed. This drug has been used in adolescents for the treatment of genital or anal warts.

What should my health care professional know before I take imiquimod?
They need to know if you have any of these conditions:

• An unusual or allergic reaction to imiquimod, other medicines, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

Are There Possible Side Effects?
Side effects that you should report to your prescriber or health care professional as soon as possible:

• Open sores with or without drainage
• Skin infection
• Skin rash
• Unusual or severe skin reaction

Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):

• Back pain
• Burning or itching
• Changes in skin color that do not always go away
• Diarrhea
• Feeling like you have the flu
• Headache
• Muscle aches
• Redness of the skin (very common but is usually not painful or harmful)
• Scabbing and crusting
• Skin peeling
• Skin that becomes hard or thickened
• Swelling of the skin

What About Interactions With Other Drugs?
Imiquimod treatment is not recommended until the skin has healed from any previous drug (example: podofilox or podophyllin resin) or surgical skin treatment.

Tell your prescriber or health care professional about all other medicines you are using or taking, including non-prescription medicines. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

What should I watch for while taking imiquimod?
a) During the treatment of genital or anal warts:
Visit your health care professional for regular checks on your progress. Females should receive regular pelvic exams as recommended by their prescribers.

You will notice improvement in your condition gradually. Most patients experience improvement within 4 weeks. However, it may take up to 16 weeks to see a full clearing of the warts. Imiquimod cream is not a cure. New warts may develop during or after treatment.

Sexual (genital, anal, oral) contact should be avoided while the cream is on the skin.

Imiquimod cream will not cure genital or anal warts. It is also not known if imiquimod cream can stop you from spreading genital or anal warts to other people. The only way to prevent infecting others with the HPV virus (the virus that causes genital warts) is to avoid direct skin-to-skin contact. If warts are visible in the genital area, sexual contact should be avoided until the warts are treated. Experts advise that using latex condoms during sexual contact may reduce, but not entirely prevent, infecting others.

Do not rely on condoms, diaphragms, cervical caps or other 'barrier' devices as your sole method of birth control. Imiquimod cream may weaken these devices and make them less effective at birth control.

Do not cover the treated area with an airtight bandage. Cotton gauze dressings can be used. Cotton underwear can be worn after applying imiquimod cream to the genital or anal area.

b) During the treatment of actinic keratosis or superficial basal cell cancer:
Visit your health care provider for regular checks on your progress. Actinic keratoses that were not seen before may appear during treatment and may later go away. The treatment area and surrounding area lighten or darken after treatment with imiquimod cream. These skin color changes may be permenant in some patients.

It is common for patients to have skin reactions in areas treated. These reactions may extend beyond the application site onto the surrounding skin. Skin reactions generally decrease in intensity or resolve after stopping imiquimod therapy. If you experience a severe reaction or any sign or symptom at the treatment site that interferes or prevents you from doing any daily activity, contact your health care provider to discuss whether you require a rest period from treatment. Treatment may resume once the reaction has improved as recommended by your prescriber.

Use sunscreen during treatment and minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatments).

Do not cover the treated area with an airtight bandage. Cotton gauze dressings can be used.

What If I Miss A Dose?
If you miss a dose, use it as soon as you can. If it is almost time for your next dose, use only that dose. Do not use double or extra doses.

How Should It Be Stored?
Keep out of the reach of children.

Store at room temperature below 25 degrees C (77 degrees F). Do not freeze. Throw away any unused portion after the expiration date.

NOTE: The above information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist, or other healthcare professional. It should not be construed to indicate that the use of the product is safe, appropriate, or effective for you. Consult your healthcare professional before taking the product.