Alitretinoin topical (for the skin) is used in adults to treat skin lesions caused by AIDS-related Kaposi's sarcoma.

Alitretinoin topical may also be used for purposes not listed in this medication guide.

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Do not take by mouth. Topical medicine is for use only on the skin.

Wash your hands before and after using this medicine, unless you are treating skin areas on your hands.

Alitretinoin topical is usually applied 2 to 4 times per day at evenly spaced intervals. Apply only to affected skin lesions, avoiding healthy skin around the lesions.

Allow the gel to dry for 3 to 5 minutes before covering treated skin with clothing. Do not cover the treated skin area with a bandage unless your doctor tells you to.

Do not bathe, shower, or swim within 20 minutes before or 3 hours after applying the medicine.

Alitretinoin gel is flammable. Do not use near high heat or open flame. Do not smoke until the gel has completely dried on your skin.

It may take up to 14 weeks or longer before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

Store at room temperature away from moisture and heat. Keep the medicine away from open flame or high heat.

Usual Adult Dose for Kaposi's Sarcoma:

Initial dose: Apply a generous coating of gel to cutaneous lesions 2 times a day; may gradually increase applications to 3 to 4 times a day based on individual lesion tolerance

Comments:
-If application site toxicity occurs, the application frequency may be reduced; if irritation is severe, application may be temporarily discontinued for a few days until symptoms subside.
-Therapy should be continued as long as the patient is deriving benefit.

Use: For the topical treatment of cutaneous lesions in patients with AIDS-related Kaposi's sarcoma; this drug is not indicated when systemic therapy is needed (e.g., more than 10 new lesions in prior month, symptomatic lymphedema, symptomatic pulmonary Kaposi's sarcoma, or symptomatic visceral involvement)

You should not use alitretinoin topical if you are allergic to alitretinoin, isotretinoin, or tretinoin (Retin-A).

May harm an unborn baby. Do not use if you are pregnant. Use effective birth control while using alitretinoin topical. Tell your doctor if you become pregnant.

Do not breastfeed.

Apply the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not apply two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medicine.

Avoid getting alitretinoin topical in your eyes, nose, mouth, lips, rectum, tip of the penis or vagina. If this does happen, rinse with water.

Do not use insect repellents or other products that contain DEET (N,N-diethyl-m-toluamide) while using alitretinoin topical.

Avoid using other medications on the areas you treat with alitretinoin topical. You may use mineral oil to help prevent dryness and itching. Do not apply mineral oil within 2 hours before or 2 hours after using alitretinoin topical.

Alitretinoin topical could make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing when you are outdoors.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Alitretinoin topical may cause serious side effects. Call your doctor at once if you have:

• severe burning, pain, or irritation after using alitretinoin topical;

• blistering, drainage, oozing; or

• severe redness or swelling.

Serious side effects may be more likely if you also have T-cell lymphoma.

Common side effects of alitretinoin topical may include:

• rash, itching, redness, or other skin irritation;

• skin peeling or flaking;

• scabs or crusting; or

• pain or burning of treated skin.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Medicine used on the skin is not likely to be affected by other drugs you use, but many drugs can interact. Tell your doctor about all your current medicines, including prescription and over-the-counter medicines, vitamins, and herbal products.