IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

ALITRETINOIN GEL – TOPICAL

(AL-i-TRET-i-noyn)

COMMON BRAND NAME(S): Panretin

USES: This medication is used to treat skin sores in patients with a certain type of AIDS-related cancer (Kaposi’s sarcoma). Alitretinoin belongs to a class of medications called retinoids. It works by affecting the growth of skin cells.

This medication should not be used when medications taken by mouth are needed to treat the Kaposi’s sarcoma (e.g., more than 10 new skin sores in the previous month, disease affects the lungs or other organs).

HOW TO USE: Use this medication on the skin only. Wait at least 20 minutes after bathing or showering before applying the medication. Apply enough medication to cover the skin sore(s) well, usually 2 to 4 times daily or as directed by your doctor. It is not necessary to rub the medication into the sore. Allow 3 to 5 minutes for the medication to dry before covering the affected area with clothing.

Do not apply the medication on unaffected skin because doing so may cause increased irritation. Do not apply the medication in or around the eyes, nose, mouth, anus, vagina, or tip of the penis. If you do get the medication in those areas, flush with plenty of water.

Wash your hands after using, unless you are using this medication to treat the hands. Do not bathe, shower, or swim for at least 3 hours after using the medication.

Do not wrap, cover, or bandage the affected area unless directed to do so by your doctor.

Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same times each day.

Do not apply other skin products, except mineral oil, on the treated sores. You may apply mineral oil at least 2 hours before or after applying this medication to help prevent skin dryness/itching.

Tell your doctor if your condition does not improve or if it worsens. You should start to see an improvement in your skin condition in as little as 2 weeks of treatment, but it may take up to 14 weeks of treatment to see the benefit.

SIDE EFFECTS: Redness, rash, pain, burning, itching, stinging, or tingling at the application site may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: blistering/crusting/oozing/peeling of the skin, severe burning/stinging of the skin, swelling of the skin.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US –

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using alitretinoin, tell your doctor or pharmacist if you are allergic to it; or to other retinoids (e.g., tretinoin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: a certain type of cancer (skin T-cell lymphoma).

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

This medication is not recommended for use during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

This drug should not be used with the following products because very serious interactions may occur: products containing DEET (e.g., some insect repellents).

If you are currently using the products listed above, tell your doctor or pharmacist before starting alitretinoin.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: This medication may be harmful if swallowed. If swallowing or overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. This product is flammable. Keep away from heat and open flame. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised May 2010. Copyright(c) 2010 First Databank, Inc.