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 (for example, if you have had more than 10 new skin sores in the previous month, or if the disease affects the lungs or other organs).

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 as directed by your doctor, usually 2 to 4 times daily. 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.

Since this drug is absorbed through the skin and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication.

Tell your doctor if your condition does not get better or if it gets worse. 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.

Redness, rash, pain, burning, itching, stinging, or tingling at the application site may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor 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 right away if you have any serious side effects, including:

• 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, get medical help right away 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 or at www.fda.gov/medwatch.

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

Before using alitretinoin, tell your doctor or pharmacist if you are allergic to it; or to vitamin A-related drugs (other retinoids such as isotretinoin); 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. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using alitretinoin. Alitretinoin may harm an unborn baby. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

Since this drug is absorbed through the skin and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this drug. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug are:

• products containing DEET (such as some insect repellents)

This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

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. Use your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature. This product is flammable. Keep away from heat and open flame. Keep all medications 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.