Bexarotene topical (for the skin) is used to treat skin lesions caused by a rare type of cancer called cutaneous T-cell lymphoma. Bexarotene is usually given after other treatments have failed.

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

Bexarotene can harm an unborn baby or cause birth defects if the mother or the father is using bexarotene. Do not use bexarotene if you are pregnant.

Both men and women using bexarotene should use effective birth control to prevent pregnancy, beginning 1 month before starting and continuing until at least 1 month after stopping treatment.

Stop using this medicine and tell your doctor right away if you stop using birth control, if you miss a menstrual period, or if a pregnancy occurs while either the mother or the father is using bexarotene.

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

Bexarotene topical is usually applied once every other day for the first week and gradually increased until you are applying the medicine 4 times every day. Follow your doctor's dosing instructions very carefully.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Wash your hands before and after using bexarotene topical, unless you are using the medication to treat the skin on your hands.

Apply only enough gel to cover each lesion. Do not cover the treated skin with a bandage.

Avoid getting bexarotene in your eyes, mouth, or nose, or on healthy skin. If this does happen, rinse or wash off the medicine.

You may need to stop using bexarotene for a short time if you have severe skin irritation.

Store at room temperature away from moisture, heat, and light.

It may take several weeks or months before you receive the full benefit of this medicine. Your doctor will determine how long to treat you.

Usual Adult Dose for Cutaneous T-cell Lymphoma:

Initial dose: Apply a generous coating to the lesion once every other day for 1 week
-Increase at weekly intervals to once day, then twice daily, then 3 times a day, up to 4 times a day according to individual lesion tolerance
Maintenance dose: 2 to 4 applications daily
Maximum dose: 4 applications per day
Duration of therapy: As long as benefit is derived

Comments:
-Most responses were seen at twice daily dosing or higher.
-Consider reducing frequency for application site toxicity.
-Temporarily discontinue for severe irritation, for a few days until symptoms subside.
-Response may occur as soon as 4 weeks, but most take longer; longest onset for first response was 392 days.
-Do not use occlusive dressings with this product.

You should not use bexarotene if you are allergic to it, or if you are pregnant.

Tell your doctor if you have ever had:

• liver disease; or

• kidney disease.

Bexarotene can harm an unborn baby or cause birth defects if the mother or the father is using this medicine.

If you are a man, use condoms during sex if your partner is pregnant or is able to get pregnant. Keep using condoms while using bexarotene and for at least 1 month after your last dose.

If you are a woman, do not use bexarotene if you are pregnant or plan to become pregnant. You must have a negative pregnancy test 7 days before you start using bexarotene and once per month during treatment.

• You should start using bexarotene on the 2nd or 3rd day of a normal menstrual period.

• Use 2 effective forms of birth control beginning 1 month before you start using bexarotene, and continuing until at least 1 month after your last dose.

• At least one of your forms of birth control should be non-hormonal such as a condom, cervical cap, contraceptive sponge, IUD, or diaphragm with spermicide.

• Stop using bexarotene and tell your doctor right away if you stop using birth control, or if you miss a menstrual period.

If a pregnancy occurs while either the mother or the father is using bexarotene, stop using the medicine and tell your doctor right away.

You should not breastfeed while you are using bexarotene topical.

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.

An overdose of bexarotene topical is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.

Grapefruit may interact with bexarotene and lead to unwanted side effects. Avoid the use of grapefruit products.

Avoid taking a vitamin A supplement without your doctor's advice. Use only the amount your doctor recommends.

Bexarotene topical could make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Avoid using other medications on the areas you treat with bexarotene topical unless your doctor tells you to.

Do not use insect repellents or other products that contain DEET (N,N-diethyl-m-toluamide) while using bexarotene topical. Bexarotene may increase DEET toxicity, which could be dangerous.

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

Stop using bexarotene topical and call your doctor at once if you have severe skin irritation (rash, itching, burning, redness, scaling) after applying the medicine.

Common side effects of bexarotene may include:

• mild rash, itching, or skin irritation; or

• skin dryness or peeling.

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.

Tell your doctor about all your current medicines. Many drugs can affect bexarotene, especially:

• gemfibrozil;

• an antibiotic or antifungal medicine;

• antiviral medicine; or

• seizure medicine.

This list is not complete and many other drugs may affect bexarotene. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.