Bexarotene 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 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. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Take with food.

Swallow the capsule whole and do not crush, chew, break, or open it. Do not dissolve a capsule in liquid or allow it to dissolve in your mouth.

Bexarotene doses are based on body surface area (height and weight). Your dose needs may change if you gain or lose weight.

You will need frequent blood tests before and during treatment with bexarotene. You may need to be fasting (nothing to eat for a certain number of hours) before your blood tests. Further doses may be delayed until your blood tests are normal.

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

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

Usual Adult Dose for Cutaneous T-cell Lymphoma:

300 mg/m2/day orally once a day with a meal

Duration of Therapy: This drug should be continued as long as the patient is deriving benefit. In clinical trials with CTCL patients, this drug was administered for up to 118 weeks.

Comments: If there is no tumor response after 8 weeks of treatment and the initial dose was well-tolerated, the dose may be escalated to 400 mg/m2/day with careful monitoring.

Use: Treatment of cutaneous manifestations of cutaneous T-cell lymphoma (CTCL) in patients refractory to at least one prior systemic therapy.

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

Tell your doctor if you have ever had:

• high cholesterol or triglycerides (a type of fat in the blood);

• pancreatitis;

• liver disease;

• a thyroid disorder;

• cataracts;

• diabetes;

• ovarian cancer;

• gallbladder disease;

• if you drink large amounts of alcohol; or

• if you are allergic to any other retinoids (isotretinoin, tretinoin, acitretin, Accutane, Soriatane, Vesanoid).

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 taking 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 taking bexarotene and once per month during treatment.

• You should start taking 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 taking 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 taking the medicine 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 taking the medicine and tell your doctor right away.

You should not breastfeed while you are using bexarotene.

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

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat, light, and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this 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 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.

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

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

• blurred vision, eye pain, or seeing halos around lights;

• low blood cell counts--fever, chills, tiredness, mouth sores, skin sores, sore throat, cough, pale skin, cold hands and feet, feeling light-headed or short of breath;

• pancreatitis--severe pain in your upper stomach spreading to your back, nausea and vomiting; or

• signs of underactive thyroid--extreme tiredness, dry skin, constipation, feeling more sensitive to cold temperatures, weight gain.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects of bexarotene may include:

• low blood cell counts;

• headache, weakness;

• nausea, stomach pain;

• rash, dry skin; or

• swelling in your hands or feet.

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;

• insulin or oral diabetes medicine.

• 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.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to bexarotene.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking bexarotene.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.