bexarotene

What is the most important information I should know about bexarotene?

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.

What is bexarotene?

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.

What should I discuss with my healthcare provider before taking bexarotene?

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).

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.

How should I use 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.

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 this medicine. 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.

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.

What happens if I miss a dose?

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.

What happens if I overdose?

What should I avoid while taking bexarotene?

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.

What are the possible side effects of bexarotene?

• 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 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.

What other drugs will affect bexarotene?

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.

Where can I get more information?

Your doctor or pharmacist can provide more information about bexarotene.