Bexarotene capsules

What are bexarotene capsules?

BEXAROTENE (Targretin®) is a medicine similar to vitamin A. Bexarotene is used to treat certain types of cancer including cutaneous T cell lymphoma (mycosis fungoides) and breast cancer. Generic bexarotene capsules are not available.

What should my health care professional know before I take bexarotene capsules?

They need to know if you have any of these conditions:

• cataracts

• diabetes mellitus

• gall bladder disease

• high cholesterol or triglycerides

• history of pancreatitis

• If you frequently drink alcohol-containing beverages

• liver disease

• thyroid disease

• an unusual or allergic reaction to bexarotene, vitamin A, other vitamin A analogs (i.e., retinoids), other medicines, foods, dyes, or preservatives

• you or your partner is pregnant or trying to get pregnant

• breast-feeding

How should I take this medicine?

Take bexarotene capsules by mouth. Follow the directions on the prescription label. Swallow the capsules whole with a drink of water. Take your all of your dose at one time with or immediately after a meal. Swallow each capsule whole; do not chew thgem or dissolve them in liquid or in your mouth.Take your doses at regular intervals; try to take doses at the same time each day. Do not take your medicine more often than directed. Do not stop taking except on your prescriber's advice.

Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What drug(s) may interact with bexarotene capsules?

• barbiturate medicines for inducing sleep or treating seizures (convulsions)

• cimetidine

• clarithromycin

• erythromycin

• fluconazole

• gemfibrozil

• grapefruit and grapefruit juice

• insulin and other medicines to treat diabetes

• itraconazole

• ketoconazole

• orlistat

• phenytoin

• rifabutin

• rifampin

• some medicines to treat HIV infection or AIDS

• vitamin A supplements

Tell your prescriber or other health care professional about all other medicines you are taking including nonprescription medicines, nutritional supplements, or herbal products. Also, tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke or if you use illegal drugs. These may affect the way your medicine works. Check before stopping or starting any of your medications.

What should I watch for while taking bexarotene capsules?

Visit your prescriber or health care professional for regular checks on your progress. You will need to have regular blood checks. Some patients with cutaneous T cell lymphoma saw improvement within the first several weeks of treatment. Most patients required several months or more of treatment to improve.

If you are capable of becoming pregnant, you must have a pregnancy test within one week before you start bexarotene therapy and monthly while you are taking bexarotene confirming you are not pregnant. Bexarotene may harm your unborn baby. You should contact your prescriber immediately if you believe or suspect you are pregnant while you are taking bexarotene and until one month after you stop taking bexarotene. You must use effective birth control continuously starting one month prior to beginning bexarotene and until one month after you stop taking bexarotene. It is recommended that you use 2 reliable forms of birth control together.

If you are a male patient and your partner is pregnant or capable of becoming pregnant, you should use a condom during sexual intercourse while taking bexarotene and for at least one month after the last dose.

Bexarotene can greatly increase blood levels of cholesterol and triglycerides. While receiving bexarotene your health care professional will monitor the levels of these and, if they increase, you may require treatment.

Bexarotene can cause an underactive thyroid and regular blood checks will be needed to detect this. Medicines to control this condition may be necessary.

Avoid eating large amounts of grapefruit or drinking large amounts of grapefruit juice while taking bexarotene. Grapefruit may increase the levels of bexarotene in your body and may cause an increase in side effects.

Bexarotene is a form of vitamin A and too much vitamin A can cause many side effects. Do not take more that the recommended daily dietary allowance of vitamin A (4000 to 5000 international units). If you take vitamins, check the label to see how much vitamin A they contain. If you are not sure, ask your prescriber or pharmacist.

Your skin may become more sensitive to sunlight while you are taking this medicine. Minimize your exposure to sunlight and use a sunscreen while out in the sun. Do not use a sunlamp or tanning bed.

What side effects may I notice from taking bexarotene capsules?

Side effects that you should report to your prescriber or health care professional as soon as possible:

• abdominal pain

• rash

• signs and symptoms of an infection such as fever or chills

Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):

• diarrhea

• difficulty sleeping

• dry skin

• fever

• hair loss

• headache

• loss of appetite

• nausea and vomiting

• shivering

• tiredness or weakness

Where can I keep my medicine?

Keep out of the reach of children.

Bexarotene capsules may be stored at 2°—25°C (36°—77°F). Avoid exposing to high temperatures and humidity after the bottle is opened. Protect from light. Do not use after the expiration date printed on the bottle.

Bexarotene skin gel

What is bexarotene skin gel?

BEXAROTENE (Targretin®) is a medicine similar to vitamin A. Bexarotene gel is used for the topical treatment of cutaneous T cell lymphoma (CTCL) or mycosis fungoides lesions. Generic bexarotene gel is not available.

What should my health care professional know before I take bexarotene skin gel?

They need to know if you have any of these conditions:

• an unusual or allergic reaction to bexarotene, vitamin A, other vitamin A analogs (i.e., retinoids), other medicines, foods, dyes, or preservatives

• you or your partner is pregnant or trying to get pregnant

• breast-feeding

How should I take this medicine?

Bexarotene gel is for application to lesions only. Do not apply the gel on or near your eyes, nose, mouth, lips, vagina, tip of penis, rectum, or anus. Wash your hands before and after applying the gel. Follow the instructions on the prescription label. Place a generous coating of gel over the entire surface of each lesion. You should not apply the gel to the healthy skin around the lesion. Proper application should leave some gel visible on the surface of the lesion. Allow 5—10 minutes for the gel to dry before covering the treated areas with clothing. If you apply bexarotene gel after your shower or bath, you should wait 20 minutes before applying the gel. You should avoid bathing, showering, or swimming for at least 3 hours after applying bexarotene gel.

Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What drug(s) may interact with bexarotene skin gel?

• insect repellents that contain DEET

• vitamin A supplements

Avoid using other topical skin products on your lesions while using bexarotene gel.

Tell your prescriber or other health care professional about all other medicines you are taking including nonprescription medicines, nutritional supplements, or herbal products. Also, tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke or if you use illegal drugs. These may affect the way your medicine works. Check before stopping or starting any of your medications.

What should I watch for while taking bexarotene skin gel?

Visit your prescriber or health care professional for regular checks on your progress. Some patients with cutaneous T cell lymphoma saw improvement within the first several weeks of treatment. Most patients required several months or more of treatment to improve. Continue to use bexarotene gel as directed by your prescriber; do not stop treatment at the first sign of improvement.

Try to avoid applying bexarotene gel to areas of healthy skin around the lesions. This may cause irritation and redness of this healthy skin. Do not cover any of the lesions treated with bexarotene gel with a bandage or other material besides loose clothing.

If you are capable of becoming pregnant, you must have a pregnancy test within one week before you start bexarotene therapy and monthly while you are taking bexarotene confirming you are not pregnant. Bexarotene may harm your unborn baby. You should contact your prescriber immediately if you believe or suspect you are pregnant while you are taking bexarotene and until one month after you stop taking bexarotene. You must use effective birth control continuously starting one month prior to beginning bexarotene and until one month after you stop taking bexarotene. It is recommended that you use 2 reliable forms of birth control together.

If you are a male patient and your partner is pregnant or capable of becoming pregnant, you should use a condom during sexual intercourse while taking bexarotene and for at least one month after the last dose.

Bexarotene is a form of vitamin A and too much vitamin A can cause many side effects. Do not take more that the recommended daily dietary allowance of vitamin A (4000 to 5000 international units). If you take vitamins, check the label to see how much vitamin A they contain. If you are not sure, ask your prescriber or pharmacist.

Your skin may become more sensitive to sunlight while you are taking this medicine. Minimize your exposure to sunlight and use a sunscreen while out in the sun. Do not use a sunlamp or tanning bed.

This product contains alcohol and should be kept away from open flame.

What side effects may I notice from taking bexarotene skin gel?

Severe side effects to bexarotene gel are rare. If you notice any unusual side effects, report them to your prescriber or health care provider immediately.

Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):

• burning, irritation, itching, redness, and scaling at the application site(s)

• increased sensitivity to sunlight

• pain at application site

• rash

Where can I keep my medicine?

Keep out of the reach of children.

Always close the tube tightly after use. Store at room temperature. Keep away from heat or flame. Throw away any unused gel after the expiration date printed on the label.