Bexarotene Oral capsule

What is this medicine?

BEXAROTENE (bexs AIR oh teen) is used to treat the skin manifestations of cutaneous T-cell lymphoma. This medicine should only be used in patients who have not responded to at least one other treatment.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

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

• cataracts

• diabetes

• 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 use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Swallow the capsules whole. Do not chew or allow them to dissolve before swallowing. Take all of your dose at one time with or immediately after a meal. Take your doses at regular intervals. Do not take your medicine more often than directed. Do not stop taking except on the advice of your doctor or health care professional.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

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 may interact with this medicine?

Do not take this medicine with any of the following medications:

• gemfibrozil

• other medicines known as retinoids like acitretin, adapalene, isotretinoin, and tretinoin

• vitamins and other supplements containing vitamin A

This medicine may also interact with the following medications:

• barbiturate medicines for inducing sleep or treating seizures

• birth control pills

• cimetidine

• erythromycin

• grapefruit and grapefruit juice

• insulin and other medicines to treat diabetes

• itraconazole

• ketoconazole

• phenytoin

• rifabutin

• rifampin

• some medicines to treat HIV

• tamoxifen

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor 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.

Do not become pregnant while taking this medicine. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. If you are capable of becoming pregnant, you must have a pregnancy test within one week before you start therapy and monthly while you are taking this medicine to confirm you are not pregnant. Women must use effective birth control continuously starting one month prior to beginning this medicine and until one month after you stop taking it. It is recommended that you use 2 reliable forms of birth control together. Because this drug may decrease the effect of hormonal birth control, one of the forms of birth control should be non-hormonal. Talk to your health care professional or pharmacist for more information. Do not breast-feed an infant while taking this medicine.

Men, with a partner who is pregnant or who is capable of becoming pregnant, use a condom during sexual activity while taking this medicine and for 1 month after stopping this medicine.

This medicine can greatly increase blood levels of cholesterol and triglycerides. Your health care professional will monitor these levels and, if they increase, you may require treatment.

This medicine 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 this medicine. Grapefruit may increase the levels of this medicine in your body and may cause an increase in side effects.

This medicine 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 doctor or pharmacist.

This medicine can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.

What side effects may I notice from receiving this medicine?

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

• back or stomach pain

• feel unusually cold

• nausea and vomiting

• rash

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

• tiredness or weakness

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

• diarrhea

• dry skin

• hair loss

• headache

• loss of appetite

• trouble sleeping

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store between 2 and 25 degrees C (36 and 77 degrees F). Protect from heat and moisture. Protect from light. Throw away any unused medicine after the expiration date.

Bexarotene Topical gel

What is this medicine?

BEXAROTENE (bexs AIR oh teen) is used to treat skin lesions in patients with cutaneous T-cell lymphoma. This medicine should only be used in patients who have not responded to or could not tolerate other therapies.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

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

• an unusual or allergic reaction to bexarotene, vitamin A, other vitamin A analogs or retinoids, other medicines, foods, dyes, or preservatives

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

• breast-feeding

How should I use this medicine?

This medicine 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 to 10 minutes for the gel to dry before covering the treated areas with clothing. If you apply this medicine 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 this medicine.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

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

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• gemfibrozil

• other medicines known as retinoids like acitretin, adapalene, isotretinoin, and tretinoin

• vitamins and other supplements containing vitamin A

This medicine may also interact with the following medications:

• barbiturate medicines for inducing sleep or treating seizures

• birth control pills

• cimetidine

• erythromycin

• grapefruit and grapefruit juice

• insulin and other medicines to treat diabetes

• itraconazole

• ketoconazole

• phenytoin

• rifabutin

• rifampin

• some medicines to treat HIV infection or AIDS

• tamoxifen

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor 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 therapy and monthly while you are taking this medicine to confirm you are not pregnant. This medicine may harm your unborn baby. You should contact your doctor or health care professional immediately if you believe or suspect you are pregnant while you are taking this medicine or if you have taken this medicine within the past month. You must use effective birth control continuously starting one month prior to beginning this medicine and until one month after you stop taking it. It is recommended that you use 2 reliable forms of birth control together. Because this drug may decrease the effect of hormonal birth control, one of the forms of birth control should be non-hormonal.

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 this medicine and for at least one month after the last dose.

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

This medicine 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 doctor or pharmacist.

This medicine can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.

What side effects may I notice from receiving this medicine?

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

• burning, irritation, itching, redness, pain or scaling at the application site

• increased sensitivity to sunlight

• rash

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees C). Keep away from heat or flame. Protect from humidity. Throw away any unused gel after the expiration date.