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In the U.S.—

Targretin

• Antineoplastic

Bexarotene ( beks-AIR-oh-teen) belongs to the group of medicines known as retinoids (RET-i-noyds). When applied to the skin, it is used to treat a form a cancer called cutaneous T-cell lymphoma (CTCL). It acts by interfering with the growth of cells of the tumor. It may be used after other drugs have been tried, and the tumor is still a problem.

This medicine is available only with your doctor's prescription, in the following dosage form:

Topical
• Gel (U.S.)

In deciding to use a medicine, the risks of using the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For bexarotene, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to bexarotene or to other retinoids (vitamin A) preparations. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Bexarotene must not be used during pregnancy because of the possible risks of birth defects to the infant. In addition, bexarotene must not be used if there is a chance that you may become pregnant 1 month before treatment, during treatment, and within 1 month after treatment is ended. Women who are able to have children must have a pregnancy test done within 1 week before starting bexarotene, to make sure they are not pregnant. The pregnancy test must be repeated once a month during treatment. You must use two effective forms of birth control at the same time for 1 month before treatment with bexarotene, during treatment, and for 1 month after treatment is over or abstain from having intercourse. Before using this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Male patients with sexual partners who are pregnant, or who could become pregnant must use condoms during sexual intercourse while using bexarotene and for at least 1 month after using the last dose.

Breast-feeding—It is not known whether bexarotene is passed into breast milk. However, bexarotene use is not recommended during breast-feeding, because it may cause unwanted effects to the nursing baby.

Children—Studies of this medicine have been done only in adult patients, and there is no specific information comparing the use of bexarotene in children with use in other age groups.

Older adults—This medicine has been tested in patients 65 years of age or older and has not been shown to cause different side effects or problems in older people than it does in younger adults. However, elderly patients may be more sensitive to the effects of bexarotene.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking bexarotene, it is especially important that your health care professionals know if you are using any of the following:

• Insect repellents containing DEET (N,N-diethyl-m-toluamide) (e.g., Off Insect repellant)—using the insect repellant while using bexarotene can cause you to absorb the repellant through your skin and enter your blood stream in high amounts.
• Vitamin A supplements (e.g., Aquasol A)—May increase the chance of side effects

Other medical problems—The presence of other medical problems may affect the use of bexarotene. Make sure you tell your doctor if you have any other medical problems, especially:

• Kidney disease—May increase the risk of side effects
• Liver disease—Effects of bexarotene may be increased because of slower removal from the body
• Photosensitivity—Bexarotene may cause increased sensitivity of the skin to sunlight

Apply enough bexarotene to cover the lesion with a generous coating. Use a cotton tipped applicator or your fingertips to apply the medicine to your skin. If you apply this medicine with your fingertips, make sure you wash your hands immediately afterwards, to prevent any of the medicine from accidentally getting into your eyes or mouth.

Avoid getting the medicine on the surrounding unaffected skin. Do not apply the medicine near mucosal areas (the inside of your mouth, eyes, nose, rectum or vagina).

Do not cover with bandages or dressings, unless directed to do so by your doctor. Allow the bexarotene to dry before covering with clothing.

Dosing—

Use this medicine exactly as directed by your doctor. Do not use more or less of it, and do not use it more often than your doctor ordered. The exact amount of medicine you need has been carefully worked out. Using too much will increase the risk of side effects, while using too little may not improve your condition.

The amount of bexarotene used will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of bexarotene. If your directions are different, do not change how you use it unless your doctor tells you to do so.

• For topical dosage form (gel):
  • For cutaneous T-cell lymphoma
    • Adults—The usual dose is started at applying once every other day for the first week. On week two, the dose may be increased to apply once a day. It may be increased to apply twice a day, on week three. On week four, it may be increased to apply three times a day. Finally, increased to apply four times a day on week five.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

• Apply every other day—Apply as soon as possible if you remember it on the day it should be used. However, if you do not remember the missed dose until the next day, apply it at that time. Then skip a day and start applying every other day. Do not double doses.
• Apply once daily—Apply as soon as possible. However, if you do not remember the missed dose until the next day, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
• Apply two, three or four times daily— If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses. If you have any questions about this, check with your doctor.
• If you have any questions about this, check with your doctor.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Store at room temperature.
• Protect from light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. heat or moisture may cause the medicine to break down.
• Keep the medicine from freezing. Do not refrigerate.
• Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.

It is very important that your doctor check you at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

Bexarotene may cause your skin to be more sensitive to sunlight than it is normally. Exposure to sunlight, even for brief periods of time, may cause a skin rash, itching, redness or other discoloration of the skin, or a severe sunburn. When you begin taking this medicine:

• Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible.
• Wear protective clothing, including a hat. Also, wear sunglasses.
• Apply a sun block product that has a skin protection factor (SPF) of at least 15. Some patients may require a product with a higher SPF number, especially if they have a fair complexion. If you have any questions about this, check with your health care professional.
• Apply a sun block lipstick that has an SPF of at least 15 to protect your lips.
• Do not use a sunlamp or tanning bed or booth.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Some side effects will have signs or symptoms that you can see or feel. Your doctor may watch for others by doing certain tests. Since the medication is applied externally to the skin, in general, these side effect are less common. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• More common
  • Bloating or swelling of face, hands, lower legs and/or feet;  chills, fever, or general feeling of discomfort or illness;  decreased urination;  lack or loss of strength;  rapid or unusual weight gain;  skin rash, blisters, redness, or irritation;  sticky or tacky sensation;  thickened, scaly skin ;  tingling or “pins and needles” sensation ;  sore throat;  swollen, painful or tender lymph glands in neck, armpit, or groin;  unusual bruising;  unusual tiredness or weakness.  
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome.

• More Common
  • Abnormal or excessive sweating;  blistering, burning, crusting, dryness, flaking, itching, scaling, severe redness, soreness, or swelling of skin or lesion;  headache;  increased cough;  lower back or side pain;  painful or difficult urination 
  
  

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Developed: 08/16/2001

Revised: 10/15/2001