Pronunciation:

bex-ER-oh-teen

Brand Names:

• Targretin

Dosage Forms:

• Gel/Jelly

Classifications:

Therapeutic—

Antineoplastic, Dermatological

Chemical—

Retinoid

Uses of This Medicine:

Bexarotene 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.

Before Using This Medicine:

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

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

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.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

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 this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Chlortetracycline
• Demeclocycline
• Desogestrel
• Dienogest
• Doxycycline
• Drospirenone
• Efavirenz
• Eravacycline
• Estradiol
• Ethinyl Estradiol
• Ethynodiol
• Etonogestrel
• Gemfibrozil
• Gestodene
• Levoketoconazole
• Levonorgestrel
• Lymecycline
• Meclocycline
• Medroxyprogesterone
• Mestranol
• Methacycline
• Methotrexate
• Minocycline
• Nomegestrol
• Norelgestromin
• Norethindrone
• Norgestimate
• Norgestrel
• Omadacycline
• Oxytetracycline
• Paclitaxel
• Palovarotene
• Rolitetracycline
• Sarecycline
• Segesterone
• Tetracycline
• Tigecycline
• Ulipristal

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Atorvastatin
• Erythromycin
• Fosphenytoin
• Ketoconazole
• Phenobarbital
• Phenytoin
• Rifampin
• Vitamin A

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

Other medical problems—

The presence of other medical problems may affect the use of this medicine. 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

Proper Use of This Medicine:

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—

The dose of this medicine 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 this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

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.

• 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—

If you miss a dose of this medicine, take 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.

Every Other Day Application: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.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using This Medicine:

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.

Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

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 may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.