Bexarotene topical

Topical bexarotene is used to treat cutaneous T-cell lymphoma (CTCL, a type of skin cancer) that could not be treated with other medications. Bexarotene is in a class of medications called retinoids. It works by stopping the growth of cancer cells.

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 bexarotene 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 bexarotene 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 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 bexarotene 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 bexarotene, 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.

It is very important that your doctor check you at regular visits to make sure that bexarotene 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 bexarotene:

• 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.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• It may take several weeks to see the full effects.
• Do not use bexarotene with insect repellents that have N, N-diethyl-m-toluamide (DEET).
• You may get sunburned more easily. Avoid sun, sunlamps, and tanning beds. Use sunscreen and wear clothing and eyewear that protects you from the sun.
• Talk with your doctor before you use other drugs or products on your skin.
• Talk with your doctor before you take products that have vitamin A in them.
• Do not scratch the affected area.
• This medicine may cause harm if swallowed. If this medicine is swallowed, call a doctor or poison control center right away.
• People using bexarotene may have skin reactions where this medicine is used. These reactions may include burning, irritation, itching, redness, or scaling. If these reactions get very bad, a break from using bexarotene may be needed as told by the doctor. Talk with the doctor.
• Call your doctor right away if you have a skin reaction that bothers you or if the reaction makes it hard to keep putting this medicine on. Call your doctor right away if you have a skin reaction that causes problems with daily living.
• This medicine may cause harm to the unborn baby if you use it while you are pregnant. If you get pregnant while using bexarotene or within 1 month after care ends, call your doctor right away.
• If you are a woman of childbearing age, take a pregnancy test 1 week before you start therapy and monthly while using this medicine.
• Use 2 kinds of birth control that you can trust 1 month before care begins, during care, and for at least 1 month after care ends.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.
• If you are a man with a sex partner who is pregnant or plans on getting pregnant at any time while you are being treated, talk with your doctor.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take bexarotene or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to bexarotene. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Gel, External:

Targretin: 1% (60 g) [contains alcohol, usp]

Binds to and activates retinoid X receptor subtypes. Once activated, these receptors function as transcription factors that regulate the expression of genes which control cellular differentiation and proliferation.

Absorption

Systemically absorbed following topical application (1% gel: generally less than 5 ng/mL and did not exceed 55 ng/mL)

Store at 25°C (77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F). Avoid exposure to high temperatures and humidity after the tube is opened. Protect from light. Keep away from open flame.

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience burning, itching, redness, peeling, or headache. Have patient report immediately to prescriber signs of infection, burning or numbness feeling, edema, or severe skin irritation (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Pain, redness, irritation, itching, or flaking of the skin may occur at the application site. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Bexarotene can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Therefore, seek immediate medical attention if you develop any rash.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Commonly reported side effects of bexarotene topical include: contact dermatitis, disorder of integument, pruritus, and skin rash. Other side effects include: exfoliative dermatitis, and maculopapular rash. See below for a comprehensive list of adverse effects.

Applies to bexarotene topical: topical gel/jelly

Along with its needed effects, bexarotene topical 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 while taking bexarotene topical:

• 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 of bexarotene topical 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:

• 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

The use of two reliable forms of contraception are recommended by the manufacturer for 1 month before, during, and 1 month after administration of bexarotene topical. Male patients should use condoms during sexual intercourse with women who are or may become pregnant.

Because less than 1% of the drug is excreted unchanged in the urine, caution is recommended if bexarotene topical is to be used in a patient with liver dysfunction.

Photosensitivity may occur in patients receiving bexarotene topical. Caution should be exercised if used in patients with hypersensitivity to retinoids.

Patients should be warned to limit concomitant use of topical preparations containing vitamin A because of the potential for additive adverse effects.

No overall differences in safety were reported between patients 65 years of age or older and younger patients, but greater sensitivity of some older individuals to bexarotene topical cannot be ruled out.

Safety and effectiveness in pediatric patients have not been established.