Targretin topical

You should not use bexarotene topical if you are allergic to it, or if you are pregnant.

To make sure bexarotene topical is safe for you, tell your doctor if you have:

• liver disease; or

• kidney disease.

This medication can harm an unborn baby or cause birth defects. Do not use bexarotene topical if you are pregnant, or if you are a man and your sexual partner is pregnant.

• If you are a woman, you must have a negative pregnancy test within 7 days before you start using bexarotene topical. A pregnancy test is also required every month during treatment with bexarotene topical.

• Stop using this medication and tell your doctor right away if you become pregnant, if you stop using birth control, or if you miss a menstrual period.

• If you are a man, use a condom to prevent pregnancy during your treatment. Continue using a condom for at least 30 days after you stop using bexarotene topical.

• Use at least 2 reliable forms of birth control while either sexual partner is using bexarotene topical. Keep using 2 forms of birth control for at least 30 days after you stop using bexarotene topical.

• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using bexarotene topical.

It is not known whether bexarotene topical passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using bexarotene topical.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Avoid getting this medication in your eyes, mouth, or nose. If this does happen, rinse with water.

This medicine can pass into body fluids (urine, feces, vomit). Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Avoid taking a vitamin A supplement without your doctor's advice. Use only the amount your doctor recommends.

Avoid using other medications on the areas you treat with bexarotene topical unless your doctor tells you to.

Do not use insect repellents or other products that contain DEET (N,N-diethyl-m-toluamide) while using bexarotene topical. Bexarotene may increase DEET toxicity, which could be dangerous.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using bexarotene topical and call your doctor at once if you have:

• severe skin irritation (pain, burning, stinging, itching) after applying this medication;

• severe skin rash or redness; or

• swelling, bleeding, or tearing of treated skin.

Common side effects may include:

• mild burning, stinging, or itching;

• mild pain, redness, or irritation; or

• skin dryness or peeling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

It is not likely that other drugs you take orally or inject will have an effect on topically applied bexarotene topical. But many drugs can interact with each other. Tell each of your health care providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

In the U.S.

• Targretin

Available Dosage Forms:

• Gel/Jelly

Therapeutic Class: Antineoplastic, Dermatological

Chemical Class: Retinoid

Bexarotene is used to treat skin problems from a certain type of cancer (cutaneous T-cell lymphoma-CTCL). It works by slowing or stopping the growth of these cancer cells. Bexarotene belongs to a class of drugs called retinoids (drugs related to vitamin A).

How to use Targretin Gel

Read the Patient Information Leaflet provided by your pharmacist before you start using bexarotene and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

This medication is for use on the skin only. Do not apply this medication into mucous membranes such as the eyes, nose, mouth, lips, vagina, tip of the penis, rectum, or anus. Avoid applying to healthy areas of skin because irritation or redness can occur.

Wash your hands right away with soap and water before and after using this medication. Cover the affected skin area with a generous layer of gel. Allow the gel to dry for 5 to 10 minutes before covering the area with clothing. This medication is usually applied once every other day for the first week, then increased at weekly intervals to once a day, then twice a day, then 3 times a day, and then finally 4 times a day, or as directed by your doctor. The dosage is based on your medical condition and response to treatment. If side effects occur, your doctor may direct you to apply this medication less often or temporarily stop use until the side effects lessen.

Do not cover, bandage, or wrap the treated area unless your doctor directs you to do so. Wait at least 20 minutes after showering or bathing before applying this medication. Use a mild soap when washing the skin to reduce irritation. Avoid showering, bathing, or swimming for at least 3 hours after applying this medication.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time(s) each day. You may start to see some benefit as early as 4 weeks after starting treatment, but usually you will not get the full benefit until close to a year or more of use. Continue to use this medication and do not stop until your doctor directs you to do so.

Since this drug is absorbed through the skin and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication. Learn proper technique for safe handling and disposal of this medicine and its container. Consult your pharmacist.

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

This drug should not be used with the following products because very serious interactions may occur: insect repellents that contain DEET.

If you are currently using any product listed above, tell your doctor or pharmacist before starting bexarotene.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: vitamins/supplements that contain vitamin A.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

Applies to bexarotene topical: topical gel

Dermatologic

Dermatologic side effects have included rash (56% to 72%), pruritus (18% to 36%), skin disorder (18% to 26%), contact dermatitis (8% to 14%), exfoliative dermatitis (6%), maculopapular rash (6%), and sweating (6%).[Ref]

General

General side effects have included headache (14%), asthenia (6%), infection (18%), and pain (30%).[Ref]

Metabolic

Metabolic side effects have included hyperlipidemia in 10% of patients.[Ref]

Cardiovascular

Cardiovascular side effects have included edema (10%) and peripheral edema (6%).[Ref]

Hematologic

Hematologic side effects have included leukopenia and abnormal WBC each reported in 6% of patients.[Ref]

Other

Lymphatic side effects have included lymphadenopathy (6%).[Ref]

Nervous system

Nervous system side effects have included paresthesia (6%).[Ref]

Respiratory

Respiratory side effects have included increased cough and pharyngitis in 6% of patients.[Ref]

Some side effects of Targretin Gel may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.