Generic Name: BEXAROTENE - ORAL
Pronounced: (bex-ER-oh-teen)

Targretin Oral Warning

This medication can cause severe birth defects if used during pregnancy. Women who are pregnant must not use bexarotene. If pregnancy occurs, notify your doctor immediately. You should have a pregnancy test and birth control counseling from your doctor before you start treatment with bexarotene and every month while you are taking the medication. Use 2 effective forms of birth control together (or completely avoid sexual intercourse) starting 1 month before treatment starts, during treatment, and for 1 month after you stop. One of your forms of birth control should be non-hormonal (e.g., barrier method such as condoms/cervical cap/diaphragm, copper coil IUD, or spermicide).

Males taking this medication should use a condom during sexual activity with a woman who is pregnant or may become pregnant, continuing until 1 month after their last dose.

Targretin Oral Side Effects

Headache, tiredness, nausea, vomiting, dry skin, diarrhea, or trouble sleeping may occur. If any of these effects persist or worsen, notify your doctor.

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.

This medication can frequently increase the level of "bad" fats (cholesterol/triglyceride) in your blood. Your doctor will order blood tests to measure these fats. If your blood fat levels get too high, your bexarotene dose may need to be lowered or stopped, or you may need to start cholesterol medication.

This medication can cause an underactive thyroid (hypothyroidism). Tell your doctor immediately if any of these symptoms of low thyroid occur: unusual weight gain, feeling cold, constipation, slow heartbeat, low on energy. Your doctor will order a blood test and may start you on thyroid medication.

Tell your doctor immediately if any of these unlikely but serious side effects occur:

• stomach pain
• swelling of the hands/feet
• muscle pain/stiffness/cramps
• fast/pounding heartbeat

Tell your doctor immediately if any of these rare but very serious side effects occur:

• severe abdominal/back/stomach pain
• persistent nausea/vomiting
• dark urine
• vision changes
• yellowing eyes and skin

This medication can lower the body's ability to fight an infection. Notify your doctor promptly if you develop any signs of an infection such as fever, chills, or persistent sore throat.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice the following symptoms of an allergic reaction:

• rash
• itching/swelling (especially of the face/tongue/throat)
• dizziness
• trouble breathing

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.

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

Targretin Oral Precautions

Before taking bexarotene, tell your doctor or pharmacist if you are allergic to it; or to other retinoids such as isotretinoin, acitretin, etretinate, tretinoin; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before taking this medicine, consult your doctor or pharmacist if you have:

• pancreatitis

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• frequent alcohol use
• cataracts
• high blood fats (high cholesterol/triglyceride)
• diabetes
• gallbladder disease
• liver problems
• thyroid problems (e.g., hypothyroidism)

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

Because this medication can lower your body's ability to fight an infection, wash your hands frequently to prevent the spread of infection.

This medication must not be used during pregnancy. If you become pregnant or think you may be pregnant, inform your doctor immediately. (See also Warning section.)

It is not known if this drug passes into breast milk. Due to the possible harm to the nursing infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Targretin Oral Medical Alert

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-800-854-1166 (USA) or 1-800-668-1507 (Canada).

---

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.
Copyright 2007 First DataBank, Inc.