Bexarotene 75mg Capsules

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

BEXAROTENE - ORAL

(bex-AR-oh-teen)

COMMON BRAND NAME(S): Targretin

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 right away. 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 (for example, a 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.

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

HOW TO USE: 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. Take this medication by mouth with or immediately after a meal, usually once daily or as directed by your doctor. The dosage is based on your body size, medical condition, and response to therapy. Swallow the medication whole. Do not crush or chew the medication. Do not use the capsule if it is broken or leaking. If the contents of the capsule touch your skin, immediately wash the area with soap and water and tell your doctor. Do not increase your dose or take this medication more often than prescribed. Your condition will not improve any faster, and the risk of serious side effects may be increased. It may take up to several months of continued use to see a response to treatment. Your dosage may need to be adjusted by your doctor during this time. Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the capsules. Learn proper technique for safe handling and disposal of this medicine and its container. Consult your pharmacist.

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 right away 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 right away if you have any serious side effects, including: stomach pain, swelling of the hands/feet, muscle pain/stiffness/cramps, fast/pounding heartbeat, mental/mood changes (such as depression, anxiety, thoughts of suicide). Tell your doctor right away 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 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.

PRECAUTIONS: Before taking bexarotene, tell your doctor or pharmacist if you are allergic to it; or to vitamin A-related drugs (other retinoids such as isotretinoin); 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, mental/mood problems (such as depression), thyroid problems (e.g., hypothyroidism). This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness. 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 right away. (See also Warning section.) Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the capsules. 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.

DRUG INTERACTIONS: 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 them first. This drug should not be used with the following medication because a very serious interaction may occur: gemfibrozil. If you are currently using the medication 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: tamoxifen, vitamins/supplements that contain vitamin A, drugs affecting liver enzymes that remove bexarotene from your body (for example, azole antifungals such as itraconazole/ketoconazole, macrolide antibiotics such as clarithromycin/erythromycin, cimetidine, rifamycins including rifabutin, St. John\'s wort, certain anti-seizure medicines such as phenytoin/phenobarbital). This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. You should use an additional form of reliable birth control while using this medication. (See also Warning section.) Consult your doctor or pharmacist for details. This medication may interfere with certain laboratory tests (including CA-125 levels), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug. Consult your doctor for more details. 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.

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others. Laboratory and/or medical tests (e.g., pregnancy tests, liver/thyroid tests, cholesterol/triglyceride levels, white blood count) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: If you miss a dose, take it with a meal as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

STORAGE: Store in a tightly closed container at room temperature between 36-77 degrees F (2-25 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

Information last revised October 2019. Copyright(c) 2019 First Databank, Inc.