Bexarotene

What is BEXAROTENE?

(BEXAROTENE) 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 should I use BEXAROTENE?

Read the Patient Information Leaflet if available from 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 as directed by your doctor, usually once daily. 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.

What should I tell my health care provider before I take BEXAROTENE?

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. Before using this medication, tell your doctor or pharmacist your medical history, especially of: pancreatitis, frequent alcohol use, cataracts, high blood fats (high cholesterol/triglyceride), diabetes, gallbladder disease, liver problems, mental/mood problems (such as depression), thyroid problems (such as 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. Bexarotene can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details. 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 unknown if this medication passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this medication. Consult your doctor before breastfeeding.

What may interact with BEXAROTENE?

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug are: gemfibrozil, tamoxifen, vitamins/supplements that contain vitamin A. This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. Discuss with your doctor or pharmacist about using a reliable backup birth control method while using this medication. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well. See also Warning section. This medication may interfere with certain lab tests (such as CA-125 levels), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

What should I watch for while using BEXAROTENE?

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.

What if I miss a dose of BEXAROTENE?

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.

What side effects may I notice from receiving BEXAROTENE?

Headache, tiredness, nausea, vomiting, dry skin, diarrhea, or trouble sleeping may occur. If any of these effects last or get worse, notify your doctor. Remember that this medication has been prescribed because your doctor 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 often 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: swelling of the hands/feet, muscle pain/stiffness/cramps, fast/pounding heartbeat, mental/mood changes (such as depression, anxiety, thoughts of suicide), nausea/vomiting that doesn't stop, stomach/abdominal/back pain, dark urine, vision changes, yellowing eyes/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 sore throat that doesn't go away, fever, or chills. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: 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.

Where should I keep BEXAROTENE?

Store between 36-77 degrees F (2-25 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medications 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.