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Bexarotene Safety and Warning Information

Bexarotene poses several potential risks and requires careful precautions to ensure safe use. Please review the following information carefully and consult your healthcare provider if you have any questions or concerns.

• Risk to Unborn Child: Bexarotene can cause severe birth defects. It is strictly prohibited for use by pregnant women. Women of childbearing potential must undergo a pregnancy test within one week prior to starting the medication and monthly during treatment. Effective birth control is essential, requiring two methods of contraception—one of which must be non-hormonal—beginning one month before treatment, continuing during treatment, and for one month after stopping. Males must use a condom during sexual intercourse with women who are or could become pregnant, up to one month after the final dose.

• Elevated Blood Lipids: This medication may increase blood lipid levels, including cholesterol and fats. Regular blood tests are necessary to monitor these levels, and adjustments to your medication or additional treatments may be required if your lipid levels become too high.

• Pancreatitis Risk: There is a rare but serious risk of inflammation of the pancreas (pancreatitis), which can be life-threatening. If you experience nausea, vomiting, or abdominal/back pain, contact your healthcare provider immediately. The risk is higher for individuals with a history of pancreatitis, biliary tract disease, high blood cholesterol or fats, uncontrolled diabetes, excessive alcohol consumption, or those taking medications that affect the pancreas.

• Liver Health Concerns: Bexarotene may lead to liver issues, potentially resulting in liver failure. Regular liver function tests are recommended. Seek medical attention promptly if you notice symptoms such as stomach pain, nausea, vomiting, yellowing of the skin or eyes, dark urine, or pale stools, particularly if you have pre-existing liver conditions.

• Thyroid Hormone Levels: The drug can lower thyroid hormone levels. Regular monitoring through blood tests is important, and thyroid replacement therapy might be necessary if levels become too low.

• White Blood Cell Count: Bexarotene can decrease the white blood cell count, typically occurring 4 to 8 weeks after starting treatment. This effect usually resolves after reducing the dose or discontinuing the medication. Regular blood tests are essential to monitor these changes.

• Low Blood Sugar Risk: For individuals with diabetes taking insulin or other antidiabetic medications, bexarotene may enhance the effects, raising the risk of hypoglycemia. It's important to inform your healthcare provider about all medications you are taking.

Contraindications:

• Do not use if you are currently pregnant, as it poses significant health risks.

Always ensure thorough communication with your healthcare provider to manage these risks and ensure safe and effective use of bexarotene.

Common side effects:

• Headache
• Tiredness
• Nausea
• Vomiting
• Diarrhea
• Dry skin
• Trouble sleeping

Less common but important to monitor:

• Increase in cholesterol and triglycerides
• Hypothyroidism
• Swelling of the hands, feet, or ankles
• Muscle pain or stiffness
• Rapid or pounding heartbeat
• Mental changes like depression or anxiety
• Infections due to lowered white blood cells

Serious side effects:

• Liver damage
• Pancreatitis
• Symptoms of low blood sugar
• Allergic reactions like rash, itching, swelling, dizziness, or difficulty breathing

Interactions with high risk of serious adverse effects and should be avoided:

• Hormonal Birth Control

Interactions with moderate risk that may require dose adjustment, closer monitoring, or timing changes:

• Gemfibrozil
• Vitamin A
• Chlortetracycline
• Demeclocycline
• Desogestrel
• Dienogest
• Doxycycline
• Drospirenone
• Efavirenz
• Eravacycline
• Estradiol
• EthinylEstradiol
• Ethynodiol
• Etonogestrel
• Gestodene
• Levonorgestrel
• Lymecycline
• Meclocycline
• Medroxyprogesterone
• Mestranol
• Methacycline
• Minocycline
• Nomegestrol
• Norelgestromin
• Norethindrone
• Norgestimate
• Norgestrel
• Omadacycline
• Oxytetracycline
• Paclitaxel
• Rolitetracycline
• Sarecycline
• Segesterone
• Tetracycline
• Tigecycline
• Ulipristal

Interactions with low risk that usually do not require a change in therapy:

• Atorvastatin
• Erythromycin
• Fosphenytoin
• Ketoconazole
• Phenobarbital
• Phenytoin
• Rifampin