When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to bexarotene, or if you are pregnant or breastfeeding.

How to Use This Medicine:
Capsule

• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• Your doctor will tell you how much medicine to use. Do not use more than directed.
• It is best to take this medicine with food or milk.
• Swallow each capsule whole. Do not chew or dissolve the capsule in liquid or in your mouth.
• Do not touch the capsules if they are broken or leaking. If the medicine gets on your skin, wash with soap and water right away. Then call your doctor.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any leftover medicine after you have finished your treatment. You will also need to throw away old medicine after the expiration date has passed.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines and foods can affect how bexarotene works. Tell your doctor if you are taking any of the following:
  
  • Atorvastatin, carboplatin, erythromycin, gemfibrozil, itraconazole, ketoconazole, paclitaxel, phenobarbital, phenytoin, rifampin, or tamoxifen
  • Insulin, diabetes medicine that you take by mouth (such as glimepiride, glipizide, glyburide, pioglitazone, rosiglitazone), or vitamin A supplements
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine:

• This medicine may cause birth defects if either partner is using it during conception or pregnancy. Tell your doctor right away if you or your partner becomes pregnant. Birth control pills may not work properly while you are taking this medicine. Use 2 forms of birth control together beginning 1 month before you start taking this medicine and continuing until 1 month after you stop.
• You must have a negative pregnancy test before you will be allowed to take this medicine. You will also be required to have a pregnancy test 1 week before treatment and every month during your treatment.
• Tell your doctor if you are breastfeeding or you had an allergic reaction to acitretin or similar medicines. Tell your doctor if you have kidney or liver disease, ovarian cancer, cataracts, diabetes, high cholesterol, thyroid problems, or a history of gallbladder disease or pancreatitis. Tell your doctor if you drink large amounts of alcohol.
• This medicine may cause the following problems:
  
  • Blurred vision or vision changes
  • Increased cholesterol levels
  • Pancreatitis
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• This medicine may make your skin more sensitive to sunlight. Wear sunscreen. Do not use sunlamps or tanning beds.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blurred vision or changes in vision
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Feeling tired, low on energy, or unusually cold
• Fever, chills, cough, sore throat, and body aches
• Rapid weight gain, swelling in your hands, ankles, or feet
• Shortness of breath
• Sudden and severe stomach pain, nausea, vomiting, fever, lightheadedness
• Unusual bleeding or bruising

If you notice these less serious side effects, talk with your doctor:

• Back pain
• Dry skin, itching, or mild skin rash, or skin sensitivity to sunlight
• Trouble sleeping
• Weakness or tiredness

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088