What is Bexarotene?

Bexarotene capsules are a member of the retinoid class of drugs that is associated with birth defects in humans. Bexarotene capsules also caused birth defects when administered orally to pregnant rats. Bexarotene capsules must not be administered to a pregnant woman .

Bexarotene belongs to the group of medicines known as retinoids. It is used to treat a certain type of cancer called cutaneous T-cell lymphoma. It works by interfering with the growth of the cancerous cells.

This medicine is available only with your doctor's prescription.

Use this medicine exactly as directed by your doctor. Do not use more or less of it, and do not use it more often than your doctor ordered. The exact amount of medicine you need has been carefully worked out. Using too much will increase the risk of side effects, while using too little may not improve your condition.

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsule):
  • For cutaneous T-cell lymphoma:
    • Adults—Dose is based on body size and must be determined by your doctor. The usual dose is 300 milligrams (mg) for each square meter of body surface area taken once a day with a meal. Your dose may then be adjusted by your doctor.
    • Children—Use and dose must be determined by your doctor.

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Studies of this medicine have been done only in adult patients, and there is no specific information comparing the use of bexarotene in children with use in other age groups.

This medicine has been tested in patients 60 years of age or older and has not been shown to cause different side effects or problems in older people than it does in younger adults. However, elderly patients may be more sensitive to the effects of bexarotene.

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Chlortetracycline
• Demeclocycline
• Doxycycline
• Efavirenz
• Gemfibrozil
• Lymecycline
• Meclocycline
• Methacycline
• Minocycline
• Oxytetracycline
• Paclitaxel
• Rolitetracycline
• Sarecycline
• Tetracycline

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Atorvastatin
• Desogestrel
• Dienogest
• Drospirenone
• Erythromycin
• Estradiol Cypionate
• Estradiol Valerate
• Ethinyl Estradiol
• Ethynodiol Diacetate
• Etonogestrel
• Fosphenytoin
• Ketoconazole
• Levonorgestrel
• Medroxyprogesterone Acetate
• Mestranol
• Norelgestromin
• Norethindrone
• Norgestimate
• Norgestrel
• Phenobarbital
• Phenytoin
• Rifampin
• Vitamin A

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bone marrow depression, existing or
• Infection—There may be an increased risk of infections or worsening of infections because of the body's reduced ability to fight them
• Cataracts—May cause new cataracts or worsen previous cataracts
• Chickenpox (including recent exposure) or
• Herpes zoster (shingles)—Risk of severe disease affecting other parts of the body
• Diabetes mellitus—May be more likely to experience low blood sugar (hypoglycemia).
• High cholesterol—Bexarotene can cause an increase in cholesterol levels.
• Kidney disease—May increase the chance of side effects

• Liver disease—Effects of bexarotene may be increased because of slower removal from the body.

• Pancreatitis or
• Risk factors for pancreatitis, such as:
  • Drinking large quantities of alcohol or
  • Problems with your gallbladder or biliary tract or
  • Type 2 diabetes mellitus that is not well-controlled or
  • High cholesterol that is not well-controlled or
  • Taking medicines that cause high levels of triglycerides (fat-like substances) or
  • Taking medicines that are toxic to the pancreas or
  • Prior pancreatitis—Bexarotene can cause an increase in triglyceride levels which can cause inflammation of the pancreas.
• Photosensitivity—Bexarotene may cause increased sensitivity of the skin to sunlight

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

While you are being treated with bexarotene, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval. Bexarotene may lower your body's resistance, and there is a chance you might get the infection that the immunization is meant to prevent. In addition, other persons living in your household should not take oral polio vaccine, since there is a chance they could pass the polio virus on to you. Also, avoid persons who have taken oral polio vaccine within the last several months. Do not get close to them, and do not stay in the room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.

Bexarotene can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in urine or stools; or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

Bexarotene may cause your skin to be more sensitive to sunlight than it is normally. Exposure to sunlight, even for brief periods of time, may cause a skin rash, itching, redness or other discoloration of the skin, or a severe sunburn. When you begin taking this medicine:

• Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible.
• Wear protective clothing, including a hat. Also, wear sunglasses.
• Apply a sun block product that has a skin protection factor (SPF) of at least 15. Some patients may require a product with a higher SPF number, especially if they have a fair complexion. If you have any questions about this, check with your health care professional.
• Apply a sun block lipstick that has an SPF of at least 15 to protect your lips.
• Do not use a sunlamp or tanning bed or booth.