Targretin (Oral)

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

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

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 people 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 people 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.

In deciding to use a medicine, you and your doctor need to consider the risks and benefits. For this medicine, think about the following:

Allergies

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

Pediatric

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

Geriatric

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 adults compared to younger adults. However, elderly patients may be more sensitive to the effects of bexarotene.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together with caution. If you are taking this medicine, it is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The interactions below are selected based on their potential significance and are not necessarily a complete list.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

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

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both drugs may be necessary for your treatment. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

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

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken at the same time as food or certain types of food due to possible interactions. Using alcohol or tobacco with some medicines may also cause interactions. The following interactions are selected based on their potential significance and are not necessarily a complete list.

Using this medicine with any of the following may increase the risk of certain side effects, but may be necessary in some cases. If used together, your doctor may adjust the dose or frequency of this medicine, or provide special instructions regarding food, alcohol, or tobacco.

• Grapefruit Juice

Other Medical Problems

Other medical issues may affect how you use this medicine. Be sure to inform 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 due to the body's reduced ability to fight them
• Cataracts—May cause new cataracts or worsen existing 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 increase cholesterol levels.
• Kidney disease—May increase the chance of side effects
• Liver disease—Effects of bexarotene may be increased due to slower removal from the body.
• Pancreatitis or
• Risk factors for pancreatitis, such as: Drinking large amounts of alcohol or Problems with your gallbladder or biliary tract or Uncontrolled Type 2 diabetes mellitus or Uncontrolled high cholesterol or Using medicines that cause high triglycerides or Using medicines that are harmful to the pancreas or Previous pancreatitis—Bexarotene can raise triglyceride levels, which may lead to inflammation of the pancreas.
• Photosensitivity—Bexarotene may increase skin sensitivity to sunlight.

Along with its needed effects, Targretin (Oral) may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may need medical attention.

Since this medication is given in different doses, the actual frequency of side effects may change. In general, side effects are less common with lower doses than with higher doses.

Check with your doctor as soon as possible if any of the following side effects occur:

More common

• Unusual tiredness or weakness
• Skin rash or other skin and mucous membrane lesions
• Fever
• Increase in lipid or cholesterol levels
• Coldness, dry, puffy skin or weight gain
• Chills, cough, hoarseness, lower back or side pain, or painful or difficult urination
• Swelling of the arms, feet, hands, or legs

Less Common

• Severe stomach pain with nausea or vomiting
• Shortness of breath
• Yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to Targretin (Oral). Your health care professional may also be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

More common

• Abdominal pain
• Hair loss
• Loss of appetite
• Loss of strength or energy, tiredness or weakness
• Back pain
• Diarrhea
• Dry skin
• General feeling of discomfort or illness
• Trouble sleeping
• Headache
• Nausea or vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your health care professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Targretin

Available Dosage Forms:

• Capsule
• Capsule, Liquid Filled

Therapeutic Class: Antineoplastic Agent

Chemical Class: Retinoid

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.

Dosing

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.

Missed Dose

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.

Storage

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.