TARGRETIN® (bexarotene) capsules and gel are a prescription medicine used to treat the skin problems that happen with a type of cancer called cutaneous T-cell lymphoma (CTCL), after treatment with at least one other type of medicine by mouth or injection, did not work or has stopped working. TARGRETIN gel only can be used for the topical treatment of CTCL or mycosis fungoides (MF), lesions (sometimes referred to as patches or plaques) on your skin.
It is not known if TARGRETIN is safe and effective in children.
IMPORTANT SAFETY INFORMATION INCLUDING BOXED WARNING
What is the most important information I should know about TARGRETIN?
TARGRETIN can cause serious side effects, including major birth defects to an unborn baby, if taken during pregnancy.
For females who can become pregnant:
- Avoid becoming pregnant during treatment with TARGRETIN.
- Do not take or use TARGRETIN if you are pregnant or plan to become pregnant. TARGRETIN may harm your fetus (unborn baby). Contact your doctor immediately if you believe or suspect you are pregnant while taking or using TARGRETIN and until one month after you stop TARGRETIN.
- Your healthcare provider will do a pregnancy test, within 1 week before you start TARGRETIN, and each month during treatment with TARGRETIN to make sure you are not pregnant.
- You must use two effective forms of birth control together starting 1 month before you begin treatment with TARGRETIN, during treatment, and for 1 month after stopping TARGRETIN. Birth control pills (oral contraceptives) and other hormonal forms of birth control may not be effective if used with TARGRETIN. At least one of the forms of birth control that you choose should not contain hormones. Talk to your healthcare provider about forms of birth control that may be right for you.
- You should start taking TARGRETIN on the second or third day of a normal menstrual period. Follow your healthcare provider’s instructions about when to start TARGRETIN.
- Call your healthcare provider right away, if you become pregnant or think that you are pregnant during treatment with TARGRETIN, and for 1 month after you stop taking TARGRETIN.
- You must use a condom with female partners who are pregnant, might be pregnant, or who are able to become pregnant during treatment with TARGRETIN and for at least 1 month after your last dose.
Who should not take or use TARGRETIN?
Do not take or use TARGRETIN:
- if you are pregnant, believe you may be pregnant, or plan to become pregnant
- if you are allergic to bexarotene or any of the ingredients in TARGRETIN
Before taking or using TARGRETIN, tell your healthcare provider about all of your medical conditions, including if you:
- have or have had problems with your pancreas, including pancreatitis
- have or have had gallbladder problems
- have or have had liver problems
- have thyroid problems
- have diabetes
- have high levels of fats (lipids) called cholesterol or triglycerides in your blood
- have cataracts or a history of cataracts
- drink alcohol
- are pregnant, plan to become pregnant, or think you may be pregnant
- are breastfeeding or plan to breastfeed. It is not known if TARGRETIN passes into your breast milk. You should not breastfeed during treatment with TARGRETIN. Talk to your healthcare provider about the best way to feed your baby during treatment with TARGRETIN.
- are allergic to retinoid medications (for example: Accutane [isotretinoin], Soriatane [acitretin], Tegison [etretinate], Vesinoid [tretinoin]).
Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking or using TARGRETIN with certain other medicines can affect each other.
What should I avoid while taking or using TARGRETIN and when should I be extra careful while taking or using TARGRETIN?
- Limit the amount of vitamin A that you take during treatment with TARGRETIN. Because vitamin A in large doses may cause some side effects which are similar to those seen in patients taking or using TARGRETIN, do not take more than the recommended daily dietary allowance of vitamin A (4000 to 5000 International Units). If you take vitamins, check the label to see how much vitamin A they contain. If you are not sure, ask your doctor or pharmacist.
- Limit exposure to sunlight and artificial types of sunlight. TARGRETIN can make your skin more sensitive to sunlight and you can get sunburn. Minimize exposure to sunlight and do not use a sunlamp.
What are the possible side effects of TARGRETIN?
TARGRETIN can cause serious side effects including:
- Increased levels of fats (lipids) called cholesterol or triglycerides, in your blood are common with TARGRETIN, but can also be serious. Your healthcare provider may prescribe you medicines to treat high cholesterol or triglycerides levels, reduce your dose, temporarily stop treatment or completely stop treatment with TARGRETIN if you have this problem.
- Inflammation of the pancreas (acute pancreatitis). TARGRETIN can sometimes cause pancreatitis that comes on suddenly (acute), and that can lead to death. Your risk of developing acute pancreatitis may be greater if you have had pancreatitis in the past, high levels of fats in your blood that are not controlled, drink large amounts of alcohol, have gallbladder problems, have diabetes that is not controlled, take certain medicines that can increase the amount of triglycerides in your blood, take medicines that can harm your pancreas.
- Tell your healthcare provider right away if you develop signs or symptoms of pancreatitis during treatment with TARGRETIN, including: nausea that will not go away, vomiting, and stomach-area (abdominal) or back pain
- Liver problems, including liver failure. TARGRETIN can cause increased liver function blood test results, or liver problems that can lead to death.
- Thyroid problems (hypothyroidism) are common with TARGRETIN. Your healthcare provider may prescribe thyroid hormone treatment for you if needed.
- Low white blood cell count is common with TARGRETIN, but may sometimes be severe.
- New or worse cataracts. Tell your healthcare provider about any changes in your vision during treatment with TARGRETIN. You may need to have an eye examination.
- Risk of low blood sugar in people who have diabetes. TARGRETIN can interact with certain medicines used to treat diabetes, such as insulin, sulfonylurea medicines, and thiazolidinedione medicines. If you have diabetes, talk to your healthcare provider about your diabetes medicines and your risk for low blood sugar if you take TARGRETIN.
The most common side effects of TARGRETIN include headache, asthenia, rash, nausea, infection, stomach-area (abdomen) pain, swelling of your hands, arms, feet, or legs, and dry skin.
While using TARGRETIN gel, you may experience some local effects such as redness, itching, burning, irritation, and scaling at the area of application. In clinical trials, the majority of these effects were mild or moderate, but some patients did experience more severe rash, itching, irritation, and inflammation. A few patients discontinued treatment due to these types of effects. Should these or other effects become troublesome to you, consult your health care provider. He or she can provide information on how to manage these effects.
These are not all the possible side effects of TARGRETIN. Call your doctor for medical advice about side effects and any questions or concerns you have with TARGRETIN. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please click here for full Prescribing Information for Targretin capsules, including Patient’s Instructions for Use. Please click here for full Prescribing Information for Targretin gel, including Patient’s Instructions for Use.