Targretin® (bexarotene) Capsules are a prescription medicine used to treat the skin problems that happen with a type of cancer called cutaneous T-cell lymphoma, or CTCL. It is used when treatment with at least one other type of medicine by mouth or injection did not work or stopped working. It is not known if Targretin is safe and effective in children.
IMPORTANT SAFETY INFORMATION INCLUDING PREGNANCY BOXED WARNING
What are the most important things I should know about Targretin Capsules?
Targretin can cause serious side effects, including major birth defects to an unborn baby, if taken during pregnancy.
• You should avoid becoming pregnant during treatment with Targretin.
• Do not take Targretin if you are pregnant or plan to become pregnant. Call your healthcare provider if you become pregnant or think you are pregnant while taking Targretin, and for one month after stopping treatment.
• You must use two effective forms of birth control together starting one month before you begin treatment with Targretin, during treatment, and for one month after stopping Targretin. Talk to your doctor about what forms of birth control are right for you.
• You must use a condom if you are male and your partner is pregnant or capable of becoming pregnant.
Do not take Targretin Capsules if you are allergic to this medicine.
Before taking Targretin, tell your healthcare provider about all 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 diabetes
- have high levels of fats (lipids) called cholesterol or triglycerides in your blood
- have cataracts or a history of cataracts
- have thyroid problems
- drink alcohol
- are breastfeeding or plan to breastfeed, or are pregnant or plan to become pregnant (see “What are the Most Important Things I Should Know about Targretin?”)
- are taking any other medications, including over-the-counter medicines and supplements
While taking Targretin You Should:
- Limit your exposure to the sun or artificial types of sunlight such as tanning beds and sunlamps
- Limit the amount of Vitamin A that you take
What are the possible side effects of Targretin?
- See “What are the Most Important Things I Should Know about Targretin?”
- Increased levels of fats (lipids) called cholesterol or triglycerides in your blood are common with Targretin and can be serious. It may require a dose adjustment, or interrupting or stopping treatment.
- Inflammation of the pancreas (acute pancreatitis) can sometimes be caused by Targretin and can lead to death. Ask your healthcare provider about factors that can increase the likelihood of developing pancreatitis.
– Tell your healthcare provider right away if you develop signs of pancreatitis, such as nausea that doesn’t go away, vomiting, back or stomach-area pain.
- Liver problems, including liver failure, can lead to death.
- Thyroid problems (hypothyroidism) are common with Targretin and may require treatment.
- Low white blood cell count is common with Targretin and sometimes severe.
- New or worse cataracts – tell your healthcare provider about any vision changes.
- Risk of low blood sugar in people with diabetes – talk to your doctor about your diabetes medicines to avoid drug interactions that can occur with Targretin.
The most common side effects of Targretin include headache, muscle weakness, rash, nausea, infection, stomach-area pain, swelling of hands, arms, feet or legs, and dry skin.
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 see accompanying full Prescribing Information including pregnancy Boxed Warning and Patient Information.
TARGRETIN® (bexarotene) Gel 1%
TARGRETIN (bexarotene) Gel 1% is used to treat the skin problems arising from a disease called cutaneous T-cell lymphoma, or CTCL, in patients who have not responded well to other treatments.
IMPORTANT SAFETY INFORMATION
What are the most important things I should know about Targretin Gel?
Do not use Targretin Gel if you are pregnant, believe you may be pregnant, or if you plan to become pregnant.
- Targretin Gel may harm your fetus (unborn baby). You should contact your doctor immediately if you believe or suspect you are pregnant while you are using Targretin Gel and until one month after you stop using Targretin Gel.
- If you are capable of becoming pregnant, you must have a pregnancy test, within one week before you start Targretin Gel therapy and monthly while you are using Targretin Gel, confirming you are not pregnant.
- You must use effective contraception (birth control) continuously starting one month before beginning treatment with Targretin Gel until one month after you stop using Targretin Gel. It is recommended that two reliable forms of contraception be used together.
- If you are male and your partner is pregnant or capable of becoming pregnant, you should discuss with your doctor the precautions you should take.
Do not use Targretin Gel if you are allergic to this medicine, or are pregnant or breastfeeding.
DO NOT use insect repellents containing DEET (N,N-diethyl-m-toluamide) or other products containing DEET while using Targretin Gel.
Tell your healthcare provider if you are allergic to retinoid medications (for example: Accutane [isotretinoin], Soriatane [acitretin], Tegison [etretinate], Vesanoid [tretinoin]).
When should you be extra careful while using Targretin Gel?
- 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.
- Your skin may become more sensitive to sunlight while using this medicine. Minimize exposure to sunlight and do not use a sunlamp.
You Should Avoid:
- You should avoid applying Targretin Gel to areas of healthy skin around a CTCL lesion. Exposure of healthy skin to Targretin Gel may cause unnecessary irritation or redness.
- DO NOT apply the gel on or near mucosal surfaces of the body such as eyes, nostrils, mouth, lips, vagina, tip of the penis, rectum, or anus.
- You should avoid the use of other topical products on your treated CTCL lesions.
What side effects does Targretin Gel have?
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.
All medications have side effects. You should call your healthcare provider about any questions or concerns you may have when using Targretin Gel.
You are encouraged to report negative side effects of prescription drugs to FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088
Please see accompanying full Prescribing Information, including Patient’s Instructions for Use.