Eisai Company Ltd (ESALY)

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Targretin® (bexarotene) capsules

Targretin® (bexarotene) capsules 75 mg are used to treat the skin problems arising from a disease called cutaneous T-cell lymphoma (CTCL) when at least one systemic therapy has not worked. A doctor must advise on the proper use of Targretin capsules.

CTCL is a rare disease. In CTCL, T-cells become cancerous and affect the skin and the blood. Normally T-cells are used by the body to fight infections. CTCL symptoms are often mistaken for a rash, eczema or psoriasis.

In the United States, there are nearly 2,000 new cases annually and the annual incidence continues to rise and its cause is unknown.


Do not take Targretin capsules if you are pregnant or plan to become pregnant.


Targretin capsules may harm your fetus (unborn baby). You should contact your doctor immediately if you believe or suspect you are pregnant while you are taking Targretin capsules and until one month after you stop taking Targretin capsules.
If you are capable of becoming pregnant, you must have a pregnancy test within one week before you start Targretin capsule therapy and monthly while you are on therapy, confirming you are not pregnant.
You must use effective contraception (birth control) continuously starting one month before beginning treatment with Targretin capsules until one month after you stop taking Targretin capsules. It is strongly recommended that two reliable forms of contraception be used together. At least one of these two forms of contraception should include condoms, diaphragms, cervical caps, IUDs, or spermicides.
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 take Targretin capsules if you are allergic to this medicine.

Targretin capsules can greatly increase blood levels of lipids (triglycerides and cholesterol) and these levels must be monitored and, if elevated, treated.

Targretin capsules can cause an underactive thyroid and periodic blood tests will be needed to detect this. Medication to control the condition may be necessary.

Before you start to take Targretin capsules, tell your doctor if you are pregnant, have or previously had an inflamed pancreas (pancreatitis), are breastfeeding, are taking gemfibrozil (Lopid®) a medicine to reduce high triglyceride cholesterol (fats) levels in the blood, or are taking tamoxifen (Nolvadex®).

You should tell your doctor if you are allergic to retinoid medications (for example: Accutane® [isotretinoin], Soriatane® [acitretin], Tegison [etretinate], Vesinoid® [tretinoin]), have or ever had high triglyceride (a fatty substance) levels in your blood, diabetes mellitus (sugar diabetes), gall bladder disease, any liver disease, if you regularly drink more than a small amount of alcohol, are taking any prescription medication for fungal infections, bacterial infections, or seizures, or eat a lot of grapefruit or drink a lot of grapefruit juice.

Because vitamin A in large doses may cause some side effects which are similar to those seen in patients applying Targretin gel, do not take more than the recommended daily dietary allowance of vitamin A (4000 to 5000 International Units). If you are not sure, ask your doctor or pharmacist.

Your skin may become more sensitive to sunlight while taking this medicine. Minimize exposure to sunlight and do not use a sunlamp.

The most common side effects with Targretin capsules are an increase in blood lipids (fats in the blood), headache, weakness, underactive thyroid, decreased white blood cells and diarrhea.

Please also see the Targretin capsules Full Prescribing Information and patient's instructions for use including Boxed WARNING and additional important safety information.

For more information about Targretin Capsules, visit www.Targretin.com or call Eisai Medical Services Oncology at [phone]. To report suspected adverse reactions, call [phone].

For more information about reimbursement services and patient assistance, call the Eisai Assistance hotline at [phone].

Targretin® is a registered trademark of Eisai Inc.