On February 21, 2013 Eisai and Valeant Pharmaceuticals reported that Valeant has acquired U.S. rights for Targretin (bexarotene) capsules and Targretin (bexarotene) gel 1% from Eisai for $65 million upfront, plus potential contingent payments based on certain milestones (Press release, Bausch Health, FEB 21, 2013, View Source [SID1234568997]).
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As part of the transaction, which takes effect immediately, Eisai has transferred the New Drug Application (NDA) for Targretin to Valeant, with Valeant assuming responsibilities for all regulatory obligations associated with the product in the United States. Eisai will retain its rights to Targretin outside of the United States and continue to meet the needs of its distribution partners outside of the United States.
Targretin Capsules
Indication
Targretin (bexarotene) capsules are used to treat the skin problems arising from a disease called cutaneous T-cell lymphoma, or CTCL when at least one systemic therapy has not worked. Your doctor must supervise the use of Targretin capsules.
Important Safety Information
Do not take Targretin capsules if you are pregnant or if you 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 taking, 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 or retinoid medications (for example: Accutane [isotretinoin], Soriatane [acitretin], Tegison [etretinate], Vesinoid [tretinoin])‡.
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 this medicine, tell your doctor if you are pregnant, have or previously had an inflamed pancreas, are breastfeeding, are taking gemfibrozil (Lopid)* a medicine to reduce high triglyceride cholesterol levels in the blood, or are taking tamoxifen (Nolvadex)†.
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 increase in blood lipids, headache, weakness, underactive thyroid, decreased white blood cells and diarrhea.
Please also see full prescribing information including boxed warning and patient instructions for use.