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Targretin Gel

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Targretin Gel

INDICATIONS

Targretin® (bexarotene) gel 1% is indicated for the topical treatment of cutaneous lesions in patients with CTCL (Stage IA and IB) who have refractory or persistent disease after other therapies or who have not tolerated other therapies.

DOSAGE AND ADMINISTRATION

Targretin® gel should be initially applied once every other day for the first week. The application frequency should be increased at weekly intervals to once daily, then twice daily, then three times daily and finally four times daily according to individual lesion tolerance. Generally, patients were able to maintain a dosing frequency of two to four times per day. Most responses were seen at dosing frequencies of two times per day and higher. If application site toxicity occurs, the application frequency can be reduced. Should severe irritation occur, application of drug can be temporarily discontinued for a few days until the symptoms subside. See CONTRAINDICATIONS: Pregnancy: Category X.

Sufficient gel should be applied to cover the lesion with a generous coating. The gel should be allowed to dry before covering with clothing. Because unaffected skin may become irritated, application of the gel to normal skin surrounding the lesions should be avoided. In addition, do not apply the gel near mucosal surfaces of the body.

A response may be seen as soon as four weeks after initiation of therapy but most patients require longer application. With continued application, further benefit may be attained. The longest onset time for the first response among the responders was 392 days based on the Composite Assessment of Index Lesion Severity in the multicenter study. In clinical trials, Targretin® gel was applied for up to 172 weeks.

Targretin® gel should be continued as long as the patient is deriving benefit.

Occlusive dressings should not be used with Targretin® gel.

TARGRETIN® GEL IS A TOPICAL THERAPY AND IS NOT INTENDED FOR SYSTEMIC USE. TARGRETIN® GEL HAS NOT BEEN STUDIED IN COMBINATION WITH OTHER CTCL THERAPIES.

HOW SUPPLIED

Targretin® gel is supplied in tubes containing 60 g (600 mg active bexarotene).

60 g tube ..........................................NDC 62856604-22

Store at 25°C (77°F); with excursions permitted to 15°-30°C (59°-86°F) [see USP]. Avoid exposing to high temperatures and humidity after the tube is opened. Protect from light.

Manufactured for: Eisai Inc. Woodcliff Lake, NJ 07677. by: Contract Pharmaceuticals Limited Niagara, Buffalo, NY 14213-1091. Revised (07/09)

Last reviewed on RxList: 6/2/2011
This monograph has been modified to include the generic and brand name in many instances.

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