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Pregnancy

Category X. See CONTRAINDICATIONS

General

Targretin® gel should be used with caution in patients with a known hypersensitivity to other retinoids. No clinical instances of cross-reactivity have been noted.

Vitamin A Supplementation: In clinical studies, patients were advised to limit vitamin A intake to 15,000 IU/day. Because of the relationship of bexarotene to vitamin A, patients should be advised to limit vitamin A supplements to avoid potential additive toxic effects.

Photosensitivity: Retinoids as a class have been associated with photosensitivity. In vitro assays indicate that bexarotene is a potential photosensitizing agent. There were no reports of photosensitivity in patients in the clinical studies. Patients should be advised to minimize exposure to sunlight and artificial ultraviolet light during the use of Targretin® gel.

Information for Patients

Please see accompanying “Patient's Instructions for Use”

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Long-term studies in animals to assess the carcinogenic potential of bexarotene have not been conducted. Bexarotene was not mutagenic to bacteria (Ames assay) or mammalian cells (mouse lymphoma assay). Bexarotene was not clastogenic in vivo (micronucleus test in mice). No formal fertility studies were conducted with bexarotene. Bexarotene caused testicular degeneration when oral doses of 1.5 mg/kg/day were given to dogs for 91 days.

Use in Nursing Mothers

It is not known whether bexarotene is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from bexarotene, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Of the total patients with CTCL in clinical studies of Targretin® gel, 62% were under 65 years and 38% were 65 years or older. No overall differences in safety were observed between patients 65 years of age or older and younger patients, but greater sensitivity of some older individuals to Targretin® gel cannot be ruled out. Responses to Targretin® gel were observed across all age group decades, without preference for any individual age group decade.

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