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Systemic toxicity following acute overdosage with topical application of Targretin® gel is unlikely because of low systemic plasma levels observed with normal therapeutic doses.
There is no specific antidote for overdosage. There has been no experience with acute overdose of Targretin® gel in humans. Any overdose with Targretin® gel should be treated with supportive care for the signs and symptoms exhibited by the patient.
Targretin® gel 1% is contraindicated in patients with a known hypersensitivity to bexarotene or other components of the product.
Pregnancy: Category X
Targretin® gel 1% may cause fetal harm when administered to a pregnant woman.
Targretin® gel must not be given to a pregnant woman or a woman who intends to become pregnant. If a woman becomes pregnant while taking Targretin® gel, Targretin® gel must be stopped immediately and the woman given appropriate counseling.
Bexarotene caused malformations when administered orally to pregnant rats during days 7-17 of gestation. Developmental abnormalities included incomplete ossification at 4 mg/kg/day and cleft palate, depressed eye bulge/microphthalmia, and small ears at 16 mg/kg/day. At doses greater than 10 mg/kg/day, bexarotene caused developmental mortality. The no-effect oral dose in rats was 1 mg/kg/day. Plasma bexarotene concentrations in patients with CTCL applying Targretin® gel 1% were generally less than one hundredth the Cmax associated with dysmorphogenesis in rats, although some patients had Cmax levels that were approximately one eighth the concentration associated with dysmorphogenesis in rats.
Women of child-bearing potential should be advised to avoid becoming pregnant when Targretin® gel is used. The possibility that a woman of child-bearing potential is pregnant at the time therapy is instituted should be considered. A negative pregnancy test (e.g., serum beta-human chorionic gonadotropin, beta-HCG) with a sensitivity of at least 50 mIU/L should be obtained within one week prior to Targretin® gel therapy, and the pregnancy test must be repeated at monthly intervals while the patient remains on Targretin® gel. Effective contraception must be used for one month prior to the initiation of therapy, during therapy and for at least one month following discontinuation of therapy; it is recommended that two reliable forms of contraception be used simultaneously unless abstinence is the chosen method. Male patients with sexual partners who are pregnant, possibly pregnant, or who could become pregnant must use condoms during sexual intercourse while applying Targretin® gel and for at least one month after the last dose of drug. Targretin® gel therapy should be initiated on the second or third day of a normal menstrual period. No more than a one month supply of Targretin® gel should be given to the patient so that the results of pregnancy testing can be assessed and counseling regarding avoidance of pregnancy and birth defects can be reinforced.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 6/2/2011
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