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Panretin® (alitretinoin) gel could cause fetal harm if significant absorption were to occur in a pregnant woman. 9-cis-Retinoic acid has been shown to be teratogenic in rabbits and mice. An increased incidence of fused sternebrae and limb and craniofacial defects occurred in rabbits given oral doses of 0.5 mg/kg/day (about five times the estimated daily human topical dose on a mg/m² basis, assuming complete systemic absorption of 9-cis-retinoic acid, when Panretin® (alitretinoin) gel is administered as a 60 g tube over 1 month in a 60 kg human) during the period of organogenesis. Limb and craniofacial defects also occurred in mice given a single oral dose of 50 mg/kg on day eleven of gestation (about 127 times the estimated daily human topical dose on a mg/m² basis). Oral 9-cis-retinoic acid was also embryocidal, as indicated by early resorptions and post-implantation loss when it was given during the period of organogenesis to rabbits at doses of 1.5 mg/kg/day (about 15 times the estimated daily human topical dose on a mg/m² basis) and to rats at doses of 5 mg/kg/day (about 25 times the estimated daily human topical dose on a mg/m²basis). Animal reproduction studies with topical 9-cis-retinoic acid have not been conducted. It is not known whether topical Panretin® (alitretinoin) gel can modulate endogenous 9-cis-retinoic acid levels in a pregnant woman nor whether systemic exposure is increased by application to ulcerated lesions or by duration of treatment. There are no adequate and well-controlled studies in pregnant women. If Panretin® (alitretinoin) gel is used during pregnancy, or if the patient becomes pregnant while taking it, the patient should be apprised of the potential hazard to the fetus. Women of child-bearing potential should be advised to avoid becoming pregnant.
Panretin® (alitretinoin) gel is indicated for topical treatment of Kaposi's sarcoma. Patients with cutaneous T-cell lymphoma were less tolerant of topical Panretin® (alitretinoin) gel; five of seven patients had 6 episodes of treatment-limiting toxicities—grade 3 dermal irritation—with Panretin® (alitretinoin) gel (0.01% or 0.05%).
Retinoids as a class have been associated with photosensitivity. There were no reports of photosensitivity associated with the use of Panretin® (alitretinoin) gel in the clinical studies. Nonetheless, because in vitro data indicate that 9-cis-retinoic acid may have a weak photosensitizing effect, patients should be advised to minimize exposure of treated areas to sunlight and sunlamps during the use of Panretin® (alitretinoin) gel.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term studies in animals to assess the carcinogenic potential of 9-cis-retinoic acid have not been conducted. 9-cis-Retinoic acid was not mutagenic in vitro (bacterial assays, Chinese hamster ovary cell HGPRT mutation assay) and was not clastogenic in vitro (chromosome aberration test in human lymphocytes) nor in vivo (mouse micronucleus test).
Pregnancy Category D
(see “WARNINGS” section)
It is not known whether alitretinoin or its metabolites are excreted in human milk. Because many drugs are excreted in human milk and because of the potential for adverse reactions from Panretin® (alitretinoin) gel in nursing infants, mothers should discontinue nursing prior to using the drug.
Safety and effectiveness in pediatric patients have not been established.
Inadequate information is available to assess safety and efficacy in patients age 65 years or older.
Last reviewed on RxList: 11/17/2008
This monograph has been modified to include the generic and brand name in many instances.
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