Clofarabine Pregnancy and Breastfeeding Warnings

Clofarabine is also known as: Clolar

Clofarabine Pregnancy Warnings

Clofarabine has been assigned to pregnancy category D by the FDA. Animal studies have revealed evidence of teratogenicity, developmental toxicity (reduced fetal body weight and increased postimplantation loss) and increased incidences of malformations and variations (gross external, soft tissue, skeletal, and retarded ossification). There are no controlled data in human pregnancy. Clofarabine should only be given during pregnancy when there are no alternatives and benefit outweighs risk.

Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with clofarabine. Animal studies have reported adverse effects on male reproductive organs including seminiferous tubule and testicular degeneration and atrophy. Bilateral degeneration of the seminiferous epithelium with retained spermatids and atrophy of interstitial cells have also been reported in animal studies. Ovarian atrophy or degeneration and uterine mucosal apoptosis have been reported in female animal studies.

Clofarabine Breastfeeding Warnings

There are no data on the excretion of clofarabine or its metabolites into human milk. The manufacturer has stated that female patients should be advised to avoid breast-feeding during treatment with clofarabine.

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