Cladribine Pregnancy and Breast Feeding Warnings
Cladribine is also known as: Cladribine Novaplus, Leustatin
Overview
Cladribine may cause harm to the fetus. Do not become pregnant while you are using it. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Cladribine while you are pregnant. It is not known if Cladribine is found in breast milk. Do not breast-feed while taking Cladribine .
Cladribine Pregnancy Warnings
Cladribine has been assigned to pregnancy category D by the FDA. Animal data have revealed evidence of teratogenicity, embryotoxicity, fetotoxicity, increased resorptions, reduced litter size, and fetal death at doses equivalent to the recommended dose in humans. There are no anecdotal or controlled data from human pregnancy. Although there is no evidence of teratogenicity in humans, other drugs which inhibit DNA synthesis have been teratogenic in humans. If cladribine is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Women of childbearing age should be advised to avoid becoming pregnant. Cladribine should only be given during pregnancy when there are no alternatives and benefit outweighs risk.
A single case in which cladribine was used postpartum to treat hairy cell leukemia in a 23-year-old woman has been reported. The diagnosis was made at 10 weeks' gestation. The patient wished to continue her pregnancy, and treatment was deferred until after the delivery. She underwent elective splenectomy at 16 weeks' gestation because of an enlarging spleen and abdominal discomfort. A healthy female infant was vaginally delivered at term. After six months of breast-feeding, the patient received a seven-day course of cladribine. Cure was documented by bone marrow biopsy and immunophenotyping. This single case suggests that pregnant patients with hairy cell leukemia may be allowed to continue pregnancy to term and be allowed to breast-feed before the implementation of cladribine therapy without adverse effects. When administered intravenously to monkeys, cladribine has been shown to cause suppression of rapidly generating cells, including testicular cells. The effect on human fertility is unknown.
Cladribine Lactation Warnings
There are no data on the excretion of cladribine into human milk. Because many drugs are excreted into human milk and because of the potential for serious adverse reactions in nursing infants from cladribine, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug for the mother.
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