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Decitabine Pregnancy and Breastfeeding Warnings

Decitabine is also known as: Dacogen

Decitabine Pregnancy Warnings

Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with decitabine. If decitabine is used during pregnancy, or if the patient becomes pregnant while taking decitabine, the patient should be apprised of the potential hazard to the fetus. Men should be advised not to father a child while receiving treatment with decitabine, and for 2 months afterwards. Studies on male animals have revealed evidence that testes weights were reduced, abnormal histology was observed, and significant decreases in sperm number were found. In female animals mated to males that received decitabine, the pregnancy rate was reduced and preimplantation loss was significantly increased. The mutagenic potential of decitabine was tested in several in vitro and in vivo systems. Decitabine increased mutation frequency in L5178Y mouse lymphoma cells, and mutations were produced in an Escherichia coli lac-I transgene in colonic DNA of decitabine-treated mice. Decitabine caused chromosomal rearrangements in larvae of fruit flies.

Decitabine has been assigned to pregnancy category D by the FDA. Animal studies have revealed evidence of reduced fetal survival, decreased fetal weight, supernumerary ribs, fused vertebrae and ribs, cleft palate, vertebral defects, hindlimb defects, digital defects of forelimbs and hindlimbs, increased incidences of vertebral and rib anomalies, exophthalmia, exencephaly, and reduced size and ossification of long bones of the forelimb and hindlimb. There are no controlled data in human pregnancy. Decitabine should only be given during pregnancy when there are no alternatives and benefit outweighs risk. Men should be advised not to father a child while receiving treatment with decitabine and for two months afterwards.

Decitabine Breastfeeding Warnings

There are no data on the excretion of decitabine into human milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions from decitabine in nursing infants, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

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