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Cytarabine liposomal Pregnancy and Breastfeeding Warnings

Cytarabine liposomal is also known as: DepoCyt

Cytarabine liposomal Pregnancy Warnings

There are no controlled data in human pregnancy. It is not known whether this drug can cause fetal harm or adversely affect reproductive capacity in humans. US FDA pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

This drug should be used during pregnancy only if the benefit outweighs the risk. US FDA pregnancy category: D Comments: -This drug can cause fetal harm when administered to a pregnant woman, mainly during the first trimester. The potential harm to a fetus from intrathecal administration however, is low because systemic exposure is negligible. -Women of childbearing potential should not receive this drug until pregnancy is excluded and should be advised to use a reliable contraceptive method. -Because this drug has a mutagenic potential which could induce chromosomal damage in the human spermatozoa, males undergoing therapy and their partner should be advised to use a reliable contraceptive method.

See references

Cytarabine liposomal Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown Excreted into animal milk: Data not available Comments: -The effects in the nursing infant are unknown. -The systemic exposure to free cytarabine following intrathecal treatment with was negligible.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. DepoCyt (cytarabine liposomal)." Sigma-Tau Pharmaceuticals, Gaithersburg, MD.

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. DepoCyt (cytarabine liposomal)." Sigma-Tau Pharmaceuticals, Gaithersburg, MD.

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