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Ifosfamide / mesna Pregnancy and Breastfeeding Warnings

Ifosfamide / mesna is also known as: Ifex/Mesnex

Ifosfamide / mesna Pregnancy Warnings

Ifosfamide has been assigned to pregnancy category D by the FDA. Animal studies have revealed evidence of embryotoxicity, fetotoxicity, and teratogenicity at doses 5.0% to 7.5% of the human dose on a per m2 basis. This drug can cause gene mutations and chromosomal damage in vivo. Human data have revealed evidence of fetotoxicity. If ifosfamide is used during pregnancy, or if the patient becomes pregnancy while taking this drug, the patient should be apprised of the potential hazard to the fetus. In general, the use of ifosfamide during pregnancy is considered contraindicated. Mesna has been assigned to pregnancy category B by the FDA. Animal studies have failed to reveal evidence of fetotoxicity. It is not known whether mesna can cause fetal harm or adversely affect reproductive capacity in humans. Mesna should only be given during pregnancy when benefit outweighs risk.

See references

Ifosfamide / mesna Breastfeeding Warnings

Ifosfamide is excreted into human milk. There are no data on the excretion of mesna into human milk. Because of the potential for serious adverse events and the tumorigenicity shown for ifosfamide in animal studies, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the nursing mother.

See references

References for pregnancy information

  1. "Product Information. Ifex (ifosfamide)." Bristol-Myers Squibb, Princeton, NJ.
  2. "Product Information. Mesnex (mesna)." Bristol-Myers Squibb, Princeton, NJ.

References for breastfeeding information

  1. "Product Information. Mesnex (mesna)." Bristol-Myers Squibb, Princeton, NJ.
  2. "Product Information. Ifex (ifosfamide)." Bristol-Myers Squibb, Princeton, NJ.

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