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Pralatrexate Pregnancy and Breastfeeding Warnings

Brand names: Folotyn

Medically reviewed by Last updated on Aug 11, 2023.

Pralatrexate Pregnancy Warnings

Animal studies have revealed evidence of embryotoxicity, fetotoxicity, decreased fetal viability, increased post implantation loss, abortion, and fetal lethality. There are no controlled data in human pregnancy.

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 only be given during pregnancy when there are no alternatives and the benefit outweighs the risk.

US FDA pregnancy category: D

Comments: If this drug 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.

See references

Pralatrexate 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: There is a potential for serious adverse reactions in nursing infants from this drug.

See references

References for pregnancy information

  1. Product Information. Folotyn (pralatrexate). Allos Therapeutics. 2009.

References for breastfeeding information

  1. Product Information. Folotyn (pralatrexate). Allos Therapeutics. 2009.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.