Ifosfamide Pregnancy and Breastfeeding Warnings

Brand names: Ifex

Medically reviewed by Drugs.com. Last updated on May 4, 2023.

Ifosfamide Pregnancy Warnings

Use is contraindicated.

AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned.

Risk Summary: This drug can cause fetal harm when administered to a pregnant woman. Fetal growth retardation and neonatal anemia have been reported.

Comments:
-Adequate methods of contraception should be encouraged.
-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 harm to the fetus.
-Women should not become pregnant during therapy.
-Men should not father a child during therapy and for up to 6 months after.

Animal studies have revealed evidence of embryotoxicity, gene mutations, and chromosomal damage. 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.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.

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