Cytarabine Pregnancy and Breastfeeding Warnings

Brand names: Cytosar, Cytosar-U, Tarabine PFS

Medically reviewed by Drugs.com. Last updated on Nov 24, 2023.

Cytarabine Pregnancy Warnings

UK: Contraindicated (unless the benefit to the mother outweighs the risks to the fetus)
AU, US: Use is not recommended.

AU TGA pregnancy category: D
US FDA pregnancy category: D

Comments:
-This drug can cause fetal harm when administered to a pregnant woman, mainly during the first trimester.
-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.
-Men and women should use effective contraception during and up to 6 months after therapy.

Animal studies have revealed evidence of teratogenicity, abnormal cerebellar development, and embryotoxicity. A review of the literature has shown 32 reported cases where this drug was given in human pregnancies, either alone or in combination with other cytotoxic agents. Eighteen normal infants were delivered. Four of these had first trimester exposure. Five infants were premature or of low birth weight. Twelve of the 18 normal infants were followed up at ages ranging from 6 weeks to 7 years, and showed no abnormalities. One apparently normal infant died at 90 days of gastroenteritis. Two cases of congenital abnormalities were reported, one with upper and lower distal limb defects, and the other with extremity and ear deformities. Both cases had first trimester exposure. There were seven infants with various problems in the neonatal period, including pancytopenia, transient depression of WBC, hematocrit or platelets; electrolyte abnormalities; transient eosinophilia; and one case of increased lgM levels and hyperpyrexia possibly due to sepsis. Six of the seven infants were also premature. The child with pancytopenia died at 21 days of sepsis.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

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.

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