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Imatinib Pregnancy and Breastfeeding Warnings

Imatinib is also known as: Gleevec

Imatinib Pregnancy Warnings

Imatinib mesylate was teratogenic in rats. Imatinib can cause fetal harm when administered to a pregnant woman. There have been post-market reports of spontaneous abortions and infant congenital anomalies. 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. 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.

FDA pregnancy category: D Use of imatinib is not recommended. Comments: Sexually active female patients of reproductive potential should use highly effective contraception.

See references

Imatinib Breastfeeding Warnings

Imatinib is excreted into human milk. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, women should be advised against breast-feeding while taking imatinib.

One case of imatinib concentrations in human milk has been reported. Both imatinib and its main active metabolite, the N-desmethyl derivative (CGP 74588) were extracted from milk and plasma protein. The milk-plasma ratio reached 0.5 for imatinib and 0.9 for CGP 74588.

See references

References for pregnancy information

  1. Pye SM, Cortes J, Ault P, et al. "The effects of imatinib on pregnancy outcome." Blood 111 (2008): 5505-8
  2. "Product Information. Gleevec (imatinib mesylate)." Novartis Pharmaceuticals, East Hanover, NJ.

References for breastfeeding information

  1. Gambacorti-Passerini CB, Tornaghi L, Marangon E, et al. "Imatinib concentrations in human milk." Blood 109 (2007): 1790
  2. "Product Information. Gleevec (imatinib mesylate)." Novartis Pharmaceuticals, East Hanover, NJ.

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