Glivec Use In Pregnancy & Lactation

Women of childbearing potential: Women of childbearing potential must be advised to use effective contraception during treatment and for at least 15 days after stopping treatment with Glivec.
Pregnancy: There are limited data on the use of imatinib in pregnant women. There have been post-marketing reports of spontaneous abortions and infant congenital anomalies from women who have taken Glivec. Studies in animals have however shown reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions) and the potential risk for the foetus is unknown. Glivec should not be used during pregnancy unless clearly necessary. If it is used during pregnancy, the patient must be informed of the potential risk to the foetus.
Breast-feeding: There is limited information on imatinib distribution on human milk. Studies in two breast-feeding women revealed that both imatinib and its active metabolite can be distributed into human milk. The milk plasma ratio studied in a single patient was determined to be 0.5 for imatinib and 0.9 for the metabolite, suggesting greater distribution of the metabolite into the milk. Considering the combined concentration of imatinib and the metabolite and the maximum daily milk intake by infants, the total exposure would be expected to be low (~10% of a therapeutic dose). However, since the effects of low-dose exposure of the infant to imatinib are unknown, women should not breast-feed during treatment and for at least 15 days after stopping treatment with Glivec.
Fertility: In non-clinical studies, the fertility of male and female rats was not affected, although effects on reproductive parameters were observed (Pharmacology: Toxicology: Preclinical safety data under Actions). Studies on patients receiving Glivec and its effect on fertility and gametogenesis have not been performed. Patients concerned about their fertility on Glivec treatment should consult with their physician.