Imachron Use In Pregnancy & Lactation

Fertility: Human studies on male patients receiving imatinib mesylate (Imachron) and its effect on male fertility and spermatogenesis have not been performed. Male patients concerned about their fertility on imatinib mesylate (Imachron) treatment should consult with their physician (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Pregnancy: Studies in animals have shown reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions). There are no clinical trials on the use of imatinib mesylate (Imachron) in pregnant women. There have been post-market reports of spontaneous abortions and infant congenital anomalies from women who have taken imatinib mesylate (Imachron). Imatinib mesylate (Imachron) should be used during pregnancy only if the expected benefit outweighs the potential risk to the fetus. If it is used during pregnancy, the patient must be informed of the potential risk to the fetus.
Lactation: Both imatinib and its active metabolite can be distributed into human milk. The milk plasma ratio was determined to be 0.5 for imatinib mesylate and 0.9 for the metabolite, suggesting greater distribution of the metabolite into the milk. Considering the combined concentration of imatinib and of 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 taking imatinib mesylate (Imachron) should not breast-feed.