Imatero

Imatero Use In Pregnancy & Lactation

imatinib

Manufacturer:

Amarox
Full Prescribing Info
Use In Pregnancy & Lactation
Women of child-bearing potential: Women of child-bearing potential must be advised to use highly effective contraception during treatment. Highly effective contraception is a method of birth control which results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly.
Pregnancy: There are no clinical trials on the use of Imatinib in pregnant women. There can be occur of spontaneous abortions and infant congenital anomalies from women who have taken Imatinib 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.
Breast-feeding: Both Imatinib and its active metabolite can be distributed into human milk. The milk plasma ratio 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 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 should not breast feed.
Fertility: Male patients concerned about their fertility on Imatinib treatment should consult with their physician.
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