Gavreto Pregnancy Warnings
Use should be avoided.
US FDA pregnancy category: Not assigned.
Risk Summary: There are no available data on use in pregnant women to inform drug-associated risk. Based on findings from animal studies and its mechanism of action, this drug can cause fetal harm when administered to a pregnant woman.
Comments:
-Pregnancy status should be verified prior to initiating therapy.
-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 harm to the fetus.
-Females of reproductive potential should use effective nonhormonal contraception during therapy and for 2 weeks after; this drug may render hormonal contraceptives ineffective.
-Male patients with female partners of reproductive potential should use effective contraception during therapy and for 1 week after the final dose.
Animal studies have revealed 100% post-implantation loss at dose levels approximately 1.8 times the human exposure. Post-implantation loss also occurred at dose levels approximately 0.6 times the estimated human exposure. Once daily administration in pregnant rats at dose levels approximately 0.2 times the expected human dose resulted in an increase in visceral malformations and variations (absent or small kidney and ureter, absent uterine horn, malpositioned kidney or testis, retroesophageal aortic arch) and skeletal malformations and variations (vertebral and rib anomalies and reduced ossification). There are no controlled data in human pregnancy.
Based on histopathological findings in the reproductive tissues of male and female rats and reproduction studies with both sexes, this drug may impair fertility.
US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.
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