Ayvakit Pregnancy Warnings
Animal studies have revealed evidence of decreased fetal body weights, post implantation loss, and increases in visceral (hydrocephaly, septal defect, and stenosis of the pulmonary trunk) and skeletal (sternum) malformations at doses approximately 2.7 times the equivalent human dose. There are no controlled data in human pregnancy.
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.
Use should be avoided.
US FDA pregnancy category: Not assigned.
Risk Summary: Based on findings from animal studies and its mechanism of action, this drug can cause fetal harm when administered to a pregnant woman. Administration to pregnant animals during organogenesis revealed teratogenic and embryotoxic effects at 2.7 times the equivalent human exposure.
Comments:
-This drug can harm a developing fetus.
-Adequate methods of contraception should be encouraged.
-Verify negative pregnancy status in females of reproductive potential 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.
-Advise females of reproductive potential to use effective contraception during therapy and for 6 weeks after.
-Advise males with female partners of reproductive potential to use effective contraception during therapy and for 6 weeks after.
-Based on findings from animal studies, this drug may impair both male and female fertility.
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