Pemazyre Pregnancy Warnings
Use is not recommended unless clearly needed.
US FDA pregnancy category: Not assigned.
Risk Summary: Based on findings in animal studies and its mechanism of action, this drug can cause fetal harm or loss of pregnancy when administered to a pregnant woman.
Comments:
-Verify negative pregnancy status in females of reproductive potential prior to starting therapy.
-This drug can harm a developing fetus.
-Adequate methods of contraception should be encouraged.
-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 1 week after.
-Advise males with female partners of reproductive potential to use effective contraception during therapy and for 1 week after.
Animal studies during organogenesis have revealed evidence of 100% embryofetal mortality due to post-implantation loss at approximately 0.6 times the equivalent human dose. Fetal survival was unaffected at 0.1 mg/kg/day; however, once daily oral administration at the 0.1 mg/kg dose level (approximately 0.2 times the equivalent human dose) resulted in reduced mean fetal body weight and an increase in fetal skeletal and visceral malformations, major blood vessel variations, and reduced ossification. 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.
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