Vitrakvi Pregnancy Warnings
Animal studies have revealed evidence of malformations in the fetus when this drug is administered to pregnant animals during organogenesis. 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 is not recommended.
US FDA pregnancy category: Not assigned.
Risk Summary: Based on literature reports in human subjects with congenital mutations leading to changes in TRK signaling, findings from animal studies, and its mechanism of action, this drug can cause embryofetal harm when administered to a pregnant woman. Individuals with congenital mutations in TRK pathway proteins suggest that decreases in TRK-mediated signaling are correlated with obesity, developmental delays, cognitive impairment, insensitivity to pain, and anhidrosis.
Comments:
-This drug can harm a developing fetus.
-Verify negative pregnancy status in females of reproductive potential prior to initiating therapy.
-Advise female patients of childbearing potential to use highly effective contraception while taking this drug and for at least 1 month after.
-Advise males with female partners of reproductive potential to use effective contraception during therapy and for 1 month after.
-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.
-This drug may reduce female fertility.
See references
