Pirtobrutinib Pregnancy Warnings
In pregnant rats given this drug during organogenesis, reduced fetal body weight, malformation, and variations in the urinary tract, reproductive tract, and bone were observed. Total resorption was also observed when this drug was administered at a higher 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 healthcare 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: There are no data available on the use of this drug in pregnant women to inform a drug-related risk.
Comments:
-Based on animal studies this drug can cause fetal harm when administered to a pregnant woman.
-Before initiating therapy with this drug, verify the pregnancy status of females of reproductive potential.
-The use of effective methods of contraception should be encouraged during treatment with this drug and for one week after the last dose.
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