Tagraxofusp Pregnancy Warnings
Animal reproduction/developmental toxicity studies have not been conducted with this drug. 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 its mechanism of action, this drug has the potential for adverse effects on embryofetal development.
Comments:
-Advise females of reproductive potential to use contraceptive methods during therapy and for at least 1 week 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.
-Verify negative pregnancy status in females of reproductive potential within 7 days prior to initiating therapy.
See references
