Pluvicto Pregnancy Warnings
This drug is not indicated for use in female patients.
US FDA pregnancy category: Not assigned.
Risk summary: Based on its mechanism of action, this drug can cause fetal harm; no data are available on use of this drug in pregnant women.
Comments:
-Safety and efficacy have not been established in females.
-Male patients with female partners of childbearing potential should be advised to use effective contraception during therapy and for 14 weeks after the last dose.
-The recommended cumulative dose (44.4 GBq) results in a radiation absorbed dose to the testes within the range where this drug may cause temporary or permanent infertility.
Animal studies have not been reported; however, all radiopharmaceuticals (including this drug) have the potential to cause fetal harm. 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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