Orserdu Pregnancy Warnings
Use should be avoided.
US FDA pregnancy category: Not assigned
Risk Summary: Based on findings in animals and its mechanism of action, this drug can cause fetal harm when administered to a pregnant patient. No data available on use of this drug in pregnant women to inform a drug-related risk.
Comments:
-Pregnancy status of patients of reproductive potential should be verified prior to initiating therapy.
-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 female patients of reproductive potential to use effective contraception during therapy and for 1 week after last dose.
-Advise male patients with partners of reproductive potential to use a condom during treatment and for 1 week after last dose.
-Fertility of patients with reproductive potential may be compromised by this drug.
Animal studies have revealed evidence of embryolethality, fetolethality, teratogenicity, and maternal toxicity. Findings from animal studies indicate this drug may also impair fertility in males and females of reproductive potential. There are no controlled data in human pregnancy. It is not known whether this drug can cause fetal harm or adversely affect reproductive capacity in humans.
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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