Rubraca Pregnancy Warnings
This drug should be used during pregnancy only if the benefit outweighs the risk.
US FDA pregnancy category: Not assigned.
Risk Summary: Administration of this drug to pregnant rats during organogenesis resulted in embryofetal death at maternal exposures that were 0.04 times the recommended dose in humans.
Comments:
-This drug can harm a developing fetus.
-Adequate methods of contraception should be encouraged.
-Verify negative pregnancy status in females of reproductive potential prior to initiating therapy.
-Advise females of reproductive potential to use effective contraception during therapy and for 6 months 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.
Animal studies have revealed evidence of embryotoxicity and teratogenicity. 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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