Vonjo Pregnancy Warnings
Animal studies have revealed evidence of embryofetal toxicity, embryofetal lethality, teratogenicity, and increased gestation length at maternally toxic doses. Animal studies have also revealed evidence of decreased male fertility and mating. 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.
This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.
US FDA pregnancy category: Not assigned.
Risk summary: There are no data available on use of this drug in pregnant women to inform of a drug-related risk.
Comment: 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.
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