Revcovi Pregnancy Warnings
There are no controlled data in human or animal 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.
The manufacturer makes no recommendation regarding use during pregnancy.
US FDA pregnancy category: Not assigned.
Risk Summary: Human and animal reproduction studies have not been conducted with this drug. It is not known whether it can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. No pregnancy was reported for any patients receiving this drug. There were 2 reports of confirmed cases of successful pregnancy and delivery in patients treated with pegademase bovine (the same class of enzyme replacement therapy). No teratogenic effects were reported.
Comments: More frequent monitoring of the mother and the developing fetus is recommended when this drug is used during pregnancy.
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