Gamifant Pregnancy Warnings
Animal studies have revealed no fetal harm. 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.
The manufacturer makes no recommendation regarding use during pregnancy.
US FDA pregnancy category: Not assigned.
Risk Summary: There are no available data on the use of this drug in pregnant women to inform a drug-associated risk of adverse developmental outcomes. In animal studies, a murine surrogate anti-mouse antibody administered to pregnant mice throughout gestation crossed the placental barrier, and no fetal harm was observed.
See references
Gamifant Breastfeeding Warnings
Safety has not been established.
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
Comments:
-The effects in the nursing infant are unknown.
-Available data suggest that only limited amounts of therapeutic antibodies are found in breast milk and they do not enter the neonatal and infant circulations in substantial amounts.
See references
