Takhzyro Pregnancy Warnings
The manufacturer makes no recommendation regarding use during pregnancy.
US FDA pregnancy category: Not assigned.
Risk Summary: No data exists regarding use in pregnant women. Monoclonal antibodies such as this drug are transported across the placenta during the third trimester of pregnancy, and therefore, potential fetal effects are likely to be greater during the third trimester.
Animal studies have failed to reveal evidence of fetal harm. 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.
See references
Takhzyro Breastfeeding Warnings
This drug was detected in the milk of lactating cynomolgus monkeys at approximately 0.2% of the maternal plasma concentration.
Safety has not been established. Consider benefits and risks.
Excreted into human milk: Unknown
Excreted into animal milk: Yes
Comments: The effects in the nursing infant are unknown.
See references
