Portrazza Pregnancy Warnings
Use should be avoided.
US FDA pregnancy category: Not assigned
Risk Summary: Based on animal data and its mechanism of action, this drug can cause fetal harm when administered to a pregnant woman. Disruption or depletion of EGFR in animal models results in impairment of embryofetal development including effects on placental, lung, cardiac, skin, and neural development. The absence of EGFR signaling has resulted in embryolethality and postnatal death in animals.
Comments:
-This drug can cause fetal harm when administered to a pregnant woman.
-Pregnant women should be advised of the potential risk to a fetus, and the risk to postnatal development.
-Females of reproductive potential should be advised to use effective contraception during therapy and for 3 months following the last dose.
No animal reproduction studies have been conducted with this drug. 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
Portrazza Breastfeeding Warnings
No information is available on the use of this drug during breastfeeding. Because it is a large protein molecule, the amount in milk is likely to be very low and absorption is unlikely because it is probably destroyed in the infant GI tract.
Use should be avoided.
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
Comments:
-Women should not to breastfeed during therapy and for 3 months following the last dose.
-The effects in the nursing infant are unknown.
See references
