Tecentriq Pregnancy Warnings
This drug should be used during pregnancy only if the benefit outweighs the risk.
AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned.
Risk Summary:
-Based on animal studies, this drug impairs fertility in females of reproductive potential.
-Based on its mechanism of action, this drug can cause harm to a developing fetus.
Animal reproduction studies have not been conducted to evaluate the effect on reproduction and fetal development. A literature-based assessment of the effects on reproduction demonstrated that a central function of the PD-L1/PD-1 pathway is to preserve pregnancy by maintaining maternal immune tolerance to a fetus. Blockage of PD-L1 signaling has been shown to disrupt tolerance to a fetus and to result in an increase in fetal loss. 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.
AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.
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
Tecentriq Breastfeeding Warnings
Because this drug is a large protein molecule, the amount in breastmilk is likely to be very low and absorption is unlikely as it is probably destroyed in the infant GI tract.
Use should be avoided.
Excreted into human milk: Data not available
Excreted into animal milk: Data not available
Comments:
-There is no information regarding the presence of this drug in human milk, or the effects on milk production; because human IgG is excreted in human milk, the potential for absorption and harm to the infant is unknown.
-Lactating women should not breastfeed during therapy and for at least 5 months after.
See references
