Afinitor Pregnancy Warnings
Animal studies showed embryofetal and maternal toxicities at exposures lower than expected in humans at a dose of 10 mg daily. Toxicities included increased resorption, preimplantation and postimplantation loss, decreased number of live fetuses, malformation, and retarded skeletal development. 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 C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. 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.
Use is not recommended.
AU TGA pregnancy category: C
US FDA pregnancy category: Not assigned
Risk Summary: Based on animal studies and the mechanism of action, this drug can cause fetal harm when administered to a pregnant woman.
Comments:
-Encourage use of adequate methods of contraception during therapy
and for up to 8 weeks following the last dose.
-This drug may impair fertility in males based on human and animal findings.
See references
Afinitor Breastfeeding Warnings
Use is not recommended.
Excreted into human milk: Unknown
Excreted into animal milk: Yes
Comments:
-The effects in the nursing infant are unknown.
-Animal studies have shown that this drug and/or its metabolites pass readily into milk; the concentration in the milk was 3.5 times greater than the maternal serum.
-Advise women not to breastfeed during therapy and for 2 weeks after the last dose.
No information is available on the use of this drug during breastfeeding. An alternate drug may be preferred, especially while nursing a newborn or preterm infant.
See references
