Adagrasib Pregnancy Warnings
The manufacturer makes no recommendation regarding use during pregnancy. Use should be avoided.
US FDA pregnancy category: Not Assigned
Risk summary:
-No data available on use of this drug in pregnant women to inform a drug-related risk.
Comments:
-Based on animal studies, this drug has the potential to impair fertility in males and females.
In a rat embryo-fetal development study, once-daily oral administration of this drug during the period of organogenesis caused maternal toxicity, including reduced body weight and food intake; lower fetal body weight was observed at doses approximately 2 times the recommended dose of 600 mg twice daily based on body surface area [BSA]. Drug-induced fetal toxicity included skeletal malformations, such as bent limbs, bent scapula, wavy ribs, and supernumerary short cervical ribs, secondary to maternal toxicity and reduced fetal body weight.
In a rabbit embryo-fetal development study, once-daily oral administration of this drug during the period of organogenesis caused lower fetal body weight and increased litter frequency of unossified sternebra at 30 mg/kg in association with maternal toxicities, including reduced mean body weight and decreased food consumption. 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
Adagrasib Breastfeeding Warnings
Breastfeeding is not recommended during use of this drug.
Excreted into human milk: Data not available
Excreted into animal milk: Data not available
Comments:
-This drug has the potential to cause serious adverse reactions in breastfed children.
-The effects on the nursing infant or milk production are unknown.
-Avoid breastfeeding during treatment with this drug and for 1 week after the last dose.
See references
