For pregnant and lactating patients, if Sotorasib is to be used, it should be strictly in accordance with the doctor's advice, and do not use the drug without prescription.
Sotorasib Pregnancy Warning
Principle of use: Sotorasib should be used during pregnancy only if the benefit outweighs the risk.
FDA pregnancy category: Not assigned.
Risk summary: There are no data on the use of Sotorasib in pregnant women to assess drug-associated risk.
Precautions
If Sotorasib is used during pregnancy, or if the patient becomes pregnant while using the drug, the potential hazard to the fetus should be communicated.
Animal studies
Rats: Oral administration during organogenesis at 540 mg/kg (approximately 4.6 times the human exposure at the clinical dose of 960 mg based on AUC) showed maternal toxicity, but no developmental toxicity or embryo-lethality was observed, and embryo survival was not affected.
Rabbits: Oral administration during organogenesis at 100 mg/kg (approximately 2.6 times human exposure based on AUC) showed reduced fetal body weight and decreased ossification of metacarpals, with maternal toxicity (including reduced body weight gain and decreased food intake); however, no developmental toxicity was observed, and embryo survival was not affected.
Human data: No controlled study data in pregnancy.
Sotorasib Lactation Warning
Recommendation 1: Breastfeeding is not recommended during Sotorasib treatment and for 1 week after the last dose.
Recommendation 2: The importance of the drug to the mother should be weighed against the benefit of breastfeeding to the infant, to decide whether to discontinue breastfeeding or to discontinue the drug.
Drug excretion
Human milk: Unknown whether excreted in human milk.
Animal milk: No data available.
Precautions
1. No clinical data on the use of this drug during lactation.
2. This drug has high plasma protein binding (89%), and the level in milk may be low, but there is still a potential toxicity risk to the breastfed infant; therefore, it is recommended to suspend breastfeeding during treatment and for 1 week after the last dose.
