Sotorasib (AMG510) is a KRASG12C inhibitor indicated for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with KRASG12C mutation.
Standard Dosage and Administration of Sotorasib (AMG510)
Routine Dosage
Recommended Dosage: 960 mg (8 tablets of 120 mg each) orally, once daily, until disease progression or the occurrence of intolerable toxicity.
Administration Method: Swallow the tablets whole. It can be taken with or without food. If dispersion is required for administration, add the tablets to 120 mL of room-temperature non-carbonated water, stir, and drink immediately.
Principles of Dosage Adjustment
First Dose Reduction: 480 mg (4 tablets) once daily.
Second Dose Reduction: 240 mg (2 tablets) once daily.
Permanent Discontinuation: Discontinue the drug if the 240 mg dose is not tolerable.
Management of Missed Dose
If a dose is missed by more than 6 hours, skip that missed dose and take the next dose at the regularly scheduled time on the following day.
Administration in Special Populations for Sotorasib (AMG510)
Hepatic Impairment
No dosage adjustment is needed for patients with mild to moderate hepatic impairment.
The safety of sotorasib in patients with severe hepatic impairment has not been established.
Renal Impairment
No dosage adjustment is needed for patients with mild to moderate renal impairment (eGFR ≥ 30 mL/min).
Data on the use of sotorasib in patients with severe renal impairment is lacking.
Geriatric Patients
No adjustment to the initial dose is required for patients aged ≥ 65 years, but close monitoring for adverse reactions is necessary.
Pregnancy and Lactation
Pregnancy: There are no data on the use of sotorasib in humans. Animal studies have not shown teratogenicity.
Lactation: Breastfeeding is prohibited during treatment and for 1 week after the last dose of sotorasib.
Pediatric Patients
The efficacy of sotorasib in pediatric patients has not been established.
Storage Requirements for Sotorasib (AMG510)
Environmental Conditions
Store at 20-25°C (68-77°F).
Short-term storage at 15-30°C (59-86°F) is permitted.
Packaging Characteristics
Original child-resistant bottles.
120 mg yellow film-coated tablets, imprinted with "AMG" and "120".
Stability
The dispersed solution must be administered within 2 hours of preparation.
