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Sotorasib is an oral small molecule targeted inhibitor that covalently binds to KRAS The switch pocket of the G12C mutant protein specifically inhibits GTPase activity and blocks abnormal activation of the RAS signaling pathway.
Sotoraxib is suitable for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have KRASG12C mutations confirmed by FDA-approved testing methods. These patients need to have received at least one systemic treatment (such as PD-1/PD-L1 inhibitors or platinum-based chemotherapy). Also used in combination with panitumumab for the treatment of adult patients with KRAS G12C mutated metastatic colorectal cancer (mCRC).
The standard dosage regimen is 960 mg orally taken once a day (8 tablets of 120 mg). The tablet needs to be swallowed whole and cannot be chewed or crushed. It can be taken before or after meals. If you miss a dose for more than 6 hours, skip the dose and continue taking the medicine as originally planned the next day.
For patients with dysphagia, the tablets can be dispersed in 120 mL of non-carbonated room temperature water and stirred until broken (not completely dissolved). The tablets should be taken within 2 hours, and an additional 120 mL of water should be added to rinse the container residue.
In case of hepatotoxicity (increased AST/ALT), the drug needs to be suspended until recovery to ≤ grade 1, and the dose should be reduced to 480mg/day for the first time and to 240mg/day for the second time. Medication should be suspended immediately if interstitial lung disease (ILD) is suspected and permanently if confirmed. For grade ≥3 diarrhea/nausea/vomiting or other grade ≥3 adverse reactions, the medication needs to be suspended until the symptoms are relieved to ≤grade 1, and then the dose is reduced by grade 1 to continue treatment. The maximum allowed number of reductions is 2 times, and the minimum dose is 240mg/day.
Adverse reactions with an incidence rate of ≥20% include digestive system symptoms such as diarrhea (42%), nausea (26%), vomiting (17%), systemic symptoms such as musculoskeletal pain (35%), fatigue (26%), as well as hepatotoxicity-related transaminase elevation (25%) and cough (20%). Laboratory abnormalities mainly showed lymphopenia (48%), decreased hemoglobin (43%), and increased AST (39%)/ALT (38%).
During treatment, ALT/AST/total bilirubin need to be monitored every 3 weeks, and after 3 months, it will be changed to once a month. If you develop jaundice, dark urine, or unexplained fatigue, seek medical attention immediately. New onset of cough, fever, or dyspnea requires urgent evaluation for ILD risk.
It is prohibited to use strong CYP3A4 inducers (such as rifampicin) and PPI/H2 receptor antagonists (must be combined at an interval of 4/10 hours). Use CYP3A4/P-gp substrate drugs (such as midazolam, digoxin) with caution. Breastfeeding is prohibited for lactating patients while taking the drug and within 1 week after stopping the drug. There is no safety data for patients with Child-Pugh B/C liver damage. Live vaccines should be avoided during treatment, and patients of childbearing age need to take highly effective contraceptive measures.
This product is a 120 mg/tablet yellow film-coated tablet (marked "AMG120"). The packaging specification is 240 tablets/bottle or 120 tablets*2 bottles. It needs to be stored at room temperature of 20-25°C and avoid moisture.