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SOTOXEN tablet: Each film-coated tablet contains Sotorasib INN 120 mg.
PHARMACOLOGY Mechanism of Action:Sotorasib is a potent and highly selectiveKRASG12C(Kirsten rat sarcoma viral oncogene homolog)inhibitor which covalently and irreversibly binds to the unigue cysteine of KRASG12C.Inactivation of KRASG12C by Sotorasib blocks tumour cell signalling and survival inhibits cell growth,and promotes apoptosis selectively in tumours harbouring KRASG12Can oncogenic driver of tumourigenesis across multiple cancer types.The potency and selectivity of Sotorasib is enhanceo through the unique binding to both the P2 pocket and the His95 surface groove,locking the protein in an inactive state that prevents downstream signalling without affecting wild-type KRAS.
Sotorasib demonstrated in vitro and in vivo inhibition of KRASG12C with minimal detectable off-taraet activity against other cellular proteins andprocesses.Sotorasib impaired oncogenic signalling and tumour cell surviva at clinically relevant exposures in numerous pre-clinica models expressing KRASG12C.Sotorasib also enhanced antigen presentation and inflammatory cytokine production only in tumour cells with KRASG12C.Sotorasib induced anti-tumour inflammato ry responses and immunity, driving permanent and complete tumour regressions inimmunocompetent mice implanted with KRASG12C expressing tumours.
INDICATION AND USAGE :
Sotorasib is indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer(NSCLC)，as determined by an FDA-approved testwho have received at least one prior systemic therapy.
The recommended dosage of Sotorasib is 960 mg(eight 120 mg tablets) orally once daily until disease progression or unacceptable toxicity.
Take Sotorasib at the same time each daywith or without food.Swallow tablets whole.Do not chew,crush or split tablets. If a dose of Sotorasib is missed by more than 6 hours, take the next dose as prescribed the next day. Do not take 2 doses at the same time to make up for the missed dose.
if vomiting occurs after taking Sotorasibdo not take an additional dose.Take the next dose as prescribed the next day. Administration to Patients Who Have Difficulty Swallowing Solids
Disperse tablets in 120 mL(4ounces)of non-carbonated room-temperature water without crushing.No other liquids should be used.Stir until tablets are dispersed into small pieces (the tablets will not completely dissolve) and drink immediately or within 2 hours.The appearance of the mixture may range from pale yellow to bright yellow.Swallowthe tablet dispersion.Do not chew pieces of the tablet.Rinse the container with an additional 120 mL(4 ounces)of water and drink.f the mixture is not consumed immediatelystir the mixture again to ensure that tablets are dispersed.
Dosage Modifications for Adverse Reactions
Sotorasib dose reduction levels are summarized in Table 1. Dosage modifications for adverse reactions are provided in Table2
If adverse reactions occur a maximum of two dose reductions are permitted.Discontinue SOTORASIB if patients are unable to tolerate the minimum dose of240 mg once daily.
Table 1.Recommended Sotorasib dose reduction levels
Dose reduction level Dose
First dose reduction - 480 mg (four 120 mg tablets) once daily
Second dose reduction - 240 mg (two 120 mg tablets) once daily