Monotherapy for the treatment of KRAS G12C-mutated locally advanced or metastatic NSCLC in adults who have progressed on, or are intolerant to, platinum-based chemotherapy &/or anti PD-1/PD-L1 immunotherapy.
Dosage/Direction for Use
Adult 960 mg orally once daily at the same time each day, w/ or w/o food, until disease progression or unacceptable toxicity.
Administration
May be taken with or without food: Take at the same time each day. Swallow whole unless patient has difficulty swallowing solids. Patient w/ difficulty swallowing solids: Disperse tab in 120 mL of non-carbonated, room-temp water w/o crushing. Do not use other liqd. Stir until tab are dispersed into small pieces (the tab will not completely dissolve) & drink immediately. Appearance of mixt may range from pale to bright yellow. Container must be rinsed w/ an additional 120 mL water which should be drunk immediately. If not drunk immediately, patient must stir again to ensure that the tab are dispersed. Dispersion must be discarded if not drunk w/in 2 hr.
Contraindications
Hypersensitivity.
Special Precautions
Hepatotoxicity; ILD/pneumonitis; lactose intolerance. Confirm presence of KRAS G12C mutation prior to initiation of therapy. No data in moderate or severe hepatic impairment, moderate or severe renal impairment (CrCl <60 mL/min), childn & adolescents <18 yr. Pregnancy & lactation.
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