Solung

Sotorasib

Composition: Each film coated tablet contains Sotorasib INN 120mg.

Indications: It is an inhibitor of the RAS GTPase family 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 test, who have received at least one prior systemic therapy. (1) This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Dosage and administration: The recommended dosage of Sotorasib is 960 mg (eight 120 mg tablets) orally once daily until disease progression or unacceptable toxicity. Sotorasib should be taken at the same time each day with or without food. Whole tablet should be swallowed. It should not be chewed, or crushed. If a dose of Sotorasib is missed by more than 6 hours, The next dose should take 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 Sotorasib, do not take an additional dose. Take the next dose as prescribed the next day.

Recommended Sotorasib Dose Reduction Levels for Adverse Reactions

Use in pregnancy and lactation: There are no available data on Sotorasib use in pregnant women. Lactation: There are no data on the presence of Sotorasib or its metabolites in human milk, the effects on the breastfed child or on milk production. Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with Sotorasib and for1 week after the final dose.

Use in child: The safety and effectiveness of Sotorasib have not been established in pediatric patients.

Packing: Each box contains 240 tablets in a container.