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
Dose Reduction Level |
Dose |
First dose reduction |
480 mg (4 tablets) once daily |
Second dose reduction |
240 mg (2 tablets) once daily |
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.