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Dosage of Sotorasib

1.Patient Selection

Select patients for treatment of locally advanced or metastatic NSCLC with Sotorasib based on the presence of KRAS G12C mutation in tumor or plasma specimens. If no mutation is detected in a plasma specimen, test tumor tissue.

2.Recommended Dosage and Administration

The recommended dosage of Sotorasib is 960 mg (three 320 mg tablets or eight 120 mg tablets) orally once daily until disease progression or unacceptable toxicity.

Take the daily dose of Sotorasib at the same time each day with 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 Sotorasib, do 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 (4 ounces) of non-carbonated, room-temperature water without crushing. No other liquids should be used. Stir or swirl the cup for approximately 3 minutes 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. Swallow the tablet dispersion. Do not chew pieces of the tablet. Rinse the container with an additional 120 mL (4 ounces) of water and drink. If the mixture is not consumed immediately,stir the mixture again to ensure that tablets are dispersed.

3.Dosage Modifications for Adverse Reactions

Sotorasib dose reduction levels are summarized in Table 1. Dosage modifications for adverse reactions are provided in Table 2.

If adverse reactions occur, a maximum of two dose reductions are permitted. Discontinue Sotorasib if patients are unable to tolerate the minimum dose of 240 mg once daily.

Table 1. Recommended Sotorasib Dose Reduction Levels for Adverse Reactions

Table 2. Recommended Sotorasib Dosage Modifications for Adverse Reactions

4.Coadministration of Sotorasib with Acid-Reducing Agents

Avoid coadministration of proton pump inhibitors (PPIs) and H2 receptor antagonists with Sotorasib. If treatment with an acid-reducing agent cannot be avoided, take Sotorasib 4 hours before or 10 hours after administration of a local antacid.

from FDA，2023.04