Sotorasib Dosage

Medically reviewed by Drugs.com. Last updated on Sep 11, 2023.

Applies to the following strengths: 120 mg; 320 mg

Usual Adult Dose for:

Non-Small Cell Lung Cancer

Additional dosage information:

Renal Dose Adjustments
Liver Dose Adjustments
Dose Adjustments
Precautions
Dialysis
Other Comments

Usual Adult Dose for Non-Small Cell Lung Cancer

960 mg orally once a day
Duration of therapy: Until disease progression or unacceptable toxicity

Comments:

This indication is approved under accelerated approval based on overall response rate and duration of response; continued approval may depend on verification and description of clinical benefit in confirmatory trial(s).

Use: For the treatment of 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 1 prior systemic therapy

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

If hepatotoxicity develops during therapy:

Grade 2 AST or ALT with symptoms OR Grade 3 to 4 AST or ALT: This drug should be withheld until recovery to Grade 1 or less or baseline; therapy should resume at the next lower dose level.
First dose reduction: 480 mg orally once a day
Second dose reduction: 240 mg orally once a day
AST or ALT greater than 3 times the upper limit of normal (3 x ULN) with total bilirubin greater than 2 x ULN without alternative causes: This drug should be permanently discontinued.

Dose Adjustments

If adverse reactions occur, a maximum of 2 dose reductions are permitted. This drug should be discontinued if patients are unable to tolerate the minimum dose of 240 mg orally once a day.

Dose Reduction for Adverse Reactions:

First dose reduction: 480 mg orally once a day
Second dose reduction: 240 mg orally once a day

Dose Modifications for Adverse Reactions:
Interstitial lung disease (ILD)/pneumonitis:

Any Grade: This drug should be withheld if ILD/pneumonitis is suspected; this drug should be permanently discontinued if ILD/pneumonitis is confirmed.

Nausea or vomiting despite appropriate supportive care (including antiemetic therapy):

Grade 3 to 4: This drug should be withheld until recovery to Grade 1 or less or baseline; therapy should resume at the next lower dose level.

Diarrhea despite appropriate supportive care (including antidiarrheal therapy):

Grade 3 to 4: This drug should be withheld until recovery to Grade 1 or less or baseline; therapy should resume at the next lower dose level.

Other adverse reactions:

Grade 3 to 4: This drug should be withheld until recovery to Grade 1 or less or baseline; therapy should resume at the next lower dose level.

Coadministration with Acid-Reducing Agents:

Coadministration of proton pump inhibitors and H2-receptor antagonists with this drug should be avoided.
If treatment with an acid-reducing agent cannot be avoided, this drug should be administered 4 hours before or 10 hours after administration of a local antacid.

Precautions

CONTRAINDICATIONS: None

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

Prior to use, select patients 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.
For information on US FDA-approved tests for detection of KRAS G12C: http://www.fda.gov/CompanionDiagnostics
Administer this drug at the same time each day with or without food.
Swallow tablets whole; do not chew, crush, or split tablets.
If patient has difficulty swallowing solids:
Disperse tablets in 120 mL (4 ounces) of noncarbonated, room-temperature water without crushing; do not use other liquids.
Stir until tablets are dispersed into small pieces (tablets will not completely dissolve) and drink immediately or within 2 hours; the mixture appearance 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 not consumed immediately, stir the mixture again to ensure that tablets are dispersed.
If a dose is missed by more than 6 hours, administer the next dose as prescribed the next day; do not administer 2 doses at the same time to make up for the missed dose.
If vomiting occurs after dosing, do not administer an additional dose; administer the next dose as prescribed the next day.

Storage requirements:

Store at 20C to 25C (68F to 77F); excursions permitted from 15C to 30C (59F to 86F).

Monitoring:

Hepatic: Liver function tests, including ALT, AST, and total bilirubin (before starting therapy, every 3 weeks for first 3 months of therapy, then once a month or as clinically indicated; more often in patients with transaminase and/or bilirubin elevations)
Respiratory: For new/worsening pulmonary symptoms indicative of ILD/pneumonitis

Patient advice:

Read the US FDA-approved patient labeling (Patient Information).
Contact health care provider immediately for signs/symptoms of liver dysfunction or to report new/worsening respiratory symptoms.
Do not breastfeed during therapy and for 1 week after the last dose.
Avoid proton pump inhibitors and H2-receptor antagonists while taking this drug; if coadministration cannot be avoided, take this drug 4 hours before or 10 hours after a locally-acting antacid.
If a dose is missed by more than 6 hours, resume therapy as prescribed the next day.