Sotorasib Dosage

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

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.

Frequently asked questions

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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