Lumakras Dosage

Generic name: SOTORASIB 120mg
Dosage form: tablet, coated
Drug class: Miscellaneous antineoplastics

Medically reviewed by Drugs.com. Last updated on Jan 22, 2025.

Patient Selection

KRAS G12C-mutated Locally Advanced or Metastatic NSCLC

Select patients for treatment of locally advanced or metastatic NSCLC with LUMAKRAS 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.

KRAS G12C-mutated mCRC

Select patients for treatment of mCRC based on the presence of KRAS G12C mutation in tumor specimens.

Information on FDA-approved tests for the detection of KRAS G12C mutations is available at: http://www.fda.gov/CompanionDiagnostics.

Recommended Dosage and Administration

LUMAKRAS as a Single Agent for KRAS G12C-mutated Locally Advanced or Metastatic NSCLC

The recommended dosage of LUMAKRAS is 960 mg (three 320 mg tablets or four 240 mg tablets or eight 120 mg tablets) orally once daily until disease progression or unacceptable toxicity.

LUMAKRAS in Combination with Panitumumab for KRAS G12C-mutated mCRC

The recommended dosage of LUMAKRAS is 960 mg (three 320 mg tablets or four 240 mg tablets or eight 120 mg tablets) orally once daily in combination with panitumumab until disease progression or unacceptable toxicity. Administer the first dose of LUMAKRAS prior to first panitumumab infusion.

Refer to the panitumumab full prescribing information for recommended panitumumab dosage information.

Take the daily dose of LUMAKRAS at the same time each day with or without food. Swallow tablets whole. Do not chew, crush or split tablets. If a dose of LUMAKRAS 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 LUMAKRAS, 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.

Dosage Modifications for Adverse Reactions

LUMAKRAS dose reduction levels are summarized in Table 1.

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

When LUMAKRAS is administered in combination with panitumumab, and LUMAKRAS is temporarily withheld or permanently discontinued, temporarily withhold or permanently discontinue panitumumab, respectively. Refer to the full prescribing information of panitumumab for dose modifications for adverse reactions associated with the use of panitumumab.

Treatment with LUMAKRAS as a single agent may be continued if panitumumab is permanently discontinued.

Refer to Table 2 for dose modification guidelines and management of adverse reactions associated with the use of LUMAKRAS as a single agent or as combination therapy with panitumumab.

Table 1. Recommended LUMAKRAS Dose Reduction Levels for Adverse Reactions
Dose Reduction Level	Dose
First dose reduction	480 mg (two 240 mg or four 120 mg tablets) once daily
Second dose reduction	240 mg (one 240 mg or two 120 mg tablets) once daily

Table 2. Recommended LUMAKRAS Dosage Modifications for Adverse Reactions
Adverse Reaction	Severity*	Dosage Modification†
ALT = alanine aminotransferase; AST = aspartate aminotransferase; ULN = upper limit of normal
* Grading defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. † When LUMAKRAS is administered in combination with panitumumab, withhold or permanently discontinue treatment with panitumumab when withholding or permanently discontinuing treatment with LUMAKRAS.
Hepatotoxicity	AST or ALT > 3 × and up to 5 × ULN (or > 3 × and up to 5 × baseline if baseline abnormal) with symptoms or AST or ALT > 5 × ULN (or > 5 × baseline if baseline abnormal)	Withhold LUMAKRAS until recovery to ≤ 3 × ULN or to ≤ 3 × baseline if baseline abnormal. Resume LUMAKRAS at the next lower dose level.
Hepatotoxicity	AST or ALT > 3 × ULN with total bilirubin > 2 × ULN	Permanently discontinue LUMAKRAS if no alternative cause is identified. If alternative cause is identified, do not resume LUMAKRAS until AST/ALT/bilirubin return to baseline.
Interstitial Lung Disease (ILD)/ pneumonitis	Any Grade	Withhold LUMAKRAS if ILD/pneumonitis is suspected. Permanently discontinue LUMAKRAS if ILD/pneumonitis is confirmed.
Nausea or vomiting despite appropriate supportive care (including anti-emetic therapy)	Grade 3 to 4	Withhold LUMAKRAS until recovery to ≤ Grade 1 or baseline. Resume LUMAKRAS at the next lower dose level.
Diarrhea despite appropriate supportive care (including anti-diarrheal therapy)	Grade 3 to 4	Withhold LUMAKRAS until recovery to ≤ Grade 1 or baseline. Resume LUMAKRAS at the next lower dose level.
Other adverse reactions	Grade 3 to 4	Withhold LUMAKRAS until recovery to ≤ Grade 1 or baseline. Resume LUMAKRAS at the next lower dose level.

Coadministration of LUMAKRAS with Acid-Reducing Agents

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