INDICATION

LUMAKRAS® is 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.

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).
NSCLC
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Dosing Dose modifications Coadministration

Dosing

LUMAKRAS® (sotorasib) is the only once-daily oral KRAS G12C therapy1,2

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LUMAKRAS® confirmed dose: 960 mg orally1,2

Treat until disease progression or unacceptable toxicity

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  • Patients should take the daily dose of LUMAKRAS® at the same time each day, with or without food1

  • LUMAKRAS® tablets are comparable in size to a dime1,3

LUMAKRAS® can be dispersed in water1

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Administration to patients who have difficulty swallowing solids1

    • 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 dispersed tablet. 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

    Missed dose or vomiting1

      • 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

      KRAS, Kirsten rat sarcoma viral oncogene homolog.

      LUMAKRAS® dosing resources

      Dose modification fact sheet

      Dosing flyer for your patients

      Dose modifications

      5% of patients experienced a dose reduction due to an adverse reaction in CodeBreaK 100 (N=204)1

      • 34% of patients experienced a dosage interruption due to an adverse reaction

         

      Four yellow oval tablets labeled 240, arranged in a row. Below, text in blue reads 4x 240 mg tablets once daily, indicating dosage instructions. Four yellow oval tablets labeled 240, arranged in a row. Below, text in blue reads 4x 240 mg tablets once daily, indicating dosage instructions.
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      Image of two yellow pills with 240 on them, labeled first dose reduction (480 mg). Text below reads 2 x 240 mg tablets once daily on a teal background Image of two yellow pills with 240 on them, labeled first dose reduction (480 mg). Text below reads 2 x 240 mg tablets once daily on a teal background
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      Yellow oval pill marked 240 on left; text: Second Dose Reduction (240 mg). Below, 1x 240 mg tablets once daily in blue Yellow oval pill marked 240 on left; text: Second Dose Reduction (240 mg). Below, 1x 240 mg tablets once daily in blue

      If ARs occur, a maximum of two dose reductions are permitted1

      Hepatotoxicity¹

      AST or ALT > 3 x and up to 5 x ULN (or > 3 x and up to 5 x baseline if baseline is abnormal) with symptoms

      or

      AST or ALT > 5 x ULN (or > 5 × baseline if baseline abnormal)

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      • Withhold LUMAKRAS® until recovered to ≤ 3 x ULN or to ≤ 3 x baseline if baseline is abnormal
      • Resume LUMAKRAS® at the next lower dose level

      AST or ALT > 3 x ULN with total bilirubin > 2 x ULN

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      • 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
       ILD/pneumonitis¹

      Any grade suspected

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      • Withhold LUMAKRAS® and permanently discontinue if confirmed
       Nausea or vomiting, diarrhea, or other adverse reactions despite supportive care¹

      Grade 3–4

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      • Withhold LUMAKRAS® until recovered to ≤ Grade 1 or baseline. After recovery, resume LUMAKRAS® at the next lower dose level

      • LUMAKRAS® should be discontinued if patients are unable to tolerate the minimum dose of 240 mg once daily1

      • No clinically meaningful differences in the pharmacokinetics of LUMAKRAS® were observed based on age, sex, race, body weight, line of therapy, ECOG PS, mild and moderate renal impairment (eGFR ≥ 30 mL/min/1.73 m2), or mild hepatic impairment (AST or ALT < 2.5 x ULN or total bilirubin < 1.5 x ULN)1

      • No dose adjustment is recommended in patients with mild-to-moderate hepatic impairment (Child-Pugh A or B)1

      • The effect of severe hepatic impairment (Child-Pugh C) on the safety of LUMAKRAS® is unknown. Monitor for adverse reactions with LUMAKRAS® in patients with hepatic impairment more frequently since these patients may be at increased risk for adverse reactions, including hepatotoxicity1

      • No dose adjustment is required on the basis of age1

      ALT, alanine transaminase; AR, adverse reaction; AST, aspartate transaminase; ECOG PS, Eastern Cooperative Oncology Group performance status; eGFR, estimated glomerular filtration rate; ILD, interstitial lung disease; ULN, upper limit of normal.

      Coadministration
      Table comparing the effects of other drugs on Lumakras. Left column under 'Effects of other drugs on Lumakras' lists guidance for acid-reducing agents and strong CYP3A4 inducers, advising to avoid coadministration. Right columns under 'Effects of Lumakras on other drugs' discuss interactions with CYP3A4 substrates, P-gp substrates, and BCRP substrates, recommending avoidance or dosage adjustments dosing-mobile-table

      • Per the USPI, there are no requirements to avoid concomitant use of LUMAKRAS® with products that may prolong the QTc interval. Please note the other interactions mentioned above1,*,†

      *Concomitant usage of acid-reducing agents was not part of the exclusion criteria for CodeBreaK 100. 52% of patients with NSCLC used PPIs, H2 receptor antagonists, and/or antacids in the trial.4
      †There are no clinical studies to assess the impact of acid-reducing agents on clinical outcomes.5
      BCRP, breast cancer resistance protein; CYP3A4, cytochrome P450 3A4; NSCLC, non-small cell lung cancer; P-gp, P-glycoprotein; PI, prescribing information; PPI, proton pump inhibitor; QTc, corrected QT interval; USPI, United States Prescribing Information.

      Explore support for your patients

      IMPORTANT SAFETY INFORMATION

      Hepatotoxicity

      • LUMAKRAS® can cause hepatotoxicity and increased ALT or AST which may lead to drug-induced liver injury and hepatitis.
      • In the pooled safety population of NSCLC patients who received single agent LUMAKRAS® 960 mg hepatotoxicity occurred in 27% of patients, of which 16% were Grade ≥ 3. Among patients with hepatotoxicity who required dosage modifications, 64% required treatment with corticosteroids.
      • In this pooled safety population of NSCLC patients who received single agent LUMAKRAS® 960 mg, 17% of patients who received LUMAKRAS® had increased alanine aminotransferase (ALT)/increased aspartate aminotransferase (AST); of which 9% were Grade ≥ 3. The median time to first onset of increased ALT/AST was 6.3 weeks (range: 0.4 to 42). Increased ALT/AST leading to dose interruption or reduction occurred in 9% of patients treated with LUMAKRAS®. LUMAKRAS® was permanently discontinued due to increased ALT/AST in 2.7% of patients. Drug-induced liver injury occurred in 1.6% (all grades) including 1.3% (Grade ≥ 3).
      • In this pooled safety population of NSCLC patients who received single agent LUMAKRAS® 960 mg, a total of 40% patients with recent (≤ 3 months) immunotherapy prior to starting LUMAKRAS® had an event of hepatotoxicity. An event of hepatotoxicity was observed in 18% of patients who started LUMAKRAS® more than 3 months after last dose of immunotherapy and in 17% of those who never received immunotherapy. Regardless of time from prior immunotherapy, 94% of hepatotoxicity events improved or resolved with dosage modification of LUMAKRAS®, with or without corticosteroid treatment.
      • Monitor liver function tests (ALT, AST, alkaline phosphatase, and total bilirubin) prior to the start of LUMAKRAS®, every 3 weeks for the first 3 months of treatment, then once a month or as clinically indicated, with more frequent testing in patients who develop transaminase and/or bilirubin elevations. Withhold, reduce the dose or permanently discontinue LUMAKRAS® based on severity of the adverse reaction. Consider administering systemic corticosteroids for the management of hepatotoxicity.

      Interstitial Lung Disease (ILD)/Pneumonitis

      • LUMAKRAS® can cause ILD/pneumonitis that can be fatal.
      • In the pooled safety population of NSCLC patients who received single agent LUMAKRAS® 960 mg ILD/pneumonitis occurred in 2.2% of patients, of which 1.1% were Grade ≥ 3, and 1 case was fatal. The median time to first onset for ILD/pneumonitis was 8.6 weeks (range: 2.1 to 36.7 weeks). LUMAKRAS® was permanently discontinued due to ILD/pneumonitis in 1.3% of LUMAKRAS®-treated patients. Monitor patients for new or worsening pulmonary symptoms indicative of ILD/pneumonitis (e.g., dyspnea, cough, fever). Immediately withhold LUMAKRAS® in patients with suspected ILD/pneumonitis and permanently discontinue LUMAKRAS® if no other potential causes of ILD/pneumonitis are identified.

      Most Common Adverse Reactions

      • The most common adverse reactions ≥ 20% were diarrhea, musculoskeletal pain, nausea, fatigue, hepatotoxicity, and cough.

      Drug Interactions

      • Advise patients to inform their healthcare provider of all concomitant medications, including prescription medicines, over‑the‑counter drugs, vitamins, dietary and herbal products.
      • Inform patients to avoid proton pump inhibitors and H2 receptor antagonists while taking LUMAKRAS®.
      • If coadministration with an acid-reducing agent cannot be avoided, inform patients to take LUMAKRAS® 4 hours before or 10 hours after a locally acting antacid.

      INDICATION

      LUMAKRAS® is 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.

      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).

       

      Please see full LUMAKRAS® Prescribing Information.

      • References: 1. LUMAKRAS® (sotorasib) prescribing information, Amgen. 2. Hochmair MJ, et al. Eur J Cancer. 2024;208:114204. 3. Data on file, Amgen [Sotorasib Tablet Size]; 2023. 4. Clinicaltrials.gov. https://clinicaltrials.gov/study/NCT03600883. Accessed July 31, 2025. 5. Data on file, Amgen; [CodeBreaK 100 Acid-Reducing Agent Use].