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. ...Read More

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).

LUMAKRAS • loo-ma-krass
SOTORASIB • soh-toh-rass-ib
About KRAS G12C
Prevalence
KRASG12C inhibition
Efficacy
CodeBreaK 100
Expanded Access Program
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Dosing

LUMAKRAS is the only once-daily oral KRASG12C inhibitor1

LUMAKRAS® (sotorasib) recommended dose is 960mg orally, once daily

LUMAKRAS confirmed dose: 960 mg orally, once daily1,2


  • Treat until disease progression or unacceptable toxicity
Take LUMAKRAS® (sotorasib) with or without food

LUMAKRAS can be taken with or without food1

Take LUMAKRAS® (sotorasib) at the same time each day

Patients should take the daily dose of LUMAKRAS at the same time each day1

LUMAKRAS has two dosing options to meet your patients' needs1

LUMAKRAS 320 mg tablets

Three LUMAKRAS® (sotorasib) 320mg tablets once daily

LUMAKRAS 320 mg tablets have a beige color and are supplied in one bottle containing 90 tablets

LUMAKRAS tablets are comparable in size to a dime3,*

LUMAKRAS® (sotorasib) 320mg tablet

*Tablet as seen on screen may not reflect actual size; scale to dime is accurate.

LUMAKRAS® (sotorasib) 320mg tablet bottle and box LUMAKRAS® (sotorasib) 320mg tablet bottle and box

LUMAKRAS 120 mg tablets

LUMAKRAS® pill bottle

LUMAKRAS 120 mg tablets have a yellow color and are supplied in one bottle containing 240 tablets

LUMAKRAS tablets are comparable in size to a dime3,*

LUMAKRAS® (sotorasib) 120mg tablet

*Tablet as seen on screen may not reflect actual size; scale to dime is accurate.

LUMAKRAS® (sotorasib) 120mg tablet bottle and box LUMAKRAS® (sotorasib) 120mg tablet bottle and box

LUMAKRAS can be dispersed in water1

Recommended LUMAKRAS® dose reductions

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

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 in CodeBreaK 100 (N=204)
Recommended LUMAKRAS® dose reductions

Recommended dose reductions1


  • If adverse reactions occur, a maximum of two dose reductions are permitted
Starting dose options
Starting dose is three LUMAKRAS® (sotorasib) 320mg tablets once daily

or

Starting dose is eight LUMAKRAS® (sotorasib) 120mg tablets once daily
Dose reductions for adverse reactions
First Dose Reduction1
(480 mg)
First dose reduction is four LUMAKRAS® (sotorasib) 120mg tablets once daily
Second Dose Reduction1
(240 mg)
Second dose reduction is two LUMAKRAS® (sotorasib) 120mg tablets once daily
Dose modifications for adverse reactions
Dose modifications for adverse reactions Dose modifications for adverse reactions
  • 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, and ECOG PS1
  • No dosage modification is recommended in patients with mild-to-moderate hepatic impairment (Child Pugh A or B)1
    • The effect of severe hepatic impairment on the safety of LUMAKRAS is unknown (Child Pugh C). Monitor for LUMAKRAS adverse reactions 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

Coadministration

LUMAKRAS and other drugs1

LUMAKRAS® (sotorasib) and other drugs LUMAKRAS® (sotorasib) and other drugs

  • 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 PPI, H2 receptor antagonists, and/or antacids in the trial1,4
  • There are no clinical studies to assess the impact of acid-reducing agents on clinical outcomes

ALT, alanine transaminase; AST, aspartate transaminase; BCRP, breast cancer resistance protein; CYP3A4, cytochrome P450 3A4; ECOG PS, Eastern Cooperative Oncology Group performance status; ILD, interstitial lung disease; NSCLC, non-small cell lung cancer; P-gp, P-glycoprotein; PI, prescribing information; PPI, proton pump inhibitor; QTc, QT corrected for heart rate; ULN, upper limit of normal; USPI, United States Prescribing Information.

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IMPORTANT SAFETY INFORMATION

Hepatotoxicity

  • LUMAKRAS can cause hepatotoxicity, which may lead to drug-induced liver injury and hepatitis.
  • Among 357 patients who received LUMAKRAS in CodeBreaK 100, hepatotoxicity occurred in 1.7% (all grades) and 1.4% (Grade 3). A total of 18% of patients who received LUMAKRAS had increased alanine aminotransferase (ALT)/increased aspartate aminotransferase (AST); 6% were Grade 3 and 0.6% were Grade 4. In addition to dose interruption or reduction, 5% of patients received corticosteroids for the treatment of hepatotoxicity.
  • Monitor liver function tests (ALT, AST, 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, dose reduce or permanently discontinue LUMAKRAS based on severity of adverse reaction.

Interstitial Lung Disease (ILD)/Pneumonitis

  • LUMAKRAS can cause ILD/pneumonitis that can be fatal. Among 357 patients who received LUMAKRAS in CodeBreaK 100 ILD/pneumonitis occurred in 0.8% of patients, all cases were Grade 3 or 4 at onset, and 1 case was fatal. LUMAKRAS was discontinued due to ILD/pneumonitis in 0.6% of 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 Prescribing Information.

Important Safety Information

Hepatotoxicity

  • LUMAKRAS can cause hepatotoxicity, which may lead to drug-induced liver injury and hepatitis.
  • Among 357 patients who received LUMAKRAS in CodeBreaK 100, hepatotoxicity occurred in 1.7% (all grades) and 1.4% (Grade 3). A total of 18% of patients who received LUMAKRAS had increased alanine aminotransferase (ALT)/increased aspartate aminotransferase (AST); 6% were Grade 3 and 0.6% were Grade 4. In addition to dose interruption or reduction, 5% of patients received corticosteroids for the treatment of hepatotoxicity.
  • Monitor liver function tests (ALT, AST, 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, dose reduce or permanently discontinue LUMAKRAS based on severity of adverse reaction.