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Full Prescribing Information

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Testing For KRAS G12C Heading
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IMPORTANT CONSIDERATIONS

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Trends in advanced CRC ↓

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FDA-approved tests ↓

Targeted therapy may help address unmet needs in previously treated advanced CRC

Before targeted treatment was available, fewer patients with KRAS G12C-mutated mCRC were treated in later lines of therapy compared to first line1-3

Of patients who are diagnosed with KRAS G12C-mutated mCRC (n=2043)*:

image-arrow-crc 

FIRST LINE

73%

of patients received first-line therapy

SECOND LINE

39%

of patients received second-line therapy

THIRD LINE

26%

of patients received third-line therapy

*Data are based on extrapolation of incidences from a real-world study (Fakih et al) that were applied to the SEER 2023 and Thompson et al 2011 data for newly diagnosed and recurrent mCRC, respectively.

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommendations for testing for metastatic CRC4,5

  • All patients should be tested for KRAS, including G12C, as part of an NGS panel
  • The testing can be performed on the primary tumor and/or the metastasis
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Now you can identify KRAS G12C as an actionable driver mutation to give patients an alternative to chemotherapy in 2L+ advanced CRC

Identify patients with KRAS G12C-mutated CRC with an FDA-approved test

Qiagen test for KRAS G12C-mutated CRC

More Information

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2L=second line; CRC=colorectal cancer; mCRC=metastatic colorectal cancer; NCCN=National Comprehensive Cancer Network; NGS=next-generation sequencing; PCR=polymerase chain reaction; SEER=Surveillance, Epidemiology, and End Results Program.

Explore the KRAZATI study design  →

References:

  1. Fakih M, Tu H, Hsu H, et al. Real-world study of characteristics and treatment outcomes among patients with KRAS p.G12C-mutated or other KRAS mutated metastatic colorectal cancer. Oncologist. 2022;27(8):663-674.
  2. Thompson TD, Pollack LA, Johnson CJ, et al. Breast and colorectal cancer recurrence and progression captured by five U.S. population-based registries: Findings from National Program of Cancer Registries patient-centered outcome research. Cancer Epidemiol. 2020;64:101653.
  3. National Cancer Institute. Cancer stat facts: colorectal cancer. Accessed April 18, 2024. https://seer.cancer.gov/statfacts/html/colorect.html
  4. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Colon Cancer V.5.2024. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed October 29, 2024. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. 
  5. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Rectal Cancer V.4.2024. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed October 29, 2024. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Gastrointestinal Adverse Reactions

 

  • KRAZATI can cause severe gastrointestinal adverse reactions

  • Monitor and manage patients using supportive care, including antidiarrheals, antiemetics, or fluid replacement, as indicated. Withhold, reduce the dose, or permanently discontinue KRAZATI based on severity

QTc Interval Prolongation

 

  • KRAZATI can cause QTc interval prolongation, which can increase the risk for ventricular tachyarrhythmias (eg, torsades de pointes) or sudden death

  • Avoid concomitant use of KRAZATI with other products with a known potential to prolong the QTc interval. Avoid use of KRAZATI in patients with congenital long QT syndrome and in patients with concurrent QTc prolongation

  • Monitor ECGs and electrolytes, particularly potassium and magnesium, prior to starting KRAZATI, during concomitant use, and as clinically indicated in patients with congestive heart failure, bradyarrhythmias, electrolyte abnormalities, and in patients who are unable to avoid concomitant medications that are known to prolong the QT interval. Correct electrolyte abnormalities. Withhold, reduce the dose, or permanently discontinue KRAZATI, depending on severity

Hepatotoxicity

 

  • KRAZATI can cause hepatotoxicity, which may lead to drug-induced liver injury and hepatitis

  • Monitor liver laboratory tests (AST, ALT, alkaline phosphatase, and total bilirubin) prior to the start of KRAZATI, and monthly for 3 months or as clinically indicated, with more frequent testing in patients who develop transaminase elevations. Reduce the dose, withhold, or permanently discontinue KRAZATI based on severity

Interstitial Lung Disease/Pneumonitis

 

  • KRAZATI can cause interstitial lung disease (ILD)/pneumonitis, which can be fatal

  • Monitor patients for new or worsening respiratory symptoms indicative of ILD/pneumonitis (eg, dyspnea, cough, fever) during treatment with KRAZATI. Withhold KRAZATI in patients with suspected ILD/pneumonitis and permanently discontinue KRAZATI if no other potential causes of ILD/pneumonitis are identified

ADVERSE REACTIONS

 

  • Serious adverse reactions occurred in 30% of 94 patients who received adagrasib in combination with cetuximab. The most common adverse reactions in CRC patients (≥20%) were rash, nausea, diarrhea, vomiting, fatigue, musculoskeletal pain, hepatotoxicity, headache, dry skin, abdominal pain, decreased appetite, edema, anemia, dizziness, cough, constipation, and peripheral neuropathy

DRUG INTERACTIONS

 

  • Strong CYP3A4 Inducers: Avoid concomitant use.

  • Strong CYP3A4 Inhibitors: Avoid concomitant use until adagrasib concentrations have reached steady state (after ~8 days).

  • Sensitive CYP3A4 Substrates: Avoid concomitant use with sensitive CYP3A4 substrates.

  • Sensitive CYP2C9 or CYP2D6 Substrates or P-gp Substrates: Avoid concomitant use with sensitive CYP2C9 or CYP2D6 substrates or P-gp substrates where minimal concentration changes may lead to serious adverse reactions.

  • Drugs That Prolong QT Interval: Avoid concomitant use with KRAZATI.

Please see Drug Interactions Section of the Full Prescribing Information for additional information.

USE IN SPECIFIC POPULATIONS

Females and Males of Reproductive Potential

 
  • Infertility: Based on findings from animal studies, KRAZATI may impair fertility in females and males of reproductive potential

Lactation

 
  • Advise not to breastfeed

Please see Full Prescribing Information.

 

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