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Full Prescribing Information

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DOSING DETAILS

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Dosage modifications ↓

KRAZATI + CETUXIMAB:

KRAZATI recommended dosage: 600 mg BID1

Until disease progression or unacceptable toxicity.

KRAZATI® (adagrasib) tablets dosing

KRAZATI is available as immediate-release tablets1

  • Advise patients to take KRAZATI at the same time every day with or without food
  • KRAZATI tablets should be swallowed whole (not chewed, crushed, or split)
  • If a patient misses a dose by more than 4 hours or if vomiting occurs after taking KRAZATI, advise patients not to take an additional dose. Resume dosing at the next scheduled time
  • There are no restrictions for use of PPIs or H2-receptor antagonists in the KRAZATI Prescribing Information
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Refer to the cetuximab Prescribing Information for cetuximab dosage information.

KRAZATI dosage modifications for adverse reactions (ARs)1

If ARs occur, a maximum of 2 dose reductions is permitted. Permanently discontinue KRAZATI in patients who are unable to tolerate 600 mg once daily.

Dosing modifications for KRAZATI® (adagrasib)

Refer to the cetuximab Prescribing Information for dose modifications for ARs associated with cetuximab.

Treatment with KRAZATI as a single agent may be continued if cetuximab is permanently discontinued.

In some cases, patients can continue treatment at a lower dose of KRAZATI to manage adverse reactions.​

Refer to the KRAZATI Prescribing Information and Therapy Management Guide for information about dosage modifications for specific ARs.
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A dosage reduction doesn’t immediately require a new prescription

BID=twice-daily; PPI=proton pump inhibitor; QD=once-daily.

Resources for you and your patients  →

Reference:

  1. KRAZATI®. Prescribing information. Princeton, NJ. Mirati Therapeutics, Inc., a Bristol Myers Squibb company; 2024.

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.

 

1914-US-2400618  01/25

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© 2024 Mirati Therapeutics, Inc., a Bristol Myers Squibb company. KRAZATI® and the related logo are registered trademarks of Mirati Therapeutics, Inc.

This website is intended for U.S. residents 18 years of age or older.

1914-US-2400470   10/24

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