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Indications

Full Prescribing Information

Patient Information

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KRAZATI DOSAGE

The recommended dosage of KRAZATI is 600 mg orally twice daily until disease progression or unacceptable toxicity.1

KRAZATI RECOMMENDED DOSAGE: 600 MG BID1

3 TABLETS ORALLY | 2X DAILY

Until disease progression or unacceptable toxicity

Twice a day icon
AM

Take (3) 200-mg tablets by mouth in the morning

PM

Take (3) 200-mg tablets by mouth at night

How Large Is One Tablet of KRAZATI?

Krazati tablet size comparison chart
Immediate release tablets icon

Available as immediate-release tablets

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Advise patients to take KRAZATI at the same time every day with or without food

Glass of water icon

KRAZATI tablets should be swallowed whole (not chewed, crushed, or split)

Greater than 4 hours icon

If a patient misses a dose by more than 4 hours or if vomiting occurs, they should resume dosing at the next scheduled time

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There are no restrictions for use of PPIs or H2-receptor antagonists in the KRAZATI Prescribing Information

BID=twice daily; PPI=proton pump inhibitor.

KRAZATI DOSING MODIFICATIONS1

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

Recommended dosage: 600 mg orally | 2x daily

First dose reduction icon

FIRST DOSE REDUCTION

400 MG TWICE DAILY
(2) 200-mg tablets

Second dose reduction icon

SECOND DOSE REDUCTION

600 MG ONCE DAILY
(3) 200-mg tablets

Refer to the KRAZATI Prescribing Information and Therapy Management Guide for information about dosage modifications for specific ARs.

If you determine that a dosage reduction is necessary, your patient can continue therapy at the next lower dose without immediately requiring a new prescription

DOSAGE MODIFICATIONS CAN HELP SUPPORT KEEPING PATIENTS ON THERAPY

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 57% of 116 patients who received adagrasib in NSCLC patients. The most common adverse reactions in NSCLC patients (≥20%) were diarrhea, nausea, fatigue, vomiting, musculoskeletal pain, hepatotoxicity, renal impairment, dyspnea, edema, decreased appetite, cough, pneumonia, dizziness, constipation, abdominal pain, and QTc interval prolongation

  • 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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© 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.

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