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Krazati

adagrasib
KRAS G12C Inhibitor FDA Approved 2022 Mirati / BMS
Route
Oral
Half-Life
23 hrs
FDA Approved
2022
Manufacturer
Mirati / BMS
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1. Indications and Usage

NSCLC: KRAS G12C-mutated NSCLC after ≥1 prior systemic therapy.

2. Dosage and Administration

600 mg orally twice daily.

3. Dosage Forms and Strengths

Tablets: 200 mg

4. Contraindications

None listed.

5. Warnings and Precautions
  • Hepatotoxicity: Monitor LFTs.
  • ILD/Pneumonitis: Fatal cases reported.
  • QTc Prolongation: Dose-dependent. Monitor ECGs.
  • Embryo-Fetal Toxicity: Can cause fetal harm.
6. Adverse Reactions
Most Common Adverse Reactions

Nausea (54%), Diarrhea (50%), Fatigue (43%), Vomiting (38%), Musculoskeletal Pain (32%), Hepatotoxicity (29%), Decreased Appetite (25%), Edema (19%)

Nausea
54%
Diarrhea
50%
Fatigue
43%
Vomiting
38%
Musculoskeletal Pain
32%
Hepatotoxicity
29%
Decreased Appetite
25%
Edema
19%

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

7. Drug Interactions

CYP3A Substrates: Strong CYP3A inhibitor. Avoid sensitive substrates.

8. Use in Specific Populations
Pregnancy

Consult the full prescribing information for pregnancy-related considerations.

Lactation

Refer to prescribing information for lactation guidance.

Pediatric Use

Pediatric safety and efficacy information is detailed in the full label.

Hepatic/Renal Impairment

Dose modifications for organ impairment are specified in the complete prescribing information.

12. Clinical Pharmacology
Mechanism of Action

Selective irreversible KRAS G12C inhibitor locking KRAS in inactive GDP-bound state.

Pharmacokinetics

Tmax: 8h. Protein binding: 98%. t½: 23h. Feces 74%.

14. Clinical Studies

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

Pivotal Clinical Trials
Additional Resources
📋 All Krazati Trials on ClinicalTrials.gov ↗ 📚 PubMed: Krazati Clinical Trials ↗
FDA-Approved Tumor Types

Krazati has FDA-approved indications across the following cancer types covered on CancerDrugEvidence:

Non-Small Cell Lung Cancer
External Resources
📋 DailyMed Label ↗ 🏛️ FDA Drugs@FDA ↗ 🔬 ClinicalTrials.gov ↗ 📚 PubMed Pivotal Trials ↗
Important Notice: This page is intended as a navigational reference to the FDA-approved prescribing information for Krazati. It does not replace the full prescribing information. Healthcare professionals should consult the complete package insert available at DailyMed before making prescribing decisions. Patient-specific factors should always guide clinical decision-making.

Frequently Asked Questions

What is Krazati (adagrasib) approved for?

Krazati (adagrasib) is an FDA-approved oncology agent. Refer to the full prescribing information for complete indication details.

How is Krazati (adagrasib) administered?

Refer to the full prescribing information for dosing schedules, administration instructions, and dose modifications.

How does Krazati (adagrasib) work?

Selective irreversible KRAS G12C inhibitor locking KRAS in inactive GDP-bound state.

What are the most common side effects?

Nausea (54%), Diarrhea (50%), Fatigue (43%), Vomiting (38%), Musculoskeletal Pain (32%), Hepatotoxicity (29%), Decreased Appetite (25%), Edema (19%) Nausea 54% Diarrhea 50% Fatigue 43% Vomiting 38% Musculoskeletal Pain 32% Hepatotoxicity 29% Decreased Appetite 25% Edema 19%

← All Therapies Full Prescribing Information ↗