On December 12, 2022, the US Food and Drug Administration (FDA) approved KRAZATI® (adagrasib) 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 objective response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of a clinical benefit in a confirmatory trial(s).1
The National Drug Code (NDC) for KRAZATI is as follows:
The recommended dosage of KRAZATI is 600 mg orally twice daily.1
Please see Full Prescribing Information.
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 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 taking medications that
are known to prolong the QT interval. 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
∙ The most common adverse reactions in NSCLC patients (≥20%)
are diarrhea, nausea, fatigue, vomiting, musculoskeletal pain,
hepatotoxicity, renal impairment, dyspnea, edema, decreased
appetite, cough, pneumonia, dizziness, constipation, abdominal
pain, and QTc interval prolongation
Females and Males of Reproductive Potential
∙ Infertility: Based on findings from animal studies, KRAZATI may
impair fertility in females and males of reproductive potential
Please see Full Prescribing Information.