Miscellaneous antineoplastics
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Krazati Dosage

Drug Detail:Krazati (Adagrasib)

Generic Name: ADAGRASIB 200mg

Dosage Form: tablet, coated

Drug Class: Miscellaneous antineoplastics

Contents
Uses Warnings Before Taking Dosage Side effects Interactions

Patient Selection

Select patients for treatment of locally advanced or metastatic NSCLC with KRAZATI based on the presence of KRAS G12C mutation in plasma or tumor specimens [see Clinical Studies (14)]. If no mutation is detected in a plasma specimen, test tumor tissue.

Information on FDA-approved tests for the detection of a KRAS G12C mutation is available at: https://www.fda.gov/CompanionDiagnostics

Recommended Dosage

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

Take KRAZATI at the same time every day with or without food [see Clinical Pharmacology (12.3)]. Swallow tablets whole. Do not chew, crush or split tablets.

If vomiting occurs after taking KRAZATI, do not take an additional dose. Resume dosing at the next scheduled time.

If a dose is inadvertently missed, it should be skipped if greater than 4 hours have elapsed from the expected dosing time. Resume dosing at the next scheduled time.

Dosage Modifications for Adverse Reactions

Recommended dose reductions for adverse reactions are outlined in Table 1. If adverse reactions occur, a maximum of two dose reductions are permitted. Permanently discontinue KRAZATI in patients who are unable to tolerate 600 mg once daily.

Table 1: Recommended KRAZATI Dosage Reductions for Adverse Reactions
Dose Reduction Dosage
First dose reduction 400 mg twice daily
Second dose reduction 600 mg once daily

The recommended dosage modifications for adverse reactions are provided in Table 2.

Table 2: Recommended KRAZATI Dosage Modifications for Adverse Reactions
Adverse reaction Severity* Dosage Modification
ALT = alanine aminotransferase; AST = aspartate aminotransferase; ULN = upper limit of normal
*
Grading defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0
Nausea or vomiting despite appropriate supportive care
(including anti-emetic therapy)
[see Warnings and Precautions (5.1)]		 Grade 3 or 4
  • Withhold KRAZATI until recovery to ≤ Grade 1 or return to baseline.
  • Resume KRAZATI at the next lower dose level.
Diarrhea despite appropriate supportive care (including anti-diarrheal therapy)
[see Warnings and Precautions (5.1)]		 Grade 3 or 4
  • Withhold KRAZATI until recovery to ≤ Grade 1 or return to baseline.
  • Resume KRAZATI at the next lower dose level.
QTc Interval Prolongation
[see Warnings and Precautions (5.2)]		 QTc absolute value greater than 500 ms
or
Greater than an increase of 60 ms from baseline
  • Withhold KRAZATI until QTc interval less than 481 ms or return to baseline.
  • Resume KRAZATI at the next lower dose level.
Torsade de pointes, polymorphic ventricular tachycardia or signs or symptoms of serious or life-threatening arrhythmia
  • Permanently discontinue KRAZATI.
Hepatotoxicity
[see Warnings and Precautions (5.3)]		 Grade 2
AST or ALT
  • Decrease KRAZATI to the next lower dose level.
Grade 3 or 4
AST or ALT
  • Withhold KRAZATI until recovery to ≤ Grade 1 or return to baseline.
  • Resume KRAZATI at the next lower dose level.
AST or ALT > 3 × ULN with total bilirubin > 2 × ULN in the absence of alternative causes
  • Permanently discontinue KRAZATI.
Interstitial Lung Disease / Pneumonitis
[see Warnings and Precautions (5.4)]		 Any Grade
  • Withhold KRAZATI if ILD/pneumonitis is suspected.
  • Permanently discontinue KRAZATI if ILD/pneumonitis is confirmed.
Other Adverse Reactions
[see Adverse Reactions (6.1)]		 Grade 3 or 4
  • Withhold KRAZATI until ≤ Grade 1 or return to baseline.
  • Resume KRAZATI at the next lower dose level.
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