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Dosage of Capmatinib

Adults

Non-small cell lung cancer (NSCLC)

Administer orally, 400 mg twice daily. Continue treatment until disease progression or unacceptable toxicity occurs.

Dose Modifications for Toxicity

For adverse reactions, temporary interruption of treatment, dose reduction, and/or permanent discontinuation may be required.

The recommended dose reduction schedule for capmatinib toxicity (initial dose: 400 mg twice daily) is as follows:

After the first dose reduction, resume treatment at 300 mg twice daily;

After the second dose reduction, resume treatment at 200 mg twice daily;

After the third dose reduction, permanent discontinuation is required.

Pulmonary Effects

Permanently discontinue capmatinib if interstitial lung disease (ILD) or pneumonitis occurs.

Hepatotoxicity

1. If Grade 3 elevations in ALT or AST concentrations occur (with no elevation in total bilirubin concentrations), interrupt treatment until values return to baseline. If recovery occurs within 7 days, capmatinib may be resumed at the same dose. If recovery takes longer than 7 days, resume capmatinib at the next lower dose level.

2. If Grade 4 elevations in ALT or AST concentrations occur (with no elevation in total bilirubin concentrations), permanently discontinue capmatinib.

3. If ALT or AST concentrations > 3 times the upper limit of normal (ULN) and total bilirubin concentrations > 2 times ULN occur (without cholestasis or hemolysis), permanently discontinue capmatinib.

4. If Grade 2 elevation in total bilirubin concentration occurs (with no elevation in ALT and/or AST concentrations), interrupt treatment until values return to baseline. If recovery occurs within 7 days, capmatinib may be resumed at the same dose. If recovery takes longer than 7 days, resume capmatinib at the next lower dose level.

5. If Grade 3 elevation in total bilirubin concentration occurs (with no elevation in ALT and/or AST concentrations), interrupt treatment until values return to baseline. If recovery occurs within 7 days, resume capmatinib at the next lower dose level. Otherwise, permanently discontinue capmatinib.

6. If Grade 4 elevation in total bilirubin concentration occurs (with no elevation in ALT and/or AST concentrations), permanently discontinue capmatinib.

Pancreatic Toxicity

If Grade 3 or 4 pancreatitis occurs, permanently discontinue capmatinib.

If Grade 4 elevations in lipase or amylase concentrations occur, permanently discontinue capmatinib. If Grade 3 elevations in lipase or amylase concentrations occur, hold capmatinib until elevations resolve to ≤ Grade 2 or baseline. If recovery occurs within 14 days, resume capmatinib at a reduced dose; otherwise, permanently discontinue capmatinib.

Hypersensitivity Reactions

If a hypersensitivity reaction of any grade is suspected based on clinical judgment, hold capmatinib until the event resolves. For patients who experience severe hypersensitivity reactions, permanently discontinue capmatinib.

Other Toxicities

If any Grade 2 adverse reaction occurs, capmatinib may be continued at the same dose. If the Grade 2 adverse reaction is intolerable, consider interrupting treatment. Once toxicity resolves, resume capmatinib at the next lower dose level.

If any Grade 3 adverse reaction occurs, interrupt treatment. Once toxicity resolves, resume capmatinib at the next lower dose level.

If any Grade 4 adverse reaction occurs, permanently discontinue capmatinib.

Special Populations

Hepatic Impairment

No specific dose recommendations are available at present.

Renal Impairment

1. Mild to moderate renal impairment (creatinine clearance: 30–89 mL/min): No dose adjustment is required.

2. Severe renal impairment (creatinine clearance: < 30 mL/min): No specific dose recommendations are available at present.

Geriatric Patients

No specific dose recommendations are available at present.

from FDA,2023.03