• Assess for worsening respiratory symptoms (dyspnea, coughing, fever) during therapy; may indicate ILD or pneumonitis. If signs and symptoms occur, hold medication. If ILD confirmed, permanently discontinue capmatinib.
• Monitor for signs and symptoms of hepatotoxicity (fatigue, abdominal pain, nausea, vomiting, jaundice, anorexia, fever, dark urine, clay-colored stools).
• Monitor for signs and symptoms of pancreatitis (upper abdominal pain, nausea, vomiting, tachycardia, jaundice, fever, clay-colored stools). If pancreatitis develops, permanently discontinue therapy.
• Monitor for signs and symptoms of hypersensitivity reactions (fever, chills, pruritus, rash, ↓ BP, nausea, vomiting). If hypersensitivity suspected, hold therapy until resolved. If serious hypersensitivity event, permanently discontinue therapy.
• Monitor for signs and symptoms of other adverse reactions (dyspnea, pneumonia, pleural effusion, musculoskeletal pain, fatigue, edema, vomiting). If Grade 2 toxicity develops, maintain current dose. If intolerable, consider holding therapy until resolved and then resume therapy at ↓ dose. If Grade 3 toxicity develops,hold therapy until resolved and then resume at ↓ dose. If Grade 4 toxicity develops, permanently discontinue therapy.

Lab Test Considerations:

• Verify negative pregnancy test before starting therapy.Patient selection is based on presence of MET exon 14 skipping mutations in tumor specimens. Confirm MET mutation by an FDA-approved test prior to treatment. Information on FDA-approved tests for the detection of MET mutations is available at http://www.fda.gov/companiondiagnostics.
  • Monitor liver function tests, including ALT, AST, and total bilirubin, prior to the start of therapy, every 2 wk during the first 3 mo of treatment, and then once monthly or as clinically indicated thereafter; more frequent monitoring may be necessary in patients who develop ↑ ALT/AST or bilirubin. If Grade 2 ↑ in total bilirubin (without ↑ ALT or AST), hold therapy until bilirubin returns to baseline. If recovery occurs within 7 days, resume therapy at same dose; otherwise, resume therapy at ↓ dose. If Grade 3 ↑ in ALT or AST (without ↑ total bilirubin), Hold therapy until recovery to baseline ALT/AST. If recovery occurs within 7 days, resume therapy at same dose; otherwise, resume therapy at ↓ dose. If Grade 3 ↑ in total bilirubin (without ↑ ALT or AST), hold therapy until recovery to baseline bilirubin. If recovery occurs within 7 days, resume therapy at ↓ dose; otherwise, permanently discontinue therapy. If Grade 4 ↑ in ALT, AST, or total bilirubin, permanently discontinue therapy. If AST and/or ALT ↑ by >3 times upper limit of normal (ULN) with total bilirubin ↑ by >2 times ULN, permanently discontinue therapy.
  • May cause ↑ amylase and lipase; monitor regularly during therapy.If Grade 3 ↑ in lipase or amylase (without pancreatitis), hold therapy until ≤Grade 2. If recovery occurs within 14 days, resume at ↓ dose. If Grade 4 ↑ in lipase or amylase or pancreatitis occurs, permanently discontinue therapy.