Drug Detail:Capmatinib (systemic) (monograph) (Tabrecta)
Drug Class:
Usual Adult Dose for Non-Small Cell Lung Cancer
400 mg orally 2 times daily
Use: For the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an approved test
Renal Dose Adjustments
Mild (CrCl 60 to 89 mL/min) to moderate (CrCl 30 to 59 mL/min): No adjustment recommended.
Severe (CrCl 15 to 29 mL/min): Data not available
Liver Dose Adjustments
Data not available
Dose Adjustments
DOSE MODIFICATION RECOMMENDATIONS:
- First dose reduction: 300 mg orally 2 times daily
- Second dose reduction: 300 mg orally 2 times daily
- Permanently discontinue this drug in patients who are unable to tolerate 200 mg orally 2 times daily.
DOSE MODIFICATION FOR ADVERSE REACTIONS:
INTERSTITIAL LUNG DISEASE (ILD)/PNEUMONITIS:
- Any Grade: Permanently discontinue this drug.
- Grade 3: Withhold therapy until recovery to baseline ALT/AST; if recovered to baseline within 7 days, resume this drug at the same dose; otherwise resume at a reduced dose.
- Grade 4: Permanently discontinue this drug.
ALT and/or AST greater than 3 times the upper limit of normal (ULN) with total bilirubin greater than 2 x ULN: Permanently discontinue this drug.
INCREASED TOTAL BILIRUBIN WITHOUT CONCURRENT INCREASED ALT AND/OR AST:
- Grade 2: Withhold therapy until recovery to baseline bilirubin; if recovered to baseline within 7 days, resume this drug at the same dose; otherwise resume at a reduced dose.
- Grade 3: Withhold therapy until recovery to baseline bilirubin; if recovered to baseline within 7 days, resume this drug at reduced dose; otherwise permanently discontinue this drug.
- Grade 4: Permanently discontinue this drug.
- Grade 2: Maintain dose level; if intolerable, consider withholding this drug until resolved, then resume at a reduced dose.
- Grade 3: Withhold this drug until resolved then resume at reduced dose.
- Grade 4: Permanently discontinue this drug.
Precautions
CONTRAINDICATIONS:
- None
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Dialysis
Data not available
Other Comments
Administration advice:
- This drug may be taken with or without food.
- Tablets should be swallowed whole; not broken, crushed, or chewed.
- If a dose is missed or vomited, do not make up the dose but take the next dose at its scheduled time.
Storage requirements:
- Dispense this drug in the original package with the desiccant cartridge.
- Store at 20C to 25C (68F to 77F), excursions permitted between 15C to 30C (59F to 86F).
- Protect from moisture.
- Discard any unused drug remaining after 6 weeks of first opening the bottle.
Frequently asked questions
- How effective is Tabrecta?