Tabrecta (Capmatinib) – NSCLC | DengYue Medicine

Tabrecta Application Scope

Tabrecta is an oral kinase inhibitor used to treat adult patients with metastatic NSCLC whose tumors have a MET exon 14 skipping mutation.

 

Characteristics

• Ingredients: Capmatinib

• Properties:

  • Kinase inhibitor targeting MET‑exon 14 skipping mutations

  • Solubility decreases with increasing pH

• Packaging Specification:

  • Film‑coated tablets, ovaloid

    • 150 mg (orange-brown, DU/NVR)

    • 200 mg (yellow, LO/NVR)

• Storage: Refer to label—typically room temperature, protect from moisture/light

• Expiry Date: State-specific; see packaging for exact expiration date

• Executive Standard: U.S. FDA approved; meets EMA/EU standards since June 2022

• Approval Number:

  • FDA original approval (accelerated)

  • NDC and approval details in the Nov 2020 label

• Date of Revision: U.S. prescribing info revised March 2024

• Manufacturer: Novartis Pharmaceuticals Corporation

Guidelines for the Use of Tabrecta

• Dosage and Administration:

  • 400 mg orally twice daily, with or without food

  • Swallow whole; if a dose is missed or vomited up

  • Skip it and continue the next scheduled dose

  • Dose reductions (for toxicity):

    1. Reduce to 300 mg twice daily

    2. 200 mg twice daily; discontinue if still not tolerated

• Adverse Reactions:

  • Common (≥ 20%):

    • peripheral edema, nausea, fatigue, vomiting, dyspnea, cough, decreased appetite

  • Serious:

    • ILD/pneumonitis, hepatotoxicity (elevated ALT/AST)

    • pancreatic toxicity, hypersensitivity, and photoallergy reactions

  • Most common lab abnormalities: elevated ALT, AST, amylase, lipase, creatinine

• Contraindications: None specified

• Precautions:

  • Monitor for ILD/pneumonitis—discontinue if suspected

  • Regular liver function tests and pancreatic enzymes

  • Advise on sun protection due to photosensitivity

  • Not recommended during pregnancy or lactation

Tabrecta Interactions

• Drug Interactions:

  • Avoid strong/moderate CYP3A inducers (reduce efficacy)

  • Strong CYP3A inhibitors increase exposure—monitor

  • Tabrecta increases the exposure of CYP1A2 (e.g., theophylline)

  • P‑gp/BCRP substrates (eg, digoxin, rosuvastatin)—dose adjustments recommended

Note:

• If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
• It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.