Entrectinib Application Scope

ROZLYTREK® is indicated for the treatment of adult and pediatric patients (≥12 years old) with ROS1-positive, metastatic non-small cell lung cancer (NSCLC) who have not received prior ROS1-targeted therapy.NTRK gene fusion-positive solid tumors (locally advanced or metastatic) in patients who have no satisfactory alternative therapies, regardless of tumor type, including both adult and pediatric populations.

Entrectinib Characteristics

Ingredients: Entrectinib
Properties: Tyrosine kinase inhibitor (TKI); targeted therapy
Packaging Specification: 100 mg & 200 mg capsules × 30 capsules/box
Storage: Store at 20–25°C; protect from moisture and light
Expiry Date: As per package label
Executive Standard: FDA / EMA approval standard
Approval Number: FDA NDA 209063
Date of Revision: Latest EMA SmPC: March 2023
Manufacturer: Roche / Genentech

Guidelines for the Use of Rozlytrek

Dosage and Administration:
- Recommended Dose: 600 mg orally once daily (continuous dosing)
- Administration: Take orally, with or without food; swallow capsules whole
- Missed Dose: If missed, take as soon as remembered; do not double dose
Adverse Reactions:
- Common Adverse Reactions:
  - Fatigue
  - Constipation, diarrhea
  - Dizziness, cough
  - Edema
- Serious Adverse Reactions:
  - Severe cardiac events (e.g., congestive heart failure, QT prolongation)
  - Hepatotoxicity
  - Neurological effects (cognitive disorders, seizures)
Contraindications: Hypersensitivity to excipients
Precautions:
- Monitor liver function, ECG, and neurological status.
- Dose adjustment for severe adverse events or hepatic impairment
- Use contraception during and after treatment

Entrectinib Interactions

CYP3A inhibitors/inducers may alter entrectinib exposure
Avoid strong CYP3A modulators if possible
Monitor for additive toxicity with other TKIs

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.