ALIENTRECTINIB

COMPOSITION
Entrectinib………………………………………..100mg
INDICATIONS

  • Adult patients with ROS1-positive metastatic non-small cell lung cancer (NSCLC).
  • Patients 1 month and older with solid tumors who meet the following conditions:
    • Have a neurotrophic receptor tyrosine kinase (NTRK) fusion-positive solid tumors.
    • Patients with locally advanced, metastatic disease, or if surgical resection may lead to serious complications.
    • Have no satisfactory standard therapy or that have progressed following treatment.

PACKAGING:
60 tablets/bottle.

Reg No: 11 L 1229/24
Download ALIENTRECTINIB Drug Registration Certificate

Brand name: ALIENTRECTINIB


Composition:
Each tablet contains:
Entrectinib………………………………………..100mg


Indications:

  • Adult patients with ROS1-positive metastatic non-small cell lung cancer (NSCLC).
  • Patients 1 month and older with solid tumors who meet the following conditions:
    • Have a neurotrophic receptor tyrosine kinase (NTRK) fusion-positive solid tumors.
    • Patients with locally advanced, metastatic disease, or if surgical resection may lead to serious complications.
    • Have no satisfactory standard therapy or that have progressed following treatment.

Dosage:

  • Adult: 600mg, once a day.
  • Patients 1 month to 6 months – 250mg/m2
  • Children over 6 months old: 300mg/m2, once a day, See table:
Body surface area(BSA) Administer once daily
1.11-1.50m2 400mg
≥1.51m2 600mg
  • The product can be taken with or without food.
  • Swallow capsules whole. Do not crush or chew the capsules.
  • Continue taking the product, until disease progression or until unacceptable toxicity.

Contraindications:

  • None.

Warnings:

  • Avoid coadministration with moderate or strong CYP3A inhibitors. If coadministration cannot be avoided, reduce the ALIENTRECTINIB dose and limit coadministration to 14 days or less.
  • Avoid administration with drugs that prolong QTc interval.
  • Pregnant and lactating women should use with caution.
  • Patients with congestive heart failure and/or skeletal fractures should use with caution.
  • Elevated risk of central nervous system effects, vision disorders, hepatotoxicity or hyperuricemia.

Adverse Effects:
Fatigue, constipation, dysgeusia, edema, dizziness, diarrhea, nausea, dysesthesia, dyspnea, myalgia, cognitive impairment, increased weight, cough, vomiting, pyrexia, arthralgia, and vision disorders.


Dosage form: Yellow opaque HPMC capsule.


Expiry date: 24 months after date of manufacture.


Packaging:

  • 60 capsules/bottle.

Storage:

  • Protected from light, sealed in original packaging, and stored at 20℃- 25℃.
  • Keep out of reach of children.

DISCLAIMER

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For your safety:

Do not self-diagnose or treat any medical condition based solely on the information on this website. If you have any questions or concerns about a medication, please talk to your doctor or pharmacist.