ALILAROTINIB

COMPOSITION
Larotrectinib Sulfate…………………………100mg
INDICATION

For the treatment of adult and pediatric patients with solid tumors that:

  • Have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation.
  • Patients with locally advanced, metastatic diseases, or surgical resection that may lead to serious complications.
  • Have no satisfactory alternative treatments or that have progressed following treatment.

PACKAGING:
30 capsules/bottle.

Reg No: 11 L 1228/24
Download ALILAROTINIB Drug Registration Certificate

Brand name: ALILAROTINIB


Composition:
Each tablet contains:
Larotrectinib Sulfate…………………………100mg


Indications:

For the treatment of adult and pediatric patients with solid tumors that:

  • Have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation.
  • Patients with locally advanced, metastatic diseases, or surgical resection that may lead to serious complications.
  • Have no satisfactory alternative treatments or that have progressed following treatment.

Dosage:

  • Orally, with or without food;
  • Recommended Dosage in Adult and Pediatric Patients with Body Surface Area of 1 Meter-Squared or greater: 100 mg orally twice daily.
  • Recommended Dosage in Pediatric Patients with Body Surface Area of less Than 1 Meter-Squared: 100 mg/m2 orally twice daily.
  • Swallow capsules whole with water. Do not chew or crush the capsules.
  • Continue use until disease progression or unacceptable toxicity.

Contraindications:

  • None

Warnings:

  • Pregnant women should use with caution.
  • Reduce the starting dose of Larotrectinib in patients with moderate to severe hepatic impairment.
  • Promptly evaluate patients with signs or symptoms of fractures.
  • Hepatotoxicity
  • If coadministration of a strong CYP3A4 inhibitor cannot be avoided, reduce the Larotrectinib dose by 50%. After the inhibitor has been discontinued for 3 to 5 elimination half-lives, resume the Larotrectinib dose that was used prior to initiating the CYP3A4 inhibitor.
  • If coadministration of a strong CYP3A4 inducer cannot be avoided, double the Larotrectinib dose. After the inducer has been discontinued for 3 to 5 elimination half-lives, resume the Larotrectinib dose that was used prior to initiating the CYP3A4 inducer

Adverse Effects:

Central nervous system (CNS) adverse reactions,increased ALT, anemia musculoskeletal pain, fatigue, hypoalbuminemia, neutropenia, increased alkaline phosphatase, cough, leukopenia, constipation, diarrhea, dizziness, hypocalcemia, nausea, vomiting, pyrexia, lymphopenia, and abdominal pain.


Dosage form: White capsule.


Expiry date: 24 months from the date of manufacture.


Packaging:

  • 30 capsules/bottle.

Storage:

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

DISCLAIMER

The information on this website about our medications is intended for general educational purposes only and should not be considered a substitute for professional medical advice, diagnosis, or treatment. Never disregard professional medical advice or delay seeking care because of something you have read on this website.

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.