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PHOENTRE Entrectinib

PHOENTRE Entrectinib

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The following is the generic drug instructions for **Entrectinib (trade name: PHOENTRE)**.

Drug instructions

Drug Name

  • Generic name: entrectinib
  • Product Name: PHOENTRE
  • English name: Entrectinib

Pharmacological action and mechanism

Entrectinib is a selective tyrosine kinase inhibitor targeting tropomyosin receptor kinase (TRK) A, TRK B, TRK C, ROS1, and ALK fusion genes.

  • By inhibiting the activity of these kinases, downstream signaling pathways are blocked, thereby inhibiting the proliferation and growth of tumor cells.

Indications

  1. NTRK fusion-positive solid tumors
    • It is indicated for patients with advanced or metastatic solid tumors harboring NTRK gene fusions and without known resistance mutations, and who lack satisfactory alternative treatment options.
  2. ROS1-positive non-small cell lung cancer (NSCLC)
    • For the treatment of patients with advanced or metastatic ROS1-positive NSCLC.

Dosage

  1. Recommended dose
    • Adults and adolescents weighing ≥50 kg: 600 mg, orally once daily.
    • Adolescents weighing <50 kg: 400 mg orally once a day.
  2. Directions
    • Take with or without food, with water.
    • If you miss a dose by more than 12 hours, skip the dose and take it at your next normal time.

Contraindications

  • Patients with hypersensitivity to entrectinib or any of its ingredients.

Precautions

  1. Central nervous system toxicity
    • Entrectinib may cause central nervous system side effects such as dizziness and confusion. It is recommended to avoid driving and operating heavy machinery while taking the drug.
  2. Cardiotoxicity
    • It may cause QT interval prolongation, and electrocardiogram monitoring is recommended before and during treatment.
  3. Liver function monitoring
    • Liver function indicators (ALT, AST, bilirubin) need to be monitored regularly before and during treatment.
  4. Bone Health
    • Entrectinib may cause a decrease in bone mineral density; regular assessment of bone health is recommended.
  5. Embryo-fetal toxicity
    • Entrectinib may be toxic to the fetus, and women of childbearing age should take effective contraceptive measures until at least 5 weeks after the last dose.

Adverse Reactions

  1. Common adverse reactions
    • fatigue
    • nausea
    • Vomit
    • diarrhea
    • constipate
    • Stomatitis
    • anemia
    • Swelling (peripheral edema)
  2. Serious adverse reactions
    • Central nervous system toxicity (eg, ataxia)
    • Arrhythmias (eg, QT interval prolongation)
    • Liver impairment
    • Heart failure

Drug interactions

  1. CYP3A4 inhibitors/inducers
    • Strong CYP3A4 inhibitors (such as ketoconazole) may increase the plasma concentration of entrectinib, while strong inducers (such as rifampicin) may reduce its efficacy.
  2. Other QT-prolonging drugs
    • Caution is advised when using this drug in combination with drugs that may prolong the QT interval.

Overdose

  • Symptoms : May cause severe CNS side effects or cardiac arrhythmias.
  • Treatment : There is currently no specific antidote, so the drug should be stopped immediately and supportive treatment should be given.

Storage conditions

  • Store at 20-25°C away from moisture and light.
  • Keep out of reach of children.

Packing Specifications

  • 100 mg/capsule, 200 mg/capsule. The specific specifications are subject to the packaging.

Manufacturer

Laos State-Owned Factory No. 2.

Approval No.

See the drug packaging for details.

Note : This instruction manual is for reference only. Please read the actual instructions of the drug carefully and use it according to the doctor's instructions.

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