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东盟制药

Tepozi TEPOTINIB 225 MG 60'S Approval No. 12 L 0944/22 Expiry Date 08-12-2025

Tepozi TEPOTINIB 225 MG 60'S Approval No. 12 L 0944/22 Expiry Date 08-12-2025

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The following is the general drug instructions for **Tepotinib (trade name: Teponi)**.

Drug instructions

Drug Name

  • Generic name: Tepotinib
  • Product Name: Teponi
  • English name: Tepotinib

Pharmacological action and mechanism

Tepotinib is a mesenchymal epithelial transition factor receptor (MET) inhibitor that prevents the proliferation and migration of tumor cells by inhibiting the activity of MET kinase.

  • Specifically for patients with MET exon 14 skipping mutation-positive (METex14) non-small cell lung cancer (NSCLC).

Indications

  1. Advanced or metastatic non-small cell lung cancer (NSCLC)
    • Suitable for patients with MET exon 14 skipping mutations.
    • It is used for adult patients who have been tested and confirmed to have this mutation, and is suitable for patients who have no alternative treatment options or have failed standard treatment.

Dosage

  1. Recommended dose
    • 450 mg (two 225 mg tablets) orally once daily.
  2. Directions
    • Take with food to optimize absorption.
    • If you miss a dose, try to make up for it within 24 hours; if you have missed a dose after 24 hours, skip the dose.

Contraindications

  • Patients with hypersensitivity to tepotinib or any of its ingredients are contraindicated.

Precautions

  1. Hepatotoxicity
    • Tepotinib may cause abnormal liver function, and liver function (ALT, AST, bilirubin, etc.) needs to be monitored regularly before and during treatment.
  2. Pulmonary toxicity
    • Interstitial lung disease (ILD) or pneumonitis may occur. If respiratory symptoms (such as cough, dyspnea) occur, the drug should be discontinued and evaluated.
  3. Embryo-fetal toxicity
    • Tepotinib may be toxic to the fetus; women of childbearing potential should take effective contraceptive measures during treatment and for at least 1 week after the last dose.
  4. Impaired renal function
    • There is limited experience in using this drug in patients with moderate or severe renal impairment and it should be used with caution.

Adverse Reactions

  1. Common adverse reactions
    • Peripheral edema
    • nausea
    • diarrhea
    • Fatigue
    • Hypoproteinemia
    • Stomatitis
  2. Serious adverse reactions
    • Liver impairment
    • Interstitial lung disease/pneumonia
    • Abnormal heart rhythm

Drug interactions

  1. CYP3A4 inducers/inhibitors
    • The metabolism of tepotinib is regulated by CYP3A4 and P-gp. Strong inducers (such as rifampicin) may reduce the plasma concentration of tepotinib, while strong inhibitors (such as ketoconazole) may increase its plasma concentration.
  2. Other drugs
    • Avoid using drugs that have potential interactions with tepotinib. Please refer to your doctor's advice for details.

Overdose

  • Symptoms : May cause aggravated adverse drug reactions.
  • Treatment : There is currently no specific antidote, so the drug should be stopped immediately and symptomatic supportive treatment should be carried out.

Storage conditions

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

Packing Specifications

  • 225 mg/tablet, 60 tablets per bottle.

Manufacturer

Laos ASEAN Pharmaceuticals.

Approval No.

12 L 0944/22.

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

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