Cabozantinib 80MG 30'S Approval No. 02 L 0842/21 Expiry Date 20-8-2027

The following is the general drug instructions for **Cabozantinib (trade name: Cabonni)**.

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Drug instructions

Drug Name

• Generic name: Cabozantinib
• Product Name: Cabonni
• English name: Cabozantinib

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Pharmacological action and mechanism

Cabozantinib is a small molecule tyrosine kinase inhibitor (TKI) that targets multiple receptors, including:

• VEGFR (vascular endothelial growth factor receptor)
• MET (hepatocyte growth factor receptor)
• AXL

By inhibiting these signaling pathways, cabozantinib blocks tumor angiogenesis and tumor cell proliferation, migration, and invasion.

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Indications

1. Advanced renal cell carcinoma (RCC)
   • For use in patients who have previously received anti-angiogenic therapy.
2. Medullary thyroid cancer (MTC)
   • For patients with unresectable or metastatic MTC.
3. Advanced Hepatocellular Carcinoma (HCC)
   • For patients who have previously received sorafenib.

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Dosage

1. Recommended dose
   • Cabometyx (tablets): 60 mg, orally, once daily.
   • Cometriq (capsule): 140 mg (100 mg + 40 mg) once daily, orally.
2. Directions
   • Take on an empty stomach (at least 2 hours before or 1 hour after a meal).
3. Dosage Considerations
   • Depending on the severity of the adverse reaction, the dose may be reduced to 40 mg or 20 mg (Cabometyx tablets) or the Cometriq capsule dose may be appropriately reduced.

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Contraindications

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

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Precautions

1. Abnormal liver function
   • It is recommended to monitor liver function before and during treatment. Patients with severe hepatic impairment should avoid use.
2. Gastrointestinal perforations and fistulas
   • Cabozantinib may cause gastrointestinal perforation or fistula. If related symptoms occur, the drug should be discontinued immediately and treated.
3. Bleeding risk
   • Contraindicated in patients with active bleeding.
4. hypertension
   • Blood pressure should be monitored regularly during treatment. Severe hypertension should be treated with the drug temporarily or discontinued.
5. Poor wound healing
   • Cabozantinib should be discontinued at least 28 days before surgery. Treatment can only be restarted after surgery when the wound is fully healed.
6. QT interval prolongation
   • Cabozantinib may prolong the QT interval and electrocardiograms should be monitored during treatment.
7. Embryo-fetal toxicity
   • Cabozantinib may cause fetal toxicity; women of childbearing potential should use effective contraceptive measures during treatment and for at least 4 months after the last dose.

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Adverse Reactions

1. Common adverse reactions
   • diarrhea
   • fatigue
   • nausea
   • Decreased appetite
   • Stomatitis
   • hypertension
   • Hand-foot syndrome
2. Serious adverse reactions
   • Gastrointestinal perforation or fistula
   • Bleeding events
   • Hypertensive crisis
   • Liver impairment
   • Interstitial lung disease

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Drug interactions

1. CYP3A4 inhibitors/inducers
   • Strong CYP3A4 inhibitors (such as ketoconazole) may increase the plasma concentration of cabozantinib, and inducers (such as rifampin) may reduce the efficacy.
2. P-gp substrate drugs
   • Cabozantinib may interact with P-gp substrate drugs (such as digoxin), and close monitoring is recommended.

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Overdose

• Symptoms : May aggravate adverse reactions such as diarrhea, hypertension, fatigue, etc.
• Treatment : There is currently no specific antidote, the drug should be discontinued and supportive treatment should be given.

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Storage conditions

• Cabometyx tablets and Cometriq capsules should be stored at 20-25°C away from moisture and direct sunlight.
• Keep out of reach of children.

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Packing Specifications

• Cabonni: 80 mg, 30 capsules .
  

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Manufacturer

Laos ASEAN Pharmaceuticals.

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Approval No.

02 L 0842/21.

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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.