Zepsun (Donafenib Tosilate) – HCC | HongKong DengYue Medicine

  • Generic Name/Brand Name: ​Donafenib Tosilate/Zepsun
  • Indications: Film-coated tablet
  • Dosage Form: ​Unresectable hepatocellular carcinoma (HCC)
  • Specification: 100 mg/tablet × 40 tablets

Donafenib Tosilate Application Scope

Donafenib Tosylate is indicated for the treatment of patients with unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy.

zepsun donafenib tosilate
zepsun donafenib tosilate

Donafenib Tosilate Characteristics

  • Ingredients: Donafenib Tosylate

  • Properties:​ Oral small molecule multikinase inhibitor targeting Raf kinases, VEGFR, PDGFR, and other receptor tyrosine kinases

  • Packaging Specification:​ 100 mg tablets; typically administered as 200 mg (2 tablets) twice daily

  • Storage:​ Store at room temperature, away from moisture and heat

  • Expiry Date: Refer to packaging for specific expiry date

  • Executive Standard: ​ China National Medical Products Administration (NMPA) standards

  • Approval Number: Approved by NMPA in June 2021

  • Date of Revision: Refer to packaging for the latest revision date

  • Manufacturer:Suzhou Zelgen Biopharmaceutical Co., Ltd.

Guidelines for the Use of Donafenib Tosilate

  • Dosage and Administration:

    • Recommended Dose: 200 mg (2 tablets) orally, twice daily

    • Administration: Take with or without food

    • Missed Dose:​ If a dose is missed, take it as soon as remembered unless it’s almost time for the next dose; do not double doses

  • Adverse Reactions:

    • Common Adverse Reactions: Fatigue, diarrhea, hand-foot skin reaction (palmar-plantar erythrodysesthesia), hypertension, rash

    • Serious Adverse Reactions: Hepatotoxicity, cardiac issues (e.g., myocardial infarction, heart failure), bleeding complications, gastrointestinal perforations

  • Contraindications:

    • Absolute Contraindications: Severe liver impairment, known hypersensitivity to donafenib or any component of the formulation

    • Relative Contraindications: Pregnancy, breastfeeding, pre-existing cardiovascular conditions

  • Precautions:

    • Monitoring: Regular monitoring of liver enzymes, blood pressure, and cardiac function is essential

    • Drug Interactions: Caution when used with other medications metabolized by CYP3A4 or those that affect P-glycoprotein (P-gp)

Donafenib Tosilate Interactions

  • CYP3A4 Substrates: Donafenib may increase the plasma concentrations of drugs metabolized by CYP3A4

  • P-glycoprotein Substrates: Donafenib may affect the absorption and elimination of P-glycoprotein substrates

  • Anticoagulants: Monitor closely when used with warfarin or other anticoagulants due to potential bleeding risks

 

Note:

  • If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
  •  This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.
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