Hengmu (Tenofovir Amibufenamide) | CHB | HongKong DengYue

Tenofovir Amibufenamide Application Scope

Treatment of adult patients with chronic hepatitis B infection.

 

Tenofovir Amibufenamide Characteristics

• Ingredients:

  • Active ingredient: Tenofovir amibufenamide (TMF), a novel phosphoramidated tenofovir prodrug

• Properties:

  • Liver‑targeted prodrug with enhanced plasma stability

  • Requires <10% dose compared to tenofovir disoproxil fumarate (TDF) for similar efficacy

  • Superior bone and kidney safety, minimal lipid and metabolic impact

• Packaging Specification:​ Typically supplied in blisters or bottles providing 25 mg per tablet
  Pack size varies by manufacturer (see local labelling)

• Storage:

  • Store at room temperature (below 30 °C), keep in a dry place, away from direct light

• Expiry Date: ​As per manufacturer’s label, generally 2–3 years from manufacture

• Executive Standard: ​Meets Chinese Pharmacopoeia standards; approved under special/priority review

• Approval Number: China: Approval granted June 24, 2021; marketed as Hengmu by Jiangsu Hengrui/Hansen Pharmaceutical

• Date of Revision: ​First approved June 2021; 96‑week Phase III data published in mid‑2024

• Manufacturer: Jiangsu Hansoh Pharmaceutical Group Co., Ltd.

Guidelines for the Use of Tenofovir Amibufenamide

• Dosage and Administration:

  • Dosage: 25 mg orally once daily with food

  • Administration: Can be taken with or without food; food enhances pharmacokinetics

• Adverse Reactions:

  Based on TMF and TAF class profiles (including data from related drugs):

  • Common: headache, fatigue, nausea, abdominal pain, back pain, diarrhea, joint pain, cough

  • Metabolic: possible increases in LDL cholesterol; TMF shows minimal lipid impact compared to TAF

  • Rare but serious: lactic acidosis, hepatotoxicity, hepatic steatosis, kidney issues — standard for tenofovir class

• Contraindications:

  • No formal contraindications listed; avoid in patients with hypersensitivity to tenofovir derivatives.

  • Standard class contraindication: risk of severe acute exacerbation if abruptly discontinued

• Precautions:

  • Monitor renal function, bone mineral density, hepatic function, and lactate levels during treatment

  • Use caution in patients with pre-existing liver disease — potential for lactic acidosis

Tenofovir Amibufenamide Interactions

• Drug Interactions:​

• No severe drug interactions noted

• Potential interactions (class effects):

  • P‑gp/CYP inhibitors (e.g., amiodarone, clarithromycin) may increase systemic TMF — monitoring recommended

  • Co-administration with nephrotoxic agents (aminoglycosides, NSAIDs) may increase renal risk

  • P‑gp inducers (e.g., rifampicin, rifapentine) reduce TMF levels — not recommended without dose adjustment

 

Note:

• If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
• It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.