Epclusa (Sofosbuvir and Velpatasvir) – HCV | HongKong DengYue Medicine

Epclusa Application Scope

Epclusa is an antiviral medication used to treat chronic hepatitis C virus (HCV) infection in adults and children aged 3 years and older.

Characteristics

• Ingredients: Sofosbuvir and Velpatasvir

• Properties:

  • Fixed-dose combination antiviral

  • Sofosbuvir: NS5B RNA polymerase inhibitor

  • Velpatasvir: NS5A inhibitor

• Packaging Specification:

  • Tablets: Bottles containing 28 film-coated tablets

  • Oral pellets: Sachets in cartons, each carton contains 28 sachets

• Storage:

  • Store below 30°C (86°F)

  • Dispense only in original container

• Expiry Date: ​Shelf life of 2 years

• Executive Standard: Refer to local regulatory guidelines and prescribing information

• Approval Number: PLGB 11972/0056 (UK)

• Date of Revision: December 8, 2022

• Manufacturer: Gilead Sciences Ireland UC

Guidelines for the Use of Epclusa

• Dosage and Administration:

  • Adults and children ≥12 years or ≥30 kg: One tablet (400 mg sofosbuvir/100 mg velpatasvir) once daily for 12 weeks

  • With decompensated cirrhosis: Epclusa plus weight-based ribavirin for 12 weeks

  • Can be taken with or without food

• Adverse Reactions:

  • Common (≥10%): Headache, fatigue

  • Pediatric patients <6 years: Vomiting, spitting up the drug

  • With ribavirin: Fatigue, anemia, nausea, headache, insomnia, diarrhea

• Contraindications:

  • Hypersensitivity to sofosbuvir, velpatasvir, or any excipients

  • Concurrent use with strong P-gp and CYP inducers (e.g., rifampin, St. John’s wort)

• Precautions:

  • Risk of severe bradycardia when coadministered with amiodarone

  • Monitor for hepatitis B reactivation

  • Use with caution in patients with severe renal impairment

Epclusa Interactions

• Drug Interactions:

  • Avoid coadministration with:

    • Amiodarone

    • Proton-pump inhibitors (e.g., omeprazole)

    • Anticonvulsants (e.g., phenytoin, carbamazepine)

    • Rifampin, St. John’s wort

  • Potential interactions with statins (e.g., rosuvastatin)

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.