Zepatier Application Scope

Zepatier is a prescription medication used to treat chronic hepatitis C virus (HCV) infections, specifically genotypes 1 and 4, in adults and pediatric patients aged 12 years and older or weighing at least 30 kg.

zepatier

Characteristics

Ingredients: Elbasvir and Grazoprevir

Properties:
- Elbasvir: NS5A inhibitor, impedes viral RNA replication.
- Grazoprevir: NS3/4A protease inhibitor, blocks viral polyprotein processing.
- Together, they target multiple stages of the HCV lifecycle .
Packaging Specification: Each carton contains two 14-count child-resistant dose packs, totaling 28 tablets .

Storage:
- Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F).
- Keep in original blister packaging to protect from moisture .
Expiry Date: Refer to the expiration date printed on the packaging.
Executive Standard: Approved under FDA NDA208261 .
Approval Number: FDA approval on January 28, 2016 .
Date of Revision: Label revised in July 2024 .
Manufacturer: Merck Sharp & Dohme Corp., Kenilworth, New Jersey, USA .

Guidelines for the Use of Zepatier

Dosage and Administration:
- One tablet (50 mg elbasvir/100 mg grazoprevir) taken orally once daily, with or without food.
- Duration and combination with ribavirin depend on HCV genotype, prior treatment history, and presence of resistance-associated polymorphisms .

Adverse Reactions:
- Common: Fatigue, headache, nausea.
- With ribavirin: Anemia, headache.
- Rare: Elevated liver enzymes (ALT), typically asymptomatic and resolving during or after treatment .
Contraindications:
- Moderate or severe hepatic impairment (Child-Pugh B or C).
- Concomitant use with strong CYP3A inducers (e.g., rifampin, carbamazepine) or OATP1B1/3 inhibitors (e.g., cyclosporine)
Precautions:
- Test for hepatitis B virus (HBV) infection before initiating therapy due to risk of HBV reactivation.
- Monitor liver function tests before and during treatment.
- Use in pregnancy only if the potential benefit justifies the potential risk; not recommended during breastfeeding .

Zepatier Interactions

Drug Interactions:
- Avoid concomitant use with drugs that are strong CYP3A inducers or OATP1B1/3 inhibitors.
- Adjust doses of certain statins when co-administered.
- Monitor for interactions with other medications metabolized by CYP3A .

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.