Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
ZEPATIER is indicated for the treatment of chronic hepatitis C (CHC) in adult and paediatric patients 12 years of age and older who weigh at least 30 kg (see sections 4.2, 4.4 and 5.1).
For hepatitis C virus (HCV) genotype-specific activity see sections 4.4 and 5.1.
ZEPATIER treatment should be initiated and monitored by a physician experienced in the management of patients with CHC.
The recommended dose is one tablet once daily.
Recommended regimens and treatment durations are provided in Table 1 below (see sections 4.4 and 5.1):
Table 1. Recommended ZEPATIER therapy for treatment of chronic hepatitis C infection in patients with or without compensated cirrhosis (Child-Pugh A only):
| HCV genotype | Treatment and duration |
|---|---|
| 1a | ZEPATIER for 12 weeks ZEPATIER for 16 weeks plus ribavirinA should be considered in patients with baseline HCV RNA level >800,000 IU/mL and/or the presence of specific NS5A polymorphisms causing at least a 5-fold reduction in activity of elbasvir to minimise the risk of treatment failure (see section 5.1). |
| 1b | ZEPATIER for 12 weeks |
| 4 | ZEPATIER for 12 weeks ZEPATIER for 16 weeks plus ribavirinA should be considered in patients with baseline HCV RNA level >800,000 IU/mL to minimise the risk of treatment failure (see section 5.1). |
A In the clinical studies, the dose of ribavirin was weight-based (<66 kg = 800 mg/day, 66 to 80 kg = 1,000 mg/day, 81 to 105 kg = 1,200 mg/day, >105 kg = 1,400 mg/day) administered in two divided doses with food.
For specific dosage instructions for ribavirin, including dose modification, refer to the ribavirin Summary of Product Characteristics.
Patients should be instructed that if vomiting occurs within 4 hours of dosing, an additional tablet can be taken up to 8 hours before the next dose. If vomiting occurs more than 4 hours after dosing, no further dose is needed.
In case a dose of ZEPATIER is missed and it is within 16 hours of the time ZEPATIER is usually taken, the patient should be instructed to take ZEPATIER as soon as possible and then take the next dose of ZEPATIER at the usual time. If more than 16 hours have passed since ZEPATIER is usually taken, then the patient should be instructed that the missed dose should NOT be taken and to take the next dose per the usual dosing schedule. Patients should be instructed not to take a double dose.
No dose adjustment of ZEPATIER is required for elderly patients (see sections 4.4 and 5.2).
No dose adjustment of ZEPATIER is required in patients with mild, moderate, or severe renal impairment (including patients receiving haemodialysis or peritoneal dialysis) (see section 5.2).
No dose adjustment of ZEPATIER is required in patients with mild hepatic impairment (Child-Pugh A). ZEPATIER is contraindicated in patients with moderate or severe hepatic impairment (Child-Pugh B or C) (see sections 4.3 and 5.2).
The safety and efficacy of ZEPATIER have not been established in liver transplant recipients.
No dosage adjustment of ZEPATIER is required in paediatric patients 12 years of age and older who weigh at least 30 kg (see sections 5.1 and 5.2).
The safety and efficacy of ZEPATIER in children aged less than 12 years have not been established.
For oral use.
The film-coated tablets should be swallowed whole and may be taken with or without food (see section 5.2).
Human experience of overdose with ZEPATIER is limited. The highest dose of elbasvir was 200 mg once daily for 10 days, and a single dose of 800 mg. The highest dose of grazoprevir was 1,000 mg once daily for 10 days, and a single dose of 1,600 mg. In these healthy volunteer studies, adverse reactions were similar in frequency and severity to those reported in the placebo groups.
In case of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic treatment instituted.
Haemodialysis does not remove elbasvir or grazoprevir. Elbasvir and grazoprevir are not expected to be removed by peritoneal dialysis.
3 years.
This medicinal product does not require any special temperature storage conditions. Store in the original package until use to protect from moisture.
The tablets are packaged into a carton containing two (2) cardboard cards, each cardboard card containing (2) 7-count aluminium blisters sealed in a cardboard card for a total of 28 tablets.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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