1. Name of the medicinal product
Exviera 250 mg film-coated tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 250 mg of dasabuvir (as sodium monohydrate).
Excipient with known effect: each film-coated tablet contains 44.94 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet (tablet).
Beige, ovaloid, film-coated tablets with dimensions of 14.0 mm x 8.0 mm and debossed on one side with 'AV2'.
4. Clinical particulars
4.1 Therapeutic indications
Exviera is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults (see sections 4.2, 4.4 and 5.1).
For hepatitis C virus (HCV) genotype specific activity, see sections 4.4 and 5.1.
4.2 Posology and method of administration
Treatment with Exviera should be initiated and monitored by a physician experienced in the management of chronic hepatitis C.
Posology
The recommended dose of dasabuvir is 250 mg (one tablet) twice daily (morning and evening).
Exviera must not be administered as monotherapy. Exviera should be used in combination with other medicinal products for the treatment of HCV (see section 5.1). Refer to the Summary of Product Characteristics of the medicinal products that are used in combination with Exviera.
The recommended co-administered medicinal product(s) and treatment duration for Exviera combination therapy are provided in table 1.
Table 1. Recommended co-administered medicinal product(s) and treatment duration for Exviera by patient population
Missed doses
In case a dose of Exviera is missed, the prescribed dose can be taken within 6 hours. If more than 6 hours have passed since Exviera is usually taken, the missed dose should NOT be taken and the patient should take the next dose per the usual dosing schedule. Patients should be instructed not to take a double dose.
Special populations
HIV-1 Co-infection
Follow the dosing recommendations in Table 1. For dosing recommendations with HIV antiviral agents, refer to sections 4.4 and 4.5. See sections 4.8 and 5.1 for additional information.
Liver transplant recipients
Exviera and ombitasvir/paritaprevir/ritonavir in combination with ribavirin is recommended for 24 weeks in liver transplant recipients. Lower ribavirin dose at initiation may be appropriate. In the post-liver transplant study, ribavirin dosing was individualized and most subjects received 600 to 800 mg per day (see section 5.1). For dosing recommendations with calcineurin inhibitors refer to section 4.5.
Elderly
No dose adjustment of Exviera is warranted in elderly patients (see section 5.2).
Renal impairment
No dose adjustment of Exviera is required for patients with mild, moderate, or severe renal impairment (see section 5.2).
Hepatic impairment
No dose adjustment of Exviera is required in patients with mild hepatic impairment (Child-Pugh A). The safety and efficacy of dasabuvir have not been established in HCV-infected patients with moderate hepatic impairment (Child-Pugh B); however, no dose adjustment is expected to be required based on pharmacokinetic studies. Exviera should not be used in patients with severe hepatic impairment (Child-Pugh C) (see section 5.2).
Paediatric population
The safety and efficacy of dasabuvir in children less than 18 years of age have not been established. No data are available.
Method of administration
The film-coa |
