EXVIERA Film-coated tablet Ref.[8766] Active ingredients: Dasabuvir

Treatment with dasabuvir should be initiated and monitored by a physician experienced in the management of chronic hepatitis C.

Posology

The recommended dose is 250 mg of dasabuvir (one tablet) twice daily (morning and evening).

Dasabuvir must not be administered as monotherapy. Dasabuvir 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 dasabuvir.

The recommended co-administered medicinal product(s) and treatment duration for dasabuvir combination therapy are provided in Table 1.

Table 1. Recommended co-administered medicinal product(s) and treatment duration for dasabuvir by patient population:

* Note: Follow the genotype 1a dosing recommendations in patients with an unknown genotype 1 subtype or with mixed genotype 1 infection.
** When assessing severity of liver disease using non-invasive methods, a combination of blood biomarkers or the combination of liver stiffness measurement and a blood test improves accuracy and should be undertaken prior to 8 week treatment in all patients with moderate fibrosis.

Missed doses

In case a dose of dasabuvir is missed, the prescribed dose can be taken within 6 hours. If more than 6 hours have passed since dasabuvir 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

The dosing recommendations in Table 1 should be followed. For dosing recommendations with HIV antiviral medicinal products, refer to sections 4.4 and 4.5. See sections 4.8 and 5.1 for additional information.

Liver transplant recipients

Dasabuvir 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 dasabuvir is warranted in elderly patients (see section 5.2).

Renal impairment

No dose adjustment of dasabuvir is required for patients with mild, moderate, or severe renal impairment or end-stage-renal disease on dialysis (see section 5.2). For patients that require ribavirin, refer to the ribavirin Summary of Product Characteristics for information regarding use in patients with renal impairment.

Hepatic impairment

No dose adjustment of dasabuvir is required in patients with mild hepatic impairment (Child-Pugh A). Dasabuvir should not be used in patients with moderate to severe hepatic impairment (Child-Pugh B or 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-coated tablets are for oral use. Patients should be instructed to swallow the tablets whole (i.e. patients should not chew, break or dissolve the tablet). To maximise absorption, dasabuvir tablets should be taken with food, without regard to fat and calorie content (see section 5.2).

The highest documented single dose of dasabuvir administered to healthy volunteers was 2 g. No study drug-related adverse reactions or clinically significant laboratory abnormalities were observed.

In case of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions or effects and appropriate symptomatic treatment instituted immediately.

Shelf life: 3 years.

This medicinal product does not require any special storage conditions.

PVC/PE/PCTFE aluminium foil blister packs.

Pack-size of 56 tablets (multipack carton containing 4 inner cartons of 14 tablets each).

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.