Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany
Viekirax 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.
Treatment with Viekirax should be initiated and monitored by a physician experienced in the management of chronic hepatitis C.
The recommended oral dose of Viekirax is two 12.5 mg/75 mg/50 mg tablets once daily with food.
Viekirax should be used in combination with other medicinal products for the treatment of HCV (see Table 1).
Table 1. Recommended co-administered medicinal product(s) and treatment duration for Viekirax by patient population:
| Patient population | Treatment* | Duration |
|---|---|---|
| Genotype 1b, without cirrhosis or with compensated cirrhosis | Viekirax + dasabuvir | 12 weeks 8 weeks may be considered in previously untreated genotype 1b- infected patients with minimal to moderate fibrosis** (see section 5.1, GARNET study) |
| Genotype 1a, without cirrhosis | Vekirax + dasabuvir + ribavirin* | 12 weeks |
| Genotype 1a, with compensated cirrhosis | Viekirax + dasabuvir + ribavirin* | 24 weeks (see section 5.1.) |
| Genotype 4, without cirrhosis or with compensated cirrhosis | Viekirax + ribavirin | 12 weeks |
* 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.
For specific dosage instructions for dasabuvir and ribavirin, including dose modification, refer to the respective Summaries of Product Characteristics.
In case a dose of Viekirax is missed, the prescribed dose can be taken within 12 hours. If more than 12 hours have passed since Viekirax 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.
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.
Viekirax and dasabuvir in combination with ribavirin is recommended for 24 weeks in liver transplant recipients with genotype 1 HCV infection. Viekirax in combination with ribavirin is recommended in genotype 4 infection. 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 see section 4.5.
No dose adjustment of Viekirax is warranted in elderly patients (see section 5.2).
No dose adjustment of Viekirax 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.
No dose adjustment of Viekirax is required in patients with mild hepatic impairment (Child-Pugh A). Viekirax is contraindicated in patients with moderate to severe hepatic impairment (Child-Pugh B or C) (see sections 4.3 and 5.2).
The safety and efficacy of Viekirax in children less than 18 years of age have not been established. No data are available.
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, Viekirax tablets should be taken with food, without regard to fat and calorie content (see section 5.2).
The highest documented single dose administered to healthy volunteers was 400 mg for paritaprevir (with 100 mg ritonavir), 200 mg for ritonavir (with 100 mg paritaprevir) and 350 mg for ombitasvir. No study related adverse reactions with paritaprevir, ritonavir, or ombitasvir were observed. Transient increases in indirect bilirubin were observed at the highest doses of paritaprevir/ritonavir. 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.
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.
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