Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Gilead Sciences Ireland UC, Carrigtohill, County Cork, T45 DP77, Ireland
Vosevi is indicated for the treatment of chronic hepatitis C virus (HCV) infection in patients aged 12 years and older and weighing at least 30 kg (see sections 4.2, 4.4 and 5.1).
Vosevi treatment should be initiated and monitored by a physician experienced in the management of patients with HCV infection.
The recommended dose of Vosevi in patients aged 12 years and older and weighing at least 30 kg is one 400 mg/100 mg/100 mg tablet or two 200 mg/50 mg/50 mg tablets, taken orally, once daily with food (see section 5.2).
The recommended durations of treatment applicable to all HCV genotypes are shown in Table 1.
Table 1. Recommended treatment durations for Vosevi for all HCV genotypes in patients 12 years and older and weighing at least 30 kg:
| Patient population | Treatment duration |
|---|---|
| DAA naïve patients without cirrhosis | 8 weeks |
| DAA naïve patients with compensated cirrhosis | 12 weeks 8 weeks may be considered in genotype 3 infected patients (see section 5.1) |
| DAA experienced patients* without cirrhosis or with compensated cirrhosis | 12 weeks |
DAA: direct-acting antiviral agent
* In clinical studies the DAA experienced patients had been exposed to combination regimens containing any of the following: daclatasvir, dasabuvir, elbasvir, grazoprevir, ledipasvir, ombitasvir, paritaprevir, sofosbuvir, velpatasvir, voxilaprevir (administered with sofosbuvir and velpatasvir for less than 12 weeks).
If a dose of Vosevi is missed and it is within 18 hours of the normal time, patients should be instructed to take the tablet(s) as soon as possible and then patients should take the next dose at the usual time. If it is after 18 hours then patients should be instructed to wait and take the next dose of Vosevi at the usual time. Patients should be instructed not to take a double dose of Vosevi.
Patients should be instructed that if vomiting occurs within 4 hours of dosing an additional dose of Vosevi should be taken. If vomiting occurs more than 4 hours after dosing, no further dose of Vosevi is needed (see section 5.1).
No dose adjustment is warranted for elderly patients (see section 5.2).
No dose adjustment of Vosevi is required for patients with mild or moderate renal impairment.
Safety data are limited in patients with severe renal impairment (estimated Glomerular Filtration Rate [eGFR] <30 mL/min/1.73 m²) and end stage renal disease (ESRD) requiring haemodialysis. Vosevi has not been studied in patients with ESRD requiring dialysis. Vosevi can be used in these patients with no dose adjustment when no other relevant treatment options are available (see section 4.4, 4.8,5.1 and 5.2).
No dose adjustment of Vosevi is required for patients with mild hepatic impairment (Child-PughTurcotte [CPT] Class A). Vosevi is not recommended in patients with moderate or severe hepatic impairment (CPT Class B or C) (see section 5.2).
The safety and efficacy of Vosevi in children aged less than 12 years and weighing less than 30 kg have not yet been established. No data are available.
For oral use.
Patients should be instructed to swallow the tablet(s) whole with food (see section 5.2). Due to the bitter taste, it is recommended that the film-coated tablet is not chewed or crushed.
The highest documented doses of sofosbuvir, velpatasvir and voxilaprevir were single doses of 1,200 mg, 500 mg, and 900 mg, respectively. In healthy adult volunteer studies with sofosbuvir and velpatasvir, there were no untoward effects observed at these dose levels, and adverse events were similar in frequency and severity to those reported in the placebo groups. The most common adverse reactions in patients receiving voxilaprevir 900 mg were diarrhoea (34%), nausea (17%) and headache (9%).
No specific antidote is available for overdose with Vosevi. If overdose occurs the patient must be monitored for evidence of toxicity. Treatment of overdose with Vosevi consists of general supportive measures including monitoring of vital signs, as well as observation of the clinical status of the patient. Haemodialysis can efficiently remove the predominant circulating metabolite of sofosbuvir, GS-331007, with an extraction ratio of 53%. Haemodialysis is unlikely to result in significant removal of velpatasvir or voxilaprevir since velpatasvir and voxilaprevir are highly bound to plasma proteins.
4 years.
This medicinal product does not require any special temperature storage conditions.
Store in the original package in order to protect from moisture. Keep the bottle tightly closed.
High density polyethylene (HDPE) bottle with a polypropylene child-resistant closure containing 28 film-coated tablets with polyester coil and a silica gel desiccant.
Pack size: outer carton containing 1 bottle of 28 film-coated tablets.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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