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EPCLUSA Film-coated tablet (2020)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Epclusa 400 mg/100 mg film-coated tablets. Epclusa 200 mg/50 mg film-coated tablets.

2. Qualitative and quantitative composition

<u>Epclusa 400 mg/100 mg film-coated tablets:</u> Each film-coated tablet contains 400 mg sofosbuvir and 100 mg velpatasvir. <u>Epclusa 200 mg/50 mg film-coated tablets:</u> Each film-coated tablet contains ...

3. Pharmaceutical form

Film-coated tablet. <u>Epclusa 400 mg/100 mg film-coated tablets:</u> Pink, diamond-shaped, film-coated tablet of dimensions 20 mm x 10 mm, debossed on one side with GSI and 7916 on the other side. <u> ...

4.1. Therapeutic indications

Epclusa is indicated for the treatment of chronic hepatitis C virus (HCV) infection in patients aged 6 years and older and weighing at least 17 kg (see sections 4.2, 4.4 and 5.1).

4.2. Posology and method of administration

Epclusa treatment should be initiated and monitored by a physician experienced in the management of patients with HCV infection. Posology The recommended dose of Epclusa in adults is one 400 mg/100 mg ...

4.3. Contraindications

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. Use with strong P-gp and strong CYP inducers Medicinal products that are strong P-glycoprotein (P-gp) and/or ...

4.4. Special warnings and precautions for use

Epclusa should not be administered concurrently with other medicinal products containing sofosbuvir. Severe bradycardia and heart block Life-threatening cases of severe bradycardia and heart block have ...

4.5. Interaction with other medicinal products and other forms of interaction

As Epclusa contains sofosbuvir and velpatasvir, any interactions that have been identified with these active substances individually may occur with Epclusa. Potential for Epclusa to affect other medicinal ...

4.6. Fertility, pregnancy and lactation

Pregnancy There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of sofosbuvir, velpatasvir or Epclusa in pregnant women. Sofosbuvir Animal studies do not indicate direct ...

4.7. Effects on ability to drive and use machines

Epclusa has no or negligible influence on the ability to drive and use machines.

4.8. Undesirable effects

Summary of the safety profile In pooled Phase 3 clinical studies of patients with genotype 1, 2, 3, 4, 5 or 6 HCV infection the proportion of patients who permanently discontinued treatment due to adverse ...

4.9. Overdose

The highest documented doses of sofosbuvir and velpatasvir were a single dose of 1,200 mg and a single dose of 500 mg, respectively. In these healthy adult volunteer studies, there were no untoward effects ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Antivirals for systemic use; Direct acting antiviral ATC code: J05AP55 Mechanism of action Sofosbuvir is a pan-genotypic inhibitor of the HCV NS5B RNA-dependent RNA polymerase, ...

5.2. Pharmacokinetic properties

Absorption The pharmacokinetic properties of sofosbuvir, GS-331007 and velpatasvir have been evaluated in healthy adult subjects and in patients with chronic hepatitis C. Following oral administration ...

5.3. Preclinical safety data

Sofosbuvir Exposure to sofosbuvir in rodent studies could not be detected likely due to high esterase activity and exposure to the major metabolite GS-331007 was instead used to estimate exposure margins. ...

6.1. List of excipients

<u>Tablet core:</u> Copovidone Microcrystalline cellulose Croscarmellose sodium Magnesium stearate <u>Film-coating:</u> Polyvinyl alcohol Titanium dioxide (E171) Polyethylene glycol Talc Iron oxide red ...

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

4 years.

6.4. Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5. Nature and contents of container

Epclusa tablets are supplied in high density polyethylene (HDPE) bottle with a polypropylene child-resistant closure containing 28 film-coated tablets with polyester coil. The following pack sizes are ...

6.6. Special precautions for disposal and other handling

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

7. Marketing authorization holder

Gilead Sciences Ireland UC, Carrigtohill, County Cork, T45 DP77, Ireland

8. Marketing authorization number(s)

EU/1/16/1116/001 EU/1/16/1116/002

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 06 July 2016

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