EPCLUSA

Pays: Israël

Langue: anglais

Source: Ministry of Health

Ingrédients actifs:

SOFOSBUVIR; VELPATASVIR

Disponible depuis:

GILEAD SCIENCES ISRAEL LTD

Code ATC:

J05AX15

forme pharmaceutique:

FILM COATED TABLETS

Composition:

VELPATASVIR 100 MG; SOFOSBUVIR 400 MG

Mode d'administration:

PER OS

Type d'ordonnance:

Required

Fabriqué par:

GILEAD SCIENCES IRELAND UC, IRELAND

Domaine thérapeutique:

SOFOSBUVIR

indications thérapeutiques:

Epclusa is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults.

Date de l'autorisation:

2017-04-26

Notice patient

1
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ (PRODUCTS)
REGULATIONS -
1986
This medicine is to be supplied by doctor’s prescription only
EPCLUSA
®
Film-coated tablets
ACTIVE INGREDIENTS: Each tablet contains –
sofosbuvir
400 mg
velpatasvir
100 mg
Inactive and allergenic substances: see section 6 _“Additional
information_”.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU. This leaflet contains
essential information
about this medicine. If you have any further questions, ask your
doctor or pharmacist.
Keep this leaflet. You may need to read it again. This medicine has
been prescribed
for you only. Do not pass it on to others. It may harm them, even if
it seems to you
that their illness is similar to yours. If you experience any side
effects, talk to your
doctor or pharmacist. Even if you experience any side effects that are
not listed in
this leaflet (see section 4).
This medicine is intended for adults aged 18 years and over.
HEPATITIS B VIRUS REACTIVATION:
BEFORE STARTING TREATMENT WITH EPCLUSA, YOUR HEALTHCARE PROVIDER WILL
DO
BLOOD TESTS TO CHECK FOR HEPATITIS B VIRUS INFECTION. IF YOU HAVE OR
HAD IN THE
PAST AN INFECTION WITH HEPATITIS B VIRUS, TREATMENT WITH EPCLUSA MIGHT
CAUSE
REACTIVATION OF HEPATITIS B, WHICH IN SOME CASES MIGHT BE FATAL OR
CAUSE
SERIOUS LIVER PROBLEMS (SUCH AS LIVER FAILURE).
REACTIVATION OF HEPATITIS B CAN OCCUR DURING TREATMENT OR AT THE END
OF
TREATMENT WITH EPCLUSA. IF YOU ARE AT RISK OF HEPATITIS B REACTIVATION
YOU MUST
BE MONITORED CLOSELY DURING AND AFTER TREATMENT WITH EPCLUSA.
FOR MORE INFORMATION ABOUT THE SIDE EFFECTS, SEE SECTION 4.
1.
WHAT IS EPCLUSA INTENDED FOR?
Epclusa is given to treat a chronic (long-term) viral infection of the
liver called
hepatitis C in adults of 18 years and older.
THERAPEUTIC GROUP:
•
VELPATASVIR AND SOFOSBUVIR are direct-acting antivirals for systemic
use.
The medicine Epclusa is a single tablet regimen that contains the
following two active
substances:

Résumé des caractéristiques du produit

1
EPCLUSA
®
(SOFOSBUVIR / VELPATASVIR)
FILM-COATED TABLETS
1.
NAME OF THE MEDICINAL PRODUCT
Epclusa
®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 400 mg sofosbuvir and 100 mg
velpatasvir.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
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.
4.
CLINICAL PARTICULARS
WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS
COINFECTED WITH HCV AND HBV
TEST ALL PATIENTS FOR EVIDENCE OF CURRENT OR PRIOR HEPATITIS B VIRUS
(HBV) INFECTION BEFORE
INITIATING TREATMENT WITH EPCLUSA. HBV REACTIVATION HAS BEEN REPORTED
IN HCV/HBV
COINFECTED PATIENTS WHO WERE UNDERGOING OR HAD COMPLETED TREATMENT
WITH HCV DIRECT
ACTING ANTIVIRALS AND WERE NOT RECEIVING HBV ANTIVIRAL THERAPY. SOME
CASES HAVE
RESULTED IN FULMINANT HEPATITIS, HEPATIC FAILURE, AND DEATH. MONITOR
HCV/HBV
COINFECTED PATIENTS FOR HEPATITIS FLARE OR HBV REACTIVATION DURING HCV
TREATMENT AND
POST-TREATMENT FOLLOW-UP. INITIATE APPROPRIATE PATIENT MANAGEMENT FOR
HBV INFECTION
AS CLINICALLY INDICATED _[SEE SPECIAL WARNINGS AND PRECAUTIONS FOR USE
(SECTION 4.4)]_
.
4.1
THERAPEUTIC INDICATIONS
Epclusa is indicated for the treatment of chronic hepatitis C virus
(HCV) infection in adults (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 is one tablet, taken orally, once
daily with or without food (see
section 5.2).
2
TABLE 1: RECOMMENDED TREATMENT AND DURATION FOR ALL HCV GENOTYPES
PATIENT POPULATION
A
TREATMENT AND DURATION
Patients without cirrhosis and patients with
compensated cirrhosis
Epclusa for 12 weeks
Addition of ribavirin may be considered for genotype 3 infected
patients with compensated cirrhosis (see section 5.1.)
Patients with decompensated cirrhosis
Epclu