VOSEVI

Country: Ísrael

Tungumál: enska

Heimild: Ministry of Health

Virkt innihaldsefni:

SOFOSBUVIR; VELPATASVIR; VOXILAPREVIR

Fáanlegur frá:

GILEAD SCIENCES ISRAEL LTD

ATC númer:

J05AP56

Lyfjaform:

FILM COATED TABLETS

Samsetning:

VOXILAPREVIR 100 MG; VELPATASVIR 100 MG; SOFOSBUVIR 400 MG

Stjórnsýsluleið:

PER OS

Gerð lyfseðils:

Required

Framleitt af:

GILEAD SCIENCES IRELAND UC, IRELAND

Lækningarsvæði:

SOFOSBUVIR, VELPATASVIR AND VOXILAPREVIR

Ábendingar:

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

Leyfisdagur:

2023-02-28

Upplýsingar fylgiseðill

1
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ (PRODUCTS)
REGULATIONS - 1986
This medicine is to be supplied by doctor’s prescription only
VOSEVI
®
Film-coated tablets
ACTIVE INGREDIENTS:
Each tablet contains –
sofosbuvir
400 mg
velpatasvir
100 mg
voxilaprevir 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. This
medicine has been prescribed for
you only. Do not pass it on to others. It may harm them, even if it
seems that their medical condition is
similar to yours.
1.
WHAT IS VOSEVI INTENDED FOR?
Vosevi is given to adults of 18 years and older to treat a chronic
(long-term) viral infection of the liver
called hepatitis C.
THERAPEUTIC GROUP:
•
VELPATASVIR, VOXILAPREVIR AND SOFOSBUVIR
are direct-acting antivirals.
Vosevi is a medicine that contains the active substances sofosbuvir,
velpatasvir and voxilaprevir in a
single tablet. The active substances in this medicine work together by
blocking three different proteins
that the hepatitis C virus needs to grow and reproduce itself, causing
the infection to be eliminated
from the body.
2.
BEFORE TAKING VOSEVI
.
X
. DO NOT TAKE THIS MEDICINE IF:
•
YOU ARE ALLERGIC
to sofosbuvir, velpatasvir, voxilaprevir or any of the other
ingredients
of this medicine (listed in section 6 of this leaflet).

If this applies to you,
DO NOT TAKE VOSEVI AND TELL YOUR DOCTOR IMMEDIATELY.
HEPATITIS B VIRUS REACTIVATION:
BEFORE STARTING TREATMENT WITH VOSEVI, 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 VOSEVI MIGHT CAUSE REACTIVATION OF HEPATITIS B, WHICH
IN SOME CASES MIGHT BE FATAL
OR CAUSE SERIOUS LIVER PROBLEMS (SUCH AS LIVER FAILURE).
REACTIVATION O

Vara einkenni

1
VOSEVI
®
(SOFOSBUVIR, VELPATASVIR, VOXILAPREVIR)
FILM-COATED TABLETS
1.
NAME OF THE MEDICINAL PRODUCT
Vosevi
®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 400 mg sofosbuvir, 100 mg velpatasvir
and 100 mg voxilaprevir.
Excipients with known effect
Each film-coated tablet contains 111 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Beige, capsule-shaped, film-coated tablet of dimensions 10 mm x 20 mm,
debossed with “GSI” on one
side and “3” 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 VOSEVI. HBV REACTIVATION HAS BEEN REPORTED
IN HCV/HBV
COINFECTED PATIENTS WHO WERE UNDERGOING OR HAD COMPLETED TREATMENT
WITH HCV DIRECT
ACTING ANTIVIRALS (DAA) 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
Vosevi is indicated for the treatment of chronic hepatitis C virus
(HCV) infection in adults (see
sections 4.2, 4.4 and 5.1).
2
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Vosevi treatment should be initiated and monitored by a physician
experienced in the management of
patients with HCV infection.
Posology
The recommended dose of Vosevi is one tablet, 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
PATIENT POPULATION
TREATMENT DURATION
DAA naïve patients without cirrhosi