ZEPATIER

Land: Ísrael

Tungumál: enska

Heimild: Ministry of Health

Virkt innihaldsefni:

ELBASVIR; GRAZOPREVIR

Fáanlegur frá:

MERCK SHARP & DOHME (ISRAEL - 1996) COMPANY LTD, ISRAEL

ATC númer:

J05AX68

Lyfjaform:

TABLETS

Samsetning:

ELBASVIR 50 MG; GRAZOPREVIR 100 MG

Stjórnsýsluleið:

PER OS

Gerð lyfseðils:

Required

Framleitt af:

MERCK SHARP & DOHME CORP., USA

Lækningarsvæði:

ELBASVIR AND GRAZOPREVIR

Ábendingar:

ZEPATIER is indicated for the treatment of chronic hepatitis C (CHC) genotypes 1 or 4 infection in adults

Leyfisdagur:

2021-05-31

Upplýsingar fylgiseðill

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS REGULATIONS
(PREPARATIONS) - 1986
This medicine is marketed upon doctor's prescription only
ZEPATIER
®
50 MG/100 MG
TABLETS
Each tablet contains:
elbasvir 50 mg and grazoprevir 100 mg
For a list of inactive ingredients see section 6.1 "What ZEPATIER
contains?".
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
•
This leaflet contains concise information about ZEPATIER. If you have
any further questions, ask your
doctor or pharmacist.
•
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their
ailment seems similar to yours.
•
Your doctor may prescribe ZEPATIER with a medicine called ribavirin.
IF YOU TAKE ZEPATIER AND
RIBAVIRIN, BE SURE YOU READ THE PATIENT LEAFLET FOR RIBAVIRIN.
•
This medicine is intended for adults above 18 years of age.
•
Before you take this medicine, be sure you understand what it is for
and how to take it safely.
WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT ZEPATIER?
ZEPATIER can cause serious side effects, including:
HEPATITIS B VIRUS REACTIVATION: Before starting treatment with
ZEPATIER, your doctor will
do blood tests to check for hepatitis B virus infection. If you have
ever had hepatitis B virus infection, the
hepatitis B virus could become active again during or after treatment
of hepatitis C virus infection with
ZEPATIER. Hepatitis B virus becoming active again (called
reactivation) may cause serious liver
problems including liver failure and death. Your doctor will monitor
you if you are at risk for
hepatitis B virus reactivation during treatment and after you stop
taking ZEPATIER.
FOR MORE INFORMATION ABOUT SIDE EFFECTS, SEE SECTION 4 “SIDE
EFFECTS".
1. WHAT IS ZEPATIER INTENDED FOR?
ZEPATIER is a prescription medicine to treat chronic (long-lasting)
hepatitis C genotypes 1 or 4 infection in
adults.
THERAPEUTIC GROUP: elbasvir- HCV NS5A inhibitor; grazoprevir- HCV
NS3/4A protease inhibitor.
2. BEF
ORE USING ZEPATIER
2.1 DO NOT US

Vara einkenni

ZEPATIER
®
50 MG/100 MG TABLETS
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredients are elbasvir 50 mg and grazoprevir 100 mg.
For the full list of excipients, see section "DESCRIPTION" below.
PHARMACEUTICAL FORM
Tablets
1
THERAPETIC INDICATIONS
ZEPATIER™ is indicated for the treatment of chronic hepatitis C
(CHC) genotypes 1 or 4 infection in
adults.
2
DOSAGE AND ADMINISTRATION
2.1
TESTING PRIOR TO THE INITIATION OF THERAPY
Testing for HBV Infection
Test all patients for evidence of current or prior HBV infection by
measuring hepatitis B surface
antigen (HBsAg) and hepatitis B core antibody (anti-HBc) before
initiating HCV treatment with ZEPATIER
[see Warnings and Precautions (5.1)].
NS5A Resistance Testing in Hepatitis C Virus (HCV) Genotype
1a-Infected Patients
Testing patients with HCV genotype 1a infection for the presence of
virus with NS5A resistance-
associated polymorphisms is recommended prior to initiation of
treatment with ZEPATIER to determine
dosage regimen and duration _ [see Dosage and Administration (2.2)],
Table 1_. In subjects receiving
ZEPATIER for 12 weeks, sustained virologic response (SVR12) rates were
lower in genotype 1a-infected
patients with one or more baseline NS5A resistance-associated
polymorphisms at amino acid positions 28,
30, 31, or 93 _[see Microbiology (12.4)], Table 11_.
Hepatic Laboratory Testing
Obtain hepatic laboratory testing prior to and during treatment with
ZEPATIER _[see Warnings and _
_Precautions (5.2, 5.3)]._
2.2
RECOMMENDED DOSAGE IN ADULTS
ZEPATIER is a two-drug, fixed-dose combination product containing 50
mg of elbasvir and 100 mg of
grazoprevir in a single tablet. The recommended dosage of ZEPATIER is
one tablet taken orally once
daily with or without food
_[see Clinical Pharmacology (12.3)]_. The film-coated tablets should
be swallowed
whole
.
ZEPATIER is used in combination with ribavirin in certain patient
populations (see Table 1)
.
When
administered with ZEPATIER, the recommended dosage of ribavirin in
patients without renal impairment
is