Epclusa tablets film-coated

Kraj: Armenia

Język: angielski

Źródło: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Składnik aktywny:

sofosbuvir, velpatasvir

Dostępny od:

Gilead Sciences Ireland UC

Kod ATC:

J05AP55

INN (International Nazwa):

sofosbuvir, velpatasvir

Dawkowanie:

400mg+ 100mg

Forma farmaceutyczna:

tablets film-coated

Sztuk w opakowaniu:

(28) plastic container

Typ recepty:

Prescription

Status autoryzacji:

Registered

Data autoryzacji:

2019-04-22

Ulotka dla pacjenta

1
PATIENT INFORMATION EPCLUSA
TM (EP-KLOO-SUH)
400 MG/100 MG
(sofosbuvir and velpatasvir)
film-coated
tablets
IMPORTANT: IF YOU TAKE EPCLUSA
TM WITH RIBAVIRIN, YOU SHOULD ALSO READ THE MEDICATION GUIDE FOR
RIBAVIRIN.
WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT EPCLUSA
TM
?
EPCLUSA
TM
can cause serious side effects, including,
HEPATITIS B VIRUS REACTIVATION: Before starting treatment
with EPCLUSA
TM
, your healthcare provider 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 with
EPCLUSA
TM
. Hepatitis B virus becoming active again (called reactivation) may
cause serious liver
problems including liver failure and death. Your healthcare provider
will monitor you if you are at risk for
hepatitis B virus reactivation during treatment and after you stop
taking EPCLUSA
TM
.
FOR MORE INFORMATION ABOUT SIDE EFFECTS, SEE THE SECTION “WHAT ARE
THE POSSIBLE SIDE EFFECTS OF
EPCLUSA
TM
?”
WHAT IS EPCLUSA
TM
?
•
EPCLUSA
TM
is a prescription medicine used to treat adults with chronic (lasting
a long time) hepatitis
C virus
(HCV) genotype 1, 2, 3, 4, 5, or 6 infection:
o
without cirrhosis or with compensated cirrhosis
o
with advanced cirrhosis (decompensated) in combination with ribavirin
It is not known if EPCLUSA
TM
is safe and effective in children under 18 years of age.
BEFORE TAKING EPCLUSA
TM
, TELL YOUR HEALTHCARE PROVIDER ABOUT ALL OF YOUR MEDICAL CONDITIONS,
INCLUDING IF YOU:
•
have ever had hepatitis B virus infection
•
have liver problems other than hepatitis C infection
•
have kidney problems or you are on dialysis
•
have HIV-1 infection
•
are pregnant or plan to become pregnant. It is not known if EPCLUSA
TM
will harm your unborn baby.
o
Females who take EPCLUSA
TM
in combination with ribavirin should avoid becoming pregnant
during treatment and for 6 months after stopping treatment. Call your
healthcare provider right
away if you

Charakterystyka produktu

1
SUMMARY OF MEDICINAL PRODUCT CHARACTERISTICS
GILEAD ACCESS PROGRAM
FULL PRESCRIBING INFORMATION
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
TM
. 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 _
_WARNINGS AND PRECAUTIONS (5.1)]_.
1
INDICATIONS AND USAGE
EPCLUSA
TM
is indicated for the treatment of adult patients with chronic
hepatitis C virus
(HCV) genotype 1, 2, 3, 4, 5, or 6 infection _[see Dosage and
Administration (2.2) and _
_Clinical Studies (14)]_:
•
without cirrhosis or with compensated cirrhosis
•
with decompensated cirrhosis for use in combination with ribavirin.
2
DOSAGE AND ADMINISTRATION
2.1
TESTING PRIOR TO THE INITIATION OF THERAPY
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 EPCLUSA
TM
_[see Warnings and Precautions (5.1)]_.
2.2
RECOMMENDED DOSAGE
The recommended dosage of EPCLUSA
TM
is one film-coated
tablet taken orally once
daily with or without food _[see Clinical Pharmacology (12.3)]_. One
film-coated
tablet of
EPCLUSA
TM
contains 400 mg of sofosbuvir and 100 mg of velpatasvir. Table 1 shows
the recommended treatment regimen and duration based on patient
population_. _
_ _
For patients with HCV/HIV-1 coinfection, follow the dosage
recommendations in Table 1
_[see Clinical Studies (14.3)]. _Refer to _Drug Interactions (7)_ for
dosage recommendation