MAVIRET

Country: Իսրայել

language: անգլերեն

source: Ministry of Health

active_ingredient:

GLECAPREVIR; PIBRENTASVIR

MAH:

ABBVIE BIOPHARMACEUTICALS LTD, ISRAEL

ATC_code:

J05AP57

pharmaceutical_form:

FILM COATED TABLETS

composition:

PIBRENTASVIR 40 MG; GLECAPREVIR 100 MG

administration_route:

PER OS

prescription_type:

Required

manufactured_by:

ABBVIE DEUTSCHLAND GMBH & CO. KG, GERMANY

therapeutic_area:

GLECAPREVIR AND PIBRENTASVIR

therapeutic_indication:

Maviret is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults and in adolescents aged 12 to <18 years

authorization_date:

2018-02-12

PIL

WEAR GLASSES IF YOU NEED THEM. IF YOU HAVE
ANY FURTHER QUESTIONS REGARDING THE USE OF THE
MEDICINE, ASK YOUR DOCTOR OR PHARMACIST.
4. SIDE EFFECTS
As with any medicine, use of Maviret may cause
side effects in some users. Do not be alarmed when
reading the list of side effects. You may not suffer
from any of them.
• IN PEOPLE WHO HAD OR HAVE ADVANCED LIVER
PROBLEMS BEFORE STARTING TREATMENT WITH
MAVIRET: RARE RISK OF WORSENING LIVER PROBLEMS,
LIVER FAILURE AND DEATH. Your doctor will check
you for signs and symptoms of worsening liver
problems during treatment with Maviret. Tell
your doctor right away if you have any of the
following signs and symptoms: nausea, tiredness,
yellowing of your skin or white part of your eyes,
bleeding or bruising more easily than normal,
confusion, dark or black or bloody stool, loss of
appetite, diarrhea, dark or brown (tea-colored)
urine, swelling or pain on the upper right side
of your stomach area (abdomen), sleepiness,
vomiting of blood, lightheadedness.
TELL YOUR DOCTOR OR PHARMACIST IF YOU NOTICE ANY
OF THE FOLLOWING SIDE EFFECTS:
VERY COMMON SIDE EFFECTS - effects that occur in
more than 1 user in 10:
• feeling very tired (fatigue)
• headache
COMMON SIDE EFFECTS - effects that occur in 1-10
users in 100:
• feeling sick (nausea)
• diarrhoea
• feeling weak or lack of energy (asthenia)
• increase in bilirubin levels (a laboratory test for
liver function)
UNCOMMON SIDE EFFECTS - effects that occur in
1-10 users in 1,000:
• swelling of the face, lips, tongue, throat, abdomen,
arms or legs
SIDE EFFECTS OF UNKNOWN FREQUENCY - effects
whose frequency has not been determined yet:
• itching
IF A SIDE EFFECT HAS OCCURRED, IF ANY OF THE SIDE
EFFECTS WORSEN OR IF YOU SUFFER FROM A SIDE
EFFECT NOT MENTIONED IN THE LEAFLET, CONSULT THE
DOCTOR.
REPORTING SIDE EFFECTS
Side effects can be reported to the Ministry of
Health by clicking on the link “Report Side Effects
due to Drug Treatment” found on the Ministry of
Health homepage (www.health.gov.il) that directs
to the on

SPC

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Page 1 of 25
1.
NAME OF THE MEDICINAL PRODUCT
Maviret
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 100 mg glecaprevir and 40 mg
pibrentasvir.
Excipient with known effect
Each film-coated tablet contains 7.48 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Pink, oblong, biconvex, film-coated tablet of dimensions 18.8 mm x
10.0 mm, debossed on one side
with ‘NXT’', plain on the other.
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 MAVIRET. 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
.
4.1.
THERAPEUTIC INDICATIONS
Maviret is indicated for the treatment of chronic hepatitis C virus
(HCV) infection in adults and in
adolescents aged 12 to <18 years (see sections 4.2, 4.4. and 5.1).
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Maviret treatment should be initiated and monitored by a physician
experienced in the management of
patients with HCV infection.
Posology
_Adults and adolescents aged 12 to <18 years _
The recommended dose of Maviret is 300 mg/120 mg (three 100 mg/40 mg
tablets), taken orally, once
daily at the same time with food (see section 5.2).
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Page 2 of 25
The recommended Maviret treatment durations for HCV genotype 1, 2, 3,
4, 5, or 6 infected patients
with compensated liver disease (with or without cirrhosis) are
provided in Table 1 and Table 2.