MAVIRET (GLECAPREVIR 100MG/ PIBRENTASVIR 40MG) FILM COATED TABLETS

Kraj: Malezja

Język: angielski

Źródło: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Składnik aktywny:

Glecaprevir; Pibrentasvir

Dostępny od:

ABBVIE SDN BHD

INN (International Nazwa):

Glecaprevir; Pibrentasvir

Sztuk w opakowaniu:

21 Tablets; 84 Tablets

Wyprodukowano przez:

Fournier Laboratories Ireland Limited

Ulotka dla pacjenta

_Consumer Medication Information Leaflet (RiMUP)_
MAVIRET FILM-COATED TABLETS
Glecaprevir 100mg/Pibrentasvir 40mg
_____________________________________________________________________________________
______________________________________________________________________
1
WHAT IS IN THIS LEAFLET
1. What Maviret is used for
2. How Maviret works
3. Before you take Maviret
4. How to take Maviret
5. While you are using Maviret
6. Side effects of Maviret
7. Storage and disposal of
Maviret
8. Product description
9. Manufacturer and
Registration Holder
10. Date of revision
WHAT MAVIRET IS USED FOR
Maviret is an antiviral medicine
used to treat adults and
adolescents (12 to less than 18
years old) with long-term
(‘chronic’) hepatitis C (an
infectious disease that affects
the liver, caused by the hepatitis
C virus).
HOW MAVIRET WORKS
Maviret works by stopping the
hepatitis C virus from
multiplying and infecting new
cells. This allows the infection to
be eliminated from the body
BEFORE YOU TAKE MAVIRET
_When you must not take Maviret _
DO NOT TAKE MAVIRET IF:

you are allergic to
glecaprevir, pibrentasvir or
any of the other ingredients
of this medicine (listed
under PRODUCT DESCRIPTION
section).

you have severe liver
problems other than from
hepatitis C.

you are taking the following
medicines:

atazanavir (for HIV
infection)

atorvastatin or
simvastatin (to lower
blood cholesterol)

carbamazepine,
phenobarbital,
phenytoin, primidone
(normally used for
epilepsy)

dabigatran etexilate (to
prevent blood clots)

ethinyl oestradiol-
containing medicines
(such as contraception
medicines, including
vaginal rings and
tablets)

rifampicin (for
infections)

St. John’s wort
(_Hypericum _
_perforatum_), (herbal
remedy used for mild
depression).
If you are not sure, talk to your
doctor or pharmacist before
taking Maviret.
_Before you start taking _
_Maviret _
YOU MUST TELL YOUR HEALTHCARE
PROVIDER ABOUT ALL YOUR
MEDICAL CONDITIONS, INCLUDING
IF YOU:
•
have liver problems other
than hepatitis C i

Charakterystyka produktu

MAVIRET (GLECAPREVIR 100MG/ PIBRENTASVIR 40MG) FILM COATED
TABLETS
PACKAGE INSERT
PRODUCT NAME
GENERIC NAME:
Glecaprevir 100mg/Pibrentasvir 40mg
TRADE NAMES
Maviret
DESCRIPTION
Pink, oblong, biconvex, film-coated tablet of dimensions 18.8 mm x
10.0 mm, debossed on one
side with ‘NXT’.
Maviret is a fixed-dose combination tablet containing glecaprevir and
pibrentasvir for oral
administration. Glecaprevir is a HCV NS3/4A PI, and pibrentasvir is a
HCV NS5A inhibitor.
Glecaprevir/Pibrentasvir Film-Coated Immediate Release Tablets
Each tablet contains 100 mg of glecaprevir and 40 mg of pibrentasvir.
Glecaprevir and
pibrentasvir are presented as a fixed-dose combination, immediate
release bilayer tablet.
Glecaprevir
The chemical name of glecaprevir is
(3a_R_,7_S_,10_S_,12_R_,21_E_,24a_R_)-7-_tert_-butyl-_N_-{(1_R_,2_R_)-2-
(difluoromethyl)-1-[(1-methylcyclopropane-1-sulfonyl)carbamoyl]cyclopropyl}-20,20-difluoro-
5,8-dioxo-2,3,3a,5,6,7,8,11,12,20,23,24a-dodecahydro-1_H_,10_H_-9,12-
methanocyclopenta[18,19][1,10,17,3,6]trioxadiazacyclononadecino[11,12-b]quinoxaline-10-
carboxamide hydrate.
The molecular formula is C
38
H
46
F
4
N
6
O
9
S (anhydrate) and the molecular weight for the drug
substance is 838.87 g/mol (anhydrate). Glecaprevir is a white to
off-white crystalline powder
with a solubility of less than 0.1 to 0.3 mg/mL across a pH range of
2–7 at 37°C and is
practically insoluble in water, but is sparingly soluble in ethanol.
Pibrentasvir
The chemical name of pibrentasvir is Methyl
{(2_S_,3_R_)-1-[(2_S_)-2-{5-[(2_R_,5_R_)-1-{3,5-difluoro-4-
[4-(4-fluorophenyl)piperidin-1-yl]phenyl}-5-(6-fluoro-2-{(2_S_)-1-[_N_-(methoxycarbonyl)-_O_-
methyl-L-threonyl]pyrrolidin-2-yl}-1_H_-benzimidazol-5-yl)pyrrolidin-2-yl]-6-fluoro-1_H_-
benzimidazol-2-yl}pyrrolidin-1-yl]-3-methoxy-1-oxobutan-2-yl}carbamate.
The molecular formula is C
57
H
65
F
5
N
10
O
8
and the molecular weight for the drug substance is
1113.18 g/mol. Pibrentasvir is a white to off-white to light yellow
crystalline powder with a
solubility of less than 0.