ZEPATIER

Krajina: Indonézia

Jazyk: indonézština

Zdroj: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Aktívna zložka:

GRAZOPREVIR HYDRATE, ELBASVIR

Dostupné z:

ORGANON PHARMA INDONESIA TBK - Indonesia

INN (Medzinárodný Name):

GRAZOPREVIR HYDRATE, ELBASVIR

Dávkovanie:

102,3 MG /50 MG

Forma lieku:

TABLET SALUT SELAPUT

Počet v balení:

DUS, 2 AMPLOP @ 2 BLISTER @ 7 TABLET SALUT SELAPUT

Výrobca:

SCHERING-PLOUGH LABO NV - Belgium

Dátum Autorizácia:

2021-06-17

Súhrn charakteristických

ZEPATIER (ELBASVIR AND GRAZOPREVIR)
FILM-COATED TABLET
1.
INDICATIONS AND USAGE
ZEPATIER is indicated for the treatment of chronic hepatitis C (CHC)
genotypes 1 (1a and
1b) infection in adults.
2.
DOSAGE AND ADMINISTRATION
2.1
GENERAL
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.
2.2
ADULTS
Treatment Regimen and Duration of Therapy
Table 1 below provides the recommended ZEPATIER treatment regimen and
duration based
on the patient population and genotype in hepatitis C virus (HCV)
mono-infected and
HCV/HIV-1 co-infected patients with or without cirrhosis.
DISETUJUI OLEH BPOM : 08/06/2021
ID : EREG100373VR12100077
TABLE 1: RECOMMENDED DOSAGE REGIMENS AND DURATIONS FOR ZEPATIER FOR
TREATMENT OF
CHRONIC HEPATITIS C INFECTION IN PATIENTS WITH OR WITHOUT CIRRHOSIS
TREATMENT*
DURATION
TREATMENT-NAÏVE OR TREATMENT-EXPERIENCED
† RELAPSERS - GENOTYPE 1A OR 1B
ZEPATIER
12 weeks
TREATMENT-EXPERIENCED
†
ON-TREATMENT VIROLOGIC FAILURES
¶ - GENOTYPE 1A OR 1B
Genotype 1b
ZEPATIER
12 weeks
Genotype 1a
ZEPATIER with ribavirin
#,Þ
16 weeks
*Refer to the prescribing information of the medicinal products that
are used in combination with
ZEPATIER for specific dosing instructions.
†
Genotype 1a or 1b patients who have failed treatment with
peginterferon alfa + ribavirin or genotype 1
patients who failed peginterferon alfa + ribavirin + boceprevir,
simeprevir, or telaprevir.
¶
On-treatment virologic failures are patients who have had a null
response, partial response, virologic
breakthrough or rebound, or intolerance to prior treatment.
#
In clinical trials, the dose of ribavirin was weight-based (<66 kg =
800 mg/day, 66 to 80 kg = 1000 mg/day,
81 to 105 kg = 1200 mg/day, >105 kg = 1400 mg/day) administered in two
divided doses with food. For
further information on ribavirin dosing and dose modifications, refer
to the ribavirin prescribing informatio