ESBRIET

Land: Indonesia

Språk: indonesisk

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

Aktiv ingrediens:

PIRFENIDONE

Tilgjengelig fra:

BOEHRINGER INGELHEIM INDONESIA - Indonesia

INN (International Name):

PIRFENIDONE

Dosering :

267 MG

Legemiddelform:

KAPSUL

Enheter i pakken:

DUS, 14 BLISTER @ 18 KAPSUL

Produsert av:

CATALENT PHARM SOLUTION - USA

Autorisasjon dato:

2018-08-02

Preparatomtale

_Draft_Esbriet_PI_MAT_CDS10.0_EN_v2_
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Page 1 of 16
ESBRIET
®
Pirfenidone
1.
DESCRIPTION
1.1
THERAPEUTIC/PHARMACOLOGIC CLASS OF DRUG
Pirfenidone belongs to the chemical class of pyridine derivative.
ATC code: L04AX05.
1.2
TYPE OF DOSAGE FORM
Hard capsule.
Two piece capsules with a white to off-white opaque cap and a white
opaque body imprinted with "PFD
267 mg" in brown ink and containing a white to pale yellow powder.
1.3
ROUTE OF ADMINISTRATION
For oral use.
1.4
STERILE/RADIOACTIVE STATEMENT
Not applicable.
1.5
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Active ingredient: _pirfenidone_. _
_ _
Esbriet (pirfenidone) 267 mg capsules.
2.
CLINICAL PARTICULARS
2.1
THERAPEUTIC INDICATION
Esbriet is indicated to slow the progression of idiopathic pulmonary
fibrosis (IPF) in adult patients
with mild to moderate IPF.
The studies beyond 48 weeks of treatment showed inconsistent efficacy
result.
2.2
DOSAGE AND ADMINISTRATION
METHOD OF ADMINISTRATION
Esbriet is to be swallowed whole with water and taken with food to
reduce the possibility of nausea and
dizziness (see sections_ 2.6 Undesirable Effects_ and_ 3.2
Pharmacokinetic Properties_).
TESTING PRIOR TO ESBRIET ADMINISTRATION
Conduct liver function tests prior to initiating treatment with
Esbriet.
DISETUJUI OLEH BPOM : 08/06/2021
EREG100364VR12000346
_Draft_Esbriet_PI_MAT_CDS10.0_EN_v2_
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Page 2 of 16
POSOLOGY
_Adults _
The recommended daily dose of Esbriet for patients with IPF is three
267 mg capsules three times a day
with food for a total of 2403 mg/day.
Upon initiating treatment, the dose should be titrated to the
recommended daily dose of nine capsules per
day over a 14 day period as follows:

Days 1 to 7: one capsule, three times a day (801 mg/day)

Days 8 to 14: two capsules, three times a day (1602 mg/day)

Day 15 onward: three capsules, three times a day (2403 mg/day)
Doses above 2403 mg/day are not recommended for any patient (see
section _2.7 Overdose)._
Patients who miss 14 consecutive days or more of Esbriet treatment
should re-initiate therapy