GILENYA

Maa: Indonesia

Kieli: indonesia

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

Aktiivinen ainesosa:

FINGOLIMOD HYDROCHLORIDE

Saatavilla:

NOVARTIS INDONESIA - Indonesia

INN (Kansainvälinen yleisnimi):

FINGOLIMOD HYDROCHLORIDE

Annos:

0.5 MG

Lääkemuoto:

KAPSUL

Kpl paketissa:

DUS, 2 BLISTER @ 14 KAPSUL

Valmistaja:

NOVARTIS PHARMA STEIN A.G., STEIN, SWISS

Valtuutus päivämäärä:

2016-03-08

Valmisteyhteenveto

GILENYA
(fingolimod)
0.5 mg hard capsules
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORM
Hard capsules
ACTIVE SUBSTANCE
Each capsule contains 0.5 mg fingolimod (as hydrochloride)
Fingolimod hydrochloride is a synthetic analogue of sphingosine. The
chemical designation is
2-amino-2[2-(4-octylphenyl)ethyl]propane-1,3-diol hydrochloride. Its
molecular formula is
C19H33NO2-HCl and it has a molecular weight of 343.93.
Fingolimod hydrochloride is a white to almost white crystalline powder
which is freely soluble
in water.
EXCIPIENTS
Mannitol, magnesium stearate, titanium dioxide, gelatin, yellow iron
oxide.
INDICATIONS
Gilenya is indicated for the treatment of Relapsing Remitting Multiple
Sclerosis in patients with
high disease activity despite treatment with at least one disease
modifying therapy to delay the
progression of disability and reduce frequency of relapse.
These patients may be defined as those who have failed to respond to a
full and adequate course
(normally at least one year of treatment) of at least one disease
modifying therapy. Patients
should have had at least 1 relapse in the previous year while on
therapy, and have at least 9 T2-
hyperintense lesions in cranial MRI or at least 1 Gadolinium-enhancing
lesion. A “non-
responder” could also be defined as a patient with an unchanged or
increased relapse rate or
ongoing severe relapses, as compared to the previous year.
DOSAGE REGIMEN AND ADMINISTRATION
GENERAL TARGET POPULATION
The recommended dose of Gilenya is one 0.5 mg capsule taken orally
once daily, which can be
taken with or without food. If a dose is missed treatment should be
continued with the next dose
as planned.
DISETUJUI OLEH BPOM : 31/03/2021
ID : EREG100005VR12000286
Novartis
Page 2
Leaflet
Gilenya
On initiation of Gilenya treatment, after the first dose, it is
recommended that all patients be
observed, with hourly pulse and blood pressure measurement, for a
period of 6 hours for signs
and symptoms of bradycardia. All patients should have an
electrocardiogram performed prior
to dosi