Negara: Indonesia
Bahasa: Bahasa Indonesia
Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
FINGOLIMOD HYDROCHLORIDE
NOVARTIS INDONESIA - Indonesia
FINGOLIMOD HYDROCHLORIDE
0.5 MG
KAPSUL
DUS, 2 BLISTER @ 14 KAPSUL
NOVARTIS PHARMA STEIN A.G., STEIN, SWISS
2016-03-08
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 Baca dokumen lengkapnya