JAKAVI

البلد: أندونيسيا

اللغة: الإندونيسية

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

العنصر النشط:

RUXOLITINIB PHOSPHATE

متاح من:

NOVARTIS INDONESIA - Indonesia

INN (الاسم الدولي):

RUXOLITINIB PHOSPHATE

جرعة:

19.80 MG

الشكل الصيدلاني:

TABLET

الوحدات في الحزمة:

DUS, 1 BLISTER @ 14 TABLET

المصنعة من قبل:

NOVARTIS PHARMA STEIN AG - Switzerland

تاريخ الترخيص:

2019-11-29

خصائص المنتج

JAKAVI
®
RUXOLITINIB
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORM(S)
5 mg tablets: round curved white to almost white tablets with
‘NVR’debossed on one side and
‘L5’ debossed on the other side
15 mg tablets: ovaloid curved white to almost white tablets with
‘NVR’ debossed on one side
and ‘L15’ debossed on the other side
20 mg tablets: elongated curved white to almost white tablets with
‘NVR’ debossed on one
side and ‘L20’ debossed on the other side
ACTIVE SUBSTANCE(S)
Ruxolitinib phosphate
Ruxolitinib 5 mg per tablet
Ruxolitinib 15 mg per tablet
Ruxolitinib 20 mg per tablet
ACTIVE MOIETY
Ruxolitinib
EXCIPIENTS
Cellulose,
microcrystalline;
Lactose
monohydrate;
Magnesium
stearate;
Silica,
colloidal
anhydrous; Sodium starch glycolate (Type A); Hydroxypropylcellulose;
Povidone
Each 5 mg tablet contains 71.45 mg of lactose monohydrate
Each 15 mg tablet contains 214.35 mg of lactose monohydrate
Each 20 mg tablet contains 285.80 mg of lactose monohydrate
INDICATIONS
_MYELOFIBROSIS _
Jakavi
®
is indicated for the treatment of patients with myelofibrosis,
including primary
myelofibrosis,
post-polycythemia
vera
myelofibrosis
or
post-essential
thrombocythemia
myelofibrosis.
_POLYCYTHEMIA VERA _
Jakavi is indicated for the treatment of patients with polycythemia
who are resistant to or
intolerant of hydroxyurea.
DISETUJUI OLEH BPOM: 19/06/2023
ID:EREG10000512200291- EREG10000512200296
Novartis
Page 2
Product Information
Jakavi
®
(ruxolitinib)
DOSAGE REGIMEN AND ADMINISTRATION
MONITORING INSTRUCTIONS
BLOOD CELL COUNTS: a blood cell count must be performed before
initiating therapy with Jakavi.
Complete blood counts should be monitored every 2 to 4 weeks until
doses are stabilized, and
then as clinically indicated (see section Warnings and precautions).
STARTING DOSE
The recommended starting dose of Jakavi in myelofibrosis (MF) is based
on platelet counts
(see Table 1):
TABLE 1
STARTING DOSES IN MYELOFIBROSIS
PLATELET COUNT
STARTING DOSE
Greater than 200,000/mm
3
100,000 to 200,000/mm
3
75,000 to