JAKAVI ruxolitinib (as phosphate) 10 mg tablet bottle

País: Australia

Idioma: inglés

Fuente: Department of Health (Therapeutic Goods Administration)

Ingredientes activos:

ruxolitinib phosphate

Disponible desde:

Novartis Pharmaceuticals Australia Pty Ltd

Designación común internacional (DCI):

Ruxolitinib phosphate

Estado de Autorización:

Registered

Ficha técnica

1
AUSTRALIAN PRODUCT INFORMATION - JAKAVI

(RUXOLITINIB)
1.
NAME OF THE MEDICINE
Australian Approved Name: ruxolitinib
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Jakavi tablets contain 5 mg, 10mg, 15 mg and 20 mg of ruxolitinib as
the phosphate salt.
Ruxolitinib phosphate is a white to almost white powder.
Excipients with known effects: Contains sugars, as lactose
monohydrate.
For the full list of excipients, section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
5MG TABLET:
Round curved white to almost white tablets of approximately 7.5 mm in
diameter
with “NVR” debossed on one side and “L5” debossed on the other
side.
10MG TABLET:
Round curved white to almost white tablets of approximately 9.3 mm in
diameter
with “NVR” debossed on one side and “L10” debossed on the
other side.
15 MG TABLET:
Ovaloid curved white to almost white tablets of approximately 15.0 x
7.0 mm
with “NVR” debossed on one side and “L15” debossed on the
other side.
20 MG TABLET:
Elongated curved white to almost white tablets of approximately 16.5 x
7.4 mm
with “NVR” debossed one one side and “L20” debossed on the
other side,.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Jakavi
®
is indicated for the treatment of disease-related splenomegaly or
symptoms in patients
with
primary
myelofibrosis,
post-polycythemia
vera
myelofibrosis
or
post-essential
thrombocythemia myelofibrosis.
Jakavi
®
is indicated for the treatment of adult patients with polycythemia
vera who are resistant
to or intolerant of hydroxyurea.
4.2 DOSE AND METHOD OF 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 Precautions section).
2
DOSE
Jakavi is given orally twice daily with or without food in
Myelofibrosis. The recommended
starting dose is based on platelet count (Table 1).
TABLE 1 RECOMMENDED JAKAVI STARTING DOSE
PLATEL