JAKAVI ruxolitinib (as phosphate) 15 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ruxolitinib phosphate, Quantity: 19.8 mg (Equivalent: ruxolitinib, Qty 15 mg)

Available from:

Novartis Pharmaceuticals Australia Pty Ltd

INN (International Name):

Ruxolitinib phosphate

Pharmaceutical form:

Tablet

Composition:

Excipient Ingredients: povidone; microcrystalline cellulose; magnesium stearate; lactose monohydrate; sodium starch glycollate type A; colloidal anhydrous silica

Administration route:

Oral

Units in package:

168, 112, 56, 224, 28, 14

Prescription type:

(S4) Prescription Only Medicine

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 thrombocythaemia myelofibrosis.,Jakavi is indicated for the treatment of adult patients with polycythemia vera who are resistant to or intolerant of hydroxyurea.,Jakavi is indicated for the treatment of patients aged 12 years and older with acute graft-versus-host disease who have inadequate response to corticosteroids.,Jakavi is indicated for the treatment of patients aged 12 years and older with chronic graft-versus-host disease who have inadequate response to corticosteroids.

Product summary:

Visual Identification: Ovaloid curved white to almost white tablet with NVR debossed on one side and L15 debossed on the other side; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2013-07-03

Patient Information leaflet

JAKAVI
®
(JAK-AH-FYE)
_Ruxolitinib phosphate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Jakavi.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
final page. More recent information
on the medicine may be available.
YOU SHOULD ENSURE THAT YOU SPEAK
TO YOUR PHARMACIST OR DOCTOR TO
OBTAIN THE MOST UP TO DATE
INFORMATION ON THE MEDICINE. YOU
CAN ALSO DOWNLOAD THE MOST UP TO
DATE LEAFLET FROM
WWW.NOVARTIS.COM.AU.
Those updates may contain important
information about the medicine and
its use of which you should be aware.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking this medicine
against the benefits they expect it
will provide.
IF YOU HAVE ANY CONCERNS ABOUT THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT JAKAVI IS USED
FOR
Jakavi is used to treat adult patients
with myelofibrosis, a rare form of
blood disorder with a variety of
symptoms such as fever, night
sweats, bone pain, weight loss.
Enlarged spleen is one of the
characteristics of myelofibrosis.
Jakavi is also used to treat patients
with polycythemia vera who are
intolerant of or not controlled with
hydroxyurea. Polycythemia vera is a
rare serious blood disorder with a
variety of troublesome symptoms
such as itching (pruritus), headache,
vision problems, severe burning pain
in the hands or feet, and blood
vessels clots. Enlarged spleen is also
sometimes present in patients with
polycythemia vera.
Jakavi contains the active substance
ruxolitinib phosphate.
This medicine belongs to a group of
medicines called Jak inhibitors.
Myelofibrosis is a disorder of the
bone marrow, in which the marrow is
replaced by scar tissue. The abnormal
marrow can no longer produce
enough normal blood cells and
results in a significantly enlarged
spleen. Jakavi can reduce

Summary of Product characteristics

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 section 4.4. Special warnings and
precautions for use).
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