Jakavi

Riik: Austraalia

keel: inglise

Allikas: Department of Health (Therapeutic Goods Administration)

Toimeaine:

Ruxolitinib phosphate

Saadav alates:

Novartis Pharmaceuticals Australia Pty Ltd

Klass:

Medicine Registered

Infovoldik

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 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 spleen size
in patients with different forms of
myelofibrosis and relieve the
symptoms.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
Jakavi is not addictive.
Jakavi is available only with a
doctor's prescription.
There is not enough information to
recommend the use of this medicine
for

Toote omadused

1 

JAKAVI


RUXOLITINIB 
NAME OF THE MEDICINE 
STRUCTURAL FORMULA: 

The active ingredient of Jakavi is ruxolitinib (as the phosphate
salt) or (_R_)-3-(4-(7_H_-
Pyrrolo[2,3-_d_]pyrimidin-4-yl)-1_H_-pyrazol-1-yl)-3-cyclopentylpropanenitrile
phosphate

INN:  

ruxolitinib   

CAS NAME .: 
1H-Pyrazole-1-propanenitrile, β-cyclopentyl-4-(7H-pyrrolo[2,3-
d]pyrimidin-4-yl)-, (βR)-, phosphate (1:1); 941678-49-5    
CAS NUMBER.: 
1092939-17-7 

MOLECULAR FORMULA:  C
17
H
18
N
6

MOLECULAR WEIGHT OF THE PHOSPHATE SALT: 404.36 
MOLECULAR WEIGHT OF THE FREE BASE: 306.37 

DESCRIPTION 
Ruxolitinib phosphate is a white to almost white powder. It is highly soluble in water, most 
soluble at low pH (pH 3.3) at 37
o
C. The pKa is 4.3 and 11.8. The BCS is Class 1. 
Jakavi tablets contain 5 mg, 15 mg and 20 mg of ruxolitinib as the
phosphate salt.  
EXCIPIENTS 
Jakavi  tablets  contain  the  following  excipients:  cellulose,  microcrystalline;  magnesium 
stearate; 
silica, 
colloidal 
anhydrous; 
sodium 
starch 
glycollate 
type 
A; 
hydroxypropylcellulose; povidone; lactose. 

2

PHARMACOLOGY 
MECHANISM OF ACTION (MOA) 
Ruxolitinib  is  an    inhibitor  of  the  Janus  Associated  Kinases  (JAKs)  JAK1  and  JAK2  with 
nanomolar potency. JAKs mediate the signaling of a number of cytokines and growth factors 
that  are  important  for  haematopoiesis  and  immune  function.  JAK  signalling  involves 
recruitment  of  STATs  (signal  transducers  and  activators  of  transcription)  to  cytokine 
receptors,  activation,  and  subsequen