Eliquis

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Apixaban

Available from:

Bristol-Myers Squibb Australia Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

ELIQUIS
®

(ELLE-E-KUIS)
_apixaban_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Eliquis.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Eliquis against
the benefits it is expected to have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT ELIQUIS IS USED
FOR
_WHAT ELIQUIS DOES_
This medicine is used to prevent
blood clots in your veins after a hip
or knee replacement surgery.
After an operation you are at an
increased risk of getting blood clots.
It is also used to prevent stroke and
blood clots in a condition called atrial
fibrillation, which is a type of
abnormal heart rhythm.
With atrial fibrillation, part of the
heart does not beat the way it should.
This can lead to blood clots forming
and increase your risk of having a
stroke.
_HOW ELIQUIS WORKS_
The active substance in Eliquis is
apixaban. It belongs to a group of
medicines called antithrombotic
agents.
It works by inhibiting a blood clot
forming substance called Factor Xa.
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.
This medicine is not addictive.
This medicine is available only with
a doctor's prescription.
This medicine is not expected to
affect your ability to drive a car or
operate machinery.
_USE IN CHILDREN_
There is not enough information to
recommend the use of this medicine
in children and adolescents under the
age of 18 years.
BEFORE YOU TAKE
ELIQUIS
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE ELIQUIS IF YOU HAVE AN
ALLERGY TO:
•
any medicine containing apixaban
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may include:
•
shortness of brea

Summary of Product characteristics

Version:bgpeliqu10713 

Supersedes: bgpeliqu10413  

Page 1 of 42 
PRODUCT INFORMATION 
ELIQUIS
®

APIXABAN 
NAME OF THE MEDICINE 
Apixaban,  a  selective  inhibitor  of  the  coagulation  Factor  Xa  (FXa),  is  chemically 
described  as  1-(4-Methoxyphenyl)-7-oxo-6-[4-(2-oxopiperidin-1-yl)phenyl]-4,5,6,7-
tetrahydro-1_H_-pyrazolo[3,4-_c_]pyridine-3-carboxamide.    Its  molecular  formula  is 
C
25
H
25
N
5
O
4
,  which  corresponds  to  a  molecular  weight  of  459.5.    Apixaban  has  the 
following structural formula: 
N
N
N
H
3
CO
H
2
N
O
O
N
O

CAS Number: 503612-47-3 
DESCRIPTION 
Apixaban is a white to pale yellow powder.  At physiological pH (1.2 - 6.8), apixaban 
does  not  ionize;  its  aqueous  solubility  across  the  physiological  pH  range  is  ~0.04 
mg/mL.  The octanol/water partition coefficient is 44.7 at pH
7.4. 
ELIQUIS  film-coated  tablets  are  available  for  oral  administration  in  strengths  of  2.5 
mg  and  5  mg  apixaban  with  the  following  inactive  ingredients:  anhydrous  lactose, 
cellulose  -  microcrystalline,  croscarmellose  sodium,  sodium  lauryl  sulfate,  and 
magnesium  stearate.    The  film  coating  contains  lactose  monohydrate,  hypromellose, 
titanium dioxide, glycerol triacetate and yellow iron oxide (2.5 mg tablets) or red iron 
oxide (5 mg tablets). 
PHARMACOLOGY 
PHARMACODYNAMICS 
The  pharmacodynamic  effects  of  apixaban  are  reflective  of  the  mechanism  of  action 
(FXa inhibition).  As a result of FXa inhibition, apixaban prolongs clotting tests such 
Version:bgpeliqu10713 

Supersedes: bgpeliqu10413  

Page 2 of 42 
as  prothrombin  time  (PT),  INR  and  activated  partial  thromboplastin  time  (aPTT).

Changes observed in these clotti