SOLIRIS

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Eculizumab

Available from:

Alexion Pharmaceuticals Australasia Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

 
Version: August 2012 

1/3 
SOLIRIS
® 

CONCENTRATED SOLUTION FOR INTRAVENOUS INFUSION 

CONSUMER MEDICINE INFORMATION 

WHAT IS IN THIS LEAFLET 

This leaflet answers some common 
questions about Soliris
®
. 

It does not contain all the available 
information. 

It does not take the place of talking 
to your doctor or a trained health-
care professional. 

All medicines have risks and 
benefits. Your doctor has weighed 
the risks of you having Soliris
®

against the benefits they expect it 
will have. 

IF YOU HAVE ANY CONCERNS ABOUT 
THIS MEDICINE, ASK YOUR DOCTOR OR 
NURSE. 

KEEP THIS LEAFLET. 
You may need to read it again. 

WHAT SOLIRIS® IS USED 
FOR 

Soliris
®
 is a medicine containing an 
active substance called eculizumab 
(rmc) which belongs to a class of 
medicines called monoclonal 
antibodies.   

Soliris
®
 is used for the treatment of 
patients with a disease that affects 
red blood cells called Paroxysmal 
Nocturnal Haemoglobinuria (PNH).  

 Soliris® may also be used to treat 
patients with a condition called 
atypical Haemolytic Uraemic 
Syndrome (aHUS). 

HOW IT WORKS 

Patients with PNH lack naturally 
occurring protective proteins on the 
surface of some of their red blood 
cells. In normal individuals, these 
proteins protect red blood cells from 
destruction by the body’s 
inflammatory response. PNH 
patients lack these protective 
proteins and their red blood cells 
can be destroyed, which can lead to 
low blood counts (anaemia), 
tiredness, difficulty in functioning, 
pain, dark urine and  kidney failure, 
shortness of breath, and blood 
clots. 

Soliris
®
 binds to a certain protein 
(C5) in this inflammatory response, 
blocks part of your immune system, 
and prevents its ability to attack and 
destroy its own vulnerable PNH red 
blood cells.  In this way Soliris
®

improves anaemia, fatigue, and 
other signs

Summary of Product characteristics

Version: 24082012 

1 
PRODUCT INFORMATION 

NAME OF THE MEDICINE 

SOLIRIS
®

Eculizumab ‘rmc’, concentrated solution for
intravenous infusion (CAS registry number:  
219685-50-4). 
DESCRIPTION 
SOLIRIS
®
 (eculizumab ‘rmc’) is
a genetically-engineered humanized monoclonal antibody 
directed against the α-chain of the C5 complement
protein. The antibody is a glycosylated 
hybrid IgG2-IgG4 kappa immunoglobulin containing human light- and
heavy-chain variable 
region
framework sequences, murine complementarity-determining region
sequences, and 
human constant region sequences. Eculizumab ‘rmc’ is composed
of two identical 448 
amino acid heavy chains and two identical 214 amino acid light
chains, and has a molecular 
weight of approximately 148 kDa. 

The eculizumab ‘rmc’ antibody is produced by murine myeloma
cell culture and purified by 
standard bioprocess
chromatographic technology, including specific viral inactivation
and 
filtration steps. 

SOLIRIS
®
 is a sterile, clear, colourless, preservative-free 10 mg/mL
solution for intravenous 
infusion, and is supplied in 30 mL (300 mg) single-use vials.
The product is formulated at 
pH 7, and each vial contains 300 mg of eculizumab ‘rmc’,
13.8 mg monobasic sodium 
phosphate monohydrate, 53.4 mg dibasic sodium phosphate
heptahydrate, 263.1 mg sodium 
chloride, 6.6 mg polysorbate 80 (vegetable origin) and Water for
Injection. 

PHARMACOLOGY 
MECHANISM OF ACTION  
A genetic mutation in patients with Paroxysmal Nocturnal
Haemoglobinuria (PNH) leads to 
the generation of populations of abnormal red blood cells
(known as PNH RBCs) that are 
deficient in terminal complement inhibitors,
rendering PNH RBCs sensitive to persistent 
terminal complement-mediated destruction. The subsequent
intravascular haemolysis is the 
primary disease manifestation in PNH
patients. The destructio