Soliris

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

Eculizumab

Available from:

Alexion Europe SAS

ATC code:

L04AA25

INN (International Name):

eculizumab

Therapeutic group:

Immunosuppressants

Therapeutic area:

Hemoglobinuria, Paroxysmal

Therapeutic indications:

Soliris is indicated in adults and children for the treatment of:Paroxysmal nocturnal haemoglobinuria (PNH).Evidence of clinical benefit is demonstrated in patients with haemolysis with clinical symptom(s) indicative of high disease activity, regardless of transfusion history (see section 5.1). Atypical haemolytic uremic syndrome (aHUS).Soliris is indicated in adults for the treatment of:Refractory generalized myasthenia gravis (gMG) in patients who are anti-acetylcholine receptor (AChR) antibody-positive (see section 5.1).Neuromyelitis optica spectrum disorder (NMOSD) in patients who are anti-aquaporin-4 (AQP4) antibody-positive with a relapsing course of the disease.

Product summary:

Revision: 36

Authorization status:

Authorised

Authorization date:

2007-06-20

Patient Information leaflet

49
B. PACKAGE LEAFLET
_ _
_ _
50
PACKAGE LEAFLET: INFORMATION FOR THE USER
SOLIRIS 300 MG CONCENTRATE FOR SOLUTION FOR INFUSION
Eculizumab
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even
if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Soliris is and what it is used for
2.
What you need to know before you use Soliris
3.
How to use Soliris
4.
Possible side effects
5.
How to store Soliris
6.
Contents of the pack and other information
1.
WHAT SOLIRIS IS AND WHAT IT IS USED FOR
WHAT IS SOLIRIS
Soliris contains the active substance eculizumab and it belongs to a
class of medicines called monoclonal
antibodies. Eculizumab binds to and inhibits a specific protein in the
body that causes inflammation and so
prevents your body’s systems from attacking and destroying
vulnerable blood cells, kidneys, muscles or
eye nerves and spinal cord.
WHAT IS SOLIRIS USED FOR
PAROXYSMAL NOCTURNAL HAEMOGLOBINURIA
Soliris is used to treat adults and children patients with a certain
type of disease affecting the blood system
called Paroxysmal Nocturnal Haemoglobinuria (PNH). In patients with
PNH, their red blood cells can be
destroyed which can lead to low blood counts (anaemia), tiredness,
difficulty in functioning, pain, dark
urine, shortness of breath, and blood clots. Eculizumab can block the
body’s inflammatory response, and
its ability to attack and destroy its own vulnerable PNH blood cells.
ATYPICAL HAEMOLYTIC UREMIC SYNDROME
Soliris is also used to treat adults and children patients with a
certain type of disease affecting the blood
system an

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Soliris 300 mg concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Eculizumab is a humanised monoclonal (IgG
2/4κ
) antibody produced in NS0 cell line by recombinant DNA
technology.
One vial of 30 ml contains 300 mg of eculizumab (10 mg/ml).
After dilution, the final concentration of the solution to be infused
is 5 mg/ml.
Excipients with known effect: Sodium (5 mmol per vial)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Clear, colorless, pH 7.0 solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATION
Soliris is indicated in adults and children for the treatment of:
-
Paroxysmal nocturnal haemoglobinuria (PNH).
Evidence of clinical benefit is demonstrated in patients with
haemolysis with clinical symptom(s)
indicative of high disease activity, regardless of transfusion history
(see section 5.1).
-
Atypical haemolytic uremic syndrome (aHUS) (see section 5.1).
-
Refractory generalized myasthenia gravis (gMG) in patients aged 6
years and above who are anti-
acetylcholine receptor (AChR) antibody-positive (see section 5.1).
Soliris is indicated in adults for the treatment of:
-
Neuromyelitis optica spectrum disorder (NMOSD) in patients who are
anti-aquaporin-4 (AQP4)
antibody-positive with a relapsing course of the disease (see section
5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Soliris must be administered by a healthcare professional and under
the supervision of a physician
experienced in the management of patients with haematological, renal,
neuromuscular or neuro-
inflammatory disorders.
Home infusion may be considered for patients who have tolerated
infusions well in the clinic. The
decision of a patient to receive home infusions should be made after
evaluation and recommendation from
the treating physician. Home infusions should be performed by a
qualified healthcare professional.
Posology
3
_Paroxysmal Nocturnal Haemoglobinuria