Bekemv

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

Eculizumab

Available from:

Amgen Technology (Ireland) UC

ATC code:

L04AA25

INN (International Name):

eculizumab

Therapeutic group:

Immunosuppressants

Therapeutic area:

Hemoglobinuria, Paroxysmal

Therapeutic indications:

Bekemv 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).

Product summary:

Revision: 1

Authorization status:

Authorised

Authorization date:

2023-04-19

Patient Information leaflet

29
B. PACKAGE LEAFLET
30
PACKAGE LEAFLET: INFORMATION FOR THE USER
BEKEMV 300 MG CONCENTRATE FOR SOLUTION FOR INFUSION
eculizumab
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
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 BEKEMV is and what it is used for
2.
What you need to know before you use BEKEMV
3.
How to use BEKEMV
4.
Possible side effects
5.
How to store BEKEMV
6.
Contents of the pack and other information
1.
WHAT BEKEMV IS AND WHAT IT IS USED FOR
WHAT IS BEKEMV
BEKEMV 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.
WHAT IS BEKEMV USED FOR
PAROXYSMAL NOCTURNAL HAEMOGLOBINURIA
BEKEMV is used to treat adults and children 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.
2.

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal
product is subject to additional monitoring. This will allow quick
identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
BEKEMV 300 mg concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Eculizumab is a humanised monoclonal (IgG
2/4κ
) antibody produced in CHO cell line by recombinant
DNA technology.
One vial of 30 mL contains 300 mg of eculizumab (10 mg/mL).
Excipients with known effect
Each mL of solution contains 50 mg sorbitol. Each vial contains 1 500
mg sorbitol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Clear to opalescent, colourless to slightly yellow, pH 5.2 solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
BEKEMV 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).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
BEKEMV must be administered by a healthcare professional and under the
supervision of a physician
experienced in the management of patients with haematological
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.
3
Posology
_PNH in adults _
The PNH dosing regimen for adult patients (≥ 18 years of age)
consists of a 4-week initial phase
followed by a maintenance phase:
•
Initial phase: 600 mg of BEKEMV administered via a 25 – 45 minute
(35 minutes ± 10 minutes) intravenous infusion every