Eperzan

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

Albiglutide

Available from:

GlaxoSmithKline Trading Services Limited

ATC code:

A10BJ04

INN (International Name):

albiglutide

Therapeutic group:

Drugs used in diabetes

Therapeutic area:

Diabetes Mellitus, Type 2

Therapeutic indications:

Eperzan is indicated for the treatment of type 2 diabetes mellitus in adults to improve glycaemic control as:MonotherapyWhen diet and exercise alone do not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate due to contraindications or intolerance.Add-on combination therapyIn combination with other glucose-lowering medicinal products including basal insulin, when these, together with diet and exercise, do not provide adequate glycaemic control (see section 4.4 and 5.1 for available data on different combinations).

Product summary:

Revision: 8

Authorization status:

Withdrawn

Authorization date:

2014-03-20

Patient Information leaflet

47
B. PACKAGE LEAFLET
Medicinal product no longer authorised
48
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
EPERZAN 30 MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
Albiglutide
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 TAKING 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 or pharmacist.
-
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, nurse or pharmacist.
This includes any possible side
effects not listed in this leaflet.See section 4.
WHAT IS IN THIS LEAFLET:
1.
WHAT EPERZAN IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE EPERZAN
3.
HOW TO TAKE EPERZAN
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE EPERZAN
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
INSTRUCTIONS FOR USE OF THE PRE-FILLED PEN
_(overleaf)_
QUESTIONS AND ANSWERS ABOUT THE INSTRUCTIONS FOR USE OF THE PRE-FILLED
PEN
_ _
READ BOTH SIDES OF THIS LEAFLET
1.
WHAT EPERZAN IS AND WHAT IT IS USED FOR
Eperzan contains the active ingredient albiglutide which belongs to a
group of medicines called GLP-1
receptor agonists that are used to lower blood sugar (glucose) in
adults with Type 2 diabetes.
You have Type 2 diabetes either:

because your body does not make enough insulin to control the level of
sugar in your blood
or

because your body is not able to use the insulin properly.
Eperzan helps your body to increase the production of insulin when
your blood sugar is high.
Eperzan is used to help control your blood sugar, either:
-
on its own if your blood sugar is not properly controlled by diet and
exercise alone, and you can’

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
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
Eperzan 30 mg powder and solvent for solution for injection
Eperzan 50 mg powder and solvent for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Eperzan 30 mg powder and solvent for solution for injection
Each pen delivers 30 mg albiglutide per 0.5 ml dose following
reconstitution.
Eperzan 50 mg powder and solvent for solution for injection
Each pen delivers 50 mg albiglutide per 0.5 ml dose following
reconstitution.
Albiglutide is a recombinant fusion protein consisting of two copies
of a 30-amino acid sequence of
modified human glucagon-like peptide 1 genetically fused in series to
human albumin.
Albiglutide is produced in
_Saccharomyces cerevisiae_
cells by recombinant DNA technology.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
Powder: lyophilised white to yellow powder.
Solvent: A clear, colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Eperzan is indicated for the treatment of type 2 diabetes mellitus in
adults to improve glycaemic control as:
Monotherapy
When diet and exercise alone do not provide adequate glycaemic control
in patients for whom use of
metformin is considered inappropriate due to contraindications or
intolerance.
Add-on combination therapy
In combination with other glucose-lowering medicinal products
including basal insulin, when these,
together with diet and exercise, do not provide adequate glycaemic
control (see section 4.4 and 5.1 for
available data on different combinations).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
Posology
The recommended dose of Eperzan is 30 mg once weekly, administered
subcutan