Eperzan

1 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
 

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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 subcutaneously. 

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The dose may be increased to 50 mg once weekly based on individual glycaemic response. 
 
When Eperzan is added to existing metformin therapy, the current metformin dose can be continued 
unchanged. It may be necessary to reduce the dose of concomitantly administered insulin secretagogues 
(such as sulphonylureas) or insulin to reduce the risk of hypoglycaemia when starting Eperzan (see sections 
4.4 and 4.8). 

The use of Eperzan does not require specific blood glucose self-monitoring. However, when used in 
combination with a sulphonylurea or a basal insulin, blood glucose self-monitoring may become necessary to 
adjust the dose of the sulphonylurea or the basal insulin. 
 
Eperzan may be administered at any time of day without regard to meals.  
 
Eperzan should be administered once a week on the same day each week. The day of weekly administration 
can be changed if necessary as long as the last dose was administered 4 or more days previously. 
 
If a dose is missed, it should be administered as soon as possible within 3 days after the missed dose. 
Thereafter, patients can resume dosing on their usual day of administration. If it is more than 3 days after the 
missed dose, patients should wait and administer their next regularly scheduled weekly dose. 
 
Elderly patients (>65 years) 
No dose adjustment is required based on age. The clinical experience in patients >75 years is very limited 
(see section 5.2). 
 
Patients with renal impairment 
No dose adjustment is necessary for patients with mild and moderate renal impairment (eGFR 60 to 89 and 
30 to 59 ml/min/1.73m2, respectively) (see sections 4.4, 4.8, 5.1, 5.2). Experience in patients with severe 
renal impairment (<30 ml/min/1.73m2) or on dialysis is very limited and therefore Eperzan is not 
recommended in this population (see sections 4.4, 4.8, 5.1, 5.2). 
 
Patients with hepatic impairment 
No dose adjustment is recommended for patients with hepatic impairment. There have been no studies in 
patients with hepatic impairment (see section 5.2). 
 
Paediatric population 
The safety and efficacy of Eperzan in children and adolescents under 18 years have not been established (see 
section 5.2). No data are available.   

Method of administration 
 
Eperzan is intended for patient self-administration as a subcutaneous injection in the abdomen, thigh or 
upper arm region.  
 
It must not be administered intravenously or intramuscularly. 
 
Each pen injector should be used by one person only and is for single use. 
 
The lyophilised powder contained within the pen must be reconstituted prior to administration. 
For full instructions on the reconstitution and administration of Eperzan see section 6.6 and the instructions 
for use included in the package leaflet. 
 
When using Eperzan with insulin, each medicinal product must be administered as a separate injection. The 
two medicinal products should never be mixed. It is acceptable to inject Eperzan and insulin in the same 
body region but the injections should not be adjacent to each other. 
 

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4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
 
4.4 Special warnings and precautions for use 
 
There is no therapeutic experience with Eperzan in patients with type 1 diabetes mellitus and it should not be 
used in these patients. Eperzan should not be used for treatment of diabetic ketoacidosis. 
 
Acute pancreatitis  
 
Use of GLP-1 receptor agonists has been associated with a risk of developing acute pancreatitis. In clinical 
trials, acute pancreatitis has been reported in association with Eperzan (see section 4.8). 
 
Patients should be informed of the characteristic symptom of acute pancreatitis. If pancreatitis is suspected, 
Eperzan should be discontinued; if pancreatitis is confirmed, Eperzan should not be restarted. Caution should 
be exercised in patients with a history of pancreatitis. 
 
Hypoglycaemia 
 
The risk of hypoglycaemia is increased when Eperzan is used in combination with insulin secretagogues 
(such as sulphonylurea) or with insulin. Therefore, patients may require a lower dose of sulphonylurea or 
insulin to reduce the risk of hypoglycaemia (see sections 4.2, 4.8). 
 
Severe gastrointestinal disease 
 
Use of GLP-1 receptor agonists may be associated with gastrointestinal adverse reactions. Eperzan has not 
been studied in patients with severe gastrointestinal disease, including severe gastroparesis, and therefore it 
is not recommended in these patients. 
 
Renal impairment 
 
Patients with severe renal impairment receiving Eperzan experienced a higher frequency of diarrhoea, 
nausea, and vomiting compared to patients with mild or moderate renal impairment. These types of 
gastrointestinal events may lead to dehydration, and worsen renal function. 
 

Dehydration  

Dehydration, sometimes leading to renal impairment and acute renal failure, has been reported in patients 
treated with albiglutide and has occurred in patients without gastrointestinal side effects. Patients treated with 
albiglutide should be advised of the potential risk of dehydration, and take precautions to avoid fluid 
depletion. 
 
Discontinuation of treatment 
 
After discontinuation, the effect of Eperzan may continue as plasma levels of albiglutide decline slowly over 
about 3 to 4 weeks. Choice of other medicinal products and dose selection should be considered accordingly, 
as adverse reactions may continue and efficacy may, at least partly, persist until albiglutide levels decline. 
 
Populations not studied 
 
There is no experience in patients with NYHA class III-IV cardiac failure. 
Eperzan has not been studied in combination with prandial insulin, dipeptidyl peptidase-4 (DPP-4) inhibitors, 
or sodium/glucose cotransporter 2 (SGLT2) inhibitors. 
 
There is limited experience of albiglutide when combined with thiazolidinediones alone, sulphonylureas + 
thiazolidinediones, and metformin + sulphonylureas + thiazolidinediones. 

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Sodium content 
 
This medicinal product contains less than 1 mmol sodium (23 mg) per 0.5 ml dose, i.e. essentially “sodium-
free”. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Albiglutide delays gastric emptying, and has the potential to impact the absorption of concomitantly 
administered oral medicinal products. Albiglutide slowed gastric emptying compared with placebo for both 
solids and liquids when 100 mg was administered as a single dose in healthy subjects (see section 5.1). 
Caution should be exercised in patients receiving medicinal products with a narrow therapeutic index or 
medicinal products that require careful clinical monitoring. 
 
Acarbose 
 
Acarbose is contraindicated in patients with intestinal obstruction. Caution is advised if used concomitantly 
with albiglutide (see section 4.8). 
 
Simvastatin 
 
A single dose of simvastatin (80 mg) was administered with steady-state albiglutide (50 mg weekly). 
Simvastatin AUC was decreased by 40% and simvastatin Cmax was increased by 18%. The AUC of 
simvastatin acid was increased by 36% and Cmax was increased by approximately 100%. A decrease in half-
life of simvastatin and simvastatin acid from ~7 hours to 3.5 hours was observed. Albiglutide showed no 
impact on the safety of simvastatin in clinical studies. 
 
Digoxin 
 
Albiglutide did not meaningfully alter the pharmacokinetics of a single-dose of digoxin (0.5 mg) when co-
administered with steady-state albiglutide (50 mg weekly). 
 
Warfarin 
 
No clinically relevant effects on the pharmacokinetics of R-and S- enantiomers of warfarin were observed 
when a single dose of racemic warfarin (25 mg) was administered with steady-state albiglutide (50 mg 
weekly). In addition, albiglutide did not significantly alter the pharmacodynamic effects of warfarin as 
measured by the international normalized ratio. 
 
Oral contraceptives 
 
Albiglutide (50 mg weekly at steady-state) had no clinically relevant effects on the steady-state 
pharmacokinetics of a combination oral contraceptive containing norethindrone 0.5 mg and ethinyl estradiol 
0.035 mg. In addition no clinically relevant effects on luteinizing hormone, follicle-stimulating hormone, or 
progesterone were observed when albiglutide and a combination oral contraceptive were co-administered. 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
 
There are no or limited amount of data from the use of Eperzan in pregnant women. Studies in animals have 
shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown. Eperzan should not 
be used during pregnancy, and is not recommended in women of childbearing potential not using effective 
contraception.  

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Eperzan should be discontinued at least 1 month before a planned pregnancy due to the long washout period 
for albiglutide. 
 
Breast-feeding 
 
There are no adequate data to support the use of Eperzan during breast-feeding in humans.  
It is not known if albiglutide is excreted in human milk. Given that albiglutide is an albumin-based protein 
therapeutic agent, it is likely to be present in human milk. A decision should be made whether to discontinue 
breast-feeding or to discontinue therapy, taking into account the benefit of breast-feeding for the child and 
the benefit of therapy for the mother. Decreased body weight in offspring was observed in mice treated with 
albiglutide during gestation and lactation (see section 5.3). 
 
Fertility 
 

There are no data on the effects of Eperzan on human fertility. Studies in mice showed reduced oestrous 
cycling at maternally toxic doses, but did not indicate harmful effects with respect to fertility (see section 
5.3). The potential risk for humans is unknown. 

4.7 Effects on ability to drive and use machines 
 
Eperzan has no or negligible influence on the ability to drive or use machines. When Eperzan is used in 
combination with insulin secretagogues (such as sulphonylureas) or insulin, patients should be advised to 
take precautions to avoid hypoglycaemia while driving and using machines (see section 4.4). 
 
4.8 Undesirable effects 
 
Summary of the safety profile 
 
Over 2,300 patients have received Eperzan in 8 placebo- or active-controlled phase III studies. 
 
Background therapies in these studies included diet and exercise, metformin, sulphonylurea, 
thiazolidinedione, insulin glargine, or a combination of antidiabetic medicinal products. 
 
The duration of studies ranged from 32 weeks to up to 3 years. Frequency categories below reflect combined 
data for the 2 doses of Eperzan, 30 mg or 50 mg weekly subcutaneously. 
 
The most serious adverse reaction in clinical trials was acute pancreatitis (see section 4.4). 
 
The most frequent adverse reactions during clinical trials which occurred in 5% of patients receiving 
Eperzan were diarrhoea, nausea, and injection site reactions including rash, erythema, or itching at the 
injection site. 
 
Tabulated summary of adverse reactions 
 
The table presents the adverse reactions that occurred more frequently among patients treated with Eperzan 
than patients treated with all comparators. Adverse reactions reported from a pooled analysis of seven 
placebo- and active-controlled phase III studies over the entire treatment period are presented in Table 1. 
 
Patient frequencies are defined as: very common ≥1/10; common ≥1/100 to <1/10; uncommon ≥1/1,000 to 
<1/100; rare: ≥1/10,000 to <1/1,000; very rare: <1/10,000 and not known (cannot be estimated from the 
available data). Within each frequency grouping, adverse reactions are presented in order of decreasing 
seriousness. 
 

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Table 1. Adverse reactions from phase III studies during the entire treatment periods and postmarketing 
reports 
 
System organ 
class 

Very common Common 
 

Uncommon Rare Not known 

Infections and 
infestations 
 

 Pneumonia 
 

   

Immune system 
disorders 

   Hypersensitivity 
reaction 
 

 

Metabolism and 
nutrition 
disorders 

Hypoglycaemia 
(when Eperzan 
is used in 
combination 
with insulin or 
sulphonylurea) 
 

Hypoglycaemia 
(when Eperzan 
is used as 
monotherapy or 
in combination 
with metformin 
or pioglitazone) 
 

  Decreased 
appetite 
 

Cardiac 
disorders 

 Atrial 
fibrillation/flutt
er 
 

   

Gastrointestinal 
disorders 

Diarrhoea, 
nausea 
 

Vomiting, 
constipation, 
dyspepsia, 
gastrooesophag
eal reflux 
disease 
 

Pancreatitis, 
intestinal 
obstruction 
 

  

General 
disorders and 
administration 
site conditions 
 

Injection site 
reactions 

    

 
Description of selected adverse reactions: 
 
Allergic reactions 
Possible hypersensitivity reactions including angioedema, erythema, generalised pruritus and rash with 
dyspnoea, have been reported with albiglutide. 
 
Pancreatitis 
The incidence of pancreatitis (adjudicated as likely to be related to therapy) in the clinical studies was 0.3% 
for Eperzan compared to 0% for placebo and 0.1% for comparators (i.e. liraglutide, pioglitazone, 
glimepiride, sitagliptin, and insulin glargine) with or without additional background antidiabetic therapy (e.g. 
metformin). 
 
Gastrointestinal events 
Gastrointestinal events occurred with a higher frequency for Eperzan compared to all comparators (38% 
versus 32%). Diarrhoea (13% versus 9%), nausea (12% versus 11%), vomiting (5% versus 4%), and 
constipation (5% versus 4%) were the most frequently reported, and the majority of events occurred within 
the first 6 months. 
 

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Gastrointestinal events with Eperzan occurred more frequently in patients with moderate to severe renal 
impairment (eGFR 15 to 59 ml/min/1.73 m2) than in those with mild renal impairment or normal renal 
function. 
 
Injection site reactions 
Injection site reactions (typically including rash, erythema, or itching at the injection site) occurred in 15% of 
patients treated with Eperzan compared to 7% with all comparators and led to discontinuation in 2% of all 
patients treated with Eperzan. Generally, injection site reactions were mild in intensity and did not require 
treatment. 
 
Immunogenicity 
The percentage of patients who developed antibodies to albiglutide on treatment was 4% (137/3,267). None 
of these antibodies were shown to neutralise the activity of albiglutide in an in vitro assay and antibody 
formation was generally transient and was not associated with reduced efficacy (HbA1c and FPG).  
Although most patients with injection site reactions were antibody negative (~85%), injection site reactions 
were reported more frequently for antibody positive (41%, N = 116) than antibody negative patients (14%, N 
= 1,927). These events were predominately mild and did not lead to discontinuation.  Otherwise, the pattern 
of adverse events was generally similar for antibody positive and negative patients.  
 
Hypoglycaemia 
Severe hypoglycaemia requiring the assistance of another person for treatment occurred uncommonly: 0.3% 
among patients receiving Eperzan and 0.4% among patients receiving a comparator. Most patients with 
severe hypoglycaemic events in clinical studies were receiving concurrent sulphonylurea or insulin and none 
required hospitalisation or led to withdrawal of treatment. 

When Eperzan was used as monotherapy, the incidence of symptomatic hypoglycaemia (<3.9 mmol/l) was 
similar for Eperzan 30 mg (2%), Eperzan 50 mg (1%) and placebo (3%). 

The rate of symptomatic hypoglycaemia was higher for Eperzan when used in combination with a 
sulphonylurea (15% to 22%) or with insulin (18%) compared to combinations not including a sulphonylurea 
or insulin (1% to 4%). Among patients randomised to other comparators, the incidence of symptomatic 
hypoglycaemia was 7% to 33% when used with a sulphonylurea or insulin and 2% to 4% in combinations 
without these medicinal products. 
 
Pneumonia 
Pneumonia occurred in 2% of patients receiving Eperzan compared to 0.8% of patients in the all comparators 
group. For Eperzan, these were single episodes of pneumonia in patients participating in studies with 32 
weeks up to 3 years of observation. 
 
Atrial fibrillation/flutter 
Atrial fibrillation/flutter occurred in 1% of patients receiving Eperzan and 0.5% of patients in the all 
comparators group. In both the Eperzan and all comparator groups, patients with events were generally male, 
older, or had renal impairment. 
 
Heart rate 
In the Phase III studies in type 2 diabetes patients, small increases in heart rate (1 to 2 bpm) were observed 
with albiglutide. In a thorough QT study in healthy subjects, an increase in heart rate (6 to 8 bpm) was 
observed after repeat dosing with albiglutide 50 mg compared to baseline values. 
 
Withdrawals 
In clinical trials of at least 2 years duration, 8% of subjects in the Eperzan group discontinued active 
treatment because of an adverse event compared with 6% in the all comparators group. The most common 
events leading to discontinuation of Eperzan were reactions at the injection site and GI related events, each 
< 2%. 
 

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Reporting of suspected adverse reactions 
 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows 
continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked 
to report any suspected adverse reactions via the national reporting system listed in Appendix V. 
 
4.9 Overdose 
 
During clinical studies of patients with type 2 diabetes, the highest dose of Eperzan administered was 
100 mg subcutaneously every four weeks for 12 weeks. This dose was associated with an increased 
frequency of nausea, vomiting, and headache.  
 
There is no specific antidote for overdose with Eperzan. In the event of a suspected overdose, the appropriate 
supportive clinical care should be instituted, as dictated by the subject’s clinical status. Anticipated 
symptoms of an overdose may be severe nausea, vomiting or headache. A prolonged period of observation 
and treatment for these symptoms may be necessary, taking into account the half-life of albiglutide (5 days). 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: Drugs used in diabetes. Other blood glucose lowering drugs excl. insulins. 
Glucagon-like peptide-1 (GLP-1) analogues. ATC code: A10BJ04 
 
Mechanism of action 
 
Albiglutide is an agonist of the GLP-1 receptor and augments glucose-dependent insulin secretion. 
Albiglutide also slows gastric emptying. 
 
Pharmacodynamic effects 
 
Glucose control 
Eperzan lowers fasting glucose and reduces postprandial glucose excursions. The majority of the observed 
reduction in fasting plasma glucose occurs after a single dose, consistent with the pharmacokinetic profile of 
albiglutide. 
 
In patients with type 2 diabetes who received 2 doses of albiglutide 32 mg (Day 1 and 8), a statistically 
significant reduction (24%) in postprandial glucose AUC(0.5-4.5 h) was observed compared to placebo 
following a standardised breakfast meal on Day 9. 
 
A single dose of albiglutide 50 mg did not impair the glucagon, epinephrine, norepinephrine, cortisol or 
growth hormone counter-regulatory hormone response to hypoglycaemia. 
 
Gastric motility 
Albiglutide slowed gastric emptying compared with placebo for both solids and liquids when 100 mg was 
administered as a single dose in healthy subjects. For solids, gastric emptying t1/2 increased from 1.14 h to 
2.23 h (p=0.0112). For liquids, gastric emptying t1/2 increased from 0.28 h to 0.69 h (p=0.0018). 
 
Clinical efficacy and safety 
 
A total of 2,365 patients with type 2 diabetes were treated with Eperzan and 2,530 received other study 
medications in 8 active and placebo-controlled phase III clinical trials. Studies evaluated the use of Eperzan 
30 mg and 50 mg once weekly, allowing for optional titration of Eperzan from 30 mg to 50 mg once weekly 
in 5 of the 8 studies. Across the 8 clinical trials, and including subjects in all treatment groups, a total of 19% 
of patients (N = 937) were 65 years of age and older, and 2% (N = 112) were 75 years of age and older, 52% 

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were male, with a mean body mass index (BMI) of 33 kg/m2. Sixty seven percent of patients were 
Caucasian, 15% African American/African heritage and 11% Asian; 26% of patients were Hispanic/Latino. 

No overall differences in glycaemic effectiveness or body weight were observed across demographic 
subgroups (age, gender, race/ethnicity, duration of diabetes). 

Monotherapy 
 
The efficacy of Eperzan was evaluated in a 3-year randomised, double-blind, placebo-controlled, multicentre 
study (n = 296) in patients inadequately controlled on diet and exercise. Patients were randomised (1:1:1) to 
Eperzan 30 mg once weekly, Eperzan 30 mg once weekly uptitrated to 50 mg once weekly at week 12, or 
placebo. The primary endpoint was change in HbA1c from baseline at 52 weeks. Compared to placebo, 
treatment with Eperzan 30 mg and 50 mg SC weekly resulted in statistically significant reductions in HbA1c 
from baseline at Week 52. The change from baseline in HbA1c at the 6 month timepoint was also statistically 
significant for the 30 mg (0.9%) and 50 mg (1.1%) weekly doses of Eperzan (see Table 2). 
 
Table 2. Results at 52 weeks in a placebo-controlled study with two doses of Eperzan (30 vs. 50 mg SC 
weekly) as monotherapy 
 

 Eperzan  
30 mg weekly 

Eperzan  
50 mg weekly Placebo 

ITTa (N) N = 100 N = 97 N = 99 
HbA1c (%)    
Baseline (mean) 
Change at Week 52b  
Difference from placebob (95% CI)  

8.05 
-0.70 

-0.8 (-1.1, -0.6) c 

8.21 
-0.9 

-1.0 (-1.3, -0.8) c 

8.02 
+0.2 

Patients (%) Achieving HbA1c <7% 49 40 21 
Body Weight (kg)    
Baseline (mean) 
Change at Week 52b 
Difference from placebob (95% CI) 

96 
-0.4 

0.3 (-0.9, 1.5) 

97 
-0.9 

-0.2 (-1.4, 1.0) 

96 
-0.7 

a Intent to treat population – last observation carried forward  
b Adjusted mean 
c P<0.05 for treatment difference 
 
Combination Therapy 
 
Add-on to metformin 
The efficacy of Eperzan was evaluated in a 3-year, randomised, double-blind, multicentre study (n = 999). 
On background therapy of metformin 1,500 mg daily, Eperzan 30 mg SC weekly (with optional uptitration 
to 50 mg weekly after a minimum of 4 weeks) was compared to sitagliptin 100 mg daily, glimepiride 2 mg 
daily (with optional titration to 4 mg daily), or placebo. The primary endpoint was change in HbA1c from 
baseline at 2 years compared to placebo. Results at 104 weeks are presented in Table 3. Eperzan 
demonstrated glycaemic lowering and was statistically superior in reduction in HbA1c from baseline 
compared to placebo, sitagliptin, or glimepiride (see Table 3). 
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Table 3. Results at 104 weeks in a placebo-controlled study comparing Eperzan 30 mg SC weekly (with 
optional uptitration to 50 mg weekly) to sitagliptin 100 mg daily and glimepiride 2 to 4 mg daily as add-on 
therapy in patients inadequately controlled on metformin >1,500 mg daily 
 

 
Eperzan  

30 mg/50 mg 
Weekly + 

Metformin 
1,500 mg daily

Placebo 
+ 

Metformin 
1,500 mg  

daily

Sitagliptin 
100 mg 
daily + 

Metformin 
1,500 mg 

daily 

Glimepiride 
2 to 4 mg 
daily + 

Metformin 
1,500 mgd

aily
ITT a (N)  297 100 300  302
HbA1c (%)   
Baseline (mean) 
Change at Week 104b 
Difference from placebo + metforminb, 
(95% CI)  
Difference from sitagliptin + 
metforminb,  (95% CI) 
Difference from glimepiride + 
metforminb, (95% CI) 

8.1 
-0.6 

-0.9 (-1.2, -0.7)c 
 

-0.4 (-0.5, -0.2)c 
 

-0.3 (-0.5, -0.1)c 

8.1 
+0.3 

8.1 
-0.3 

8.1 
-0.4 

Proportion Achieving HbA1c <7%  39 16 32  31
Body Weight (kg)   
Baseline (mean) 
Change at Week 104 b 
Difference from placebo + metforminb, 
(95% CI) 
Difference from sitagliptin + 
metforminb , (95% CI)  
Difference from glimepiride + 
metforminb , (95% CI) 

90 
-1.2 

-0.2 (-1.1, 0.7)  
 

-0.4 (-1.0, 0.3)  
 

-2.4 (-3.0, -1.7)c 

92 
-1.0 

90 
-0.9 

92 
+1.2 

 a Intent to treat population – last observation carried forward  
 b Adjusted mean 
 c P<0.05 for treatment difference 

 
Add-on to pioglitazone 
The efficacy of Eperzan was evaluated in a 3-year, randomised, double-blind, multicentre study (n = 299). 
Eperzan 30 mg SC weekly was compared to placebo in patients inadequately controlled on pioglitazone 30 
mg daily (with or without metformin 1,500 mg daily).  
Compared to placebo, treatment with Eperzan resulted in statistically significant reductions from baseline in 
HbA1c (-0.8% for Eperzan versus -0.1% for placebo, p<0.05) and FPG (-1.3 mmol/l for Eperzan versus +0.4 
mmol/l for placebo, p<0.05) at 52 weeks. The change from baseline in weight did not differ significantly 
between treatment groups (see Table 4). 

 

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Table 4. Results at 52 weeks in a placebo-controlled study comparing Eperzan 30 mg SC weekly as add-on 
therapy in patients inadequately controlled on pioglitazone >30 mg daily  metformin >1,500 mg daily  
 

 Eperzan 30 mg 
Weekly + 

Pioglitazone  
30 mg daily 

(+/- Metformin 
1,500 mg daily) 

Placebo + 
Pioglitazone  
30 mg daily 

(+/- Metformin  
1,500 mg daily) 

ITTa (N) N = 150 N = 149 
HbA1c (%)   
Baseline (mean) 
Change at Week 52b 
Difference from placebo + pioglitazoneb (95% 
CI)  

8.1 
-0.8 

-0.8 (-1.0, -0.6) c 

8.1 
-0.05 

Proportion Achieving HbA1c <7% 44 15 
Body Weight (kg)   
Baseline (mean) 
Change at Week 52b 
Difference from placebo + pioglitazoneb (95% 
CI) 

98 
0.3 

-0.2 (-1.2, 0.8) 

100 
+0.5 

 a  Intent to treat population – last observation carried forward  
 b Adjusted mean 
 c P<0.05 for treatment difference 

 
Add-on to metformin plus sulphonylurea 
The efficacy of Eperzan was evaluated in a 3-year, randomised, double-blind, multicentre study (n = 657). 
On background therapy of metformin 1,500 mg daily plus glimepiride 4 mg daily, Eperzan 30 mg SC 
weekly (with optional uptitration to 50 mg weekly after a minimum of 4 weeks) was compared to  placebo or 
pioglitazone 30 mg daily (with optional titration to 45 mg/day). The primary endpoint was change in HbA1c 
from baseline at 52 weeks compared to placebo. At 52 weeks, treatment with Eperzan resulted in statistically 
significant reductions from baseline in HbA1c compared to placebo. Treatment with Eperzan did not meet the 
pre-specified noninferiority margin (0.3%) against pioglitazone for HbA1c. The change from baseline in 
weight for Eperzan did not differ significantly from placebo but was significantly less compared to 
pioglitazone (see Table 5). 
 

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Table 5. Results at 52 weeks in a placebo-controlled study comparing Eperzan 30 mg SC weekly (with 
optional uptitration to 50 mg weekly) to pioglitazone 30 mg daily (with optional titration to 45 mg/day) as 
add-on therapy in patients inadequately controlled on metformin + sulphonylurea (glimepiride 4 mg daily) 
 
 Eperzan 

30 mg/50 mg Weekly 
+ Metformin 

1,500 mg daily + 
Glimepiride 4 mg 

daily 

Placebo +  
Metformin 

1,500 mg daily + 
Glimepiride 4 mg 

daily 

Pioglitazone + 
Metformin 

1,500 mg daily 
+ Glimepiride 

4 mg daily 
ITTa (N) 269 115 273 
HbA1c (%)    
Baseline (mean) 
Change at Week 52b 
Difference from placebo + met + 
glimb (95% CI) 
Difference from pioglitazone + 
met + glimb (95% CI) 

8.2 
-0.6 

-0.9 (-1.1, -0.7)c 
 

0.3 (0.1, 0.4)  

8.3 
+0.33 

8.3 
-0.80 

Proportion Achieving HbA1c <7% 30 9 35 
Body Weight (kg)    
Baseline (mean) 
Change at Week 52b 
Difference from placebo + met + 
glimb (95% CI) 
Difference from pioglitazone + 
met + glimb (95% CI) 

91 
-0.4 

-0.03 (-0.9, 0.8) 
 

-4.9 (-5.5, -4.2)c 

90 
-0.4 

91 
+4.4 

 a Intent to treat population – last observation carried forward  
 b Adjusted mean 
 c P<0.05 for treatment difference 

 
 

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Add-on to insulin glargine 
The efficacy of Eperzan was evaluated in a 52 week, randomised, open-label, multicentre noninferiority 
study (n = 563). On background therapy of insulin glargine (started at 10 units and titrated to  20 units per 
day), Eperzan 30 mg SC once weekly (with uptitration to 50 mg if inadequately controlled after Week 8) was 
compared to prandial insulin lispro (administered daily at mealtimes, started according to standard of care 
and titrated to effect). The primary endpoint was change in HbA1c from baseline at 26 weeks. At Week 26, 
the mean daily dose of insulin glargine was 53 IU for Eperzan and 51 IU for lispro. The mean daily dose of 
insulin lispro at Week 26 was 31 IU, and at Week 52, 69% of patients treated with Eperzan were on 50 mg 
weekly. At 26 weeks, the between-treatment difference in HbA1c of 0.2% for Eperzan and insulin lispro met 
the pre-specified noninferiority margin (0.4%). Treatment with Eperzan resulted in a mean weight loss for 
Eperzan (-0.7 kg) compared to a mean weight gain for insulin lispro (+0.8 kg) and the difference between 
treatment groups was statistically significant (see Table 6). 
Table 6. Results at 26 weeks in a study comparing Eperzan 30 mg SC weekly (with optional uptitration to 
50 mg weekly) to prandial insulin lispro as add-on therapy in patients inadequately controlled on insulin 
glargine alone 
 

 Eperzan 
 + 

Insulin glargine 
( 20 units per day) 

Insulin lispro 
+ 

Insulin glargine 
( 20 units per day) 

ITT a (N) N = 282 N = 281 
HbA1c (%)   
Baseline (mean) 
Change at Week 26b 
Difference from lispro insulinb (95% CI) 

P value (noninferiority) 

8.47 
-0.8 

-0.2 (-0.3, 0.0) 
<0.0001 

8.43 
-0.6 

Proportion Achieving HbA1c <7% 30% 25% 
Body Weight (kg)   
Baseline (mean) 
Change at Week 26b 
Difference from lispro insulinb (95% CI) 

93 
-0.7 

-1.5 (-2.1, -1.0) c 

92 
+0.8 

 a Intent to treat population – last observation carried forward  
 b Adjusted mean 
 c P<0.05 for treatment difference 

 
In patients who completed the study (52 weeks), the adjusted mean change in baseline in HbA1c was -1.0% 
for Eperzan (N = 121) and -0.9% for insulin lispro (N = 141). The adjusted mean change in body weight 
from baseline at 52 weeks was -1.0 kg for Eperzan (N = 122) and +1.7 kg for insulin lispro (N = 141). These 
data exclude the use of antidiabetic therapies permitted after the efficacy assessment if glycaemic thresholds 
were exceeded. 
 
Active-controlled study versus insulin glargine as add-on to metformin  sulphonylurea 
The efficacy of Eperzan was evaluated in a 3-year, randomised (2:1), open-label, insulin glargine-controlled 
noninferiority study (n = 735). On background therapy of metformin 1,500 mg daily (with or without 
sulphonylurea), Eperzan 30 mg SC weekly (with optional uptitration to 50 mg weekly) was compared to 
insulin glargine (started at 10 units and titrated weekly per prescribing information). The primary endpoint 
was change in HbA1c from baseline at 52 weeks. The starting total daily dose of insulin glargine ranged 
between 2 and 40 units (median daily dose of 10 units) and ranged between 3 and 230 units (median daily 
dose of 30 units) at Week 52. The median daily dose of insulin glargine used prior to hyperglycaemic rescue 
was 10 units (range 2 to 40 units) at study start and 30 units (range 3 to 230 units) at Week 52. At Week 156, 
77% of patients treated with Eperzan were uptitrated to 50 mg SC weekly. The between-treatment difference 
in HbA1c of 0.1% (-0.04, 0.27) from baseline at 52 weeks for Eperzan and insulin glargine met the pre-
specified noninferiority margin (0.3%). A statistically significant decrease in body weight was observed for 
Eperzan compared to an increase in body weight for insulin glargine and the difference in weight change was 
statistically significant (see Table 7). 
 

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Table 7. Results at 52 weeks in an active-controlled study comparing Eperzan 30 mg SC weekly (with 
optional uptitration to 50 mg weekly) to insulin glargine (titrated weekly per prescribing information) as add-
on therapy in patients inadequately controlled on metformin  sulfonylurea 
 

 Eperzan  
30 mg/50 mg Weekly 
 Metformin (with or 

without sulphonylurea) 

Insulin glargine 
 Metformin (with or 

without sulphonylurea) 
ITTa (N) 496 239 
HbA1c (%)   
Baseline (mean) 
Change at Week 52b 
Difference from insulin glargineb (95% CI) 
P value (noninferiority) 

8.28 
-0.7 

0.1 (-0.04, 0.3)  

<0.0086 

8.36 
-0.8 

Proportion Achieving HbA1c <7% 32 33 
Body Weight (kg)   
Baseline (mean) 
Change at Week 52b 
Difference from insulin glargineb (95% CI) 

95 
-1.1 

-2.6 (-3.2, -2.0) c 

92 
1.6 

 a Intent to treat population – last observation carried forward  
 b Adjusted mean 
 c P<0.05 for treatment difference 

 
In patients who were treated for at least 104 weeks, the adjusted mean change in baseline in HbA1c 
was -0.97% for Eperzan (N = 182) and -1.04% for insulin glargine (N = 102). The adjusted mean change in 
body weight from baseline at 104 weeks was -2.6 kg for Eperzan (N = 184) and +1.4 kg for insulin glargine 
(N = 104). These data exclude the use of antidiabetic therapies permitted after the efficacy assessment if 
glycaemic thresholds were exceeded. 
 
Active-controlled study versus liraglutide in combination with metformin, thiazolidinedione, or 
sulphonylurea (as monotherapy or dual therapy) 
The efficacy of Eperzan was evaluated in a 32-week, randomised, open-label, liraglutide-controlled 
noninferiority study (N = 805). Eperzan 30 mg SC weekly (with uptitration to 50 mg weekly at Week 6) was 
compared to liraglutide 1.8 mg daily (titrated up from 0.6 mg at Week 1 and 1.2 mg at Week 1 to Week 2) in 
patients inadequately controlled on monotherapy or combination oral antidiabetic therapy (metformin, 
thiazolidinedione, or sulphonylureas). The primary endpoint was change in HbA1c from baseline at 32 weeks. 
Treatment with Eperzan did not meet the pre-specified noninferiority margin (0.3%) against liraglutide for 
HbA1c (see Table 8). 

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Table 8. Results of an active-controlled trial of Eperzan 30 mg SC weekly (with uptitration to 50 mg weekly) 
versus liraglutide 1.8 mg daily at 32 weeksa 
 

 Eperzan 
30 mg/50 mg Weekly 

Liraglutide 
1.8 mg Daily 

Intent to Treat Population (N) 402 403 
HbA1c (%)   
Baseline (mean) 
Change at Week 32b 
Difference from liraglutideb (95% CI) 

P value (noninferiority) 

8.2 
-0.8 

0.2 (0.1, 0.3) 
p = 0.0846 

8.2 
-1.0 

Proportion Achieving HbA1c <7% 42% 52% 
Body Weight (kg)   
Baseline (mean) 
Change at Week 32b 
Difference from liraglutideb (95% CI) 

92 
-0.6 

1.55 (1.05, 2.06) c 

93 
-2.2 

 a Intent to treat population – last observation carried forward  
 b Adjusted mean 
 c P<0.05 for treatment difference 

 
Active-controlled study versus sitagliptin in patients with type 2 diabetes and different degrees of renal 
impairment 
The efficacy of Eperzan was evaluated in a randomised, double-blind, active-controlled 52-week study in 
486 patients with mild, moderate, and severe renal impairment inadequately controlled on a current regimen 
of diet and exercise or other antidiabetic therapy. Eperzan 30 mg SC weekly (with uptitration to 50 mg 
weekly if needed) was compared to sitagliptin. Sitagliptin was dosed according to creatinine clearance 
estimated by Cockcroft-Gault formula (100 mg daily in mild, 50 mg daily in moderate, and 25 mg daily in 
severe renal impairment)  The primary endpoint was change in HbA1c from baseline at 26 weeks. 
Treatment with Eperzan resulted in statistically significant reductions in HbA1c from baseline at Week 26 
compared to sitagliptin. The model-adjusted mean decrease in HbA1c from baseline with Eperzan was -0.80 
(n = 125), -0.83 (n = 98), and -1.08 (n = 19) in patients with mild (eGFR 60 to 89 ml/min/1.73m2), moderate 
(eGFR 30 to 59 ml/min/1.73m2), and severe (eGFR <30 ml/min/1.73m2) renal impairment, respectively (see 
Table 9). 
 
Table 9. Results at 26 weeks in a study of Eperzan 30 mg SC weekly (with uptitration to 50 mg weekly if 
needed) versus sitagliptin (dosed according to renal function) in patients with different degrees of renal 
impairment  
 

 Eperzan 
30 mg/50 mg Weekly  

Sitagliptin 

Intent to Treat Population (N) 
 

246  
(125 mild, 98 moderate, 

19 severe)a 

240 
(122 mild, 99 moderate, 15 

severe)a 
HbA1c (%)   
Baseline (mean) 
Change at Week 26b 
Difference from sitagliptinb (95% CI) 

8.1 
-0.8 

-0.3 (-0.5, -0.2)c 

8.2 
-0.5 

Proportion Achieving HbA1c <7% 43% 31% 
Body Weight (kg)   
Baseline (mean) 
Change at Week 26b 
Difference from sitagliptinb (95% CI) 

84 
-0.8 

-0.6 (-1.1, -0.1)c 

83 
-0.19 

a Intent to treat population – Last Observation Carried Forward (ITT-LOCF) 
b Adjusted mean 
c P<0.05 for treatment difference 
 

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Durability of glycaemic control 
 
The durability of glycaemic control for Eperzan over time relative to other classes of type 2 antidiabetic 
agents and placebo is shown in Figure 1 as add-on to metformin. 
 
Figure 1: Kaplan-Meier curve showing durability of glycaemic control (measured by time to rescue) for 
Eperzan, relative to two active controls (sitagliptin and glimepiride) and placebo 

Page 1 of 1

0 4 12 26 52 104

0.0

0.1

0.2

0.3

0.4

0.5

0.6

0.7

0.8

0.9

1.0

Weeks ( Rescue Free )

Pr
ob

ab
ili

ty
 o

f E
ve

nt

Placebo
Sitagliptin
Glimepiride
Albiglutide

 
x axis; Weeks (Rescue free), y axis; Probability of event 
 
Fasting plasma glucose 
 
Treatment with Eperzan alone or in combination with one or two oral antidiabetic medicinal products 
resulted in a reduction in fasting plasma glucose from baseline as compared to placebo of 1.3 to 2.4 mmol/l. 
Most of this reduction was observed within the first two weeks of treatment. 
 
Cardiovascular Evaluation:  
 
A meta-analysis of 9 clinical studies (8 major effectiveness studies and 1 phase II dose finding study) of up 
to 3 years duration was conducted to assess the cardiovascular safety of Eperzan (N=2,524) compared to all 
comparators (N=2,583) within these trials. An endpoint called MACE+ (major adverse cardiac events plus) 
included hospitalisation for unstable angina in addition to the MACE endpoints (acute myocardial infarction, 
stroke, and CV death). The hazard ratio for Eperzan versus comparators for MACE+ was 1.0 (95% CI 0.68, 
1.49). The incidence rates observed for first MACE+ were 1.2 and 1.1 events per 100 person-years for 
Eperzan versus all comparators, respectively. 
 
Paediatric population 
 
The European Medicines Agency has deferred the obligation to submit the results of studies with Eperzan in 
one or more subsets of the paediatric population in the treatment of type 2 diabetes mellitus (see section 4.2 
for information on paediatric use). 
 

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5.2 Pharmacokinetic properties 
 
Absorption 
 
Following SC administration of a single 30 mg dose to subjects with type 2 diabetes, maximum 
concentrations were reached 3 to 5 days post dose with mean peak albiglutide concentration (Cmax) of 
1.74 mcg/ml and mean area under the time-concentration curve (AUC) of 465 mcg.h/ml. The average weekly 
steady state concentrations following SC administration of 30 mg or 50 mg albiglutide estimated in the 
population PK analyses from phase III patient studies were approximately 2.6 mcg/ml and 4.4 mcg/ml, 
respectively. Steady-state exposures are achieved following 3-5 weeks of once-weekly administration. 
Exposures at the 30 mg and 50 mg dose levels were consistent with a dose-proportional increase. However, 
in healthy volunteers following 50 mg the steady state concentration was 7.39 µg/ml at day 36, thus higher 
than population PK analyses from phase III patient studies predicted. Similar exposure is achieved with SC 
administration of albiglutide in the abdomen, thigh, or upper arm.  
 
Distribution 
 
The mean estimate of apparent volume of distribution of albiglutide following SC administration is 11 litres. 
As albiglutide is an albumin fusion molecule, plasma protein binding has not been assessed. 
 
Biotransformation 
 
Albiglutide is a protein for which the expected metabolic pathway is degradation to small peptides and 
individual amino acids by ubiquitous proteolytic enzymes. 
 
Elimination 
 
The mean apparent clearance of albiglutide is 67 ml/h with an elimination half-life of approximately 5 days 
based on estimations from the population PK analyses from phase III patient studies and measured values. 
 
Special populations 
 
Patients with renal impairment 
 In a population pharmacokinetic analysis including a phase III trial in patients with mild, moderate and 
severe renal impairment, exposures were increased by approximately 30 to 40% in severe renal impairment 
compared to those observed in type 2 diabetic patients with normal renal function. In addition, a clinical 
pharmacology study showed a similar increased exposure for patients with moderate or severe renal 
impairment or those on haemodialysis relative to patients without renal impairment. These differences were 
not considered clinically relevant (see section 4.2). 
 
Patients with hepatic insufficiency 
No clinical studies were conducted to examine the effects of hepatic impairment on the pharmacokinetics of 
Eperzan. Therapeutic proteins such as albiglutide are catabolised by widely distributed proteolytic enzymes, 
which are not restricted to hepatic tissue; therefore, changes in hepatic function are unlikely to have any 
effect on the elimination of Eperzan (see section 4.2). 
 
Gender 
Based on the results of population pharmacokinetic analyses, there is no clinically relevant effect of gender 
on clearance. 
 
Race and ethnicity 
Based on the results of population pharmacokinetic analyses that included Caucasian, African 
American/African, Asian and Hispanic/Non-Hispanic patients, race and ethnicity had no clinically 
meaningful effect on the pharmacokinetics of Eperzan clearance. 
Japanese patients showed approximately 30 to 40% higher exposures than Caucasians, likely attributable to 
lower body weight. This effect was not considered clinically relevant. 

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Elderly patients (>65 years) 
Age had no clinically relevant effect on the pharmacokinetics of albiglutide based on a population 
pharmacokinetic analysis of subjects aged 24-83 years (see section 4.2). 
 
Body weight 
Body weight has no clinically relevant effect on albiglutide AUC over the range 44 to 158 kg. A 20% 
increase in body weight resulted in an approximate 18.5% increase in clearance. 
 
Paediatric population: 
No pharmacokinetic data are available in paediatric patients. 
 
5.3 Preclinical safety data 
 
Non-clinical data reveal no special hazards for humans based on studies of safety pharmacology or repeat-
dose toxicity. As albiglutide is a recombinant protein, no genotoxicity studies have been conducted. 

In a 52-week monkey study, there was a small increase in pancreas tissue weight at 50 mg/kg/week (75 times 
clinical exposure based on AUC) associated with acinar cell hypertrophy. A small increase in islet cell 
number was also observed. The pancreas changes were not associated with histomorphologic abnormalities 
or evidence of increased proliferation. 
 
No carcinogenicity studies have been performed with albiglutide due to immunogenicity in rodents. Thyroid 
C-cell tumours were observed in 2 year rodent carcinogenicity studies with other GLP-1 receptor agonists. 
Increased serum calcitonin levels have been associated with the thyroid C-cell hyperplasia and tumours 
observed in rodent studies with these other agents. Albiglutide also produced dose-dependent increases in 
serum calcitonin levels in a 21-day study in mice, suggesting that thyroid tumours in rodents are a theoretical 
possibility for albiglutide as well. There were no albiglutide related findings in thyroids of monkeys given up 
to 50 mg/kg/week for up to 52 weeks (75 times clinical exposure based on AUC). The clinical relevance of 
the observed thyroid C-cell tumours in rodents is unknown. 

In reproductive toxicology studies with albiglutide in mice, there were no effects on mating or fertility at 
doses up to 50 mg/kg/day (at low multiple of clinical exposure). Reductions in oestrous cycles were observed 
at 50 mg/kg/day, a dose associated with maternal toxicity (body weight loss and reduced food consumption). 
Effects on embryo-foetal development (embryo-foetal lethality and skeletal variations) were observed at 
50 mg/kg/day (at low multiple of clinical exposure). Offspring of mice dosed with 50 mg/kg/day during 
organogenesis had reduced weight during the pre-weaning period (which recovered after weaning), 
dehydration and coldness, and a delay in balanopreputial separation. No effects were seen at 5 mg/kg/day (at 
exposures similar to clinical exposure). 

In pre- and postnatal development studies in mice administered albiglutide during pregnancy or while 
nursing, reduced pre-weaning body weight of F1 offspring was observed at 1 mg/kg/day (at exposures 
below clinical exposure). Reduced F1 body weight reversed post-weaning with the exception of F1 females 
from dams treated perinatally (end of gestation to 10 days postpartum) at 5 mg/kg/day with no other effects 
on development. Trace levels of albiglutide were detected in plasma of offspring. It is unknown whether the 
reduced offspring body weight was caused by a direct albiglutide effect on the offspring or secondary to 
effects on the dam. 

Increased mortality and morbidity were seen at all doses (1 mg/kg/day) in lactating females in mouse pre- 
and postnatal development studies. Mortalities have not been observed in previous toxicology studies in non-
lactating or non-pregnant mice, nor in pregnant mice. These findings are consistent with lactational ileus 
syndrome which has been previously reported in mice. Since the relative stress of lactation energy demands 
is much lower in humans than mice and humans have large energy reserves, the mortalities observed in 
lactating mice are considered not relevant to humans. 
 
 

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6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Powder for solution for injection: 
 
Sodium dihydrogen phosphate monohydrate  

Disodium phosphate, anhydrous 

Trehalose dihydrate 

Mannitol (E421) 
 
Polysorbate 80 

Solvent: 

Water for injections 
 
6.2 Incompatibilities 
 
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal 
products. 
 
6.3 Shelf life 
 
3 years. 

After reconstitution, the pen should be used within 8 hours.  Use the pen immediately after the needle is 
attached otherwise the solution can dry inside the needle and block it. 
 
6.4 Special precautions for storage 
 
Store refrigerated at 2C to 8C. Do not freeze.  
 
Patients may store the pens at room temperature, not exceeding 30C, for no more than a total of 4 weeks 
prior to use. At the end of this period the pen should be used or discarded. 

For shelf life of the reconstituted product, see section 6.3. 

6.5 Nature and contents of container 
 
Dual Chamber Cartridge (DCC) composed of a Type 1 glass barrel sealed with bromobutyl rubber stoppers 
and a bromobutyl rubber closure disc encased in a polypropylene snap on cap.  Each cartridge is assembled 
into a disposable single use plastic pen injector (pen). 
 
Each pen delivers a single 30 mg or 50 mg dose of Eperzan in a volume of 0.5 ml. 
 
Pack sizes: 
Carton of 4 single-dose pens and 4 pen needles. 
Multipack containing 12 single-dose pens and 12 pen needles (3 packs of 4 pens and 4 needles). 
 
Not all pack sizes may be marketed. 
 

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6.6 Special precautions for disposal and other handling 
 
Disposal 
 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements.  
 
Instructions for use 
 
Eperzan that has been frozen must not be used. 
 
Inspect the pen to ensure that the number ‘1’ is visible in the number window. Do not use the pen if the 
number ‘1’ is not showing. 
 
Reconstitution and administration by the patient 
Full instructions for reconstitution and administration to be used by the patient are provided in the 
Instructions for Use section of the Package Leaflet. 
 
Instruct the patient to read the full Instructions for Use (IFU) including the Questions and Answers before 
starting the therapy and refer back to the IFU each time before injecting the dose. 
 
Alternate method of reconstitution (healthcare professional use only):  
The Instructions for Use included in the Package Leaflet provide directions for the patient to wait 15 minutes 
for the 30 mg pen and 30 minutes for the 50 mg pen after the lyophilised powder and diluent are mixed to 
ensure reconstitution. Healthcare professionals may utilise the following alternate method of reconstitution 
that allows for more rapid dissolution. Because this method relies on appropriate swirling and visual 
inspection of the solution, it is intended only for healthcare professionals. 
 
Inspect the pen for ‘1’ in the number window and expiration date. Follow instructions to twist the cartridge 
until ‘2’ appears in the number window and a “click” is heard. This mixes the diluent in the rear chamber of 
the cartridge with the lyophilised powder in the front chamber. With the clear cartridge pointing up, gently 
swirl the pen for one minute. Avoid shaking as this can result in foaming. Inspect, and continue to swirl the 
pen until all the powder is dissolved. Complete dissolution for the 30 mg pen usually occurs within 2 minutes 
but may take up to 5 minutes, as confirmed by visual inspection for a clear solution free of particles. 
Complete dissolution for the 50 mg pen usually occurs within 7 minutes but may take up to 10 minutes. A 
small amount of foam on top of the solution at the end of the reconstitution is normal. After reconstitution, 
continue to follow the steps in the instructions for use to attach the needle, prime the pen injector and 
administer the injection. 

Use Eperzan only if it is a clear yellow solution and contains no particles. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
GlaxoSmithKline Trading Services Limited,  
Currabinny,  
Carrigaline,  
County Cork,  
Ireland 
 
 

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8. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/13/908/001 
EU/1/13/908/002 
EU/1/13/908/003 
EU/1/13/908/004 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 21 March 2014 
 
 
10. DATE OF REVISION OF THE TEXT 
 
 
 
 
 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu. 
 

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ANNEX II 
 

A. MANUFACTURER OF THE BIOLOGICAL ACTIVE 
SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR 
BATCH RELEASE 

 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND 

USE 
 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE 
MARKETING AUTHORISATION 

 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE 

SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 

 
 

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A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER 
RESPONSIBLE FOR BATCH RELEASE 

 
Name and address of the manufacturer of the biological active substance 
 

GlaxoSmithKline LLC 
Building 40 
893 River Road 
Conshohocken, PA 19428 
USA 

 
Name and address of the manufacturer responsible for batch release 
 

Glaxo Operations UK Limited (Trading as Glaxo Wellcome Operations) 
Harmire Road 
Barnard Castle 
Durham, DL12 8DT  
United Kingdom 

 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE  
 
Medicinal product subject to medical prescription. 
 
 
C.  OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION 
 
 Periodic Safety Update Reports 
 
The requirements for submission of periodic safety update reports for this medicinal product are set 
out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 
2001/83/EC and any subsequent updates published on the European medicines web-portal. 
 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE 

OF THE MEDICINAL PRODUCT   
 
 Risk Management Plan (RMP) 

 
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the 
agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent 
updates of the RMP. 
 
An updated RMP should be submitted: 

 At the request of the European Medicines Agency; 
 Whenever the risk management system is modified, especially as the result of new information being 

received that may lead to a significant change to the benefit/risk profile or as the result of an important 
(pharmacovigilance or risk minimisation) milestone being reached. 

 
 

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ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
 

 
 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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A. LABELLING 
 

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PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON – 4 pen pack 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Eperzan 30 mg powder and solvent for solution for injection.  
albiglutide 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each dose contains 30 mg per 0.5 ml following reconstitution. 
 
 
3. LIST OF EXCIPIENTS 
 
Also contains: Sodium dihydrogen phosphate monohydrate, disodium phosphate, anhydrous, trehalose 
dihydrate, mannitol (E421), polysorbate 80, water for injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Powder and solvent for solution for injection 
 
4 pens 
4 pen needles 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read package leaflet. 
Subcutaneous use  
Once weekly. 

 
 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF 
THE SIGHT AND REACH OF CHILDREN 

 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
  
Single use only. 
Discard pen after use. 
Read package leaflet 
After mixing, wait 15 minutes before injection 
 
 
8. EXPIRY DATE 
 
EXP 

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9. SPECIAL STORAGE CONDITIONS 
 
Store refrigerated at 2C to 8C.  
Do not freeze. 
 
Pens may be stored at room temperature, not exceeding 30C, for no more than a total of 4 weeks prior to 
use.  
 
Use within 8 hours of reconstitution.  
Use immediately after needle is attached. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR 
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
GlaxoSmithKline Trading Services Limited 
Currabinny 
Carrigaline 
County Cork 
Ireland 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/13/908/001 
 
 
13. BATCH NUMBER 
 
Lot  
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
eperzan 30 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 

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18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: 
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PARTICULARS TO APPEAR ON INTERMEDIATE PACKAGING 
 
CARTON – Multipack containing 12 single-dose pens and 12 pen needles (3 packs of 4 pens and 4 
needles ) – without blue box 
 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Eperzan 30 mg powder and solvent for solution for injection.  
Albiglutide 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each dose contains 30 mg per 0.5 ml following reconstitution. 
 
 
3. LIST OF EXCIPIENTS 
 
Also contains: Sodium dihydrogen phosphate monohydrate, disodium phosphate, anhydrous, trehalose 
dihydrate, mannitol (E421), polysorbate 80, water for injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Powder and solvent for solution for injection 
 
Component of a multipack comprising 3 packs, each containing 4 pens and 4 pen needles. 
Do not sell separately. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read package leaflet. 
Subcutaneous use  
Once weekly. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF 

THE REACH AND SIGHT OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
Single use only. 
Discard pen after use. 
Read package leaflet 
After mixing, wait 15 minutes before injection 
 

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8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store refrigerated at 2C to 8C.  
Do not freeze. 
 
A single carton of 4 pens and 4 needles may be stored at room temperature, not exceeding 30C, for no more 
than a total of 4 weeks prior to use.  Remaining cartons must be stored at 2C to 8C until required. 
 
Use within 8 hours of reconstitution.  
Use immediately after needle is attached. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR 
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
GlaxoSmithKline Trading Services Limited 
Currabinny 
Carrigaline 
County Cork 
Ireland 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/13/908/003 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
eperzan 30 
 
 

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17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
 
 

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PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER LABEL – Multipack containing 12 single-dose pens and 12 pen needles (3 packs of 4 pens and 
4 needles ) –with blue box 
 
 
1.  NAME OF THE MEDICINAL PRODUCT 
 
Eperzan 30 mg powder and solvent for solution for injection.  
albiglutide 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
Each dose contains 30 mg per 0.5 ml following reconstitution. 
 
 
3. LIST OF EXCIPIENTS 
 
Also contains: Sodium dihydrogen phosphate monohydrate, disodium phosphate, anhydrous, trehalose 
dihydrate, mannitol (E421), polysorbate 80, water for injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Powder and solvent for solution for injection 
 
Multipack:12 pens (3 cartons of 4 pens/4 needles) 
Do not sell separately 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet. 
Subcutaneous use  
Once weekly. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF 

THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
Single use only. 
Discard pen after use. 
Read package leaflet 
After mixing, wait 15 minutes before injection 
 
 
8. EXPIRY DATE 
 

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EXP 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store refrigerated at 2C to 8C.  
Do not freeze. 
 
A single carton of 4 pens and 4 needles may be stored at room temperature, not exceeding 30C, for no more 
than a total of 4 weeks prior to use.  Remaining cartons must be stored at 2C to 8C until required. 
 
Use within 8 hours of reconstitution.  
Use immediately after needle is attached. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR 
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
GlaxoSmithKline Trading Services Limited 
Currabinny 
Carrigaline 
County Cork 
Ireland 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/13/908/003 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
eperzan 30 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 

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18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: 
SN: 
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PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON – 4 pen pack 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Eperzan 50 mg powder and solvent for solution for injection.  
Albiglutide 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each dose contains 50 mg per 0.5 ml following reconstitution. 
 
 
3. LIST OF EXCIPIENTS 
 
Also contains: Sodium dihydrogen phosphate monohydrate, disodium phosphate, anhydrous, trehalose 
dihydrate, mannitol (E421), polysorbate 80, water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Powder and solvent for solution for injection 
 
4 pens 
4 pen needles 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read package leaflet. 
Subcutaneous use 
Once weekly. 
 

 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF 

THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
  
Single use only. 
Discard pen after use. 
Read package leaflet 
Reconstitution time 
After mixing, wait 30 minutes before injection 
 
 

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8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store refrigerated at 2C to 8C. 
Do not freeze. 
Pens may be stored at room temperature, not exceeding 30C, for no more than a total of 4 weeks prior to 
use. 
 
Use within 8 hours of reconstitution. 
Use immediately after needle is attached. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR 
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
GlaxoSmithKline Trading Services Limited 
Currabinny 
Carrigaline 
County Cork 
Ireland 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/13/908/002 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
eperzan 50 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 

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2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: 
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PARTICULARS TO APPEAR ON INTERMEDIATE PACKAGING 
 
CARTON - Multipack containing 12 single-dose pens and 12 pen needles (3 packs of 4 pens and 4 
needles) – without blue box 
 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Eperzan 50 mg powder and solvent for solution for injection.  
albiglutide 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each dose contains 50 mg per 0.5 ml following reconstitution. 
 
 
3. LIST OF EXCIPIENTS 
 
Also contains: Sodium dihydrogen phosphate monohydrate, disodium phosphate, anhydrous, trehalose 
dihydrate, mannitol (E421), polysorbate 80, water for injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Powder and solvent for solution for injection 
 
Component of a multipack comprising 3 packs, each containing 4 pens and 4 pen needles 
Do not sell separately 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read package leaflet. 
Subcutaneous use  
Once weekly. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF 

THE REACH AND SIGHT OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
Single use only. 
Discard pen after use. 
Read package leaflet 
Reconstitution time 
After mixing, wait 30 minutes before injection 
 

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8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store refrigerated at 2C to 8C.  
Do not freeze. 
 
A single carton of 4 pens and 4 needles may be stored at room temperature, not exceeding 30C, for no more 
than a total of 4 weeks prior to use.  Remaining cartons must be stored at 2C to 8C until required. 
 
Use within 8 hours of reconstitution.  
Use immediately after needle is attached. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR 
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
GlaxoSmithKline Trading Services Limited 
Currabinny 
Carrigaline 
County Cork 
Ireland 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/13/908/004 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
eperzan 50 
 
 

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17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
 

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PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER  LABEL – Multipack containing 12 single-dose pens and 12 pen needles (3 packs of 4 pens 
and 4 needles ) –with blue box 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Eperzan 50 mg powder and solvent for solution for injection.  
albiglutide 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each dose contains 50 mg per 0.5 ml following reconstitution. 
 
 
3. LIST OF EXCIPIENTS 
 
Also contains: Sodium dihydrogen phosphate monohydrate, disodium phosphate, anhydrous, trehalose 
dihydrate, mannitol (E421), polysorbate 80, water for injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Powder and solvent for solution for injection 
 
Multipack:12 pens (3 cartons of 4 pens/4 needles) 
Do not sell separately 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet. 
Subcutaneous use  
Once weekly. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF 

THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
Single use only. 
Discard pen after use. 
Read package leaflet 
Reconstitution time 
After mixing, wait 30 minutes before injection 
 
 

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8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store refrigerated at 2C to 8C.  
Do not freeze. 
 
A single carton of 4 pens and 4 needles may be stored at room temperature, not exceeding 30C, for no more 
than a total of 4 weeks prior to use.  Remaining cartons must be stored at 2C to 8C until required. 
 
Use within 8 hours of reconstitution.  
Use immediately after needle is attached. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR 
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
GlaxoSmithKline Trading Services Limited 
Currabinny 
Carrigaline 
County Cork 
Ireland 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/13/908/004 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
eperzan 50 
 
 

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17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: 
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MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PRE-FILLED PEN LABEL 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Eperzan 30 mg powder and solvent for solution for injection 
albiglutide 
Subcutaneous use 
Once weekly 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
30  mg 
 
 
6. OTHER 
 

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MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PRE-FILLED PEN LABEL 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Eperzan 50 mg powder and solvent for solution for injection 
albiglutide 
Subcutaneous use 
Once weekly 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
50  mg 
 
 
6. OTHER 
 
 

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B. PACKAGE LEAFLET 
 
 
 

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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’t take 

metformin (another diabetes medicine) 
or 
- in combination with other diabetes medicines that are taken by mouth (such as metformin, or medicines 

known as sulphonylureas or thiazolidinediones), or with insulin. 
 

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It is very important that you continue to follow any diet and lifestyle advice from your doctor while taking 
Eperzan. 
 
2. What you need to know before you use Eperzan 
 
Don’t use Eperzan: 
 

 if you are allergic to albiglutide or any of the other ingredients of this medicine (listed in 
section 6). 

 
If you think this applies to you, don’t use Eperzan until you have checked with your doctor, nurse or 
pharmacist. 
 
Warnings and precautions 
 
Talk to your doctor, nurse or pharmacist before using Eperzan: 
 

 if you have Type 1 (insulin-dependent) diabetes or ketoacidosis (a very serious complication of 
diabetes which happens when your body is not able to break down glucose because there is not 
enough insulin), this medicine will not be right for you. Speak to your doctor about how to recognise 
the symptoms of ketoacidosis and seek urgent medical treatment if they occur. 
 

 if you have ever had pancreatitis (inflammation of the pancreas). Your doctor will decide if you can 
use Eperzan, and will explain the symptoms of pancreatitis (see ‘Conditions you need to look out for' 
in section 4). 

 if you are taking a sulphonylurea or insulin for your diabetes, as low blood sugar (hypoglycaemia) 
can occur. Your doctor may need to change your dose of these other medicines to reduce this risk. 
(See ‘Very common side effects’ in section 4 for signs of low blood sugar). 

 
 if you have a serious problem with emptying your stomach (gastroparesis) or if you have severe 

bowel disease (severe gastrointestinal disease). Eperzan is not recommended if you have these 
conditions. 
 

 When initiating treatment with albiglutide, you may experience fluid loss from vomiting, nausea, 
diarrhoea or dehydration. It is important to avoid dehydration by drinking plenty of fluids. 
 

Check with your doctor, nurse or pharmacist before you use Eperzan if you think any of these apply to 
you. 
 
Children and adolescents 
It is not known if Eperzan is safe and effective in people under 18 years of age. Eperzan is not recommended 
for children and adolescents. 
 
Other medicines and Eperzan 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines, (see also earlier in section 2 ‘Warnings and precautions’).  
 
You should not take acarbose if you suffer from bowel obstruction.  
Talk to your doctor if you are taking acarbose and Eperzan at the same time. 
 
Pregnancy, breast-feeding and fertility 
If you are pregnant or breast-feeding, if you think you may be pregnant, or are planning to have a baby, ask 
your doctor, nurse or pharmacist for advice before using this medicine. If there is a possibility that you could 
become pregnant, you must use effective contraception while using this medicine. 
 
Pregnancy 

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Tell your doctor, nurse or pharmacist immediately if you become pregnant during treatment with 
Eperzan. 
There is no information about the safety of Eperzan in pregnant women. Eperzan should not be used while 
you're pregnant. 

 
If you are planning to have a baby, your doctor may decide to stop your treatment with Eperzan at least one 
month before you try to get pregnant. This is because it takes time for Eperzan to clear from your body. 
 
Breast-feeding 
If you are breast-feeding you must check with your doctor before you use Eperzan.  It is not known if 
Eperzan passes into your breast milk. You and your doctor should decide whether you will use Eperzan or 
breast-feed. You should not do both. 
 
Fertility 
For both men and women, it is not known if Eperzan could affect your fertility. 
 
Driving and using machines 
Eperzan has no or negligible influence on your ability to drive or use machines. However, if you take 
Eperzan with sulphonylurea or insulin, you may get low blood sugar (hypoglycaemia).  This can make it 
difficult to concentrate and make you dizzy or sleepy. If this happens, don’t drive or use machines. 
 
Sodium content 
This medicine contains less than 1 mmol sodium (23 mg) per 0.5 ml dose, so is essentially ‘sodium free’. 
 
 
3. How to use Eperzan 
 
Always use this medicine exactly as your doctor, nurse or pharmacist has told you. Check with your doctor, 
nurse or pharmacist if you are not sure. 
 
The recommended dose is 30 mg once a week, injected on the same day each week.  Your doctor may 
increase your dose to 50 mg once weekly if your blood sugar is not controlled by the 30 mg dose. If 
necessary you can change the day of the week on which you use Eperzan, as long as it is at least 4 days since 
your last dose. 
 
You can use Eperzan at any time of day, with or without meals. 
 
Eperzan comes in a pen injector that you can inject yourself. Talk to your doctor, nurse or pharmacist about 
how to inject Eperzan the right way. You inject Eperzan under your skin in your stomach area, upper leg 
(thigh) or in the back of your upper arm. You can inject the same area of your body each week, but don’t 
inject in exactly the same place every time.  
 
Eperzan must not be injected into a vein (intravenously) or into a muscle (intramuscularly). 
 
The pen injector contains powder and water which you need to mix before you can use it. After section 6 of 
this leaflet there are Instructions For Use giving you step-by-step instructions on how to mix your medicine 
and how to inject it. If you have questions or do not understand how to use your pen, talk to your doctor, 
nurse or pharmacist. 
 
Never mix insulin and Eperzan together. If you need to give yourself both at the same time, use two 
separate injections. You may give both injections in the same body area (for example, your stomach area), 
but you should not give the injections very close together. 
 
If you use more Eperzan than you should 
If you use too much Eperzan, contact a doctor or pharmacist for advice. If possible show them the pack, or 
this leaflet. You may feel very sick (severe nausea), be sick (vomit), or get a headache. 
 

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If you forget to use Eperzan 
If you miss a dose, inject the next dose as soon as possible within 3 days after the missed dose. After that, 
you can go back to having your injection on the usual day. If it is more than 3 days since you missed your 
dose, wait until your usually scheduled day for your next injection. Do not inject a double dose to make up 
for a forgotten dose. 
 
If you stop using Eperzan 
Use Eperzan for as long as your doctor recommends. If you stop using Eperzan, your blood sugar levels may 
be affected. Don’t stop unless your doctor advises you to. 
 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Conditions you need to look out for: 
 
Risk of acute pancreatitis (an inflamed pancreas)  
Pancreatitis has been reported as an uncommon side effect. It may affect up to 1 in 100 people. 
Pancreatitis can be severe and life-threatening. 
 
If you get: 

 severe stomach (abdominal) pain that does not go away, this can be a symptom of pancreatitis.  
The pain may happen with or without you being sick (vomiting). You may feel the pain going from 
your front (abdomen) through to your back. 

 
 Stop taking Eperzan and talk to your doctor straight away 
 
Severe allergic reactions  
These are rare in people taking Eperzan (may affect up to 1 in 1000 people).  
Signs include: 

 raised and itchy rashes, 
 swelling, sometimes of the face, mouth or throat, causing difficulty in breathing. 

 
 Get medical help immediately if you get these symptoms. Stop taking Eperzan. 
 
Other side effects reported with Eperzan 
 
Very common: may affect more than 1 in 10 people: 
 

 low blood sugar (hypoglycaemia) when you use Eperzan in combination with insulin or 
sulphonylurea. The warning signs of low blood sugar may include cold sweat, cool pale skin, 
headache, feeling drowsy, weakness, dizziness, feeling confused or irritable, feeling hungry, fast 
heart beat and feeling jittery. Your doctor will tell you what to do if you get low blood sugar. 

 diarrhoea 
 feeling sick (nausea) 
 rash, redness or itching of the skin where you have injected Eperzan 

 
Common: may affect up to 1 in 10 people: 
 

 chest infection (pneumonia) 
 low blood sugar (hypoglycaemia) if you use Eperzan on its own or in combination with metformin 

or pioglitazone 
 irregular heartbeat 

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 being sick (vomiting) 
 constipation 
 indigestion 
 heartburn (gastro-oesophageal reflux) 

 
Uncommon: may affect up to 1 in 100 people: 
 

 bowel obstruction 
 
Rare: may affect up to 1 in 1000 people: 
 

 allergic reaction (hypersensitivity); this includes symptoms such as local or widespread rash, redness 
or itching of the skin and difficulty breathing (also see ‘Conditions you need to look out for’ at the 
beginning of this section) 

 
In addition some other side effects have been reported (frequency not known, cannot be estimated from the 
available data): 
 

 reduced appetite 
 
Reporting of side effects 
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects 
not listed in this leaflet. You can also report side effects directly via the national reporting system listed in 
Appendix V. By reporting side effects you can help provide more information on the safety of this medicine. 
 
 
5. How to store Eperzan 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the pen and the carton after ‘EXP’. The 
expiry date refers to the last day of that month. 
 
Store pens and needles in the original carton until use. 
 
Store in a refrigerator (between 2C and 8C). Do not freeze. The medicine can be stored at room 
temperature (less than 30C) for no more than a total of 4 weeks before use. After this time, pens should be 
used or thrown away. 
   
 After the powder and liquid are mixed within the pen, the pen should be used within 8 hours. 
 Use the pen immediately after you have attached and primed the needle otherwise the solution can dry 

up inside the needle and block it. 
 
Use each pen only once. 
 
After you have used the pen, do not remove the needle. Dispose of the pen as instructed by your doctor, 
pharmacist or nurse. 
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw 
away medicines you no longer use. These measures will help protect the environment. 
 
 

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6. Contents of the pack and other information 
 
What Eperzan contains  
 
- The active substance is albiglutide. 

Each 30 mg pen delivers 30 mg albiglutide in a volume of 0.5 ml. 

- The solvent is water for injections. 

- The other ingredients are: sodium dihydrogen phosphate monohydrate and disodium phosphate, 
anhydrous (see section 2 under ‘Sodium content’), trehalose dihydrate, mannitol, polysorbate 80. 

 
What Eperzan looks like and contents of the pack 
 
Eperzan is supplied as a pen for self injection. Each pen contains a white to yellow powder and a colourless 
solvent in separate compartments. A needle is provided with each pen. 
 
Pens are supplied in packs of 4 pens and 4 needles and multipacks comprising 3 packs, each containing 4 
pens and 4 needles. 
 
Not all pack sizes may be marketed. 
 
 
Marketing Authorisation Holder 
 
GlaxoSmithKline Trading Services Limited, Currabinny, Carrigaline, County Cork, Ireland  
 
 
Name and address of the manufacturer responsible for batch release: 
 
Glaxo Operations UK Limited (Trading as Glaxo Wellcome Operations) 
Harmire Road 
Barnard Castle 
Durham 
DL12 8DT 
United Kingdom 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien  
GlaxoSmithKline Pharmaceuticals s.a./n.v. 
Tél/Tel: + 32 (0)10 85 52 00 

Luxembourg/Luxemburg  
GlaxoSmithKline Pharmaceuticals s.a./n.v. 
Belgique/Belgien 
Tél/Tel: + 32 (0)10 85 52 00 
 

България  
ГлаксоСмитКлайн ЕООД 
Teл.: + 359 2 953 10 34 
 

Magyarország  
GlaxoSmithKline Kft. 
Tel.: + 36 1 225 5300 

Česká republika  
GlaxoSmithKline s.r.o. 
Tel: + 420 222 001 111 
cz.info@gsk.com 

Malta  
GlaxoSmithKline Malta 
Tel: + 356 21 238131 

Danmark  
GlaxoSmithKline Pharma A/S 

Nederland  
GlaxoSmithKline BV 

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Tlf: + 45 36 35 91 00 
info@glaxosmithkline.dk 
 

Tel: + 31 (0)30 6938100 
nlinfo@gsk.com 

Deutschland  
GlaxoSmithKline GmbH & Co. KG 
Tel.: + 49 (0)89 36044 8701 
produkt.info@gsk.com 

Norge  
GlaxoSmithKline AS 
Tlf: + 47 22 70 20 00 
firmapost@gsk.no 
 

Eesti  
GlaxoSmithKline Eesti OU 
Tel: + 372 6676 900 
estonia@gsk.com 
 

Österreich  
GlaxoSmithKline Pharma GmbH 
Tel: + 43 (0)1 97075 0 
at.info@gsk.com 

Ελλάδα  
GlaxoSmithKline A.E.B.E. 
Τηλ: + 30 210 68 82 100 
 

Polska  
GSK Services Sp. z.o.o. 
Tel.: + 48 (0)22 576 9000 
 

España  
GlaxoSmithKline, S.A. 
Tel: + 34 902 202 700 
es-ci@gsk.com 

Portugal  
GlaxoSmithKline – Produtos 
Farmacêuticos, Lda. 
Tel: + 351 21 412 95 00 
FI.PT@gsk.com  
 

France  
Laboratoire GlaxoSmithKline 
Tél: + 33 (0)1 39 17 84 44 
diam@gsk.com 
 
Hrvatska 
GlaxoSmithKline d.o.o. 
Tel:++385 1 6051 999 
 

România  
GlaxoSmithKline (GSK) S.R.L. 
Tel: + 4021 3028 208 

 
Ireland  
GlaxoSmithKline (Ireland) Limited 
Tel: + 353 (0)1 4955000 

 
Slovenija  
GlaxoSmithKline d.o.o. 
Tel: + 386 (0)1 280 25 00 
medical.x.si@gsk.com 
 

Ísland  
Vistor hf. 
Sími: + 354 535 7000 

Slovenská republika  
GlaxoSmithKline Slovakia s. r. o. 
Tel: + 421 (0)2 48 26 11 11 
recepcia.sk@gsk.com 
 

Italia  
GlaxoSmithKline S.p.A. 
Tel: + 39 (0)45 9218 111 

Suomi/Finland  
GlaxoSmithKline Oy 
Puh/Tel: + 358 (0)10 30 30 30 
Finland.tuoteinfo@gsk.com 
 

Κύπρος  
GlaxoSmithKline (Cyprus) Ltd 
Τηλ: + 357 22 39 70 00 
gskcyprus@gsk.com 
 

Sverige  
GlaxoSmithKline AB 
Tel: + 46 (0)31 67 09 00 
info.produkt@gsk.com 
 

Latvija  
GlaxoSmithKline Latvia SIA 
Tel: + 371 67312687 

United Kingdom  
GlaxoSmithKline UK 
Tel: + 44 (0)800 221441 

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lv-epasts@gsk.com 
 

customercontactuk@gsk.com  

Lietuva  
GlaxoSmithKline Lietuva UAB 
Tel: + 370 5 264 90 00 
info.lt@gsk.com 

 

  
 
This leaflet was last revised in <{MM/YYYY}> 
 
 
Other sources of information 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu.  
----------------------------------------------------------------------------------------------------------------------------- 

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INSTRUCTIONS FOR USE 

 
 
Once weekly Eperzan pen 30 mg 
Read all of this leaflet carefully before you start taking this medicine, as well as all the instructions including 
the Pen Storage and Important Warnings.  
Follow the steps below in the exact order they are presented. 
 
This medicine is injected once a week. The pen has the medicine powder in one compartment and the water 
in another compartment. You will mix them together by twisting the pen. Each pen is used to deliver one 
dose. A pen cannot be re-used. 
 
Pen storage 
 
 Store your pens at room temperature, not to exceed 30°C, for up to 4 weeks. Always store in the box. 
 If a box of pens will be stored for more than 4 weeks, keep them refrigerated (2°C to 8°C). 
 If stored in the refrigerator, allow the pen to sit at room temperature for 15 minutes before starting 

Step 1. 
 DO NOT allow the pen to freeze. Throw away the pen if frozen. 
Important warnings 
 
 DO NOT attach needle until instructed in Step 5. 
 DO NOT reuse needles, recap needles, or remove used needles from the pen. Throw out the pen in a 

container for pen disposal right away after injecting, as shown in Step 9. 
 Throw away the pen if leaking or jammed. 
 Keep your pen out of the sight and reach of children 
For each injection, gather the following items: 
• A new pen (Figure A). 
• A new needle (Figure B). 
• A clean empty cup (Figure C). 
• A clock or timer (Figure C). 
• A container for pen disposal. 
 
The cup, timer and container are not provided in 
the pack. 

Pen 

 

 
Figure A 

* Injection Button is inside the pen until the pen is 
ready for injection. 

† The numbers on the clear cartridge represent 
stages of preparation for your medicine. 

Viewing Window Number Window 
Injection Button*

Pen Body Clear Cartridge✝ Me
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Pen Needle 

            
Figure B 

Other Supplies Needed 

 

 

 
 

Figure C 

Step 1 Check Pen 

1a Wash your hands (Figure D). 
 

Wash Hands and Check Pen 

 
Figure D 

1b Check dosage and expiration date on pen (Figure E). 
  

DO NOT use if the pen is expired or shows the incorrect dose. 
  

Figure E 

 
1c Check that the pen has a [1] in the number window (Figure F). 
  

DO NOT use if the [1] is not showing. 
 

 
 

 
 

Figure F 

Step 2 Mix Medicine 

2a Hold pen body with clear cartridge pointing up so that you can 
see the [1] in the window. 

  
Twist clear cartridge several times in the direction of the arrow 
until you feel/hear the pen “click” into place. You should see 
the [2] in the number window (Figure G). This will mix the 
medicine powder and liquid. 

Hold Upright & Twist to 2 
 
 
 
 
 
 
 
 

Figure G 

Outer Needle Cap 

Inner Needle Cap 

Needle 

Tab 

Clean Empty Cup Clock/Timer 

Twist Pen to Mix Medicine 

“Click” 

min. sec. 

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2b Slowly and gently rock the pen side-to-side 5 times (like a 
windscreen wiper) (Figure H). 

 This will help mix the medicine. 
  

DO NOT shake the pen to avoid foaming, which may affect 
your dose. 

Rock Pen 
 
 
 
 
 
 

Figure H 

Step 3 Wait 15 minutes 

3 Place pen into cup with clear cartridge pointing up (Figure I). 
  

Set a timer for 15 minutes. You must wait 15 minutes for the 
medicine to dissolve before continuing. 

Wait 15 Minutes 
 
 
 
 
 
 

Figure I 
IMPORTANT: Make sure you have waited 15 minutes before continuing onto step 4.  
This is to make sure the medicine has dissolved. 
Step 4 Rock Pen and Check Medicine 

4a Again, slowly and gently rock the pen side-to-side side 5 times 
(like a windscreen wiper) (Figure J). 

  
DO NOT shake the pen to avoid foaming, which may affect 
your dose. 

 

Rock Pen Again 
 
 
 
 
 

 
Figure J 

4b Check medicine through the viewing window. It should be 
yellow and see-through, without any particles (Figure K). 

  
DO NOT use pen if there are still particles in the liquid.  
 
It is okay to have large air bubbles on top of the liquid. These 
are removed in step 6. 

Check Medicine 
 
 
 
 
 

Figure K 
IMPORTANT: Make sure you do not twist the pen to [3] until you have attached the needle in step 5. 
The needle must be attached to allow air to escape while turning the cartridge from [2] to [3] in the 
number window. 

Look for Particles

5 Times 

5 Times 

min. sec. 

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Step 5      Attach needle 

5a Peel tab from outer needle cap (Figure L). 
  

Hold the pen upright before attaching the needle. 
 

Peel Off Tab 
 
 

Figure L 

5b Push needle straight down onto the clear cartridge until you 
hear a “click” and feel the needle “snap” into place. This 
means the needle is attached (Figure M). 
 
DO NOT attach at an angle. 
DO NOT attach by screwing the needle on 

 

Attach Needle 
 
 
 
 
 
 
 

Figure M 
IMPORTANT: After the needle has been securely attached, make sure to complete the remaining steps 
of the injection procedure right away. Waiting may result in a blocked or clogged needle. 

Step 6 Remove Air from Cartridge 

6a With needle pointing up, gently tap the clear cartridge 2-3 
times to bring large air bubbles to the top (Figure N). Small air 
bubbles are okay and do not need to rise to the top. 

 

Tap Pen Cartridge 
 
 
 
 

Figure N 

6b Hold pen upright, slowly twist the clear cartridge several times 
in the direction of the arrow until you feel/hear the pen “click” 
and you see the [3] in the number window (Figure O). This 
removes the large air bubbles. 

 
 The white injection button will also pop out from the bottom of 

the pen. 
 DO NOT use the pen if the injection button does not pop out. 

Hold Upright and Twist to 3 
 
 
 
 
 
 
 
 

Figure O 
IMPORTANT: You may hear a “click” when you first start twisting the cartridge from [2] to [3]. Keep 
twisting until you see [3] in the window. 

Push Straight Down 

Twist Pen to Prime the Needle 

“Click” 

“Click” 

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Step 7 Prepare for injection 

7a  Choose your injection site (Figure P). You can use your 
abdomen, thigh, or upper arm. 

Choose Injection Site 
 
 
 
 

Figure P 
IMPORTANT: There are two needle caps, an outer and inner needle cap. 
7b While holding the pen in the air, remove outer needle cap 

(Figure Q) and inner needle cap (Figure R). A few drops of 
liquid may come out of the needle. This is normal. 

  
DO NOT rest the back of the device (where the injection 
button is exposed) on a flat surface while removing needle 
caps. 

 
7c Place both needle caps into a container for pen disposal. 
 

Pull off Needle Caps and Discard
 
 
 
 
 
 
 
 

          Figure Q            Figure R 

Step 8 Deliver injection 

8a Insert needle straight into the injection site. 
 
 
8b Press the injection button down slowly and steadily until you 

hear a “click” (Figure S). 
 

The slower you press, the easier the injection will feel. 
 

Insert, Push Button, & Wait 
 
 
 
 
 
 
 

Figure S 

Step 1 
Remove Outer  
Needle Cap 

Step 2 
Remove Inner  
Needle Cap 

Push Down Slowly 

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8c After hearing the “click,” continue holding down the injection 
button and slowly count to 5 to deliver the full dose of 
medicine (Figure T). 

 
 
 
 
 
 
 

Figure T 
-------WAIT! Count to 5------- 

 
 
 
 

Step 9 Dispose pen 

 
9a Pull the needle out of your skin (Figure U). 

DO NOT recap the needle or take the needle off the pen. 
 
9b Immediately put the pen (with needle attached) in a container 

for pen disposal. Do not dispose of the used pen in the 
household waste. Dispose of it as your doctor or pharmacist 
has instructed. 

Lift Pen from Skin 
 
 
 
 
 
 

Figure U 

 

QUESTIONS AND ANSWERS 

MIXING YOUR MEDICINE AND WAITING 15 MINUTES (STEPS 2-3) 

 What if I do not wait 15 minutes after turning the pen to the Number 2? 
If you do not wait the full 15 minutes the medicine may not be mixed with the water the right way. 
This can result in particles floating in the clear cartridge, not getting your full dose, or a blocked 
needle. Waiting the full 15 minutes ensures that the medicine powder and water are mixed the right 
way, even though it may look like it is mixed sooner. 

 What if I leave my pen for more than 15 minutes after turning the pen to the Number 2 (Step 
2)? 

 As long as the needle has not been attached, the pen can be used for up to 8 hours from the time Step 
2 was started. If it has been more than 8 hours since the medicine was mixed in Step 2, throw away 
the pen and use another pen. If you have attached the needle, EPERZAN should be used right away. 

“Click” 

Count to 5 

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ATTACHING NEEDLE, REMOVING AIR FROM CARTRIDGE, AND PREPARING PEN FOR 
INJECTION (STEPS 5-7) 

 What if I leave my pen with the needle attached (Step 5), and then come back to finish the next 
step much later? 

 This can cause your needle to block, you should continue from Step 5 to Step 6 right away. 
 
 What if I do not attach the needle at Step 5? 
 If the needle is attached before Step 5, some of the medicine may be lost during mixing. 
 DO NOT attach the needle before Step 5. 
 DO NOT turn the cartridge to [3] (Step 6b) before attaching the needle (Step 5). 
 The needle must be attached to allow air to escape while turning the cartridge from [2] to [3] in 

the number window. 
 
 What if I do not attach the needle as instructed? 
 If you do not push the needle on completely, the pen may jam or leak. 
 If the pen is jammed or leaking, throw it away and use another pen.  
 What if I do not hear the “click” when the [2] or when the [3] is moved into the Number 

Window? 
 If you do not hear a “click” when the [2] or when the [3] is moved into the number window, you may 

not have the number fully centered in the window. Twist the clear cartridge slightly in the direction 
of the arrows (clockwise) to complete the “click” and center the number in the window. 
If you are unable to turn to position [3], throw it away and use another pen. 

REMOVING BOTH NEEDLE CAPS AND INJECTING YOUR MEDICINE (STEPS 7-8) 

 After I turn the pen to Number 3 (Step 6), there are still some small air bubbles remaining. 
Can I still use the pen? 
Seeing small air bubbles remaining is normal and you can still use the pen. 

 After I give my medicine, there is some liquid still seen in the clear cartridge. 
This is normal. If you have heard and felt the injection button “click” and slowly counted to 5 before 
pulling the needle out of your skin, you should have received the full dose of your medicine. 

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Package leaflet: Information for the patient 
 

Eperzan 50 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’t take 

metformin (another diabetes medicine) 
or 

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- in combination with other diabetes medicines that are taken by mouth (such as metformin, or medicines 
known as sulphonylureas or thiazolidinediones), or with insulin. 

 
It is very important that you continue to follow any diet and lifestyle advice from your doctor while taking 
Eperzan. 
 
2. What you need to know before you use Eperzan 
 
Don’t use Eperzan: 
 

 if you are allergic to albiglutide or any of the other ingredients of this medicine (listed in 
section 6). 

 
If you think this applies to you, don’t use Eperzan until you have checked with your doctor, nurse or 
pharmacist. 
 
Warnings and precautions 
 
 
Talk to your doctor, nurse or pharmacist before using Eperzan: 
 

 if you have Type 1 (insulin-dependent) diabetes or ketoacidosis (a very serious complication of 
diabetes which happens when your body is not able to break down glucose because there is not 
enough insulin), this medicine will not be right for you. Speak to your doctor about how to recognise 
the symptoms of ketoacidosis and seek urgent medical treatment if they occur. 
 

 if you have ever had pancreatitis (inflammation of the pancreas). Your doctor will decide if you can 
use Eperzan, and will explain the symptoms of pancreatitis (see ‘Conditions you need to look out for' 
in section 4). 

 if you are taking a sulphonylurea or insulin for your diabetes, as low blood sugar (hypoglycaemia) 
can occur. Your doctor may need to change your dose of these other medicines to reduce this risk. 
(See ‘Very common side effects’ in section 4 for signs of low blood sugar). 

 
 if you have a serious problem with emptying your stomach (gastroparesis) or if you have severe 

bowel disease (severe gastrointestinal disease). Eperzan is not recommended if you have these 
conditions. 

 
 When initiating treatment with albiglutide, you may experience fluid loss from vomiting, nausea, 

diarrhoea or dehydration. It is important to avoid dehydration by drinking plenty of fluids. 
 

Check with your doctor, nurse or pharmacist before you use Eperzan if you think any of these apply to 
you. 
 
Children and adolescents 
It is not known if Eperzan is safe and effective in people under 18 years of age. Eperzan is not recommended 
for children and adolescents. 
 
Other medicines and Eperzan 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines, (see also earlier in section 2 ‘Warnings and precautions’).  
 
You should not take acarbose if you suffer from bowel obstruction. 
Talk to your doctor if you are taking acarbose and Eperzan at the same time. 
 
Pregnancy, breast-feeding and fertility 

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If you are pregnant or breast-feeding, if you think you may be pregnant, or are planning to have a baby, ask 
your doctor, nurse or pharmacist for advice before using this medicine. If there is a possibility that you could 
become pregnant, you must use effective contraception while using this medicine. 
 
 
Pregnancy 
Tell your doctor, nurse or pharmacist immediately if you become pregnant during treatment with 
Eperzan. 
There is no information about the safety of Eperzan in pregnant women. Eperzan should not be used while 
you're pregnant. 

 
If you are planning to have a baby, your doctor may decide to stop your treatment with Eperzan at least one 
month before you try to get pregnant. This is because it takes time for Eperzan to clear from your body. 
 
Breast-feeding 
If you are breast-feeding you must check with your doctor before you use Eperzan.  It is not known if 
Eperzan passes into your breast milk. You and your doctor should decide whether you will use Eperzan or 
breast-feed. You should not do both. 
 
Fertility 
For both men and women, it is not known if Eperzan could affect your fertility. 
 
Driving and using machines 
Eperzan has no or negligible influence on your ability to drive or use machines. However, if you take 
Eperzan with sulphonylurea or insulin, you may get low blood sugar (hypoglycaemia).  This can make it 
difficult to concentrate and make you dizzy or sleepy. If this happens, don’t drive or use machines. 
 
Sodium content 
This medicine contains less than 1 mmol sodium (23 mg) per 0.5 ml dose, so is essentially ‘sodium free’. 
 
 
3. How to use Eperzan 
 
Always use this medicine exactly as your doctor, nurse or pharmacist has told you. Check with your doctor, 
nurse or pharmacist if you are not sure. 
 
The recommended dose is 30 mg once a week, injected on the same day each week. Your doctor may 
increase your dose to 50 mg once weekly if your blood sugar is not controlled by the 30 mg dose. If 
necessary you can change the day of the week on which you use Eperzan, as long as it is at least 4 days since 
your last dose. 
 
You can use Eperzan at any time of day, with or without meals. 
 
Eperzan comes in a pen injector that you can inject yourself. Talk to your doctor, nurse or pharmacist about 
how to inject Eperzan the right way. You inject Eperzan under your skin in your stomach area, upper leg 
(thigh) or in the back of your upper arm.  You can inject the same area of your body each week, but don’t 
inject in  exactly the same place every time.  
Eperzan must not be injected into a vein (intravenously) or into a muscle (intramuscularly). 
 
The pen injector contains powder and water which you need to mix before you can use it. After section 6 of 
this leaflet there are Instructions For Use giving you step-by-step instructions on how to mix your medicine 
and how to inject it. If you have questions or do not understand how to use your pen, talk to your doctor, 
nurse or pharmacist. 
 
Never mix insulin and Eperzan together. If you need to give yourself both at the same time, use two 
separate injections. You may give both injections in the same body area (for example, your stomach area), 
but you should not give the injections very close together. 

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66 

 
If you use more Eperzan than you should 
If you use too much Eperzan, contact a doctor or pharmacist for advice. If possible show them the pack, or 
this leaflet. You may feel very sick (severe nausea), be sick (vomit), or get a headache. 
 
If you forget to use Eperzan 
If you miss a dose, inject the next dose as soon as possible within 3 days after the missed dose. After that, 
you can go back to having your injection on the usual day. If it is more than 3 days since you missed your 
dose, wait until your usually scheduled day for your next injection. Do not inject a double dose to make up 
for a forgotten dose. 
 
If you stop using Eperzan 
Use Eperzan for as long as your doctor recommends. If you stop using Eperzan, your blood sugar levels may 
be affected. Don’t stop unless your doctor advises you to. 
 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Conditions you need to look out for: 
 
Risk of acute pancreatitis (an inflamed pancreas)  
Pancreatitis has been reported as an uncommon side effect. It may affect up to 1 in 100 people. 
Pancreatitis can be severe and life-threatening. 
 
If you get: 

 severe stomach (abdominal) pain that does not go away, this can be a symptom of pancreatitis.  
The pain may happen with or without you being sick (vomiting). You may feel the pain going from 
your front (abdomen) through to your back. 

 
 Stop taking Eperzan and talk to your doctor straight away 
 
Severe allergic reactions  
These are rare in people taking Eperzan (may affect up to 1 in 1000 people).  
Signs include: 

 raised and itchy rashes, 
 swelling, sometimes of the face, mouth or throat, causing difficulty in breathing. 

 
 Get medical help immediately if you get these symptoms. Stop taking Eperzan. 
 
Other side effects reported with Eperzan 
 
Very common: may affect more than 1 in 10 people: 
 

 low blood sugar (hypoglycaemia) when you use Eperzan in combination with insulin or 
sulphonylurea. The warning signs of low blood sugar may include cold sweat, cool pale skin, 
headache, feeling drowsy, weakness, dizziness, feeling confused or irritable, feeling hungry, fast 
heart beat and feeling jittery. Your doctor will tell you what to do if you get low blood sugar. 

 diarrhoea 
 feeling sick (nausea) 
 rash, redness or itching of the skin where you have injected Eperzan 

 
Common: may affect up to 1 in 10 people: 

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67 

 
 chest infection (pneumonia) 
  low blood sugar (hypoglycaemia) if you use Eperzan on its own or in combination with metformin or 

pioglitazone 
  irregular heartbeat 
 being sick (vomiting) 
 constipation 
 indigestion 
 heartburn (gastro-oesophageal reflux) 

 
Uncommon: may affect up to 1 in 100 people: 
 

 bowel obstruction 
 
Rare: may affect up to 1 in 1000 people: 
 

 allergic reaction (hypersensitivity) ; this includes symptoms such as local or widespread rash, redness 
or itching of the skin and difficulty breathing (also see ‘Conditions you need to look out for’ at the 
beginning of this section) 

In addition some other side effects have been reported (frequency not known, cannot be estimated from the 
available data): 
 

 reduced appetite 
 
Reporting of side effects 
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects 
not listed in this leaflet. You can also report side effects directly via the national reporting system listed in 
Appendix V. By reporting side effects you can help provide more information on the safety of this medicine. 
 
 
5. How to store Eperzan 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the pen and the carton after ‘EXP’. The 
expiry date refers to the last day of that month. 
 
Store pens and needles in the original carton until use. 
 
Store in a refrigerator (between 2C and 8C). Do not freeze. The medicine can be stored at room 
temperature (less than 30C) for no more than a total of 4 weeks before use. After this time, pens should be 
used or thrown away. 
 
 After the powder and liquid are mixed within the pen, the pen should be used within 8 hours.  
 Use the pen immediately after you have attached and primed the needle otherwise the solution can dry 

up inside the needle and block it. 
 
Use each pen only once. 
 
After you have used the pen, do not remove the needle. Dispose of the pen as instructed by your doctor, 
pharmacist or nurse. 
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw 
away medicines you no longer use. These measures will help protect the environment. 
 
 

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68 

6. Contents of the pack and other information 
 
What Eperzan contains  
 
- The active substance is albiglutide. 

Each 50 mg pen delivers 50 mg albiglutide in a volume of 0.5 ml. 

- The solvent is water for injections. 

- The other ingredients are: sodium dihydrogen phosphate monohydrate and disodium phosphate, 
anhydrous (see section 2 under ‘Sodium content’), trehalose dihydrate, mannitol, polysorbate 80. 

 
What Eperzan looks like and contents of the pack 
 
Eperzan is supplied as a pen for self injection. Each pen contains a white to yellow powder and a colourless 
solvent in separate compartments. A needle is provided with each pen. 
 
Pens are supplied in packs of 4 pens and 4 needles and multipacks comprising 3 packs, each containing 4 
pens and 4 needles. 
 
 Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder 
 
GlaxoSmithKline Trading Services Limited, Currabinny, Carrigaline, County Cork, Ireland  
 
 
Name and address of the manufacturer responsible for batch release: 
 
Glaxo Operations UK Limited (Trading as Glaxo Wellcome Operations) 
Harmire Road 
Barnard Castle 
Durham 
DL12 8DT 
United Kingdom 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien  
GlaxoSmithKline Pharmaceuticals s.a./n.v. 
Tél/Tel: + 32 (0)10 85 52 00 

Luxembourg/Luxemburg  
GlaxoSmithKline Pharmaceuticals s.a./n.v. 
Belgique/Belgien 
Tél/Tel: + 32 (0)10 85 52 00 
 

България  
ГлаксоСмитКлайн ЕООД 
Teл.: + 359 2 953 10 34 
 

Magyarország  
GlaxoSmithKline Kft. 
Tel.: + 36 1 225 5300 

Česká republika  
GlaxoSmithKline s.r.o. 
Tel: + 420 222 001 111 
cz.info@gsk.com 

Malta  
GlaxoSmithKline Malta 
Tel: + 356 21 238131 

Danmark  
GlaxoSmithKline Pharma A/S 
Tlf: + 45 36 35 91 00 

Nederland  
GlaxoSmithKline BV 
Tel: + 31 (0)30 6938100 

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69 

info@glaxosmithkline.dk 
 

nlinfo@gsk.com 

Deutschland  
GlaxoSmithKline GmbH & Co. KG 
Tel.: + 49 (0)89 36044 8701 
produkt.info@gsk.com 

Norge  
GlaxoSmithKline AS 
Tlf: + 47 22 70 20 00 
firmapost@gsk.no 
 

Eesti  
GlaxoSmithKline Eesti OU 
Tel: + 372 6676 900 
estonia@gsk.com 
 

Österreich  
GlaxoSmithKline Pharma GmbH 
Tel: + 43 (0)1 97075 0 
at.info@gsk.com 

Ελλάδα  
GlaxoSmithKline A.E.B.E. 
Τηλ: + 30 210 68 82 100 
 

Polska  
GSK Services Sp. z.o.o. 
Tel.: + 48 (0)22 576 9000 
 

España  
GlaxoSmithKline, S.A. 
Tel: + 34 902 202 700 
es-ci@gsk.com 

Portugal  
GlaxoSmithKline – Produtos 
Farmacêuticos, Lda. 
Tel: + 351 21 412 95 00 
FI.PT@gsk.com  
 

France  
Laboratoire GlaxoSmithKline 
Tél: + 33 (0)1 39 17 84 44 
diam@gsk.com 
 
Hrvatska 
GlaxoSmithKline d.o.o. 
Tel:++385 1 6051 999 
 

România  
GlaxoSmithKline (GSK) S.R.L. 
Tel: + 4021 3028 208 
 

 
Ireland  
GlaxoSmithKline (Ireland) Limited 
Tel: + 353 (0)1 4955000 

 
Slovenija  
GlaxoSmithKline d.o.o. 
Tel: + 386 (0)1 280 25 00 
medical.x.si@gsk.com 
 

Ísland  
Vistor hf. 
Sími: + 354 535 7000 

Slovenská republika  
GlaxoSmithKline Slovakia s. r. o. 
Tel: + 421 (0)2 48 26 11 11 
recepcia.sk@gsk.com 
 

Italia  
GlaxoSmithKline S.p.A. 
Tel: + 39 (0)45 9218 111 

Suomi/Finland  
GlaxoSmithKline Oy 
Puh/Tel: + 358 (0)10 30 30 30 
Finland.tuoteinfo@gsk.com 
 

Κύπρος  
GlaxoSmithKline (Cyprus) Ltd 
Τηλ: + 357 22 39 70 00 
gskcyprus@gsk.com 
 

Sverige  
GlaxoSmithKline AB 
Tel: + 46 (0)31 67 09 00 
info.produkt@gsk.com 
 

Latvija  
GlaxoSmithKline Latvia SIA 
Tel: + 371 67312687 
lv-epasts@gsk.com 

United Kingdom  
GlaxoSmithKline UK 
Tel: + 44 (0)800 221441 
customercontactuk@gsk.com  

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70 

 
Lietuva  
GlaxoSmithKline Lietuva UAB 
Tel: + 370 5 264 90 00 
info.lt@gsk.com 

 

  
 
This leaflet was last revised in <{MM/YYYY}> 
 
 
Other sources of information 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu.  
----------------------------------------------------------------------------------------------------------------------------- 

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71 

 

 

 

INSTRUCTIONS FOR USE 

 
 
Once weekly Eperzan pen 50 mg 
Read all of this leaflet carefully before you start taking this medicine, as well as all the instructions including 
the Pen Storage and Important Warnings.  
Follow the steps below in the exact order they are presented. 
 
This medicine is injected once a week. The pen has the medicine powder in one compartment and the water 
in another compartment. You will mix them together by twisting the pen. Each pen is used to deliver one 
dose. A pen cannot be re-used. 
 
Pen storage 
 
 Store your pens at room temperature, not to exceed 30°C, for up to 4 weeks. Always store in the box. 
 If a box of pens will be stored for more than 4 weeks, keep them refrigerated (2°C to 8°C). 
 If stored in the refrigerator, allow the pen to sit at room temperature for 15 minutes before starting 

Step 1. 
 DO NOT allow the pen to freeze. Throw away the pen if frozen. 
Important warnings 
 
 DO NOT attach needle until instructed in Step 5. 
 DO NOT reuse needles, recap needles, or remove used needles from the pen. Throw out the pen in a 

container for pen disposal right away after injecting, as shown in Step 9. 
 Throw away the pen if leaking or jammed. 
 Keep your pen out of the sight and reach of children 
For each injection, gather the following items: 
• A new pen (Figure A). 
• A new needle (Figure B). 
• A clean empty cup (Figure C). 
• A clock or timer (Figure C). 
• A container for pen disposal. 
 
The cup, timer and container are not provided in 
the pack. 

Pen 

 

 

Figure A 

* Injection Button is inside the pen until the pen is 
ready for injection. 

† The numbers on the clear cartridge represent 
stages of preparation for your medicine. 

Viewing Window Number Window Injection Button*

Pen Body 
Clear Cartridge✝ Me

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72 

Pen Needle 

            
Figure B 

Other Supplies Needed 

 

 

 
 

Figure C 

Step 1 Check pen 

1a Wash your hands (Figure D). 
 

Wash Hands and Check Pen 

 
Figure D 

1b Check dosage and expiration date on pen (Figure E). 
  

DO NOT use if the pen is expired or shows the incorrect 
dose. 

 

 
 
 
 
 
 

Figure E 
 
1c Check that the pen has a [1] in the number window (Figure 

F). 
  

DO NOT use if the [1] is not showing. 
 

 
 
 

 
 

Figure F 

Step 2 Mix Medicine 

2a Hold pen body with clear cartridge pointing up so that you 
can see the [1] in the window. 

  
Twist clear cartridge several times in the direction of the 
arrow until you feel/hear the pen “click” into place. You 
should see the [2] in the number window (Figure G). This will 
mix the medicine powder and liquid. 

Hold Upright & Twist to 2 
 
 
 
 
 
 
 
 

Figure G 

Outer Needle Cap 

Inner Needle Cap 

Needle 

Tab 

Twist Pen to Mix Medicine 

“Click” 

Clean Empty Cup Clock/Timer 

min. sec. 

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73 

2b Slowly and gently rock the pen side-to-side 5 times (like a 
windscreen wiper) (Figure H). 

 This will help mix the medicine. 
  

DO NOT shake the pen to avoid foaming, which may affect 
your dose. 

Rock Pen 
 
 
 
 
 
 

Figure H 

Step 3 Wait 30 minutes 

3 Place pen into cup with clear cartridge pointing up (Figure I). 
  

Set a timer for 30 minutes. You must wait 30 minutes for 
the medicine to dissolve before continuing. 

Wait 30 Minutes 
 
 
 
 
 
 

Figure I 
 

IMPORTANT: Make sure you have waited 30 minutes before continuing onto step 4.  
This is to make sure the medicine has dissolved. 

Step 4 Rock pen and check medicine 

4a Again, slowly and gently rock the pen side-to-side side 5 
times (like a windscreen wiper) (Figure J). 

  
DO NOT shake the pen to avoid foaming, which may affect 
your dose. 

 

Rock Pen Again 
 
 
 
 
 

 
Figure J 

4b Check medicine through the viewing window. It should be 
yellow and see-through, without any particles (Figure K). 

  
DO NOT use pen if there are still particles in the liquid.  
 
It is okay to have large air bubbles on top of the liquid. These 
are removed in step 6. 

Check Medicine 
 
 
 
 
 

Figure K 
IMPORTANT: Make sure you do not twist the pen to [3] until you have attached the needle in step 5. 
The needle must be attached to allow air to escape while turning the cartridge from [2] to [3] in the 
number window. 

Look for Particles

5 Times 

5 Times 

min. sec. 

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74 

Step 5      Attach needle 

5a Peel tab from outer needle cap (Figure L). 
  

Hold the pen upright before attaching the needle. 
 

Peel Off Tab 
 
 

Figure L 

5b Push needle straight down onto the clear cartridge until you 
hear a “click” and feel the needle “snap” into place. This 
means the needle is attached (Figure M). 
 
DO NOT attach at an angle. 
DO NOT attach by screwing the needle on 

 

Attach Needle 
 
 
 
 
 
 
 

Figure M 
IMPORTANT: After the needle has been securely attached, make sure to complete the remaining steps 
of the injection procedure right away. Waiting may result in a blocked or clogged needle. 

Step 6 Remove air from cartridge 

6a With needle pointing up, gently tap the clear cartridge 2-3 
times to bring large air bubbles to the top (Figure N). Small 
air bubbles are okay and do not need to rise to the top. 

 

Tap Pen Cartridge 
 
 
 
 

Figure N 

6b Hold pen upright, slowly twist the clear cartridge several 
times in the direction of the arrow until you feel/hear the pen 
“click” and you see the [3] in the number window (Figure O). 
This removes the large air bubbles. 

 
 The white injection button will also pop out from the bottom 

of the pen. 
 DO NOT use the pen if the injection button does not pop out. 

Hold Upright and Twist to 3 
 
 
 
 
 
 
 
 

Figure O 
IMPORTANT: You may hear a “click” when you first start twisting the cartridge from [2] to [3]. Keep 
twisting until you see [3] in the window. 

Push Straight Down 

Twist Pen to Prime the Needle 

“Click” 

“Click” 

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Step 7 Prepare for injection  

7a  Choose your injection site (Figure P). You can use your 
abdomen, thigh, or upper arm. 

Choose Injection Site 
 
 
 
 

Figure P 
IMPORTANT: There are two needle caps, an outer and inner needle cap. 
7b While holding the pen in the air, remove outer needle cap 

(Figure Q) and inner needle cap (Figure R). A few drops of 
liquid may come out of the needle. This is normal. 

  
DO NOT rest the back of the device (where the injection 
button is exposed) on a flat surface while removing needle 
caps. 

 
7c Place both needle caps into a container for pen disposal. 
 

Pull off Needle Caps and Discard 
 
 
 
 
 
 
 
 

          Figure Q            Figure R 

Step 8 Deliver injection 

8a Insert needle straight into the injection site. 
 
 
8b Press the injection button down slowly and steadily until you 

hear a “click” (Figure S). 
 

The slower you press, the easier the injection will feel. 
  

Insert, Push Button, & Wait 
 
 
 
 
 
 
 

Figure S 

Step 1 
Remove Outer  
Needle Cap 

Step 2 
Remove Inner  
Needle Cap 

Push Down Slowly 

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76 

8c After hearing the “click,” continue holding down the injection 
button and slowly count to 5 to deliver the full dose of 
medicine (Figure T). 

 
 
 
 
 

 
 
 
 
 
 
 

Figure T 
-------WAIT! Count to 5------- 

 
 
 

 

Step 9 Dispose pen 

 
9a Pull the needle out of your skin (Figure U). 

DO NOT recap the needle or take the needle off the pen. 
 
9b Immediately put the pen (with needle attached) in a container 

for pen disposal. Do not dispose of the used pen in the 
household waste. Dispose of it as your doctor or pharmacist 
has instructed. 

Lift Pen from Skin 
 
 
 
 
 
 

Figure U 
 

 

 QUESTIONS AND ANSWERS 

MIXING YOUR MEDICINE AND WAITING 30 MINUTES (STEPS 2-3) 

 What if I do not wait 30 minutes after turning the pen to the Number 2? 
If you do not wait the full 30 minutes the medicine may not be mixed with the water the right way. 
This can result in particles floating in the clear cartridge, not getting your full dose, or a blocked 
needle. Waiting the full 30 minutes ensures that the medicine powder and water are mixed the right 
way, even though it may look like it is mixed sooner. 

 What if I leave my pen for more than 30 minutes after turning the pen to the Number 2 (Step 
2)? 

 As long as the needle has not been attached, the pen can be used for up to 8 hours from the time Step 
2 was started. If it has been more than 8 hours since the medicine was mixed in Step 2, throw away 
the pen and use another pen. If you have attached the needle, EPERZAN should be used right away. 

“Click” 

Count to 5 

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77 

ATTACHING NEEDLE, REMOVING AIR FROM CARTRIDGE, AND PREPARING PEN FOR 
INJECTION (STEPS 5-7) 

 What if I leave my pen with the needle attached (Step 5), and then come back to finish the next 
step much later? 

 This can cause your needle to block, you should continue from Step 5 to Step 6 right away. 
 
 What if I do not attach the needle at Step 5? 
 If the needle is attached before Step 5, some of the medicine may be lost during mixing. 
 DO NOT attach the needle before Step 5. 
 DO NOT turn the cartridge to [3] (Step 6b) before attaching the needle (Step 5). 
 The needle must be attached to allow air to escape while turning the cartridge from [2] to [3] in 

the number window. 
 
 What if I do not attach the needle as instructed? 
 If you do not push the needle on completely, the pen may jam or leak. 
 If the pen is jammed or leaking, throw it away and use another pen.  
 What if I do not hear the “click” when the [2] or when the [3] is moved into the Number 

Window? 
 If you do not hear a “click” when the [2] or when the [3] is moved into the number window, you may 

not have the number fully centered in the window. Twist the clear cartridge slightly in the direction 
of the arrows (clockwise) to complete the “click” and center the number in the window. 
If you are unable to turn to position [3], throw it away and use another pen. 

REMOVING BOTH NEEDLE CAPS AND INJECTING YOUR MEDICINE (STEPS 7-8) 

 After I turn the pen to Number 3 (Step 6), there are still some small air bubbles remaining. 
Can I still use the pen? 
Seeing small air bubbles remaining is normal and you can still use the pen. 

 After I give my medicine, there is some liquid still seen in the clear cartridge. 
This is normal. If you have heard and felt the injection button “click” and slowly counted to 5 before 
pulling the needle out of your skin, you should have received the full dose of your medicine. 

 
 
 

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	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERRESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USEOF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET