Eperzan

Medicinal product no longer authorised 3 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.

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. 2). 2). 2). Patients with hepatic impairment No dose adjustment is recommended for patients with hepatic impairment. 2). 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. 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. Medicinal product no longer authorised 4

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. 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). Medicinal product no longer authorised 7 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.

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.

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. 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.

1.