Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: GlaxoSmithKline Trading Services Limited, Currabinny, Carrigaline, County Cork, Ireland
Eperzan is indicated for the treatment of type 2 diabetes mellitus in adults to improve glycaemic control as:
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.
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).
The recommended dose of Eperzan is 30 mg once weekly, administered subcutaneously.
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.
No dose adjustment is required based on age. The clinical experience in patients ≥75 years is very limited (see section 5.2).
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).
No dose adjustment is recommended for patients with hepatic impairment. There have been no studies in patients with hepatic impairment (see section 5.2).
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.
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.
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).
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.
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.
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.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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.
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.
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.
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