Advice for Healthcare professionals during MURs: BYDUREON once weekly injections (exenatide). BYDUREON is indicated for treatment of type 2 diabetes mellitus in combination with • Metformin • Sulphonylurea • Thiazolidinedione • Metformin and sulphonylurea • Metformin and thiazolidinedione **The recommended dose is 2 mg exenatide once weekly.*** - Patients switching from exenatide twice daily (BYETTA) to BYDUREON may experience transient elevations in blood glucose concentrations, which generally improve within the first two weeks after initiation of therapy. - When BYDUREON is added to existing metformin and/or thiazolidinedione therapy, the current dose of metformin and/or thiazolidinedione can be continued. ********IMPORTANT*********** When BYDUREON is added to sulphonylurea therapy, a reduction in the dose of sulphonylurea should be considered to reduce the risk of hypoglycaemia. ************************************************ BYDUREON 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 next dose is administered at least one day (24 hours) later. - BYDUREON can be administered at any time of day, with or without meals. - If a dose is missed, it should be administered as soon as practical. Thereafter, patients can resume their once weekly dosing schedule. Two injections should not be given on the same day. The use of BYDUREON does not require additional self-monitoring. Blood glucose self-monitoring may be necessary to adjust the dose of sulphonylurea. If a different antidiabetic treatment is started after the discontinuation of BYDUREON, consideration should be given to the prolonged release of BYDUREON. Method of administration BYDUREON is for self administration by the patient. Each kit should be used by one person only and is for single use. Appropriate training is recommended for non-healthcare professionals administering the product. The “Instructions for the User”, provided in the carton, must be followed carefully by the patient. - After reconstitution the suspension must be injected immediately. Each dose should be administered in the abdomen, thigh, or the back of the upper arm as a subcutaneous injection immediately after suspension of the powder in the solvent. BYDUREON should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. BYDUREON must not be administered by intravenous or intramuscular injection. •Special precautions for storage - Store in a refrigerator (2°C - 8°C). - Do not freeze. - The kit may be kept for up to 4 weeks below 30°C prior to use. - Store in the original package in order to protect from light. •Special precautions for disposal and other handling - The patient should be instructed to discard the syringe safely, with the needle still attached after each injection. - The patient should recap the needle. - The patient does not need to save any part of the single-use kit. - The solvent should be visually inspected prior to use. The solvent should only be used if it is clear and free of particulate matter. - After suspension, BYDUREON should only be used if the mixture is white to off white and cloudy. - BYDUREON must be injected immediately after suspension of the powder in the solvent. - BYDUREON that has been frozen must not be used. - Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Posted on: Sat, 05 Oct 2013 19:40:50 +0000
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