Bydureon BCise

Exenatide

In combination w/ other glucose-lowering medicinal products including basal insulin, to improve glycaemic control in adults ≥18 yr w/ type 2 DM when the therapy in use, together w/ diet & exercise, does not provide adequate glycaemic control.

SC 2 mg once wkly. Administer once a wk on the same day each wk. The day of wkly administration can be changed if necessary, as long as the last dose was administered at least 3 days before. Can be administered at any time of day, w/ or w/o meals.

Hypersensitivity.

Should not be used in patients w/ type 1 DM or for the treatment of diabetic ketoacidosis. Not a substitute for insulin. Not for IV or IM inj. Not recommended in patients w/ severe GI disease. Risk of developing acute pancreatitis. Discontinue use if pancreatitis is suspected. Monitor patients w/ rapid wt loss (>1.5 kg/wk) for signs & symptoms of cholelithiasis. Concurrent use w/ IR exenatide is not recommended. Concomitant use w/ D-phenylalanine derivatives (meglitinides), α-glucosidase inhibitors, dipeptidyl peptidase-4 inhibitors or other GLP-1 receptor agonists; warfarin; sulphonylurea. Effect of PR exenatide may continue as plasma levels of exenatide decline over 10 wk. Minor influence on ability to drive & use machines. Not recommended in patients w/ moderate renal impairment (CrCl 30-50 mL/min), end-stage renal disease or severe renal impairment (CrCl <30 mL/min). Women of childbearing potential should use contraception during treatment. Discontinue use at least 3 mth before a planned pregnancy. Should not be used during pregnancy & lactation. Safety & efficacy have not been established in childn & adolescents <18 yr.

Hypoglycaemia (w/ sulphonylurea). Hypoglycaemia (w/ insulin); headache, dizziness; nausea, diarrhoea, vomiting, constipation, dyspepsia, GERD, abdominal distension, abdominal pain; inj site pruritus, inj site erythema, fatigue.

Increased risk of hypoglycaemia w/ sulphonylureas. Monitor INR during initiation of PR exenatide therapy in patients on warfarin &/or coumarol derivatives. Monitor lipid profiles as appropriate in patients concomitantly taking HMG CoA-reductase inhibitors.

Antidiabetic Agents

A10BJ01 - exenatide ; Belongs to the class of glucagon-like peptide-1 (GLP-1) analogues. Used in the treatment of diabetes.

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