Company: Eli Lilly and Co (Ireland) Ltd.
Legal category: Prescription. GMS reimbursable. Sport permitted.
Active ingredient: Dulaglutide 0.75mg/0.5ml, 1.5mg/0.5ml.
Description: Solution for injection in pre-filled pens.
Presentation: 0.75mg/0.5ml-4, €103.90; 1.5mg/0.5ml-4, €103.90.
Indications: For type 2 diabetes mellitus in adults to improve glycaemic control when diet and exercise alone are inadequate; as monotherapy when metformin is inappropriate due to intolerance or contraindications, or as add-on therapy in combination with other glucose-lowering medicines including insulin.
Pharmacology: Dulaglutide is a longacting glucagonlike peptide 1 (GLP1) receptor agonist. It is resistant to degradation by DPP4. Its large size slows absorption and reduces renal clearance resulting in a soluble formulation and a prolonged halflife of 4.7 days, therefore making it suitable for once-weekly subcutaneous administration. In addition, the dulaglutide molecule prevents the Fcg receptor-dependent immune response and reduces its immunogenic potential. Dulaglutide exhibits several antihyperglycaemic actions of GLP1. In the presence of elevated glucose concentrations, it increases intracellular cyclic AMP in pancreatic beta cells leading to insulin release. It suppresses glucagon secretion which is inappropriately elevated in type 2 diabetes patients. Lower glucagon concentrations lead to decreased hepatic glucose output. Dulaglutide also slows gastric emptying.
Dosage: Adult: Administer by subcutaneous injection in abdomen, thigh or upper arm. Monotherapy: 0.75mg once weekly. Add-on therapy: 1.5mg once weekly. Can continue current metformin and/or pioglitazone dose. Consider reducing sulphonylurea (SU) or prandial insulin dose to reduce risk of hypoglycaemia. Elderly: Monotherapy: As per adults. Add-on therapy: ≥75 years, consider 0.75mg once weekly starting dose. Children: Under 18 years, not recommended.
Contraindications: Hypersensitivity to the active substance or to any of the excipients. Pregnancy, lactation.
Special precautions: Do not administer by intravenous or intramuscular injection. Not for type 1 diabetes or diabetic ketoacidosis. Not recommended: Severe renal impairment, end stage renal disease, severe gastrointestinal disease (including severe gastroparesis). Acute pancreatitis reported (suspend if suspected, permanently discontinue if confirmed). Congestive heart failure (limited experience). Driving/using machines (avoid hypoglycaemia with SU or prandial insulin).
Drug interactions: Caution: Oral drugs requiring rapid gastrointestinal absorption. Prolonged release drugs, sitagliptin.
Adverse drug reactions: Hypoglycaemia, gastrointestinal disorders, fatigue, sinus tachycardia, first degree atrioventricular block.
Full prescribing information and references available from Eli Lilly and Co (Ireland) Ltd. Telephone: +353 1 664 0446.
E-mail: ukmedinfo@lilly.com.