Xultophy

Insulin degludec 100 u, liraglutide 3.6 mg

Adjunct to diet & exercise for the treatment of adults w/ insufficiently controlled type 2 DM, in addition to other medicinal products for the treatment of DM.

SC Administer once daily, preferably at the same time each day. Max daily dose: 50 dose steps (50 u insulin degludec & 1.8 mg liraglutide). Add-on to oral glucose-lowering medicinal products Recommended starting dose: 10 dose steps (10 u insulin degludec & 0.36 mg liraglutide). Transfer from GLP-1 receptor agonist or from any insulin regimen including a basal insulin component Recommended starting & max dose: 16 dose steps (16 u insulin degludec & 0.6 mg liraglutide). Therapy w/ GLP-1 receptor agonist or other insulin regimens should be discontinued prior to Xultophy initiation.

May be taken with or without food.

Hypersensitivity.

Do not administer by IV or IM. Do not draw from the cartridge of the pre-filled pen into a syringe. Always rotate inj sites w/in the same region to reduce risk of lipodystrophy & cutaneous amyloidosis. Blood glucose monitoring is recommended after change in the inj site from an affected area (inj site w/ lipodystrophy, cutaneous amyloidosis) to an unaffected area, & dose adjustment of antidiabetic medications may be considered. Do not use in patients w/ type 1 DM or for the treatment of diabetic ketoacidosis. Risk of hypoglycaemia w/ excessive dose, omitted meal, or unplanned, strenuous physical exercise. Dose adjustment may be necessary if patients undertake increased physical activity, change their usual diet, or during concomitant illness (concomitant diseases in the kidney, liver or affecting the adrenal, pituitary or thyroid gland). Change in usual warning symptoms of hypoglycaemia in patients w/ greatly improved blood glucose control (eg, by intensified therapy); disappearance of usual warning symptoms in patients w/ longstanding diabetes. Prolonged effect of Xultophy may delay recovery from hypoglycaemia. Inadequate dosing &/or treatment discontinuation may lead to hyperglycaemia & potentially to hyperosmolar coma. Reports of cardiac failure when pioglitazone was used in combination w/ insulin medicinal products, especially in patients w/ risk factors for development of cardiac heart failure. Intensification of insulin therapy w/ abrupt improvement in glycaemic control may be associated w/ temporary worsening of diabetic retinopathy. Insulin &/or liraglutide Ab formation. Risk of developing acute pancreatitis. Reports of thyroid adverse events (eg, goitre) w/ GLP-1 receptor agonists, particularly in patients w/ pre-existing thyroid disease. Potential risk of dehydration. Not recommended in patients w/ inflammatory bowel disease & diabetic gastroparesis; CHF NYHA class IV; ESRD or w/ severe hepatic impairment. Transfer to Xultophy from doses of basal insulin <20 & >50 u has not been studied. May impair ability to drive or use machine. Discontinue treatment if patient wishes to become pregnant or pregnancy occurs. Do not use during breast-feeding. Intensify glucose monitoring & adjust insulin dose on an individual basis in patients w/ mild, moderate or severe renal impairment, in patients w/ mild or moderate hepatic impairment, & the elderly. No relevant use in paed patients.

Hypoglycaemia. Decreased appetite; nausea, diarrhoea, vomiting, constipation, dyspepsia, gastritis, abdominal pain, GERD, abdominal distension; inj site reaction; increased lipase & amylase.

Reduced Xultophy requirement w/ antidiabetic medicinal products, MAOIs, β-blockers, ACE inhibitors, salicylates, anabolic steroids & sulfonamides. Increased Xultophy requirement w/ OCs, thiazides, glucocorticoids, thyroid hormones, sympathomimetics, growth hormones & danazol. β-blockers may mask symptoms of hypoglycaemia. Either increased or decreased Xultophy requirement w/ octreotide/lanreotide. Intensified or reduced hypoglycaemic effect w/ alcohol. Clinically relevant interaction w/ active substances w/ poor solubility or narrow therapeutic index eg, warfarin cannot be excluded.

Antidiabetic Agents

A10AE56 - insulin degludec and liraglutide ; Belongs to the class of long-acting insulins and analogues for injection. Used in the treatment of diabetes.

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