Xultophy

Adjunct to diet & exercise to improve glycaemic control in adults w/ insufficiently controlled type 2 DM in addition to other oral medicinal products.

SC Administer once daily, preferably at the same time each day. Individualised dose. 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 basal insulin Recommended starting & max dose: 16 dose steps (16 u insulin degludec & 0.6 mg liraglutide).

May be taken with or without food.

Hypersensitivity. Patients w/ personal or family history of medullary thyroid carcinoma; type 2 multiple endocrine neoplasia syndrome.

Not to be administered IV or IM. Discontinue use if acute pancreatitis is suspected & not to be restarted if confirmed. Not to be used in type 1 DM or diabetic ketoacidosis. Not recommended in patients w/ inflammatory bowel disease & diabetic gastroparesis; CHF NYHA class IV. Dizziness or fainting. Risk of hypoglycaemia w/ higher dose, omission of meal or unplanned strenuous physical exercise. Hyperglycaemia w/ inadequate dosing &/or discontinuation potentially leading to hyperosmolar coma; concomitant illness especially infections. Concomitant kidney & liver diseases or diseases affecting adrenal, pituitary or thyroid gland. Usual warning symptoms may disappear in patients w/ long-standing diabetes. Prolonged effect may delay recovery from hypoglycemia. Untreated hyperglycaemic events leading to hyperosmolar coma/diabetic ketoacidosis. Temporary worsening of diabetic retinopathy due to intensification of insulin therapy w/ abrupt improvement in glycaemic control. Potential risk of dehydration; avoid fluid depletion. May cause insulin &/or liraglutide Ab formation. Patients w/ pre-existing thyroid disease. Pulmonary aspiration in patients receiving GLP-1 receptor agonists undergoing general anaesth; consider increased risk of residual gastric content due to delayed gastric emptying prior to performing procedures w/ general anaesth or deep sedation. Perform continuous inj site rotation to reduce risk of developing lipodystrophy & cutaneous amyloidosis. Monitor blood glucose & consider dose adjustment after change in inj site from affected to unaffected area. Close glucose monitoring is recommended during transfer from GLP-1 receptor agonist or other insulin regimens w/ basal insulin & in the following wk. Discontinue other insulin regimens prior to treatment initiation; concomitant pioglitazone therapy if any deterioration in cardiac symptoms occurs. Observe for signs & symptoms of heart failure, wt gain & oedema in combination w/ pioglitazone. Transfer to Xultophy from doses of basal insulin <20 & >50 u. May affect ability to drive & use machines. Not recommended in ESRD & severe hepatic impairment. Discontinue during pregnancy; in women who want to get pregnant. Not to be used during breast-feeding. No relevant use in paed. Intensified glucose monitoring in elderly ≥65 yr.

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

Reduced requirement w/ antidiabetics, MAOIs, β-blockers, ACE inhibitors, salicylates, anabolic steroids, sulfonamides. Increased requirement w/ OCs, thiazides, glucocorticoids, thyroid & growth hormones, sympathomimetics, danazol. Masked hypoglycaemic symptoms w/ β-blockers. Increased or decreased requirement w/ octreotide/lanreotide. Intensified or reduced hypoglycaemic effect w/ alcohol. Concomitant use w/ warfarin or other coumarin derivatives (may require more frequent INR monitoring).

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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