Xultophy

Treatment of adults w/ insufficiently controlled type 2 DM to improve glycaemic control as adjunct to diet & exercise in addition to other oral medicinal products for the treatment of diabetes.

SC Administer once daily, preferably at the same time of the day, as dose steps (1 dose step = insulin degludec 1 u & liraglutide 0.036 mg), by inj in the thigh, upper arm, or abdomen. Always ensure a min of 8 hr between inj. Max daily dose: 50 dose steps (insulin degludec 50 u & liraglutide 1.8 mg). Add-on to oral glucose-lowering medicinal products Recommended starting dose: 10 dose steps (insulin degludec 10 u & liraglutide 0.36 mg). Transfer from GLP-1 receptor agonist Discontinue therapy w/ GLP-1 receptor agonists prior to initiation of Xultophy. Recommended starting & max dose: 16 dose steps (insulin degludec 16 u & liraglutide 0.6 mg). Transfer from any insulin regimen w/ basal insulin component Discontinue therapy w/ other insulin regimens prior to initiation of Xultophy. Recommended starting & max dose: 16 dose steps, may be reduced to avoid hypoglycaemia in selected cases.

May be taken with or without food.

Hypersensitivity.

Must not be administered intravenously or intramuscularly. Must not be drawn from the cartridge of the pre-filled pen into a syringe to avoid dosing errors & potential overdose. Should not be used in patients w/ type 1 DM or for the treatment of diabetic ketoacidosis. Risk of hypoglycaemia w/ dose higher than required, omission of a meal, or unplanned strenuous physical exercise. Concomitant diseases in the kidney, liver or diseases affecting the adrenal, pituitary or thyroid gland may require dose changes. Prolonged effect may delay recovery from hypoglycaemia. Inadequate dosing &/or discontinuation of antidiabetic treatment may lead to hyperglycaemia & potentially to hyperosmolar coma. Concomitant illness, especially infections, may lead to hyperglycaemia. Continuously rotate inj site to reduce risk of developing lipodystrophy & cutaneous amyloidosis; potential risk of delayed insulin absorption & worsened glycaemic control following insulin inj at sites w/ these reactions. Monitor blood glucose after change in inj site from an affected to an unaffected area, & consider dose adjustment of antidiabetic medications. Reports of cardiac failure w/ combined use of pioglitazone & insulin medicinal products. Intensified therapy w/ insulin w/ abrupt improvement in glycaemic control may be associated w/ temporary worsening of diabetic retinopathy. May cause Ab formation against insulin degludec &/or liraglutide. Risk of acute pancreatitis. Reports of thyroid adverse events eg, goitre. Caution in patients w/ pre-existing thyroid disease. Not recommended in patients w/ inflammatory bowel disease & diabetic gastroparesis. Potential risk of dehydration in relation to GI side effects. Reports of pulmonary aspiration in patients undergoing general anaesth or deep sedation. Consider increased risk of residual gastric content due to delayed gastric emptying prior to performing procedures w/ general anaesth or deep sedation. Transfer from basal insulin doses <20 & >50 u has not been studied. Not recommended in patients w/ CHF NYHA class IV. Ability to concentrate & react may be impaired as a result of hypoglycaemia. Intensify glucose monitoring & individually adjust dose in elderly patients, patients w/ mild, moderate or severe renal impairment, & patients w/ mild or moderate hepatic impairment. Not recommended in patients w/ ESRD & patients w/ severe hepatic impairment. Should be discontinued if patient wishes to become pregnant, or pregnancy occurs. Should not be used during breast-feeding. No relevant use in paed population.

Hypoglycaemia. Decreased appetite; dizziness; nausea, diarrhoea, vomiting, constipation, dyspepsia, gastritis, abdominal pain/distension, GERD; 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. Masked symptoms of hypoglycaemia w/ β-blockers. Increased or decreased Xultophy requirement w/ octreotide/lanreotide. Intensified or reduced hypoglycaemic effect w/ alcohol. Clinically relevant interaction cannot be excluded w/ active substances w/ poor solubility or narrow therapeutic index eg, warfarin.

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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