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Xultophy

Xultophy

Manufacturer:

Novo Nordisk

Distributor:

Novo Nordisk
Concise Prescribing Info
Contents
Per mL Insulin degludec 100 u, liraglutide 3.6 mg
Indications/Uses
Type 2 DM in adults to improve glycaemic control in combination w/ oral glucose-lowering medicinal products when these alone or combined w/ a GLP-1 receptor agonist or basal insulin do not provide adequate glycaemic control.
Dosage/Direction for Use
SC Administer once daily, preferably at the same time each day. Individualised dosage. 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). Therapy w/ GLP-1 receptor agonist or basal insulin should be discontinued prior to Xultophy initiation. The recommended starting dose should not be exceeded.
Contraindications
Special Precautions
Do not administer by IV or IM. Do not use in patients w/ type 1 DM or for the treatment of diabetic ketoacidosis. Risk of hypoglycemia especially when in omission of a meal or unplanned strenuous physical exercise, in combination w/ sulfonylurea, kidney or liver diseases or diseases affecting the adrenal, pituitary or thyroid gland. Inadequate dosing &/or discontinuation of anti-diabetic treatment may lead to hyperglycaemia & to hyperosmolar coma. Cardiac failure when in combination w/ pioglitazone. Intensification of therapy w/ abrupt improvement in glycaemic control may be associated w/ temporary worsening of diabetic retinopathy. May cause Ab formation. History of pancreatitis. Patients w/ pre-existing thyroid disease, inflammatory bowel disease, diabetic gastroparesis. Potential risk of dehydration. Transfer to Xultophy from doses of basal insulin <20 & >50 u; in combination w/ dipeptidyl peptidase 4 (DPP-4) inhibitors, glinides or prandial insulin; patients w/ CHF NYHA class I-IV. May impair ability to drive or use machines. Not recommended in patients w/ severe hepatic & severe renal impairment including those w/ end-stage renal disease. Pregnancy & lactation. Elderly ≥75 yr.
Adverse Reactions
Hypoglycemia. Decreased appetite, nausea, diarrhoea, vomiting, constipation, dyspepsia, gastritis, abdominal pain, GERD, abdominal distension, inj site reaction, increased lipase, increased amylase.
Drug Interactions
Reduced Xultophy requirement w/ anti-diabetics, MAOIs, β-blockers, ACE inhibitors, salicylates, anabolic steroids & sulfonamides. Increased Xultophy requirement w/ OCs, thiazides, glucocorticoids, thyroid hormones, sympathomimetics, growth hormones & danazol. May mask symptoms of hypoglycemia w/ β-blockers. May either increase or decrease Xultophy requirement w/ octreotide/lanreotide. May intensify or reduce hypoglycemic effect w/ alcohol. Warfarin or other coumarin derivatives (may require more frequent INR monitoring).
MIMS Class
ATC Classification
A10AE56 - insulin degludec and liraglutide ; Belongs to the class of long-acting insulins and analogues for injection. Used in the treatment of diabetes.
Presentation/Packing
Form
Xultophy soln for inj 100 u/mL + 3.6 mg/mL
Packing/Price
3 mL x 5 × 1's
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