Adult: Type 1: Insulin-naive patient: Initially, 1/3 to 1/2 the total daily insulin dose, given once daily; remainder of total daily dose should be given as a short- or rapid-acting insulin. General recommendation for initial total daily insulin dose is 0.2-0.4 units/kg. Insulin-experienced patient: Start at same dose as the total daily long- or intermediate-acting insulin unit dose from which the patient is being converted. Type 2: Insulin-naive patient: Initially, 10 units once daily. Insulin-experienced patient: Start at the same dose as the total daily long- or intermediate-acting insulin unit dose. Individualise and titrate dose every 3-4 days based on patient’s metabolic needs, blood glucose monitoring results, and glycaemic control goal. Administer missed dose as soon as possible, ensure at least 8 hours between consecutive doses. Child: ≥1 year Type 1 or 2: Insulin-naive patient: Same as adult dose. Insulin-experienced patient: Start at 80% of the total daily long- or intermediate-acting insulin unit dose.
Dosage reduction may be needed.
Dosage reduction may be needed.
Hypersensitivity. Hypoglycaemic episodes.
Patient with infections, fever, diseases affecting the adrenal, pituitary and thyroid gland, and those at risk for hypokalaemia. Not intended for treatment of diabetic ketoacidosis. Hepatic and renal impairment. Children. Lactation.
Significant: Lipodystrophy, hypoglycaemia, hypokalaemia, formation of insulin antibodies. Gastrointestinal disorders: Gastroenteritis, diarrhoea. General disorders and administration site conditions: Inj site reactions (e.g. haematoma, swelling, erythema), peripheral oedema. Immune system disorders: Urticaria. Investigations: Weight gain. Nervous system disorders: Headache. Respiratory, thoracic and mediastinal disorders: Nasopharyngitis, upper respiratory infection, sinusitis. Potentially Fatal: Severe hypoglycaemia, severe allergic reactions, including anaphylaxis.
Patient Counseling Information
Rotate injection sites within the same body region and use a new needle for each injection. This drug may cause hypoglycaemia which may impair ability to concentrate or react, if affected, do not drive or operate machinery.
Closely monitor plasma glucose levels (especially during transfer from other insulin product); HbA1c (at least twice yearly), electrolytes, lipid profile, renal and hepatic function, weight. Assess for signs of hypoglycaemia.
Symptoms: Severe hypoglycaemia and hypokalaemia. Management: Administer oral glucose or other sugar-containing products to treat mild hypoglycaemia. For severe hypoglycaemic episodes, treatment includes IM or SC administration of glucagon 0.5-1 mg, or concentrated IV glucose if patient does not respond to glucagon within 10-15 minutes. Oral carbohydrates may be given to the patient upon regaining consciousness to prevent relapse.
Risk of fluid retention and CHF when given with peroxisome proliferator-activated receptor (PPAR)-γ agonists (e.g. pioglitazone). Increased risk of hypoglycaemia with oral antidiabetic agents, glucagon-like peptide-1 (GLP-1) receptor agonists, ACE inhibitors, MAOIs, salicylates, sodium-glucose cotransporter 2 (SGLT2) inhibitors, sulfonamides, and anabolic steroids. Decreased glucose lowering effect with oral contraceptives, glucocorticoids, thiazides, thyroid hormones, growth hormone, sympathomimetics, glucagon, niacin, protease inhibitors, danazol. Somatostatin analogues (e.g. octreotide, lanreotide) may either increase or decrease insulin requirement. Beta-blockers, clonidine, guanethidine, lithium and reserpine may mask the symptoms of hypoglycaemia.
Alcohol may enhance or reduce the hypoglycaemic effect of insulin.
Description: Insulin degludec is a biosynthetic (rDNA origin), long-acting human insulin analogue that binds specifically to human insulin receptor, resulting in the same pharmacological effects as the human insulin. It lowers blood glucose concentrations by stimulating peripheral glucose uptake in skeletal muscle and adipose tissue and by inhibiting hepatic glucose production. It also inhibits lipolysis and proteolysis, and enhances protein synthesis. Onset: Approx 1 hour. Duration: >42 hours. Pharmacokinetics: Absorption: Time to peak plasma concentration: 9 hours. Distribution: Plasma protein binding: >99%, to albumin. Excretion: Elimination half-life: Approx 25 hours.
Unopened preparation: Store between 2-8°C. Do not freeze. Protect from light. Once opened, cartridge or prefilled syringe may be stored between 2-8°C or below 30°C up to 56 days. Do not freeze. Protect from direct heat and light.
A10AE06 - insulin degludec ; Belongs to the class of long-acting insulins and analogues for injection. Used in the treatment of diabetes.
Anon. Insulin Degludec. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 01/03/2018.Joint Formulary Committee. Insulin Degludec. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 01/03/2018.McEvoy GK, Snow EK, Miller J et al (eds). Insulin Degludec. AHFS Drug Information (AHFS DI) [online]. American Society of Health-System Pharmacists (ASHP). https://www.medicinescomplete.com. Accessed 01/03/2018.Tresiba Injection, Solution (Novo Nordisk). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 01/03/2018.