Insulin degludec


Concise Prescribing Info
Indications/Uses
Diabetes mellitus.
Dosage/Direction for Use
Adult : SC Type 1: Insulin-naive patient: Initial: 1/3 to 1/2 the total daily insulin dose, given once daily. Insulin-experienced patient: Initial: 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: Initial: 10 units once daily. Insulin-experienced patient: Initial: 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.
Dosage Details
Subcutaneous
Diabetes mellitus
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.
Renal Impairment
Dosage reduction may be needed.
Hepatic Impairment
Dosage reduction may be needed.
Contraindications
Hypersensitivity. Hypoglycaemic episodes.
Special Precautions
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.
Adverse Reactions
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.
MonitoringParameters
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.
Overdosage
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.
Drug Interactions
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.
Food Interaction
Alcohol may enhance or reduce the hypoglycaemic effect of insulin.
Action
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.
Chemical Structure

Chemical Structure Image
Insulin degludec

Source: National Center for Biotechnology Information. PubChem Database. Insulin degludec, CID=118984462, https://pubchem.ncbi.nlm.nih.gov/compound/Insulin-degludec (accessed on Jan. 21, 2020)

Storage
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.
ATC Classification
A10AE06 - insulin degludec ; Belongs to the class of long-acting insulins and analogues for injection. Used in the treatment of diabetes.
References
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.

Disclaimer: This information is independently developed by MIMS based on Insulin degludec from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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