Lixisenatide


Concise Prescribing Info
Indications/Uses
Adjunct to type 2 diabetes mellitus.
Dosage/Direction for Use
Adult : SC Initial: 10 mcg once daily for 14 days, given within 1 hour before morning or evening meal. May increase dose to 20 mcg once daily starting on day 15.
Dosage Details
Subcutaneous
Adjunct to Type 2 diabetes mellitus
Adult: Initially, 10 mcg once daily for 14 days, given within 1 hour before morning or evening meal. May increase dose to 20 mcg once daily starting on day 15. Missed dose should be given within 1 hour of the next meal.
Renal Impairment
ESRD: Not recommended.

CrCl (mL/min) Dosage
<30 Not recommended.
Special Precautions
Patient with history of hypersensitivity or pancreatitis, volume depletion, severe gastrointestinal disease (e.g. gastroparesis). Not intended for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. Renal impairment (including ESRD). Pregnancy and lactation.
Adverse Reactions
Significant: Antibody formation, acute kidney injury, severe gastroparesis, serious hypersensitivity reactions (e.g. anaphylaxis, angioedema).
Gastrointestinal disorders: Nausea, vomiting, diarrhoea, constipation, dyspepsia, abdominal distention, upper abdominal pain.
General disorders and administration site conditions: Inj site pain, pruritus, erythema.
Infections and infestations: Influenza, viral infection.
Musculoskeletal and connective tissue disorders: Back pain.
Nervous system disorders: Headache, dizziness, somnolence.
Renal and urinary disorders: Cystitis.
Respiratory, thoracic and mediastinal disorder: Upper respiratory tract infection.
Potentially Fatal: Acute pancreatitis, including fatal and non-fatal haemorrhagic or necrotising pancreatitis.
MonitoringParameters
Monitor serum glucose, HbA1c, renal function, signs and symptoms of pancreatitis and hypersensitivity.
Overdosage
Symptoms: Gastrointestinal disorders. Management: Supportive treatment.
Drug Interactions
Increased risk of hypoglycaemia with sulfonylureas or basal insulin. May reduce the rate of absorption of oral medications (e.g. antibiotics, paracetamol, oral contraceptives).
Action
Description: Lixisenatide binds to and activates glucagon-like peptide-1 (GLP-1) receptor to stimulate glucagon-dependent insulin secretion, suppress glucagon secretion and slow gastric emptying.
Pharmacokinetics:
Absorption: Rapidly absorbed. Time to peak plasma concentration: Approx 1-3.5 hours.
Distribution: Volume of distribution: Approx 100 L. Plasma protein binding: Approx 55%.
Metabolism: Undergoes proteolytic degradation into smaller peptides and amino acids.
Excretion: Mainly via urine. Terminal elimination half-life: Approx 3 hours.
Chemical Structure

Chemical Structure Image
Lixisenatide

Source: National Center for Biotechnology Information. PubChem Database. Lixisenatide, CID=90472060, https://pubchem.ncbi.nlm.nih.gov/compound/Lixisenatide (accessed on Jan. 22, 2020)

Storage
Store between 2-8°C prior to initial use. Store below 30°C after initial use. Do not freeze. Protect from light.
MIMS Class
ATC Classification
A10BJ03 - lixisenatide ; Belongs to the class of glucagon-like peptide-1 (GLP-1) analogues. Used in the treatment of diabetes.
References
Adlyxin Injection, Solution (Sanofi-Aventis U.S. LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 02/02/2018.

Anon. Lixisenatide. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 02/02/2018.

Anon. Lixisenatide. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 02/02/2018.

Buckingham R (ed). Lixisenatide. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 02/02/2018.

Joint Formulary Committee. Lixisenatide. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 02/02/2018.

Disclaimer: This information is independently developed by MIMS based on Lixisenatide 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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