Adult: Each mL of solution contains 100 units insulin glargine and 33 mcg lixisenatide Each mL of solution contains 100 units insulin glargine and 50 mcg lixisenatide
In combination with metformin with or without sodium-glucose co-transporter-2 (SGLT-2) inhibitors as an adjunct to diet and exercise: Dosage is individualised and adjusted according to the patient's metabolic requirement, blood glucose level, and glycaemic control goal. As 100 units/33 mcg ("30-60") pen: Initial dose recommendation: Patients naive to basal insulin or glucagon-like peptide-1 (GLP-1) agonist, or currently on a GLP-1 agonist or <30 units of basal insulin/day: 15 units (15 units insulin glargine/5 mcg lixisenatide) once daily. Patients currently on 30-60 units of basal insulin/day, with or without a GLP1-agonist: 30 units (30 units insulin glargine/10 mcg lixisenatide) once daily. Doses are titrated upwards or downwards by 2-4 units (2-4 units insulin glargine/0.66-1.32 mcg lixisenatide) weekly until desired plasma glucose is achieved. Usual dose range: 15 units (15 units insulin glargine/5 mcg lixisenatide) to 60 units (60 units insulin glargine/20 mcg lixisenatide) daily. Max: 60 units (60 units insulin glargine/20 mcg lixisenatide) daily. As 100 units/50 mcg ("10-40") pen: Initial dose recommendation: Patients naive to basal insulin or currently on <20 units of basal insulin/day: 10 units (10 units insulin glargine/5 mcg lixisenatide) once daily. Patients currently on 20-<30 units of basal insulin/day: 20 units (20 units insulin glargine/10 mcg lixisenatide) once daily. Patients currently on ≥30 units of basal insulin/day: Not recommended. Doses are adjusted until desired plasma glucose is achieved. Usual dose range: 10 units (10 units insulin glargine/5 mcg lixisenatide) to 40 units (40 units insulin glargine/20 mcg lixisenatide) daily. Max: 40 units (40 units insulin glargine/20 mcg lixisenatide) daily. Dosage adjustments may be necessary during acute illness or with changes in physical activity, meal patterns, or concurrent medications. Dosing recommendations may vary among individual products and between countries (refer to specific product guidelines).
What are the brands available for Insulin glargine + Lixisenatide in Philippines?
Mild to moderate: Dose adjustment may be necessary. Severe and ESRD: Not recommended.
Hepatic Impairment
Dose adjustment may be necessary.
Administration
Insulin glargine + Lixisenatide Should be taken with food. Administer w/in 1 hr before the first meal of the day.
Contraindications
Hypersensitivity. Episodes of hypoglycaemia.
Special Precautions
Patient with history of pancreatitis; history of anaphylaxis or angioedema with another GLP-1 agonist. Not recommended in patients with severe gastrointestinal disease (including severe gastroparesis). Not indicated for type 1 diabetes mellitus or diabetic ketoacidosis. Patients undergoing surgeries or procedures requiring deep sedation or anaesthesia may have an increased risk of pulmonary aspiration due to residual gastric contents caused by delayed gastric emptying associated with GLP-1 agonists. Available preparations differ in dose range and ratio of insulin glargine to lixisenatide; dosage adjustment and monitoring of blood glucose may be necessary when switching between preparations. Renal and hepatic impairment. Pregnancy and lactation.
Adverse Reactions
Significant: Hypoglycaemia; delayed gastric emptying, which may lead to pulmonary aspiration (particularly in patients undergoing general anaesthesia or deep sedation); antibody formation against insulin glargine and/or lixisenatide; acute kidney injury and worsening of chronic renal failure; hypokalaemia; gallbladder diseases (e.g. cholelithiasis, cholecystitis); gastrointestinal effects (e.g. nausea, vomiting, diarrhoea) which may lead to dehydration; risk of suicidal thoughts or actions. Gastrointestinal disorders: Abdominal pain, dyspepsia, dysgeusia. General disorders and administration site conditions: Inj site reaction, fatigue. Hepatobiliary disorders: Cholelithiasis, cholecystitis. Nervous system disorders: Dizziness, headache. Respiratory, thoracic and mediastinal disorders: Nasopharyngitis, URTI. Skin and subcutaneous tissue disorders: Urticaria. Potentially Fatal: Anaphylaxis and other serious hypersensitivity reactions (including angioedema); acute pancreatitis, including haemorrhagic or necrotising pancreatitis.
Patient Counseling Information
This drug may impair the ability to concentrate and react due to hypoglycaemia; if affected, do not drive or operate machinery. This drug may also cause gastrointestinal effects (e.g. vomiting, diarrhoea) that may result in dehydration; ensure adequate fluid intake during treatment. Continuously rotate inj sites within the same body region to lower the risk of inj site reactions.
Monitoring Parameters
Monitor plasma glucose, electrolytes, renal and hepatic function, and weight; HbA1c (at least twice yearly in patients with stable glycaemic control; quarterly in patients not meeting treatment goals or with treatment change). Assess for signs and symptoms of hypokalaemia, hypoglycaemia, pancreatitis, gallbladder disease, and new or worsening depression, suicidal thoughts, unusual mood/behavioural changes.
Overdosage
Symptoms: Hypoglycaemia and gastrointestinal reactions. Management: Supportive treatment. Give oral carbohydrates for mild episodes of hypoglycaemia. May administer IM/SC glucagon or concentrated IV glucose for more severe episodes of hypoglycaemia.
Drug Interactions
Increased risk of hypoglycaemia with sulfonylureas, ACE inhibitors, ARBs, disopyramide, fibrates, fluoxetine, MAOIs, pentoxifylline, propoxyphene, salicylates and sulfonamide antibiotics. May reduce the blood-glucose lowering effect with corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, estrogens, progestogens, phenothiazine derivatives, somatropin, sympathomimetic drugs (e.g. epinephrine, salbutamol, terbutaline), thyroid hormones, atypical antipsychotic drugs (e.g. clozapine, olanzapine) and protease inhibitors. Increased risk of hypoglycaemia or hyperglycaemia with pentamidine. May blunt the signs of hypoglycaemia with β-blockers, clonidine, guanethidine, reserpine.
Insulin glargine: May potentiate or weaken the blood-glucose-lowering effect with β-blockers, clonidine and lithium. Increased risk of fluid retention leading to heart failure with peroxisome proliferator-activated receptor (PPAR)-γ agonists (including thiazolidinediones).
Lixisenatide: May reduce the rate of absorption of orally administered drugs.
Food Interaction
Insulin glargine: May either potentiate or weaken the blood glucose-lowering effect with alcohol.
Action
Description: Mechanism of Action: Insulin glargine, a long-acting insulin analogue, stimulates peripheral glucose uptake (particularly by skeletal muscle and fat) and inhibits hepatic glucose production, thus reducing blood glucose levels. It prevents lipolysis in the adipocyte, inhibits proteolysis, and increases protein synthesis.
Lixisenatide is a selective glucagon-like peptide-1 (GLP-1) receptor agonist antidiabetic agent. It acts on the same receptor as endogenous hormone incretin, resulting in increased glucose-dependent insulin secretion and decreased inappropriate glucagon secretion. Additionally, lixisenatide delays gastric emptying, thereby decreasing the rate at which the meal-derived glucose is absorbed and appears in the circulation. Duration: Insulin glargine: Approx 24 hours or longer. Pharmacokinetics: Absorption: Insulin glargine: Slowly absorbed.
Lixisenatide: Rapidly absorbed. Time to peak plasma concentration: 1-3.5 hours. Distribution: Lixisenatide: Plasma protein binding: Approx 55%. Metabolism: Insulin glargine: Partially metabolised at the carboxyl terminus of the B chain to form 2 active metabolites, M1 (21A-Gly-insulin) and M2 (21A-Gly-des-30B-Thr-insulin).
Lixisenatide: Metabolised via proteolytic degradation. Excretion: Lixisenatide: Via urine. Elimination half-life: Approx 3 hours.
Chemical Structure
Insulin glargine Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 44146714, Insulin-glargine. https://pubchem.ncbi.nlm.nih.gov/compound/Insulin-glargine. Accessed Apr. 28, 2025.
Lixisenatide Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 90472060, Lixisenatide. https://pubchem.ncbi.nlm.nih.gov/compound/Lixisenatide. Accessed Nov. 25, 2024.
Storage
Unopened pen: Store between 2-8°C. Do not freeze. Protect from light. Opened (in-use) pen: Store below 25°C for up to 28 days. Do not refrigerate or freeze. Protect from direct heat or light.
A10AE54 - insulin glargine and lixisenatide ; Belongs to the class of long-acting insulins and analogues for injection. Used in the treatment of diabetes.
References
Brayfield A, Cadart C (eds). Lixisenatide. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 03/04/2025.GLP-1 and Dual GIP/GLP-1 Receptor Agonists: Potential Risk of Pulmonary Aspiration During General Anaesthesia or Deep Sedation. Medicines & Healthcare products Regulatory Agency. https://www.gov.uk/drug-safety-update. Accessed 24/04/2025.GLP-1 Receptor Agonists: Reminder of the Potential Side Effects and to Be Aware of the Potential for Misuse. Medicines & Healthcare products Regulatory Agency. https://www.gov.uk/drug-safety-update. Accessed 24/04/2025.Insulin Glargine and Lixisenatide. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 03/04/2025.Insulin Glargine. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 03/04/2025.Joint Formulary Committee. Insulin Glargine with Lixisenatide. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 03/04/2025.Lixisenatide. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 03/04/2025.Soliqua 100/33 Injection, Solution (Sanofi-Aventis U.S. LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 03/04/2025.Soliqua Solostar 100 units/mL + 50 micrograms/mL and 100 units/mL + 33 micrograms/mL Solution for Injection in Pre-filled Pen (Sanofi-Aventis [Malaysia] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 03/04/2025.Suliqua 100 units/mL + 33 micrograms/mL Solution for Injection in Pre-filled Pen (Aventis Pharma Limited). MHRA . https://products.mhra.gov.uk. Accessed 03/04/2025.Suliqua 100 units/mL + 50 micrograms/mL Solution for Injection in Pre-filled Pen (Aventis Pharma Limited). MHRA. https://products.mhra.gov.uk. Accessed 03/04/2025.
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