Soliqua

Per 100 u/mL + 50 mcg/mL soln for inj (10-40 pen) Insulin glargine 100 u, lixisenatide 50 mcg. Per 100 u/mL + 33 mcg/mL soln for inj (30-60 pen) Insulin glargine 100 u, lixisenatide 33 mcg

For adults w/ insufficiently controlled type 2 DM to improve glycaemic control as an adjunct to diet & exercise in addition to metformin w/ or w/o SGLT2 inhibitors, when metformin alone, or metformin combined w/ another oral glucose lowering drugs, or w/ basal insulin or w/ GLP-1RA does not provide adequate glycaemic control.

Individualized dosage. Inj SC in the abdomen, deltoid, or thigh. Starting dose is based on previous anti-diabetic treatment in order not to exceed the recommended lixisenatide starting dose of 10 mcg. Soliqua 10-40 pen Previous therapy of oral anti-diabetic treatment or GLP-1 receptor agonist (insulin naïve patients) Starting dose: 10 u insulin glargine/5 mcg lixisenatide (10 dose steps). Previous therapy of insulin glargine (100 u/mL) ≥20 to <30 u Starting dose: 20 u insulin glargine/10 mcg lixisenatide (20 dose steps). Dose titration: If patient starts w/ a Soliqua 10-40 pen, dose may be titrated up to 40 dose steps. For doses >40 dose steps/day titration must be continued w/ Soliqua (30-60) pen. Soliqua 30-60 pen Previous therapy of insulin glargine (100 u/mL) ≥30 to ≤60 u Starting dose: 30 u insulin glargine/10 mcg lixisenatide (30 dose steps). Dose titration: If patient starts w/ a Soliqua 30-60 pen, dose may be titrated up to 60 dose steps. Max daily dose: 60 u insulin glargine & 20 mcg lixisenatide (60 dose steps).

Should be taken on an empty stomach: Administer w/in 1 hr before a meal.

Hypersensitivity. During episodes of hypoglycemia.

Not to be used in type 1 DM or diabetic ketoacidosis. Perform continuous rotation of the inj site to reduce risk of developing lipodystrophy & cutaneous amyloidosis. Hypoglycaemia may occur w/ administration of higher than the required dose. Associated w/ a risk of developing acute pancreatitis; GI adverse reactions. Discontinue treatment if acute pancreatitis occurs. Not recommended in patients w/ severe GI disease. May reduce absorption rate of orally administered drugs. Patients receiving oral drugs that require rapid GI absorption, requires careful clinical monitoring or have a narrow therapeutic ratio. Potential risk of dehydration. Ab formation against insulin glargine &/or lixisenatide. K shift from extracellular to intracellular space leading to hypokalemia. Fluid retention may lead to or exacerbate heart failure. Never use a syringe to draw the medicine from the cartridge in the pre-filled pen into a syringe. Concomitant use w/ dipeptidyl peptidase-4 inhibitors, sulfonylureas, glinides, pioglitazone. Contains metacresol which may cause allergic reactions. May impair ability to drive & use machines (as a result of hypo- or hyperglycaemia, or of visual impairment). Not recommended in patients w/ severe renal impairment (CrCl <30 mL/min) or ESRD. Not recommended in women of childbearing potential not using contraception. Not to be used during pregnancy & breast-feeding.

Hypoglycaemia. Dizziness, nausea, diarrhoea, vomiting; inj site reactions.

Enhanced blood glucose-lowering effect w/ anti-hyperglycaemic medicinal products, ACE inhibitors, disopyramide, fibrates, fluoxetine, MAOIs, pentoxifylline, propoxyphene, salicylates & sulfonamide antibiotics. Reduced blood glucose-lowering effect w/ corticosteroids, danazol, diazoxide, diuretics, glucagon, INH, oestrogens & progestogens, phenothiazine derivatives, somatropin, sympathomimetic medicinal products (eg, epinephrine, salbutamol, terbutaline), thyroid hormones, atypical antipsychotic medicinal products (eg, clozapine & olanzapine) & PIs. Reduced or absent signs of adrenergic counter-regulation w/ sympatholytics eg, β-blockers, clonidine, guanethidine, reserpine. Insulin: Blood glucose-lowering effect of insulin may either be potentiated or weakened by β-blockers, clonidine, lithium salts or alcohol. May cause hypoglycaemia w/ pentamidine. Lixisenatide: May reduce the rate of absorption of orally administered drugs especially drugs of either narrow therapeutic ratio or drugs that require careful clinical monitoring; oral medicinal products that are particularly dependent on threshold conc for efficacy eg, antibiotics; gastro-resistant formulations containing substances sensitive to stomach degradation.

Antidiabetic Agents / Insulin Preparations

A10AE54 - insulin glargine and lixisenatide ; Belongs to the class of long-acting insulins and analogues for injection. Used in the treatment of diabetes.

G