Soliqua

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

Adults w/ insufficiently controlled type 2 DM to improve glycaemic control as adjunct to diet & exercise in addition to metformin w/ or w/o SGLT-2 inhibitors.

SC Individualised dosing. Max daily dose: 60 u insulin glargine & 20 mcg lixisenatide (60 dose steps). Starting dose: Based on previous antidiabetic treatment in order not to exceed the recommended lixisenatide starting dose of 10 mcg. Soliqua (30-60) pen Previous therapy: Insulin glargine (100 u/mL) ≥30 to ≤60 u Initially 30 u insulin glargine/10 mcg lixisenatide (30 dose steps). Dose titration: If the patient starts w/ Soliqua (30-60) pen, dose may be titrated up to 60 dose steps. Soliqua (10-40) pen Previous therapy: Oral antidiabetic treatment or GLP-1 receptor agonist (insulin naïve patient) Initially 10 u insulin glargine/5 mcg lixisenatide (10 dose steps). Insulin glargine (100 u/mL) ≥20 to <30 u Initially 20 u insulin glargine/10 mcg lixisenatide (20 dose steps). Dose titration: If the patient starts w/ Soliqua (10-40) pen, dose may be titrated up to 40 dose steps. Continue titration w/ Soliqua (30-60) pen for doses >40 dose steps/day.

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

Hypersensitivity.

Do not use in patients w/ type 1 DM or for diabetic ketoacidosis. Discontinue basal insulin or GLP-1 receptor agonist or oral glucose-lowering medicinal product other than metformin & SGLT-2 inhibitors prior to Soliqua initiation. Perform continuous rotation of inj site to reduce risk of developing lipodystrophy & cutaneous amyloidosis; potential risk of delayed insulin absorption & worsened glycaemic control following insulin inj at sites w/ these reactions. Monitor blood glucose after change in inj site & consider dose adjustment of antidiabetic medicinal product. Closely monitor for hypoglycaemia. Patients w/ history of pancreatitis. Discontinue Soliqua if pancreatitis is suspected; do not restart lixisenatide if acute pancreatitis is confirmed. Not recommended in patients w/ severe GI disease including severe gastroparesis. Potential risk of dehydration; avoid fluid depletion. May cause Abs formation against insulin glargine &/or lixisenatide. Concomitant use w/ sulfonylurea; oral medicinal products that require rapid GI absorption, require careful clinical monitoring or have narrow therapeutic ratio; DPP-4 inhibitors, glinides & pioglitazone. Contains Na <1 mmol/dose. Contains metacresol which may cause allergic reactions. May impair ability to concentrate & react due to hypo- or hyperglycaemia; advise patients to avoid hypoglycaemia while driving & using machines. Not recommended in patients w/ severe renal impairment or ESRD. May diminish insulin requirements due to reduced insulin metabolism in patients w/ renal or hepatic impairment. Not recommended during pregnancy & in women of childbearing potential not using contraception. Discontinue breast-feeding during treatment. No relevant use in paed population. Elderly ≥75 yr; progressive deterioration of renal function may lead to steady decrease in insulin requirements.

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

May enhance blood-glucose-lowering effect w/ anti-hyperglycaemic medicinal products, ACE inhibitors, disopyramide, fibrates, fluoxetine, MAOIs, pentoxifylline, propoxyphene, salicylates & sulphonamide antibiotics. May reduce 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 antipsychotics (eg, clozapine & olanzapine) & PIs. May either potentiate or weaken blood-glucose-lowering effect of insulin by β-blockers, clonidine, lithium salts or alcohol. May cause hypoglycaemia w/ pentamidine. May reduce signs of adrenergic counter-regulation w/ sympatholytic medicinal products (eg, β-blockers, clonidine, guanethidine & reserpine). May reduce absorption rate of orally administered medicinal products.

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.

POM