Soliqua

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

Individualised dosage. Inj SC in 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. Max daily dose: 60 u insulin glargine & 20 mcg lixisenatide (60 dose steps). Soliqua 10-40 pen Previous therapy: Insulin naïve patients (oral anti-diabetic treatment or GLP-1 receptor agonist) Initially 10 u insulin glargine/5 mcg lixisenatide (10 dose steps). Dose may be titrated up to 40 dose steps. For doses >40 dose steps/day, continue titration w/ Soliqua 30-60 pen. Insulin glargine (100 u/mL) ≥20 to <30 u Initially 20 u insulin glargine/10 mcg lixisenatide (20 dose steps). Dose may be titrated up to 40 dose steps. For doses >40 dose steps/day, continue titration w/ Soliqua 30-60 pen. 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 may be titrated up to 60 dose steps. For doses >60 dose steps/day, Soliqua must not be used.

Should be taken on an empty stomach: Administer w/in 1 hr before a meal, preferably before the same meal every day.

Hypersensitivity.

Not to be used in type 1 DM patients or for treatment of diabetic ketoacidosis. Risk of hypoglycaemia. Discontinue use if pancreatitis is suspected & do not restart if acute pancreatitis is confirmed. Exercise caution in patients w/ history of pancreatitis. Not recommended in patients w/ severe GI disease, including severe gastroparesis. Perform continuous rotation of inj site to reduce risk of developing lipodystrophy & cutaneous amyloidosis. Monitor blood glucose after change in inj site & consider dose adjustment of antidiabetics. Potential risk of dehydration. May cause Ab formation against insulin glargine &/or lixisenatide. Concomitant use w/ dipeptidyl peptidase-4 inhibitors, sulfonylureas, glinides, & pioglitazone has not been studied. Use w/ caution in patients receiving oral medicinal products that require rapid GI absorption, require careful clinical monitoring or have a narrow therapeutic ratio. Not recommended in patients w/ severe renal impairment (CrCl <30 mL/min) or ESRD. Insulin requirements may be diminished in patients w/ renal & hepatic impairment; frequent glucose monitoring & dose adjustment may be necessary. Contains metacresol which may cause allergic reactions. May impair ability to concentrate & react (as a result of hypo- or hyperglycaemia, or of visual impairment). Not recommended during pregnancy & in women of childbearing potential not using contraception. Discontinue breast-feeding during treatment. No relevant use in paed population. Limited therapeutic experience in patients ≥75 yr.

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

Enhanced blood glucose-lowering effect & increased susceptibility to hypoglycaemia w/ anti-hyperglycaemic medicinal products, ACE inhibitors, disopyramide, fibrates, fluoxetine, MAOIs, pentoxifylline, propoxyphene, salicylates & sulphonamide 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. Signs of adrenergic counter-regulation may be reduced or absent w/ sympatholytic medicinal products 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. Pentamidine may cause hypoglycaemia, which may sometimes be followed by hyperglycaemia. Lixisenatide: May reduce the rate of absorption of orally administered drugs especially drugs of either narrow therapeutic ratio or those that require careful clinical monitoring.

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.

Rx