Soliqua

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 Inj in abdomen, deltoid or thigh. Individualised dosage. Starting dose is based on previous antidiabetic treatment in order not to exceed the recommended lixisenatide starting dose of 10 mcg. Soliqua 10-40 pen Previous therapy: Oral antidiabetic treatment or glucagon-like peptide-1 (GLP-1) receptor agonist (insulin naïve patients) 10 U insulin glargine/5 mcg lixisenatide (10 dose steps). Insulin glargine (100 U/mL) ≥20 to <30 U 20 U insulin glargine/10 mcg lixisenatide (20 dose steps). Dose may be titrated up to 40 dose steps. Soliqua 30-60 pen Previous therapy: Insulin glargine (100 U/mL) ≥30 to ≤60 U 30 U insulin glargine/10 mcg lixisenatide (30 dose steps). 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 meal.

Hypersensitivity.

Discontinue treatment if pancreatitis is suspected; if therapy w/ basal insulin or GLP-1 receptor agonist or oral glucose lowering medicinal product other than metformin & SGLT-2 inhibitors prior to initiation of Soliqua. Not to be used in patients w/ type 1 DM or for diabetic ketoacidosis. Not recommended in patients w/ severe GI disease including severe gastroparesis. Allergic reaction to metacresol. Potential risk of dehydration. May cause Abs formation. Patients w/ history of pancreatitis; receiving oral medicinal products requiring rapid GI absorption. Close monitoring on factors increasing susceptibility to hypoglycaemia eg, change in inj area; improved insulin sensitivity (eg, by removal of stress factors); unaccustomed, increased or prolonged physical activity; intercurrent illness (eg, vomiting, diarrhoea); inadequate food intake; missed meals; alcohol consumption; certain uncompensated endocrine disorders (eg, hypothyroidism & anterior pituitary or adrenocortical insufficiency); concomitant treatment w/ other drugs. Consider blood glucose monitoring & dose adjustment of antidiabetic medications after change in inj site. Perform continuous rotation of inj site to reduce risk of developing lipodystrophy & cutaneous amyloidosis. Not to be given in combination w/ sulfonylurea. Concomitant use w/ dipeptidyl peptidase-4 (DPP-4) inhibitors, glinides & pioglitazone. May impair ability to drive & use machines. Not recommended in patients w/ severe renal impairment (CrCl <30 mL/min) & ESRD. Frequent glucose monitoring in patients w/ hepatic & mild to moderate renal impairment. Not recommended in women of childbearing potential not using contraception. Not to be used during pregnancy & lactation. Paed patient. Progressive deterioration of renal function leading to steady decrease in insulin requirements in elderly. Elderly ≥75 yr.

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

Enhanced blood-glucose-lowering effect & increased susceptibility to hypoglycemia w/ anti-hyperglycaemics, ACE inhibitors, disopyramide, fibrates, fluoxetine, MAOIs, pentoxifylline, propoxyphene, salicylates & sulfonamides. Reduced blood-glucose-lowering effect w/ corticosteroids, danazol, diazoxide, diuretics, glucagon, INH, oestrogens & progestogens, phenothiazine derivatives, somatropin, sympathomimetics (eg, epinephrine, salbutamol, terbutaline), thyroid hormones, atypical antipsychotics (eg, clozapine & olanzapine) & PIs. May either potentiate or weaken blood-glucose-lowering effect of insulin w/ β-blockers, clonidine, lithium salts or alcohol. Hypo-/hyperglycaemia w/ pentamidine. Concomitant use w/ antibiotics; paracetamol; warfarin &/or coumarin derivatives. Reduced or absent signs of adrenergic counter-regulation w/ sympatholytics (eg, β-blockers, clonidine, guanethidine & reserpine). Reduced rate of absorption of medicinal products w/ narrow therapeutic ratio. Delayed T_max & reduced C_max of digoxin & ramipril.

Insulin Preparations / Antidiabetic Agents

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

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