Soliqua

Soliqua

insulin glargine + lixisenatide

Manufacturer:

Sanofi-Aventis

Distributor:

DKSH
Concise Prescribing Info
Contents
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
Indications/Uses
Adults w/ type 2 DM to improve glycaemic control when oral glucose-lowering drugs alone, combined w/ basal insulin, or basal insulin alone does not provide adequate glycaemic control.
Dosage/Direction for Use
Individualised dosage. Inject 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. Soliqua 10-40 pen Previous therapy: Oral anti-diabetic treatment (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 doses. 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).
Administration
Should be taken on an empty stomach: Administer w/in 1 hr before a meal.
Contraindications
Special Precautions
Do not use in patients w/ type 1 DM or for treatment of diabetic ketoacidosis. Monitor for hypoglycaemia. Concomitant use w/ sulfonylurea, oral drugs w/ rapid GI absorption, require careful monitoring or w/ a narrow therapeutic ration; DPP-4 inhibitors, glinides, pioglitazone & SGLT-2 inhibitors. History of pancreatitis. Discontinue treatment if acute pancreatitis occurs. Not recommended in patients w/ severe GI disease; severe renal impairment (CrCl <30 mL/min) or end-stage renal disease. Avoid fluid depletion. Antibody formation against insulin glargine &/or lixisenatide may occur. Allergies to metacresol. Avoid hypoglycemia which may affect the ability to drive & use machinery. Women of childbearing potential not using contraception. Pregnancy (discontinue) & lactation.
Adverse Reactions
Hypoglycemia. Dizziness; nausea, diarrhoea, vomiting.
Drug Interactions
Enhanced blood-glucose-lowering effect & increased susceptibility to hypoglycemia w/ anti-hyperglycaemic agents, ACE inhibitors, disopyramide, fibrates, fluoxetine, MAO inhibitors, 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 antispsychotic medicinal products (eg, clozapine & olanzapine) & PI. May either potentiate or weaken the blood-glucose-lowering effect of insulin w/ β-blockers, clonidine, lithium salts or alcohol. May cause hypoglycaemia w/ pentamidine. Oral drugs eg, antibiotics. Paracetamol, OCs.
ATC Classification
A10AE54 - insulin glargine and lixisenatide ; Belongs to the class of long-acting insulins and analogues for injection. Used in the treatment of diabetes.
Presentation/Packing
Form
Soliqua soln for inj 100 u/mL + 50 mcg/mL
Packing/Price
3 mL x 3 × 1's
Form
Soliqua soln for inj 100 u/mL + 33 mcg/mL
Packing/Price
3 mL x 3 × 1's
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