Soliqua

Soliqua

insulin glargine + lixisenatide

Manufacturer:

sanofi-aventis

Distributor:

sanofi-aventis
Concise Prescribing Info
Contents
Per 100 u/mL + 50 mcg/mL soln for inj (10-40 pen) Insulin glargine 3.64 mg (equiv to 100 u), lixisenatide 50 mcg. Per 100 u/mL + 33 mcg/mL soln for inj (30-60 pen) Insulin glargine 3.64 mg (equiv to 100 u), lixisenatide 33 mcg
Indications/Uses
In combination w/ metformin for adults w/ type 2 DM to improve glycaemic control when metformin alone, or metformin combined w/ another oral glucose lowering drugs, or w/ basal insulin 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, preferably before the same meal every day.
Contraindications
Special Precautions
Not for type 1 DM patients & for treatment of diabetic ketoacidosis. Hypoglycaemia. Associated w/ a risk of developing acute pancreatitis; GI adverse reactions. Not recommended in patients w/ severe renal impairment (CrCl <30 mL/min) or end-stage renal disease. Potential risk of dehydration. Antibody formation against insulin glargine &/or lixisenatide. Switch from GLP-1 receptor agonist has not been studied. Concomitant use w/ dipeptidyl peptidase-4 inhibitors, sulfonylureas, glinides, pioglitazone & SGLT-2 inhibitors. Use w/ caution in patients receiving oral medicinal products that require rapid GI absorption. Hepatic impairment. Contains metacresol which may cause allergic reactions. Not recommended in women of childbearing potential not using contraception. May impair ability to drive & use machines (as a result of hypo- or hyperglycaemia, or of visual impairment). Pregnancy & lactation.
Adverse Reactions
Hypoglycaemia. Dizziness; nausea, diarrhoea, vomiting. Nasopharyngitis, upper resp tract infection; urticaria; headache; dyspepsia, abdominal pain; fatigue, inj site reactions.
Drug Interactions
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. 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. 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.
MIMS Class
Antidiabetic Agents / Insulin Preparations
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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