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
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
Individualized dosage. SC Soliqua (10-40) pen Dose steps: 10-40 u insulin glargine/lixisenatide 5-20 mcg. Soliqua (30-60) pen Dose steps: 30-60 u insulin glargine/lixisenatide 10-20 mcg. Inject in abdomen, deltoid or thigh.
Administration
Should be taken on an empty stomach: Administer w/in 1 hr before a meal.
Contraindications
Special Precautions
Not to be used in type 1 DM or diabetic ketoacidosis. Hypoglycaemia may occur w/ administration of higher than the required dose. Acute pancreatitis; GI adverse reactions. May reduce absorption rate of orally administered drugs. Patients receiving oral drugs that require rapid GI absorption, requires careful clinical monitoring or have a narrow therapeutic ratio. Potential risk of dehydration. Ab formation against insulin glargine &/or lixisenatide. K shift from extracellular to intracellular space leading to hypokalemia. Never use a syringe to draw the medicine from the cartridge in the pre-filled pen into a syringe. Fluid retention may lead to or exacerbate heart failure. Switch from glucagon-like peptide-1 receptor agonist. Concomitant use w/ dipeptidyl peptidase-4 inhibitors, sulfonylureas, glinides, pioglitazone & sodium-glucose co-transporter-2 inhibitors. Contains metacresol which may cause allergic reactions. Not recommended in patients w/ severe renal impairment (CrCl <30 mL/min) or end-stage renal disease. Not recommended in women of childbearing potential not using contraception. Pregnancy. Not to be used during breast-feeding.
Adverse Reactions
Hypoglycaemia. Dizziness, nausea, diarrhoea, vomiting.
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 + 33 mcg/mL
Packing/Price
(pre-filled pen) 3 mL x 3 × 1's
Form
Soliqua soln for inj 100 u/mL + 50 mcg/mL
Packing/Price
(pre-filled pen) 3 mL x 3 × 1's (Rp1,621,793/boks)
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