Soliqua Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Caution For Usage Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

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

Adjunct to diet & exercise for the treatment of type 2 diabetes in adults when blood sugar levels are too high, & in combination w/ metformin w/ or w/o SGLT-2 inhibitors when other medicines are not enough to control blood sugar levels.

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Dosage/Direction for Use

SC inj in the abdomen, deltoid, or thigh. 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 of oral antidiabetic treatment or GLP-1 receptor agonist (insulin-naïve patient) Starting dose: 10 u insulin glargine/5 mcg lixisenatide (10 dose steps). Previous therapy of insulin glargine (100 u/mL) ≥20 to <30 u Starting dose: 20 u insulin glargine/10 mcg lixisenatide (20 dose steps). If patient starts w/ a Soliqua 10-40 pen, dose may be titrated up to 40 dose steps. Soliqua 30-60 pen Previous therapy of insulin glargine (100 u/mL) ≥30 to ≤60 u Starting dose: 30 u insulin glargine/10 mcg lixisenatide (30 dose steps). If patient starts w/ a Soliqua 30-60 pen, dose may be titrated up to 60 dose steps. Max daily dose: 60 u insulin glargine & 20 mcg lixisenatide (60 dose steps).

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Overdosage

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Administration

Should be taken on an empty stomach: Administer w/in 1 hr before a meal.

Contraindications

Hypersensitivity.

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Special Precautions

Not for treatment of type 1 diabetes & diabetic ketoacidosis. Caution w/ hypoglycaemia & hyperglycaemia. Risk of acute pancreatitis. Avoid dehydration, especially during the 1st wk of treatment. Rotate inj site to prevent skin changes (eg, lipoatrophy, lipohypertrophy, cutaneous amyloidosis). Contains metacresol, which may cause allergic reactions. May impair ability to drive & use machines. Has not been studied in patients w/ severe stomach or gut problems (eg, gastroparesis). Not recommended in patients w/ severe kidney disease or patients on dialysis. Do not use during pregnancy & lactation. Not recommended in childn & adolescents <18 yr.

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Use In Pregnancy & Lactation

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Adverse Reactions

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

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Drug Interactions

Risk of hypoglycaemia w/ other antidiabetics, disopyramide, fluoxetine, sulfonamide antibiotics, fibrates, MAOIs, ACE inhibitors, analgesics & antipyretics (eg, pentoxifylline, propoxyphene, ASA), pentamidine. Risk of hyperglycaemia w/ corticosteroids (eg, cortisone, prednisolone), danazol, diazoxide, PIs, diuretics, glucagon, INH, somatropin, thyroid hormones, oestrogens & progestogens, clozapine, olanzapine, phenothiazine derivatives, sympathomimetic medicines (eg, epinephrine, salbutamol, terbutaline). Increased or decreased blood sugar level w/ β-blockers, clonidine, lithium salts, alcohol. Reduced warning signs of low blood sugar w/ β-blockers, clonidine, guanethidine, reserpine. Potential interaction w/ warfarin or other anticoagulants.

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Caution For Usage

For caution against possible variation of physical aspect of medicine... Click to view Soliqua detailed prescribing information

Storage

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Description

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Action

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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.

Regulatory Classification

P₁S₁S₃

Presentation/Packing

Form

Soliqua soln for inj 100 u/mL + 33 mcg/mL

Packing/Price

3 mL x 3 × 1's

Form

Soliqua soln for inj 100 u/mL + 50 mcg/mL

Packing/Price

3 mL x 3 × 1's

Soliqua

insulin glargine + lixisenatide

Manufacturer:

Sanofi

Distributor:

DCH Auriga - Healthcare

Four Star