insulin glargine/lixisenatide (Rx)

Brand and Other Names:Soliqua 100/33
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

insulin glargine/lixisenatide

subcutaneous injection

  • (100units/33mcg) per mL
  • Available as a 3-mL single-use pen

Type 2 Diabetes Mellitus

Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus

Starting dose

  • Discontinue basal insulin or GLP-1 agonist before initiating insulin glargine/lixisenatide
  • Patients who are naïve to basal insulin or GLP-1 agonists, currently on a GLP-1 receptor agonist, or on basal insulin <30 units/day: insulin glargine 15 units/lixisenatide 5 mcg SC qDay
  • Patients currently on basal insulin 30-60 units/day with or without a GLP-1 agonist: insulin glargine 30 units/lixisenatide 10 mcg SC qDay

Dose titration

  • May titrate dose upwards or downwards by 2-4 units of insulin glargine every week based on the patient’s metabolic needs, blood glucose monitoring results, and glycemic control goal until the desired fasting plasma glucose is achieved
  • To minimize the risk of hypoglycemia or hyperglycemia, additional titration may be needed with the following
    • Changes in physical activity, meal patterns (ie, macronutrient content or timing of food intake), or renal or hepatic function
    • During acute illness
    • When used with other medications

Dosage Modifications

Renal impairment

  • Mild-to-moderate: No dosage adjustment required; monitor for lixisenatide related adverse effects
  • Severe (eGFR 15 to <30 mL/min/1.73 m²): Closely monitor; may increase occurrence of lixisenatide-associated GI and renal adverse effects
  • ESRD (eGFR <15 mL/min/1.73 m²): Not studied; use not recommended

Hepatic impairment

  • Not studied
  • Frequent glucose monitoring and dose adjustment may be needed

Dosing Considerations

Discontinue therapy with lixisenatide or basal insulin prior to initiation

Limitations of use

  • Has not been studied in patients with a history of pancreatitis; consider other antidiabetic therapies
  • Not recommended in combination with any other product containing another GLP-1 receptor agonist
  • Not indicated for type 1 diabetes mellitus or treatment of diabetic ketoacidosis
  • Has not been studied in patients with gastroparesis and is not recommended in patients with gastroparesis
  • Has not been studied in combination with prandial insulin

<18 years: Safety and efficacy not established

Initial dosing, dose increments, and maintenance dosage should be conservative to avoid hypoglycemic reactions

Hypoglycemia may be more difficult to recognize in elderly individuals

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Interactions

Interaction Checker

and insulin glargine/lixisenatide

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    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

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            Adverse Effects

            >10%

            Documented symptomatic hypoglycemia (25.6-40%)

            1-10%

            Nausea (10%)

            Nasopharyngitis (7%)

            Diarrhea (7%)

            Upper respiratory tract infection (5.5%)

            Headache (5.4%)

            Severe symptomatic hypoglycemia (1.1%)

            Injection site reactions (1.7%)

            <1%

            Anaphylaxis

            Frequency Not Defined

            Lipodystrophy

            Peripheral edema

            Weight gain

            Immunogenicity

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            Warnings

            Contraindications

            During episodes of hypoglycemia

            Hypersensitivity to either of the active drugs or any excipients

            Cautions

            Anaphylaxis reported (see Contraindications)

            Acute pancreatitis, including fatal and nonfatal hemorrhagic or necrotizing pancreatitis, reported postmarketing

            Do not share insulin pens between patients

            Caution when changing dosage regimens; increase frequency of blood glucose monitoring to detect hypoglycemia or hyperglycemia

            Do not exceed maximum dose or use with other GLP-1 agonists or basal insulins

            Hypoglycemia is the most common adverse effect of insulin; self-monitoring of blood glucose is essential to prevent and manage hypoglycemia

            Acute kidney injury reported postmarketing, some of which required hemodialysis

            Increased risk for hypokalemia; insulin shifts potassium from the extracellular to intracellular space

            Increased risk of fluid retention and CHF with coadministration of peroxisome proliferator-activated receptor (PPAR)-gamma agonists (eg, thiazolidinediones)

            No clinical studies have established conclusive evidence of macrovascular risk reduction with any antidiabetic drugs

            Drug interaction overview

            • Drugs that may increase hypoglycemia risk
              • May require dose reduction and increased glucose monitoring frequency if coadministered with drugs that cause hypoglycemia
              • Examples include antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, propoxyphene, salicylates, somatostatin analogs (eg, octreotide), and sulfonamide antibiotics
            • Drug that may decrease blood glucose-lowering effect of lixisenatide/insulin glargine
              • May require dose increase and increased glucose monitoring frequency if coadministered with drugs that increase blood glucose
              • Examples include atypical antipsychotics (eg, olanzapine and clozapine), corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens (eg, in oral contraceptives), protease inhibitors, somatropin, sympathomimetic agents (eg, albuterol, epinephrine, terbutaline), and thyroid hormones
            • Drugs that may increase or decrease the blood glucose-lowering effects of lixisenatide/insulin glargine
              • Dose adjustment in increased blood glucose monitoring may be required
              • Examples include alcohol, beta-blockers, clonidine, and lithium salts; pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia
            • Drugs that may blunt signs and symptoms of hypoglycemia
              • Increase frequency of blood glucose monitoring
              • Examples include beta-blockers, clonidine, guanethidine, and reserpine
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            Pregnancy

            Pregnancy

            Based on animal reproduction studies, there may be risks to the fetus from exposure to lixisenatide during pregnancy

            Use during pregnancy only if the potential benefit justifies the potential risk to the fetus

            There are no available data with use in pregnant women to inform a drug-associated risk for major birth defects or miscarriage

            There are clinical considerations regarding the risks of poorly controlled diabetes in pregnancy

            Lactation

            Unknown if distributed in human breast milk

            Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Lixisenatide: Incretin mimetic; analogue of human glucagonlike peptide-1 (GLP-1); acts as GLP-1 receptor agonist to augment glucose-dependent insulin secretion, decreases glucagon secretion, and slows gastric emptying

            Insulin glargine: Basal insulin analog; insulin lowers blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production; insulin inhibits lipolysis and proteolysis and enhances protein synthesis; targets include skeletal muscle, liver, and adipose tissue

            Absorption

            Peak plasma time (lixisenatide): 2.5-3 hr

            Distribution

            Protein bound (lixisenatide): 55%

            Metabolism

            Insulin glargine: Partly metabolized at the carboxyl terminus of the B chain in the subcutaneous depot to form 2 active metabolites with in vitro activity similar to that of human insulin

            Lixisenatide: Presumed to be eliminated through glomerular filtration and proteolytic degradation

            Elimination

            Half-life (lixisenatide): 3 hr

            Clearance (lixisenatide): 35 L/hr

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            Administration

            SC Administration

            The pen delivers 15-60 units of insulin glargine with each injection

            Administer SC once daily within 1 hr prior to the first meal of the day

            Inject SC in thigh, upper arm, or abdomen

            Rotate injection site within the same region from 1 injection to the next to reduce lipodystrophy risk

            Do not administer IV, IM, or by infusion pump

            Do not dilute or mix with any other insulin products or solutions

            Do not split the dose

            Missed doses

            • Resume the once-daily regimen as prescribed with the next scheduled dose
            • Do not administer an extra dose or increase the dose to make up for the missed dos

            Storage

            Prior to first use

            • Refrigerate between 36-46°F (2-8°C)
            • Do not freeze; discard if it has been frozen
            • Protect from light

            After first use

            • Store at room temperature below 86°F (30°C)
            • Replace the pen cap after each use to protect from light
            • Discard pen 14 days after first use
            • Always remove the needle after each injection and store the pen without a needle attached; this prevents contamination and/or infection, or leakage of the pen, and ensures accurate dosing
            • Always use a new needle for each injection to prevent contamination
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            Formulary

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            Tier Description
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.