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Insulin Glargine/Lixisenatide

    Brands

    DEA Class; Rx

    Common Brand Names; Soliqua 100/33

    • Antidiabetics, Glucagon-like Peptide-1 Agonists; 
    • Antidiabetics, Long-Acting Insulins

    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

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

    During episodes of hypoglycemia

    Hypersensitivity to either of the active drugs or any excipients

    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

    Localized cutaneous amyloidosis at the injection site

    Hepatobiliary: Cholecystitis, cholelithiasis requiring cholecystectomy

    Anaphylaxis reported; severe, life-threatening, generalized allergic reactions, including anaphylaxis, generalized skin reactions, angioedema, bronchospasm, hypotension, and shock reported; inform and closely monitor patients with a history of anaphylaxis or angioedema with another GLP-1 receptor agonist for allergic reactions; unknown whether such patients will be predisposed to anaphylaxis

    Acute events of gallbladder disease such as cholelithiasis or cholecystitis reported in GLP-1 receptor agonist trials and postmarketing; if cholelithiasis suspected, gallbladder studies and appropriate clinical follow-up are indicated

    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

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

    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

    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

    Specific maximum dosage information is not available. Individualize dosage based on careful monitoring of blood glucose and other clinical parameters in all patient populations.

    Insulin Glargine/lixisenatide

    subcutaneous injection

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