Classes
DEA Class; Rx
Common Brand Names; Soliqua 100/33
- Antidiabetics, Glucagon-like Peptide-1 Agonists;
- Antidiabetics, Long-Acting Insulins
Description
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
Indications
Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
Contraindications
During episodes of hypoglycemia
Hypersensitivity to either of the active drugs or any excipients
Adverse Effects
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
Warnings
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
Pregnancy and Lactation
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
Maximum Dosage
How supplied
Insulin Glargine/lixisenatide
subcutaneous injection
- (100units/33mcg) per mL
- Available as a 3-mL single-use pen
