Lixisenatide

DEA Class; Rx

Common Brand Names; Adlyxin

Documented hypersensitivity; hypersensitivity reactions, including anaphylaxis, have occurred with lixisenatide

Nausea (25%)

Hypoglycemia

• Coadministered with basal insulin +/- sulfonylurea (47.2%)
• Coadministered with basal insulin +/- metformin (28.3%)
• Coadministered with insulin glargine and metformin +/- thiazolidinedione (22%)
• Coadministered with sulfonylurea +/- metformin (14.5%)

Vomiting (10%)

Headache (9%)

Diarrhea (8%)

Dizziness (7%)

Injection site reactions (4%)

Dyspepsia (3.2%)

Constipation (2.8%)

Attenuated glycemic response with high antibodies (ie, >100 nmol/L) (2.4%)

Abdominal distension (2.2%)

Upper abdominal pain (2.2%)

Abdominal pain (2%)

Anaphylaxis (0.1%)

Acute pancreatitis

Hepatobiliary: Cholecystitis, cholelithiasis requiring cholecystectomy

Anaphylaxis (0.1%) and other hypersensitivity reactions, including angioedema, have been reported; if hypersensitivity occurs, discontinue drug and promptly seek medical attention (see Contraindications)

Acute pancreatitis, including fatal, and nonfatal hemorrhagic or necrotizing pancreatitis reported postmarketing in patients treated with GLP-1 receptor agonists; observe for signs and symptoms (eg, persistent severe abdominal pain that sometimes radiates to the back which may or may not be accompanied by vomiting); promptly discontinue if suspected; if pancreatitis confirmed, do not restart drug

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 pen between patients, even if the needle is changed; pen-sharing poses risk for transmission of blood-borne pathogens

Risk for hypoglycemia increased if coadministered with a sulfonylurea or basal insulin; risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly administered insulin secretagogues) or insulin; inform patients using these concomitant medications of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia

Acute kidney injury and worsening of chronic renal failure (sometimes requiring hemodialysis); some reports were in patients without known underlying renal disease; most of the reports described patients who had experienced nausea, vomiting, diarrhea, or dehydration

Antibody development to lixisenatide occurred in 70% of patients by week 24; a subset of patients (2.4%) with the highest antibody concentrations (ie, >100 nmol/L) showed an attenuated glycemic response; a higher incidence of allergic reactions and injection site reactions occurred in antibody-positive patients

Clinical studies have NOT shown macrovascular risk reduction with lixisenatide or any other antidiabetic drug

Limited data available are not sufficient to inform a drug-associated risk of major birth defects and miscarriage

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

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