Applies to lixisenatide: parenteral injection.

Side effects include:

Lixisenatide: Nausea, vomiting, headache, diarrhea, dizziness, hypoglycemia.

Fixed combination of insulin glargine and lixisenatide: Hypoglycemia, nausea, nasopharyngitis, diarrhea, upper respiratory tract infection, headache.

For Healthcare Professionals

Applies to lixisenatide: subcutaneous kit, subcutaneous solution.

General

The most frequently reported adverse reactions were nausea, vomiting, headache, diarrhea, dizziness, and hypoglycemia.^[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 26.5%), vomiting (up to 10.5%)

Common (1% to 10%): Dyspepsia, diarrhea, constipation, abdominal distension, abdominal pain, upper abdominal pain

Frequency not reported: Pancreatitis^[Ref]

Gastrointestinal adverse reactions including nausea and vomiting were responsible for discontinuation of treatment in 4.3% of patients. During clinical trials, the severity of gastrointestinal adverse reactions were graded as mild, moderate or severe in 64.2%, 32.3%, and 3.5% of cases, respectively. The majority of reactions occurred during the first 3 weeks of treatment.

During clinical trials, 21 cases of pancreatitis were reported including acute pancreatitis (n=3), pancreatitis (n=12), chronic pancreatitis (n=5), and edematous pancreatitis (n=1). Of these cases, some had risk factors such as a history of cholelithiasis or alcohol abuse. Fourteen cases of pancreatitis were reported in the comparator-treated.^[Ref]

Immunologic

Pooled analysis of drug-treated patients has found that almost 70% were antibody positive at 24 weeks. Of the antibody positive patients, those with the highest antibody concentrations (greater than 100 nmol/L) had attenuated glycemic responses. Additionally, a higher incidence of allergic reactions and injection site reactions occurred in antibody positive patients.^[Ref]

Very common (10% or more): Development of anti-lixisenatide antibodies (69.8%)^[Ref]

Metabolic

Very common (10% or more): Hypoglycemia (in combination with a sulfonylurea and/or a basal insulin)

Common (1% to 10%): Hypoglycemia (in combination with metformin alone)^[Ref]

Nervous system

Very common (10% or more): Headache

Common (1% to 10%): Dizziness, somnolence^[Ref]

Cardiovascular

Common (1% to 10%): Palpitations

Uncommon (0.1% to 1%): Tachycardia^[Ref]

Genitourinary

Common (1% to 10%): Cystitis^[Ref]

Local

Common (1% to 10%): Injection site reactions including pain, pruritus, erythema^[Ref]

Musculoskeletal

Common (1% to 10%): Back pain^[Ref]

Other

Common (1% to 10%): Viral infection^[Ref]

Respiratory

Common (1% to 10%): Influenza, upper respiratory tract infection^[Ref]

Dermatologic

Uncommon (0.1% to 1%): Urticaria^[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Anaphylactic reaction, angioedema, pruritus^[Ref]