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Soliqua Side Effects

Generic name: insulin glargine / lixisenatide

Medically reviewed by Philip Thornton, DipPharm. Last updated on Oct 29, 2023.

Note: This document contains side effect information about insulin glargine / lixisenatide. Some dosage forms listed on this page may not apply to the brand name Soliqua.

Applies to insulin glargine / lixisenatide: subcutaneous solution.

Serious side effects of Soliqua

Along with its needed effects, insulin glargine/lixisenatide may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking insulin glargine / lixisenatide:

Incidence not known

Other side effects of Soliqua

Some side effects of insulin glargine / lixisenatide may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Incidence not known

For Healthcare Professionals

Applies to insulin glargine / lixisenatide: subcutaneous solution.

General

The most commonly occurring adverse reactions with this combination drug include hypoglycemia, allergic reactions, nausea, nasopharyngitis, diarrhea, upper respiratory tract infection, and headache.[Ref]

Metabolic

Very common (10% or more): Hypoglycemia (up to 40%)[Ref]

The rates of hypoglycemia depend on the definition of hypoglycemia. For clinical trials with this drug, severe hypoglycemia was defined as an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Symptomatic hypoglycemia was defined as an event with typical symptoms of hypoglycemia accompanied by a self-monitored plasma glucose value of 70 mg/dL or less. Incidence of severe symptomatic hypoglycemia in 2 trials (n=469 and n=365) was 0% and 1.1% while documented symptomatic hypoglycemia was 25.6% and 40%, respectively.[Ref]

Renal

Postmarketing reports of acute kidney injury and worsening renal failure, some requiring hemodialysis, have been received in patients treated with GLP-1 receptor agonists.[Ref]

GLP-1 receptor agonists

Postmarketing reports: Acute kidney injury[Ref]

Gastrointestinal

Insulin-glargine-lixisenatide:

Very common (10% or more): Nausea (10%)

Common (1% to 10%): Diarrhea

Frequency not reported: Vomiting, constipation, dyspepsia, gastritis, abdominal pain, flatulence, gastroesophageal reflux disease, abdominal distension, decreased appetite

Lixisenatide:

Frequency not reported: Pancreatitis[Ref]

Twenty-one cases of pancreatitis were reported during clinical trials with lixisenatide compared with 14 cases in comparator-treated patients. Cases included acute pancreatitis (n=3), pancreatitis (n=12), chronic pancreatitis (n=5), and edematous pancreatitis (n=1). Some patients had risk factors for pancreatitis, such as a history of cholelithiasis or alcohol abuse. GLP-1 receptor agonists have been associated with acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis.

Gastrointestinal events occur more frequently at the beginning of therapy.[Ref]

Hypersensitivity

Insulins:

Frequency not reported: Severe, life-threatening, generalized allergy including anaphylaxis; generalized skin reactions, angioedema, bronchospasm, hypotension, shock

Lixisenatide:

Uncommon (0.1% to 1%): Anaphylaxis, allergic reactions

Frequency not reported: Angioedema[Ref]

In lixisenatide clinical trials, a higher incidence of allergic reactions occurred in antibody positive patients.[Ref]

Local

Common (1% to 10%): Injection site reactions

Frequency not reported: Lipodystrophy, lipohypertrophy[Ref]

Injection site reactions occurred in 1.7% of patients during clinical trials. Injection site reactions included injection-site hematoma, pain, hemorrhage, erythema, nodules, swelling, discoloration, pruritus, warmth, and injection-site mass.[Ref]

Immunologic

Insulin-glargine-lixisenatide:

Very common (10% or more): Antibody formation (up to 43%)

Lixisenatide:

Common (1% to 10%): High antibody concentrations with attenuated glycemic response[Ref]

Following 30 weeks of treatment with insulin glargine-lixisenatide, the incidence of anti-insulin glargine antibodies and anti-lixisenatide antibodies was up to 26.2% and approximately 43%, respectively. In about 93% of patients, anti-insulin glargine antibodies showed cross-reactivity to human insulin.

In lixisenatide clinical trials, pooled analysis has shown that 70% of lixisenatide-treated patients were antibody positive at 24 weeks. A subset (2.4%) with the highest antibody concentration showed an attenuated glycemic response. A higher incidence of allergic reactions and injection-site reactions occurred in antibody positive patients.[Ref]

Cardiovascular

Some patients have experienced edema while taking insulin glargine, especially if previously poor metabolic control was improved by intensified insulin therapy.[Ref]

Insulin Glargine:

Frequency not reported: Peripheral edema[Ref]

Nervous system

Common (1% to 10%): Headache[Ref]

Respiratory

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

Frequently asked questions

References

1. Product Information. Soliqua 100/33 (insulin glargine-lixisenatide). sanofi-aventis. 2016.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer