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Insulin glargine / lixisenatide Side Effects

For the Consumer

Applies to insulin glargine / lixisenatide: subcutaneous solution

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
  • Abdominal or stomach pain
  • agitation
  • bloating
  • blurred vision
  • chills
  • cold sweats
  • cold, clammy skin
  • coma
  • confusion
  • constipation
  • convulsions
  • cool, pale skin
  • cough
  • decreased urine output
  • difficulty swallowing
  • dizziness
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • dry mouth
  • fast heartbeat
  • fast, weak pulse
  • fever
  • flushed, dry skin
  • fruit-like breath odor
  • headache
  • hives, itching, or rash
  • hostility
  • increased hunger
  • increased thirst
  • increased urination
  • indigestion
  • irregular heartbeat
  • irritability
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • lethargy
  • lightheadedness
  • loss of appetite
  • muscle pain or cramps
  • muscle twitching
  • nausea or vomiting
  • nightmares
  • noisy breathing
  • numbness or tingling in the hands, feet, or lips
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • rapid weight gain
  • slurred speech
  • stupor
  • sweating
  • tightness in the chest
  • troubled breathing
  • unexplained weight loss
  • unusual tiredness or weakness
  • yellow eyes or skin

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
  • Body aches or pain
  • diarrhea
  • ear congestion
  • loss of voice
  • muscle aches
  • sneezing
  • sore throat
  • stuffy or runny nose
Incidence not known
  • Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

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

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]

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

Insulin Glargine:
Frequency not reported: Peripheral edema[Ref]

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

Nervous system

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

Respiratory

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

References

1. "Product Information. Soliqua 100/33 (insulin glargine-lixisenatide)." sanofi-aventis, Bridgewater, NJ.

Some side effects of insulin glargine / lixisenatide may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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