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Toujeo Max SoloStar Side Effects

Generic Name: insulin glargine

Note: This document contains side effect information about insulin glargine. Some of the dosage forms listed on this page may not apply to the brand name Toujeo Max SoloStar.

For the Consumer

Applies to insulin glargine: subcutaneous solution

Side effects requiring immediate medical attention

Along with its needed effects, insulin glargine (the active ingredient contained in Toujeo Max SoloStar) 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:

More common

  • Anxiety
  • behavior change similar to being drunk
  • blurred vision
  • chills
  • cold sweats
  • confusion
  • convulsions (seizures)
  • cool, pale skin
  • difficulty with thinking
  • dizziness or lightheadedness
  • drowsiness
  • excessive hunger
  • fast heartbeat
  • headache
  • nausea
  • nervousness
  • nightmares
  • restless sleep
  • shakiness
  • slurred speech
  • tingling in the hands, feet, lips, or tongue
  • unusual tiredness or weakness

Less common or rare

  • Fast pulse
  • skin rash or itching over the entire body
  • sweating
  • trouble breathing

Incidence not known

  • Bloating or swelling of the face, hands, lower legs, or feet
  • cough
  • decreased urine
  • difficulty with swallowing
  • dry mouth
  • hives
  • increased thirst
  • irregular heartbeat
  • muscle pain or cramps
  • numbness or tingling in the hands, feet, or lips
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • rapid weight gain
  • vomiting

Side effects not requiring immediate medical attention

Some side effects of insulin glargine 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

Less common or rare

  • Depression of the skin at the injection site
  • itching, pain, redness, or swelling at the injection site
  • thickening of the skin at injection site

For Healthcare Professionals

Applies to insulin glargine: subcutaneous solution

General

Adverse reactions associated with insulin glargine (the active ingredient contained in Toujeo Max SoloStar) include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, rash, edema, and weight gain.[Ref]

Metabolic

Very common (10% or more): Hypoglycemia

Frequency not reported: Weight gain[Ref]

The ORIGIN (Outcome Reduction with Initial Glargine Intervention) trial, an open-labeled, randomized study comparing insulin glargine to standard care in persons 50 years or older with abnormal glucose levels (impaired fasting glucose and/or impaired glucose tolerance) or early type 2 diabetes mellitus and established cardiovascular (CV) disease or CV risk factors, found over the course of the 6 year study, severe hypoglycemia occurred in 5.7% of patients receiving insulin glargine compared to 1.9% in the standard care group. The median HbA1c values in the insulin glargine group ranged from 5.9% to 6.4% while the HbA1c values in the standard care group ranged from 6.2% to 6.6%. The incidence for all hypoglycemia was 58% and 26% in the insulin glargine and standard groups, respectively.

Weight gain has been reported with insulin therapy and has been attributed to the anabolic effects of insulin and the decrease in glucosuria. In the ORIGIN trial, the median change in body weight from baseline to the last treatment visit was 2.2 kg greater in the insulin glargine group (+1.4 kg vs -0.8 kg).[Ref]

Local

Common (1% to 10%): Injection site reactions, injection site pain

Postmarketing reports: Localized cutaneous amyloidosis at the injection site[Ref]

Injection site reactions include redness, pain, itching, hives, swelling, or inflammation. In some cases, these reactions may be caused by other factors, such as irritants in skin cleansing agents. In clinical studies, there was a higher incidence of treatment-emergent injection site pain in insulin-glargine treated patients compared to NPH-treated patients (2.7% vs 0.7%). Localized cutaneous amyloidosis at the injection site has occurred and hyperglycemia has been reported with repeated insulin injections into areas of localized cutaneous amyloidosis. Hypoglycemia has been reported with a sudden change to an unaffected injection site.[Ref]

Hypersensitivity

Rare (less than 0.1%): Allergic reactions[Ref]

Hypersensitivity side effects have included both local and systemic reactions. Anaphylaxis has been reported. Local reactions have presented as erythema, local edema, and pruritus at the injection site. Most minor reactions to insulin at the injection site resolve in a few days to a few weeks.[Ref]

Other

Postmarketing reports: Medication errors

Medication errors, in which other insulins, particularly rapid-acting insulins, have been accidentally administered instead of this insulin, have been reported.

Cardiovascular

Insulin may cause sodium retention and edema, especially as metabolic control is improving. The ORIGIN (Outcome Reduction with Initial Glargine Intervention) trial, an open-labeled, randomized study in persons 50 years or older with abnormal glucose levels (impaired fasting glucose and/or impaired glucose tolerance) or early type 2 diabetes mellitus and established cardiovascular (CV) disease or CV risk factors, found the time to first occurrence of a major adverse cardiovascular event (MACE) and the incidence of MACE to be similar between insulin glargine (the active ingredient contained in Toujeo Max SoloStar) and standard care (n=12.537).[Ref]

Very common (10% or more): Hypertension (up to 19.6%)

Common (1% to 10%): Peripheral edema[Ref]

Dermatologic

Common (1% to 10%): Lipohypertrophy

Uncommon (0.1% to 1%): Lipoatrophy

Postmarketing reports: Rash urticaria[Ref]

Postmarketing reports indicate children and adolescents may experience more skin reactions such as rash and urticaria, than adults.[Ref]

Oncologic

Frequency not reported: Cancer occurrence[Ref]

The ORIGIN (Outcome Reduction with Initial Glargine Intervention) trial, an open-labeled, randomized study in persons 50 years or older with abnormal glucose levels (impaired fasting glucose and/or impaired glucose tolerance) or early type 2 diabetes mellitus and established cardiovascular (CV) disease or CV risk factors, comparing insulin glargine to standard care found the overall incidence of all types of cancer combined or death from cancers was similar between treatment groups (n=12,537). In July 2009, The US FDA reported on an ongoing safety review evaluating a possible increased risk of cancer. In February 2011, the FDA in an updated communication reported the evidence was inconclusive and it is not possible to conclude that the use of this insulin increases the risk of cancer.[Ref]

Immunologic

As with all therapeutic proteins, the potential for immunogenicity exits. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay and may be influenced by assay methodology, sample handling and collection, concomitant medications, and underlying disease. The presence of insulin antibodies may increase or decrease the efficacy of insulin and may require dose adjustment.[Ref]

Frequency not reported: Antibody formation[Ref]

Ocular

Rapid improvement in glucose control has been associated with a transitory, reversible ophthalmologic refraction disorder and worsening of diabetic retinopathy. However, long-term glycemic control decreases the risk.[Ref]

Rare (less than 0.1%): Visual impairment, retinopathy[Ref]

Gastrointestinal

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

Musculoskeletal

Rare (less than 0.1%): Myalgia[Ref]

Nervous system

Common (1% to 10%): Headache

Very rare (less than 0.01%): Dysgeusia

Frequency not reported: Peripheral neuropathy[Ref]

Rapid improvement in glucose control has been associated with a transitory, reversible acute painful peripheral neuropathy. However, long-term glycemic control decreases the risk.[Ref]

Respiratory

Very common (10% or more): Upper respiratory infection (up to 22.4%)

Common (1% to 10%): Pharyngitis, rhinitis, sinusitis[Ref]

References

1. Cerner Multum, Inc. "Australian Product Information." O 0

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. "Product Information. Toujeo SoloStar (insulin glargine)." sanofi-aventis, Bridgewater, NJ.

4. "Product Information. Basaglar (insulin glargine)." Eli Lilly Canada Inc, Toronto, ON.

5. "Product Information. Lantus (insulin glargine)" Aventis Pharmaceuticals, Swiftwater, PA.

6. FDA. U.S. Food and Drug Administration "FDA Drug Safety Communication: Update to ongoing safety review of Lantus (insulin glargine) and possible risk of cancer. Available from: URL: http://www.fda.gov/Drugs/DrugSafety/ucm239376.htm." ([2011 Jan 12]):

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.

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