Toujeo Solostar

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 SoloStar.

Applies to insulin glargine: subcutaneous solution

Along with its needed effects, insulin glargine (the active ingredient contained in Toujeo 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

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

• Fever
• sore throat
• stuffy or runny nose

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

Applies to insulin glargine: subcutaneous solution

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

The ORIGIN (Outcome Reduction with Initial Glargine Intervention) trial, an open-labeled, randomized study comparing insulin glargine (the active ingredient contained in Toujeo SoloStar) 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).

Very common (10% or more): Hypoglycemia

Frequency not reported: Weight gain

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%).

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

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.

Rare (less than 0.1%): Allergic reactions

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

Common (1% to 10%): Peripheral edema

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 and standard care (n=12.537).

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

Common (1% to 10%): Lipohypertrophy

Uncommon (0.1% to 1%): Lipoatrophy

Postmarketing reports: Rash urticaria

Frequency not reported: Cancer occurrence

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.

Frequency not reported: Antibody formation

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.

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

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.

Common (1% to 10%): Gastroenteritis

Rare (less than 0.1%): Myalgia

Common (1% to 10%): Headache

Very rare (less than 0.01%): Dysgeusia

Frequency not reported: Peripheral neuropathy

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

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

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