Medical Editor: John P. Cunha, DO, FACOEP
What Is Toujeo?
What Are Side Effects of Toujeo?
Common side effects of Toujeo include:
- cold symptoms
- upper respiratory tract infection
- low blood sugar (hypoglycemia)
- allergic reactions
- injection site reactions
- body fat redistribution (lipodystrophy)
- swelling of extremities, and
- weight gain
Dosage for Toujeo
The recommended starting dose of Toujeo in insulin naïve patients with type 1 diabetes is approximately one-third to one-half of the total daily insulin dose. The remainder of the total daily insulin dose should be given as a short-acting insulin and divided between each daily meal. As a general rule, 0.2 to 0.4 units of insulin per kilogram of body weight can be used to calculate the initial total daily insulin dose in insulin naïve patients with type 1 diabetes. The recommended starting dose of Toujeo in insulin naïve patients with type 2 diabetes is 0.2 units per kilogram of body weight once daily.
What Drugs, Substances, or Supplements Interact with Toujeo?
Toujeo may interact with other antidiabetic drugs, angiotensin converting enzyme (ACE) inhibitors, angiotensin II receptor blocking agents (ARBs), disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors (MAOIs), pentoxifylline, pramlintide, propoxyphene, salicylates, somatostatin analogs, sulfonamide antibiotics, antipsychotics, corticosteroids, danazol, diuretics, estrogens, glucagon, isonazid, niacin, oral contraceptives, phenothiazines, progestogens, protease inhibitors, somatropin, sympathomimetic drugs, thyroid hormones, alcohol, beta-blockers, clonidine, lithium salts, clonidine, guanethidine, and reserpine. Tell your doctor all medications and supplements you use.
Toujeo During Pregnancy and Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant before using Toujeo. Insulin requirements may change during pregnancy. It is unknown if Toujeo passes into breast milk. Insulin requirements may change during breastfeeding. Consult your doctor before breastfeeding.
Our Toujeo (insulin glargine) Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
The following adverse reactions are discussed elsewhere:
- Hypoglycemia [see WARNINGS AND PRECAUTIONS]
- Medication Errors [see WARNINGS AND PRECAUTIONS]
- Hypersensitivity and allergic reactions [see WARNINGS AND PRECAUTIONS]
- Hypokalemia [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug, and may not reflect the rates actually observed in clinical practice.
The data in Table 1 reflect the exposure of 304 patients with type 1 diabetes to TOUJEO with mean exposure duration of 23 weeks. The type 1 diabetes population had the following characteristics: Mean age was 46 years and mean duration of diabetes was 21 years. Fifty-five percent were male, 86% were Caucasian, 5% were Black or African American, and 5% were Hispanic. At baseline, the mean eGFR was 82 mL/min/1.73 m² and 35% of patients had eGFR ≥90 mL/min/1.73 m². The mean BMI was 28 kg/m². HbA1c at baseline was greater or equal to 8% in 58% of patients.
The data in Table 2 reflect the exposure of 1242 patients with type 2 diabetes to TOUJEO with mean exposure duration of 25 weeks. The type 2 diabetes population had the following characteristics: Mean age was 59 years and mean duration of diabetes was 13 years. Fifty-three percent were male, 88% were Caucasian, 7% were Black or African American, and 17% were Hispanic. At baseline, mean eGFR was 79 mL/min/1.73 m² and 27% of patients had an eGFR ≥90 mL/min/1.73 m². The mean BMI was 35 kg/m². HbA1c at baseline was greater or equal to 8% in 66% of patients.
Common adverse reactions were defined as reactions occurring in ≥5% of the population studied.
Common adverse reactions occurring for TOUJEO-treated subjects during clinical trials in patients with type 1 diabetes mellitus and type 2 diabetes mellitus are listed in Table 1 and Table 2, respectively. Hypoglycemia is discussed in a dedicated subsection below.
Table 1: Adverse Reactions in Two Pooled Clinical
Trials of 26 Weeks and 16 Weeks Duration in Adults with Type 1 Diabetes (with
|TOUJEO + Mealtime Insulin*, %
|Upper respiratory tract infection||9.5|
|* “mealtime insulin” refers to insulin glulisine, insulin lispro, or insulin aspart.|
Table 2: Adverse Reactions in Three Pooled Clinical
Trials of 26 Weeks Duration in Adults with Type 2 Diabetes (with incidence
|Upper respiratory tract infection||5.7|
|* one of the trials in type 2 diabetes included mealtime insulin.|
Hypoglycemia is the most commonly observed adverse reaction in patients using insulin, including TOUJEO [see WARNINGS AND PRECAUTIONS]. In the TOUJEO program, severe hypoglycemia was defined as an event requiring assistance of another person to administer a resuscitative action and documented symptomatic hypoglycemia was defined as an event with typical symptoms of hypoglycemia accompanied by a self-monitored or plasma glucose value equal to or less than 54 mg/dL.
The incidence of severe hypoglycemia in patients with type 1 diabetes receiving TOUJEO as part of a multiple daily injection regimen was 6.6% at 26 weeks. The incidence of documented symptomatic hypoglycemia was 69% at 26 weeks. There were no clinically important differences in hypoglycemia between TOUJEO and LANTUS among type 1 diabetes patients.
The incidence of severe hypoglycemia in patients with type 2 diabetes was 5% at 26 weeks in patients receiving TOUJEO as part of a multiple daily injection regimen, and 1.0% and 0.9% respectively at 26 weeks in the two studies where patients received TOUJEO as part of a basal-insulin only regimen. The incidence of documented symptomatic hypoglycemia in patients with type 2 diabetes receiving TOUJEO ranged from 8% to 37% at 26 weeks and the highest risk was again seen in patients receiving TOUJEO as part of a multiple daily injection regimen.
Insulin Initiation And Intensification Of Glucose Control
Intensification or rapid improvement in glucose control has been associated with a transitory, reversible ophthalmologic refraction disorder, worsening of diabetic retinopathy, and acute painful peripheral neuropathy. However, long-term glycemic control decreases the risk of diabetic retinopathy and neuropathy.
Insulin, including TOUJEO, may cause sodium retention and edema, particularly if previously poor metabolic control is improved by intensified insulin therapy.
Long-term use of insulin, including TOUJEO, can cause lipoatrophy (depression in the skin) or lipohypertrophy (enlargement or thickening of tissue) in some patients and may affect insulin absorption [see DOSAGE AND ADMINISTRATION].
Weight gain has occurred with some insulin therapies including TOUJEO and has been attributed to the anabolic effects of insulin and the decrease in glucosuria.
Some patients taking insulin therapy, including TOUJEO have experienced erythema, local edema, and pruritus at the site of injection. These conditions were usually self-limiting.
Severe cases of generalized allergy (anaphylaxis) have been reported [see WARNINGS AND PRECAUTIONS].
No clinical studies to establish the cardiovascular safety of TOUJEO have been conducted. A cardiovascular outcomes trial, ORIGIN, has been conducted with LANTUS. It is unknown whether the results of ORIGIN can be applied to TOUJEO.
The Outcome Reduction with Initial Glargine Intervention trial (i.e., ORIGIN) was an open-label, randomized, 12,537 patient study that compared LANTUS to standard care on the time to first occurrence of a major adverse cardiovascular event (MACE). MACE was defined as the composite of CV death, nonfatal myocardial infarction and nonfatal stroke. The incidence of MACE was similar between LANTUS and standard care in ORIGIN (Hazard Ratio [95% CI] for MACE; 1.02 [0.94, 1.11]).
In the ORIGIN trial, the overall incidence of cancer (all types combined) (Hazard Ratio [95% CI]; 0.99 [0.88, 1.11]) or death from cancer (Hazard Ratio [95% CI]; 0.94 [0.77, 1.15]) was also similar between treatment groups.
As with all therapeutic proteins, there is potential for immunogenicity.
In a 6-month study of type 1 diabetes patients, 79% of patients who received TOUJEO once daily were positive for anti-insulin antibodies (AIA) at least once during the study, including 62% that were positive at baseline and 44% of patients who developed antidrug antibody (i.e., anti-insulin glargine antibody [ADA]) during the study. Eighty percent of the AIA-positive patients on TOUJEO with antibody test at baseline remained AIA positive at month 6.
In two 6-month studies in type 2 diabetes patients, 25% of patients who received TOUJEO once daily were positive for AIA at least once during the study, including 42% who were positive at baseline and 20% of patients who developed ADA during the study. Ninety percent of the AIA-positive patients on TOUJEO with antibody test at baseline, remained AIA positive at month 6.
The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay and may be influenced by several factors such as: assay methodology, sample handling, timing of sample collection, concomitant medication, and underlying disease. For these reasons, comparison of the incidence of antibodies to TOUJEO with the incidence of antibodies in other studies or to other products may be misleading.
Read the entire FDA prescribing information for Toujeo (Insulin Glargine Injection for Subcutaneous Use)