Indicated to improve glycemic control in adults and pediatric patients 6 years of age and older with diabetes mellitus.

TOUJEO is not recommended for the treatment of diabetic ketoacidosis.

Do not administer TOUJEO intravenously or in an insulin pump.

Hypoglycemia is the most common adverse reaction associated with insulin, including TOUJEO. Severe hypoglycemia can cause seizures, may be life-threatening, or cause death. Hypoglycemia can impair concentration ability and reaction time; this may place an individual and others at risk in situations where these abilities are important (e.g., driving, or operating other machinery). Hypoglycemia can happen suddenly and symptoms may differ in each individual and change over time in the same individual. Symptomatic awareness of hypoglycemia may be less pronounced in patients with longstanding diabetes, in patients with diabetic nerve disease, in patients using medications that block the sympathetic nervous system (e.g., beta-blockers), or in patients who experience recurrent hypoglycemia.

To minimize the risk of hypoglycemia when changing patients from a once daily long acting or intermediate acting insulin product to TOUJEO, the starting dose of TOUJEO can be the same as the once daily long-acting dose. For patients controlled on LANTUS (insulin glargine, 100 units/mL) expect that a higher daily dose of TOUJEO will be needed to maintain the same level of glycemic control.

To minimize the risk of hypoglycemia when changing patients from twice-daily NPH insulin to once-daily TOUJEO, the recommended starting TOUJEO dose is 80% of the total daily NPH dosage.

TOUJEO is contraindicated during episodes of hypoglycemia.

To minimize the risk of hypoglycemia do not administer TOUJEO intravenously, intramuscularly or in an insulin pump or dilute or mix TOUJEO with any other insulin products or solutions.

Repeated insulin injections into areas of lipodystrophy or localized cutaneous amyloidosis have been reported to result in hyperglycemia, and a sudden change in the injection site (to unaffected area) has been reported to result in hypoglycemia.

All insulin products, including TOUJEO, cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia. Untreated hypokalemia may cause respiratory paralysis, ventricular arrhythmia, and death.

Thiazolidinediones (TZDs), which are peroxisome proliferator-activated receptor (PPAR)-gamma agonists, can cause dose-related fluid retention, particularly when used in combination with insulin. Fluid retention may lead to or exacerbate heart failure.

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.

As with all therapeutic proteins, there is potential for immunogenicity.

Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulin products, including TOUJEO. If hypersensitivity reactions occur, discontinue TOUJEO; treat per standard of care and monitor until symptoms and signs resolve.

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.

The risk of hypoglycemia associated with TOUJEO use may be increased with antidiabetic agents, (ACE) inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, propoxyphene, salicylates, somatostatin analogs (e.g., octreotide), and sulfonamide antibiotics. Dose adjustment and increased frequency of glucose monitoring may be required when TOUJEO is co-administered with these drugs.

The glucose lowering effect of TOUJEO may be decreased when co-administered with atypical antipsychotics (e.g., olanzapine and clozapine), corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens (e.g., in oral contraceptives), protease inhibitors, somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline) and thyroid hormones. Dose adjustment and increased frequency of glucose monitoring may be required when TOUJEO is co-administered with these drugs.

The glucose lowering effect of TOUJEO may be increased or decreased when co administered with alcohol, beta-blockers, clonidine, and lithium salts. Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia. Dose adjustment and increased frequency of glucose monitoring may be required when TOUJEO is co-administered with these drugs.

The signs and symptoms of hypoglycemia may be blunted when beta-blockers, clonidine, guanethidine, and reserpine are co-administered with TOUJEO.

Published studies with use of insulin glargine during pregnancy have not reported a clear association with insulin glargine and adverse developmental outcomes. However, these studies cannot definitely establish the absence of any risk because of methodological limitations including small sample size and some lacking comparator groups.

Endogenous insulin is present in human milk; it is unknown whether insulin glargine is excreted in human milk.

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• Use in patients under the age of 6. GoToSource

Hypoglycemia and weight gain. GoToSource

Nasopharyngitis and upper respiratory tract infections. GoToSource

Immunogenicity (immune response). GoToSource

Injection site reactions, allergic reactions, lipodystrophy (selective loss of body fat), pruritus (severe itching) and rash. GoToSource

No major injury lawsuits reported.