These highlights do not include all the information needed to use TOUJEO safely and effectively. See full prescribing information for TOUJEO®.
TOUJEO (insulin glargine injection) U-300, for subcutaneous use
Initial U.S. Approval: 2015
INDICATIONS AND USAGE
TOUJEO is a long-acting human insulin analog indicated to improve glycemic control in adults with diabetes mellitus. (1)
Limitations of Use:
Not recommended for treating diabetic ketoacidosis. (1)
DOSAGE AND ADMINISTRATION
Individualize dose based on type of diabetes, metabolic needs, blood glucose monitoring results and glycemic control goal. (2.1, 2.2, 2.3)
Administer subcutaneously once daily at any time during the day, at the same time every day. (2.1)
Rotate injection sites to reduce the risk of lipodystrophy. (2.1)
Do not dilute or mix with any other insulin or solution. (2.1)
Closely monitor glucose when changing to TOUJEO and during initial weeks thereafter. (2.3)
DOSAGE FORMS AND STRENGTHS
Injection: 300 units/mL insulin glargine in:
1.5 mL TOUJEO SoloStar disposable prefilled pen (3)
3 mL TOUJEO Max SoloStar disposable prefilled pen (3)
CONTRAINDICATIONS
During episodes of hypoglycemia (4)
Hypersensitivity to TOUJEO or one of its excipients (4)
WARNINGS AND PRECAUTIONS
Never share a TOUJEO SoloStar or TOUJEO Max SoloStar disposable prefilled pen between patients, even if the needle is changed. (5.1)
Hyperglycemia or hypoglycemia with changes in insulin regimen: Carry out under close medical supervision. (5.2)
Hypoglycemia: May be life-threatening. Increase frequency of glucose monitoring with changes to: insulin dosage, coadministered glucose-lowering medications, meal pattern, physical activity, and in patients with renal impairment or hepatic impairment or hypoglycemia unawareness. (5.3, 6.1)
Medication errors: Accidental mix-ups between insulin products can occur. Instruct patients to check insulin labels before injection. (5.4)
Hypersensitivity reactions: Severe, life-threatening, generalized allergy, including anaphylaxis, can occur. Discontinue TOUJEO, monitor and treat if indicated. (5.5, 6.1)
Hypokalemia: May be life-threatening. Monitor potassium levels in patients at risk of hypokalemia and treat if indicated. (5.6)
Fluid retention and heart failure with concomitant use of Thiazolidinediones (TZDs): Observe for signs and symptoms of heart failure; consider dosage reduction or discontinuation if heart failure occurs. (5.7)
ADVERSE REACTIONS
Adverse reactions commonly associated with TOUJEO (≥5%) are:
Hypoglycemia, allergic reactions, injection site reaction, lipodystrophy, pruritus, rash, edema, and weight gain. (6.1, 6.2)
To report SUSPECTED ADVERSE REACTIONS, contact sanofi-aventis at 1-800-633-1610 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Drugs that affect glucose metabolism: Adjustment of insulin dosage may be needed; closely monitor blood glucose. (7)
Antiadrenergic drugs (e.g., beta-blockers, clonidine, guanethidine, and reserpine): Signs and symptoms of hypoglycemia may be reduced or absent. (7)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 3/2019
