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TOUJEO (insulin glargine injection) U-300, for subcutaneous
HIGHLIGHTS OF PRESCRIBING INFORMATION
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
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Individualize dose based on type of diabetes, metabolic needs, blood glucose monitoring results and glycemic control goal. (2.1, 2.2, 2.3)
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Administer subcutaneously once daily at any time during the day, at the same time every day. (2.1)
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Rotate injection sites to reduce the risk of lipodystrophy. (2.1)
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Do not dilute or mix with any other insulin or solution. (2.1)
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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 SoloStar® disposable prefilled pen (3)
CONTRAINDICATIONS
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During episodes of hypoglycemia (4)
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Hypersensitivity to TOUJEO or one of its excipients (4)
WARNINGS AND PRECAUTIONS
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Never share a TOUJEO SoloStar® disposable prefilled pen between patients, even if the needle is changed (5.1)
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Hyper- or hypoglycemia with changes in insulin regimen: Carry out under close medical supervision. (5.2)
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Hypoglycemia: May be life-threatening. Increase frequency of glucose monitoring with changes to: insulin dosage, co-administered glucose lowering medications, meal pattern, physical activity; and in patients with renal impairment or hepatic impairment or hypoglycemia unawareness. (5.3, 6.1)
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Medication Errors: Accidental mix-ups between insulin products can occur. Instruct patients to check insulin labels before injection. (5.4)
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Hypersensitivity reactions: Severe, life-threatening, generalized allergy, including anaphylaxis, can occur. Discontinue TOUJEO, monitor and treat if indicated (5.5, 6.1)
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Hypokalemia: May be life-threatening. Monitor potassium levels in patients at risk of hypokalemia and treat if indicated (5.6).
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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:
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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.
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Drugs that affect glucose metabolism: Adjustment of insulin dosage may be needed; closely monitor blood glucose. (7.1, 7.2, 7.3)
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Anti-Adrenergic Drugs (e.g., beta-blockers, clonidine, guanethidine, and reserpine): Signs and symptoms of hypoglycemia may be reduced or absent (7.3, 7.4)
USE IN SPECIFIC POPULATIONS
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Pregnancy: Use during pregnancy only if the potential benefit justifies the potential risk to the fetus (8.1)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 2/2015
FULL PRESCRIBING INFORMATION: CONTENTS*
1. INDICATIONS AND USAGE
TOUJEO is indicated to improve glycemic control in adults with diabetes mellitus.
Limitations of Use
TOUJEO is not recommended for the treatment of diabetic ketoacidosis.
2. DOSAGE AND ADMINISTRATION
2.1 General Dosing Instructions
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Inject TOUJEO subcutaneously once a day into the abdominal area, thigh, or deltoid at the same time each day.
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Rotate injection sites within the same region from one injection to the next to reduce the risk of lipodystrophy [See Adverse Reactions (6.1)].
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Individualize and titrate the dosage of TOUJEO based on the individual's metabolic needs, blood glucose monitoring results, and glycemic control goal. The dosage of TOUJEO ranges from 1 to 80 units per one injection.
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To minimize the risk of hypoglycemia titrate the dose of TOUJEO no more frequently than every 3 to 4 days.
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Dosage adjustments may be needed with changes in physical activity, changes in meal patterns (i.e., macronutrient content or timing of food intake), changes in renal or hepatic function or during acute illness to minimize the risk of hypoglycemia or hyperglycemia [see Warnings and Precautions (5.2), and Use in Specific Populations (8.5, 8.6)].
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To minimize the risk of hypoglycemia, do not administer TOUJEO intravenously, intramuscularly or in an insulin pump.
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To minimize the risk of hypoglycemia, do not dilute or mix TOUJEO with any other insulin products or solutions.
2.2 Starting Dose in Insulin-Naïve Patients
Type 1 Diabetes:
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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.
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The maximum glucose lowering effect of a dose of TOUJEO may take five days to fully manifest and the first TOUJEO dose may be insufficient to cover metabolic needs in the first 24 hours of use [See Clinical Pharmacology (12.2)]. To minimize risks associated with insufficient insulinization when initiating TOUJEO, monitor glucose daily, titrate TOUJEO per instructions, and adjust co-administered glucose lowering therapies per standard of care.
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