HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use TRESIBA safely and effectively. See full prescribing information for TRESIBA.

TRESIBA ® (insulin degludec injection), for subcutaneous use
Initial U.S. Approval: 2015
INDICATIONS AND USAGE
TRESIBA 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.

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, 2.4).
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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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Administer subcutaneously once daily at any time of day ( 2.2).
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Do NOT perform dose conversion when using the TRESIBA U-100 or U-200 FlexTouch pens. The TRESIBA U-100 and U-200 FlexTouch pens dose window shows the number of insulin units to be delivered and NO conversion is needed ( 2.2).
DOSAGE FORMS AND STRENGTHS
TRESIBA is available in the following package sizes:

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100 units/mL (U-100): 3 mL FlexTouch ® ( 3).
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200 units/mL (U-200): 3 mL FlexTouch ® ( 3).
CONTRAINDICATIONS
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During episodes of hypoglycemia ( 4).
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Hypersensitivity to TRESIBA or one of its excipients ( 4).
WARNINGS AND PRECAUTIONS
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Never share a TRESIBA FlexTouch 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 and increase frequency of blood glucose monitoring ( 5.2).
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Hypoglycemia: May be life-threatening. Increase 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, 5.4, 6.1).
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Hypoglycemia due to medication errors: Accidental mix-ups between insulin products can occur. Instruct patients to check insulin labels before injection. DO NOT transfer TRESIBA into a syringe for administration as overdosage and severe hypoglycemia can result ( 5.4).
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Hypersensitivity reactions: Severe, life-threatening, generalized allergy, including anaphylaxis, can occur. Discontinue TRESIBA, monitor and treat if indicated ( 5.5).
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Hypokalemia: May be life-threatening. Monitor potassium levels in patients at risk for 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 TRESIBA are:

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hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, rash, edema and weight gain ( 6.1).
To report SUSPECTED ADVERSE REACTIONS, contact Novo Nordisk at 1-800-727-6500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS
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Drugs that affect glucose metabolism: Adjustment of insulin dosage may be needed; closely monitor blood glucose( 7).
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