rient 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 (5.3)].
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Instruct patients who miss a dose of TRESIBA to inject their daily dose during waking hours upon discovering the missed dose. Instruct patients to ensure that at least 8 hours have elapsed between consecutive TRESIBA injections.
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DO NOT perform dose conversion when using the TRESIBA U-100 or U-200 FlexTouch pens. The dose window for both the TRESIBA U-100 and U-200 FlexTouch pens shows the number of insulin units to be delivered and NO conversion is needed.
2.3 Starting Dose in Insulin Naïve PatientsType 1 Diabetes Mellitus:
The recommended starting dose of TRESIBA 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 administered 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.
Type 2 Diabetes Mellitus:
The recommended starting dose of TRESIBA in insulin naïve patients with type 2 diabetes mellitus is 10 units once daily.
2.4 Starting Dose in Patients Already on Insulin TherapyType 1 and Type 2 Diabetes Mellitus:
Start TRESIBA at the same unit dose as the total daily long or intermediate-acting insulin unit dose.
3 DOSAGE FORMS AND STRENGTHS
TRESIBA is available as a clear, and colorless solution for injection in:
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100 units/mL (U-100): 3 mL FlexTouch disposable prefilled pen
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200 units/mL (U-200): 3 mL FlexTouch disposable prefilled pen
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4 CONTRAINDICATIONS(What is this?)
TRESIBA is contraindicated:
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During episodes of hypoglycemia [see Warnings and Precautions (5.3)].
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In patients with hypersensitivity to TRESIBA or one of its excipients [see Warnings and Precautions (5.5)].
5 WARNINGS AND PRECAUTIONS
5.1 Never Share a TRESIBA FlexTouch Pen Between PatientsTRESIBA FlexTouch disposable prefilled pens should never be shared between patients, even if the needle is changed. Sharing poses a risk for transmission of blood-borne pathogens.
5.2 Hyperglycemia or Hypoglycemia with Changes in Insulin RegimenChanges in insulin, manufacturer, type, or method of administration may affect glycemic control and predispose to hypoglycemia or hyperglycemia. These changes should be made cautiously and only under medical supervision and the frequency of blood glucose monitoring should be increased. For patients with type 2 diabetes, adjustments in concomitant oral anti-diabetic treatment may be needed. When converting from other insulin therapies to TRESIBA follow dosing recommendations [see Dosage and Administration (2.4)].
5.3 HypoglycemiaHypoglycemia is the most common adverse reaction of insulin, including TRESIBA [see Adverse Reactions (6.1)]. 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). TRESIBA, or any insulin, should not be used during episodes o
