Tresiba
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Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
TRESIBA is indicated to improve glycemic control in adults with diabetes mellitus.
Limitations of Use
TRESIBA is not recommended for the treatment of diabetic ketoacidosis.
History
There is currently no drug history available for this drug.
Other Information
TRESIBA (insulin degludec injection) is a long-acting basal human insulin analog for subcutaneous injection. Insulin degludec is produced by a process that includes expression of recombinant DNA in Saccharomyces cerevisiae followed by chemical modification.
Insulin degludec differs from human insulin in that the amino acid threonine in position B30 has been omitted and a side-chain consisting of glutamic acid and a C16 fatty acid has been attached (chemical name: LysB29(Nε-hexadecandioyl-γ-Glu) des(B30) human insulin). Insulin degludec has a molecular formula of C274H411N65O81S6 and a molecular weight of 6103.97. It has the following structure:
Figure 1: Structural Formula of TRESIBA
TRESIBA is a sterile, aqueous, clear, and colorless solution that contains insulin degludec 100 units/mL (U-100) or 200 units/mL (U-200).
Inactive ingredients for the 100 units/mL are: glycerol 19.6 mg/mL, phenol 1.50 mg/mL, metacresol 1.72 mg/mL, zinc 32.7 mcg/mL and water for injection.
Inactive ingredients for the 200 units/mL are glycerol 19.6 mg/mL, phenol 1.50 mg/mL, metacresol 1.72 mg/mL, zinc 71.9 mcg/mL and water for injection.
TRESIBA has a pH of approximately 7.6. Hydrochloric acid or sodium hydroxide may be added to adjust pH.
Sources
Tresiba Manufacturers
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Novo Nordisk
![Tresiba (Insulin Degludec Injection) Injection, Solution [Novo Nordisk]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Tresiba | Novo Nordisk
2.1 Important Administration Instructions • Always check insulin labels before administration [see Warnings and Precautions (5.4) ]. • Inspect visually for particulate matter and discoloration. Only use TRESIBA if the solution appears clear and colorless. • Train patients on proper use and injection technique before initiating TRESIBA. Training reduces the risk of administration errors such as needle sticks and incomplete dosing. • Inject TRESIBA subcutaneously into the thigh, upper arm, or abdomen. • Rotate injection sites within the same region from one injection to the next to reduce the risk of lipodystrophy [see Adverse Reactions (6.1)]. • DO NOT administer TRESIBA intravenously, intramuscularly or in an insulin infusion pump. • DO NOT dilute or mix TRESIBA with any other insulin products or solutions. • DO NOT transfer TRESIBA from the TRESIBA pen into a syringe for administration [see Warnings and Precautions (5.4)]. 2.2 General Dosing Instructions • Inject TRESIBA subcutaneously once-daily at any time of day. • Individualize and titrate the dose of TRESIBA based on the patient’s metabolic needs, blood glucose monitoring results, and glycemic control goal. • The recommended days between dose increases is 3 to 4 days. • Dose 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 (5.3)]. • 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. • 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.
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