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Tresiba® (insulin degludec) injection 100 U/mL, 200 U/mL logo
Important Safety Information | Patient Site
Prescribing Information
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Tresiba® (insulin degludec) injection 100 U/mL, 200 U/mL logo

Prescribing Information
Important Safety Information | Patient Site
Registration

How to start your adult patients on Tresiba® (insulin degludec)

See dosing and titration instructions as well as details about prescribing once-daily Tresiba® and adding it to your EHR.

Tresiba® FlexTouch® U-100 image

Type 2 dosing     |     Type 1 dosing     |     Dosage Guidance     |     EHR instructions

Type 2 dosing

Type 1 dosing

EHR instructions

Tresiba® dosing for Type 2 Diabetes1

Already taking insulin

1:1 CONVERSION

Adults already taking insulin can start on the same unit dose as their current basal insulin

Insulin-naïve

10 units

once daily

Titrate2-4

Below FPG target
-2 units

Within FPG target
0 units

Above FPG target
+2 units

The recommended time between dose increases is 3 to 4 days1

  • Tresiba® was not studied in clinical trials using this algorithm
  • Individualize and titrate the dose of Tresiba® based on the patient’s metabolic needs, blood glucose monitoring results, and glycemic control goal. Dose adjustments may be needed with changes in physical activity, changes in meal patterns, changes in renal or hepatic function, or during acute illness to minimize the risk of hypoglycemia or hyperglycemia1

Tresiba® dosing for Type 1 Diabetes1

Already taking insulin

1:1 CONVERSION

Adults already taking insulin can start on the same unit dose as their current basal insulin

Insulin-naïve

CALCULATE

total daily insulin dose (basal + bolus)

0.2 to 0.4
units per 1 kg of body weight

START

initial Tresiba® dose at
1/3 to 1/2 of total daily insulin dose

Titrate2-4

Below FPG target
-2 units

Within FPG target
0 units

Above FPG target
+2 units

The recommended time between dose increases is 3 to 4 days1

  • Tresiba® was not studied in clinical trials using this algorithm
  • Individualize and titrate the dose of Tresiba® based on the patient’s metabolic needs, blood glucose monitoring results, and glycemic control goal. Dose adjustments may be needed with changes in physical activity, changes in meal patterns, changes in renal or hepatic function, or during acute illness to minimize the risk of hypoglycemia or hyperglycemia1

Already taking insulin

1:1 CONVERSION

Adults already taking insulin can start on the same unit dose as their current basal insulin

Insulin-naïve

10 units

once daily

Titrate2-4

Below FPG target
-2 units

Within FPG target
0 units

Above FPG target
+2 units

The recommended time between dose increases is 3 to 4 days1

  • Tresiba® was not studied in clinical trials using this algorithm
  • Individualize and titrate the dose of Tresiba® based on the patient’s metabolic needs, blood glucose monitoring results, and glycemic control goal. Dose adjustments may be needed with changes in physical activity, changes in meal patterns, changes in renal or hepatic function, or during acute illness to minimize the risk of hypoglycemia or hyperglycemia1

Already taking insulin

1:1 CONVERSION

Adults already taking insulin can start on the same unit dose as their current basal insulin

Insulin-naïve

CALCULATE

total daily insulin dose (basal + bolus)

0.2 to 0.4
units per 1 kg of body weight

START

initial Tresiba® dose at
1/3 to 1/2 of total daily insulin dose

Titrate2-4

Based on ADA and AACE guidelines2,3

Below FPG target
-2 units

Within FPG target
0 units

Above FPG target
+2 units

The recommended time between dose increases is 3 to 4 days1

  • Tresiba® was not studied in clinical trials using this algorithm
  • Individualize and titrate the dose of Tresiba® based on the patient’s metabolic needs, blood glucose monitoring results, and glycemic control goal. Dose adjustments may be needed with changes in physical activity, changes in meal patterns, changes in renal or hepatic function, or during acute illness to minimize the risk of hypoglycemia or hyperglycemia1

For adults with diabetes, if life gets in the way of a scheduled dose Tresiba® provides continued efficacy1

Michelle usually takes her Tresiba® at 7 AM each day, but her dose was delayed on Saturday after a particularly busy week

Tresiba® Dosing Chart Example

Tresiba® dosing change

Hypothetical patient schedule.

  • Tresiba® was studied at alternating dosing intervals of 8 to 40 hours between doses in adult patients1

Tresiba® missed dose guidance for adults

Tresiba® is the only basal insulin that gives adult patients the option to change day-to-day dose timing if needed.1,5-7

  • Adult patients who miss a dose of Tresiba® should inject their daily dose during waking hours upon discovering the missed dose, then continue with their regular dosing schedule1
  • Ensure that at least 8 hours have elapsed between Tresiba® injections1

Dosing for pediatric patients

Find out how to prescribe Tresiba® for your pediatric patients 1 year of age and older

See pediatric dosing
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Prescribing Information | Important Safety Information

Add Tresiba® to your ePrescribing system

Tresiba® FlexTouch® U-100

Tresiba® FlexTouch® U-100 image

Form/strength:

100 units/mL


Quantity per box:

15 mL (5 X 3 mL) 1500 units total


NDC:

0169-2660-15

Tresiba® FlexTouch® U-200

Tresiba® FlexTouch® U-200 image

Form/strength:

200 units/mL


Quantity per box:

9 mL (3 X 3 mL) 1800 units total


NDC:

0169-2550-13

Tresiba® U-100, 10-mL vial

Tresiba® U-100, 10 mL vial

Form/strength:

100 units/mL


Quantity per box:

1 vial (10 mL) 1000 units total


NDC:

0169-2662-11

Prescribing Tresiba®

When sending prescribing information, be sure to specify the right formulation of Tresiba® for your patients:

  • The U-100 pen has a maximum dose of 80 units per injection and is dosed in 1-unit increments
  • The U-200 pen has a maximum dose of 160 units per injection and is dosed in 2-unit increments
  • The U-100 vial holds a volume of 10 mL

Also be sure to include:

Check icon

Starting dose (units per day)

Check icon

Titration information

Check icon

Separate prescription for pen needles (if necessary)

Indications and Usage for Tresiba® (insulin degludec) injection 100 U/mL, 200 U/mL

Tresiba® (insulin degludec) injection is indicated to improve glycemic control in patients 1 year of age and older with diabetes mellitus.

Limitations of Use

Tresiba® is not recommended for treating diabetic ketoacidosis.

Important Safety Information

Contraindications

  • Tresiba® is contraindicated during episodes of hypoglycemia and in patients with hypersensitivity to insulin degludec or any of the excipients in Tresiba®

Warnings and Precautions

  • Never Share a Tresiba® FlexTouch® Pen, Needle, or Syringe Between Patients, even if the needle is changed. Patients using Tresiba® vials should never share needles or syringes with another person. Sharing poses a risk for transmission of blood-borne pathogens.
  • Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen: Changes in an insulin regimen (e.g., insulin strength, manufacturer, type, or injection site or method of administration) may affect glycemic control and predispose to hypoglycemia or hyperglycemia. Repeated insulin injections into areas of lipodystrophy or localized cutaneous amyloidosis have been reported to result in hyperglycemia; and a sudden change in the injection site (to an unaffected area) has been reported to result in hypoglycemia. Make any changes to a patient’s insulin regimen under close medical supervision with increased frequency of blood glucose monitoring. Advise patients who have repeatedly injected into areas of lipodystrophy or localized cutaneous amyloidosis to change the injection site to unaffected areas and closely monitor for hypoglycemia. Adjustments in concomitant anti-diabetic treatment may be needed.
  • Hypoglycemia: Hypoglycemia is the most common adverse reaction of insulin, including Tresiba®. Severe hypoglycemia can cause seizures, may be life-threatening or cause death. Hypoglycemia can impair concentration ability and reaction time; this may place the patient and others at risk in situations where these abilities are important (e.g., driving or operating other machinery). Hypoglycemia can happen suddenly and symptoms may differ in each patient and change over time in the same patient. Symptomatic awareness of hypoglycemia may be less pronounced in patients with longstanding diabetes, in patients with diabetic neuropathy, using drugs that block the sympathetic nervous system (e.g., beta-blockers) or who experience recurrent hypoglycemia. The long-acting effect of Tresiba® may delay recovery from hypoglycemia compared to shorter-acting insulins.

    Risk Factors for Hypoglycemia:
    The risk of hypoglycemia generally increases with intensity of glycemic control. The risk of hypoglycemia after an injection is related to the duration of action of the insulin and, in general, is highest when the glucose lowering effect of the insulin is maximal. As with all insulins, the glucose lowering effect time course of Tresiba® may vary among different patients or at different times in the same patients and depends on many conditions, including the area of injection as well as the injection site blood supply and temperature. Other factors which may increase the risk of hypoglycemia include changes in meal pattern, changes in level of physical activity, or changes to concomitant drugs. Patients with renal or hepatic impairment may be at higher risk of hypoglycemia. Patients and caregivers must be educated to recognize and manage hypoglycemia. In patients at higher risk for hypoglycemia and patients who have reduced symptomatic awareness of hypoglycemia, increased frequency of blood glucose monitoring is recommended.
  • Hypoglycemia Due to Medication Errors: Accidental mix-ups between insulin products have been reported. To avoid medication errors between Tresiba® and other insulins, always instruct patients to always check the insulin label before each injection. To avoid dosing errors and potential overdose, never use a syringe to remove Tresiba® from the Tresiba® FlexTouch® disposable insulin prefilled pen.
  • Hypersensitivity Reactions: Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulins, including Tresiba®. If hypersensitivity reactions occur, discontinue Tresiba®; treat per standard of care and monitor until symptoms and signs resolve.
  • Hypokalemia: All insulins, including Tresiba®, cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia. Untreated hypokalemia may cause respiratory paralysis, ventricular arrhythmia, and death. Monitor potassium levels in patients at risk for hypokalemia and treat if indicated.
  • Fluid Retention and Heart Failure with Concomitant Use of PPAR-gamma Agonists: Fluid retention and heart failure can occur with concomitant use of thiazolidinediones (TZDs), which are PPAR-gamma agonists, and insulin, including Tresiba®. Patients should be observed for signs and symptoms of heart failure. If heart failure occurs, dosage reduction or discontinuation of the TZD must be considered.

Adverse Reactions

  • Adverse reactions commonly associated with Tresiba® are hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, rash, edema, and weight gain.

Drug Interactions

  • There are certain drugs that may cause clinically significant drug interactions with Tresiba®.
    • Drugs that may increase the risk of hypoglycemia: antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, somatostatin analog (e.g., octreotide), sulfonamide antibiotics, GLP-1 receptor agonists, DPP-4 inhibitors, and SGLT-2 inhibitors
    • Drugs that may decrease the blood glucose lowering effect: atypical antipsychotics (e.g., olanzapine and clozapine), corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens (e.g., in oral contraceptives), protease inhibitors, somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline), and thyroid hormones
    • Drugs that may increase or decrease the blood glucose lowering effect: alcohol, beta-blockers, clonidine, lithium salts, and pentamidine
    • Drugs that may blunt the signs and symptoms of hypoglycemia: beta-blockers, clonidine, guanethidine, and reserpine

Please click here for Tresiba® Prescribing Information.

References:

  1. Tresiba [package insert]. Plainsboro, NJ: Novo Nordisk Inc; July 2022.
  2. Garber AJ, Handelsman Y, Grunberger G, et al. Endocr Pract. 2020;26(1):107-139.
  3. Inzucchi SE, Bergenstal RM, Buse JB, et al. Diabetes Care. 2015;38(1):140-149.
  4. Philis-Tsimikas A, Brod M, Niemeyer M, Ocampo Francisco AM, Rothman J. Adv Ther. 2013;30(6):607-622.
  5. Lantus [package insert]. Bridgewater, NJ: sanofi-aventis US LLC; June 2022.
  6. Toujeo [package insert]. Bridgewater, NJ: sanofi-aventis US LLC; March 2023.
  7. Basaglar [package insert]. Indianapolis, IN: Lilly USA LLC; July 2021.
Diabetes
Other Therapy Areas
Explore diabetes
Explore obesity
Explore rare bleeding disorders
Explore growth-related disorders
Explore rare renal disorders
Explore hormone replacement therapy
  • Diabetes Home
  • Product Information
    Products
    • Diabetes Treatments
    Professional Resources
    • Product Resources Library
      Insulin & Type 1 Diabetes
  • Sample Requests
  • Professional Education
    Diabetes Education
    • Clinical Education Library
      Diabetes Risk Assessment Tool
    Treatment Guidelines
    • ADA Standards of Care
      AACE Diabetes Guidelines
    Additional Resources
    • Organizations & Conferences
  • Patient Support
    Product Education
    • Product Education Materials
    Disease Education
    • Disease Education Library
    Prescription Savings & Coverage
    • Savings Cards
      Insurance Coverage
      Affordability Resources
      ICD-10 Codes for Diabetes
    Support Program
    • Diabetes Management

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