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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

Dose timing and other reasons to consider Tresiba® (insulin degludec) for your patients with type 1 diabetes

Patients with T1D

Continued efficacy

A1C reduction

Administration options

Savings

Continued efficacy     |      A1C reduction     |      Administration options     |      Savings

Leo with lunchbox

For adults with T1D, if life gets in the way of a scheduled dose

Tresiba® provides continued efficacy

JC takes his basal injection daily before work but sleeps in on weekends. On those days, he doesn’t know when he will dose.

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

  • 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
See dose timing guidance

As demonstrated in the BEGIN clinical trial program

Tresiba® provides proven A1C reduction1

Tresiba® efficacy and safety were studied in adult and pediatric patients with T1D. And the SWITCH 1 trial further evaluated the safety profile of Tresiba® in adult patients with T1D at increased risk of hypoglycemia.1,6

See Tresiba® efficacy

All pictures and scenarios are for illustrative purposes only.

Have patients with T1D who face challenges with dose timing at mealtimes?

Consider a bolus insulin with mealtime dosing flexibility to improve glycemic control in adult and pediatric patients with diabetes.7

See this bolus insulin

Tresiba® FlexTouch® is a prefilled insulin pen with no push-button extension

Standard insulin pen

Standard insulin pen image

Tresiba® FlexTouch® U-100

Tresiba® FlexTouch® image

No matter what dose is dialed, the Tresiba® FlexTouch® U‑100 push button doesn’t extend any higher.

Contains 300 total units

Maximum dose of 80 units in a single injection

1-unit dose increments

After opening, Tresiba® may be used for up to 8 weeks when kept at room temperature or in the refrigerator vs 4 weeks for insulin glargine U-100.1,2,a,b

aOpened (in-use) Tresiba® should be refrigerated (36°F to 46°F [2°C to 8°C]) or kept at room temperature (below 86°F [30°C]), away from direct heat and light.1

bOpened (in-use) Lantus® SoloSTAR® device must be discarded 4 weeks after being opened. Once in use, the device must be kept at room temperature.2

Leo with lunchbox

An additional option for patients who prefer vials1

  • Contains 1000 total units
  • Option for children who need half-unit increments

Once in use, the Tresiba® vial lasts 8 weeks, 2X as long as the insulin glargine U-100 vial, and 2 weeks longer than the insulin detemir vial.1-3,c,d

cIn-use Tresiba® can be kept at room temperature (below 86°F), away from direct heat and light, or refrigerated (36°F-46°F).
dThe in-use insulin glargine U-100 vial must be discarded after 4 weeks and the in-use insulin detemir vial must be discarded after 6 weeks.2,3

When starting a patient with T1D on a basal insulin

Commercially insured patients can save on Tresiba®

Eligible patients may pay as little as $25 or no more than $99 per prescription of Tresiba®e

Direct your patients to TresibaSavings.com

eEligibility and other restrictions apply.

Tresiba instant savings card graphic

These trusted partners are helping young patients with type 1 diabetes

Juvenile Diabetes Research Foundation logo
Children with Diabetes logo

Starting adults on Tresiba®

See adult dosing

Starting pediatric patients (≥1 year of age) on Tresiba®

See pediatric dosing

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 Tresiba® or one of its excipients

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 is the most common adverse reaction of insulin, including Tresiba®, and may be life-threatening. Increase monitoring with changes to: insulin dose, co-administered glucose lowering medications, meal pattern, physical activity; and in patients with hypoglycemia unawareness or renal or hepatic impairment
  • Accidental mix-ups between basal insulin products and other insulins, particularly rapid-acting insulins, have been reported. To avoid medication errors, always instruct patients to check the insulin label before each injection
  • Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulin products, including Tresiba® 
  • As with all insulins, Tresiba® use can lead to life-threatening hypokalemia, which then may cause respiratory paralysis, ventricular arrhythmia, and death. Closely monitor potassium levels in patients at risk of hypokalemia and treat if indicated
  • 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; November 2019.
  2. Lantus [package insert]. Bridgewater, NJ: sanofi-aventis US LLC; January 2021.
  3. Levemir [package insert]. Plainsboro, NJ: Novo Nordisk Inc; March 2020.
  4. Toujeo [package insert]. Bridgewater, NJ: sanofi-aventis US LLC; December 2020.
  5. Basaglar [package insert]. Indianapolis, IN: Lilly USA LLC; July 2021.
  6. Lane W, Bailey TS, Gerety G, et al. JAMA. 2017;318(1):33-44.
Diabetes
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Explore hormone replacement therapy
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