Frequently asked questions about Tresiba® (insulin degludec)
About Tresiba®
What is Tresiba®?
Tresiba® is a long-acting, once-daily basal insulin indicated to improve glycemic control in patients 1 year of age and older with diabetes mellitus.1
How is Tresiba® pronounced?
Tray-SEE-ba is the correct pronunciation of Tresiba®.
How does Tresiba® work in the body?
Prior to injection, Tresiba® exists as dihexamers inside the pen in the presence of zinc and phenol.2
After injection, phenol diffuses and Tresiba® dihexamers assemble and form multihexamer chains, resulting in a subcutaneous insulin depot.2
Zinc diffuses and insulin monomers are released slowly from the ends of the chains and are absorbed continuously from the depot into circulation.2
What makes the Tresiba® molecule different?
The molecular design of Tresiba® provides a steady rate of absorption into the bloodstream, giving it a flat and stable profile.1,3,4 This slow and steady release allows for around-the-clock glycemic control.
What are the side effects of Tresiba®?
Adverse reactions commonly associated with Tresiba® are hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, rash, edema, and weight gain.1
What do studies show about Tresiba® U-100 vs Lantus (insulin glargine) U-100?
In the DEVOTE safety outcomes study, Tresiba® U-100 demonstrated no increased risk of major adverse cardiovascular events (MACE) vs Lantus (insulin glargine) U-100 for adults with T2D and ASCVD.5,a
The secondary confirmatory endpoint in the DEVOTE study demonstrated significantly lower rates of severe hypoglycemic events as a side effect of Tresiba® U-100 vs Lantus (insulin glargine) U-100.5,b
aMACE=cardiovascular death, nonfatal MI, or nonfatal stroke.
bSevere hypoglycemia was defined as an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions and during which plasma glucose concentration may not have been available, but where neurological recovery following the return of plasma glucose to normal was considered sufficient evidence that the event was induced by a low plasma glucose concentration.
Is there data on the use of Tresiba® in pregnant women?
In an open-label clinical trial, 185 pregnant women with type 1 diabetes were treated with either Tresiba® (once daily) or insulin detemir (once or twice daily); both groups received insulin aspart 2 to 4 times daily with meals. There were no significant drug-associated differences in pregnancy outcomes or the health of the fetus and newborn between the 2 groups. There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy.1,6
Taking Tresiba®
How is Tresiba® delivered?
Tresiba® has 3 administration options:
- Tresiba® FlexTouch® U-100: Each prefilled insulin pen contains 300 total units, delivering a maximum dose of 80 units in a single injection1
- Tresiba® FlexTouch® U-200: Each prefilled insulin pen contains 600 total units, delivering a maximum dose of 160 units in a single injection for patients who need higher doses1
- Tresiba® U-100 10-mL vial: Each vial contains 1000 total units. Use this vial only with a U-100 insulin syringe1
How should Tresiba® FlexTouch® and 10-mL vial be stored?
Not in use (unopened)
If unopened, Tresiba® should be stored in a refrigerator (36°F to 46°F [2°C to 8°C]) until expiration date. It can also be stored at up to 86°F for 56 days.1
In use (opened)
After first use, Tresiba® can be stored at room temperature (up to 86°F [30°C]) or in the refrigerator (36°F to 46°F [2°C to 8°C]) without the needle attached for a maximum of 8 weeks (56 days).1
Patient support
How much does Tresiba® cost?
Cost depends on formulary coverage and savings eligibility. With the Tresiba® Savings Card, commercially insured patients pay as little as $35 or no more than $99 per prescription. Medicare Part D patients with Tresiba® formulary coverage will pay no more than $35 per 30-day supply. Low-income subsidy or Extra Help patients likely pay $10.35 per month or less. Click here to confirm formulary coverage, verify benefits, and help your patient apply for a Tresiba® Savings Card.
How can I help my patients save on Tresiba®?
Your commercial patients pay as little as $35 or no more than $99 per prescription of Tresiba® when they sign up for the Tresiba® Savings Card. Eligibility and other restrictions apply.
Is Tresiba® covered by insurance?
Tresiba® has ~89.2% national formulary coverage (commercial and Medicare Part D combined) and is covered nationwide on the majority of Medicare Part D plans.7,c-e
cFormulary status subject to change. This information should not be used to make efficacy or safety comparisons between or among mentioned products.
dFormulary data are provided by Managed Markets Insight & Technology, LLC (MMIT) and are current as of September 2022.
eMedicare Part D data are on file with Novo Nordisk and are current as of September 2022.
Study design
DEVOTE5
Population: Adult patients with T2D and ASCVD.
Study design: Treat-to-target, randomized, double-blind, active comparator-controlled, event-driven cardiovascular outcomes trial assessing the noninferiority of once-daily Tresiba® U-100 (n=3818) and once-daily insulin glargine U-100 (n=3819) in terms of the incidence of cardiovascular events.
Primary composite endpoint: Time from randomization to first occurrence of an adjudicated major adverse cardiovascular event (MACE): cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke.
Secondary confirmatory endpoints: The number and incidence of adjudicated events of severef hypoglycemia, as defined in 2013 by the American Diabetes Association.
fSevere hypoglycemia was defined as an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions and during which plasma glucose concentration may not have been available, but where neurological recovery following the return of plasma glucose to normal was considered sufficient evidence that the event was induced by a low plasma glucose concentration.
ASCVD=atherosclerotic cardiovascular disease; MACE=cardiovascular death, nonfatal MI, or nonfatal stroke.
EXPECT Trial1,6
Population: Adult pregnant females with type 1 diabetes.
Patients randomized: Tresiba® (once daily) or insulin detemir (once or twice daily); both groups received insulin aspart 2 to 4 times daily with meals.
Study design: The EXPECT study is an open-label, randomized trial of 185 pregnant women aged ≥18 years with type 1 diabetes and who were previously treated with insulin and were at 8-13 weeks' gestation or planned to become pregnant within 52 weeks. Poor glucose control during pregnancy in both groups and small sample size were limitations of the study.
Primary endpoint: The primary analysis aimed to demonstrate the noninferiority (margin of 0.4%) of Tresiba® to insulin detemir with respect to the last planned glycated hemoglobin (HbA1c) measurement prior to delivery (>16 weeks’ gestation) using ANCOVA.
Secondary endpoints: Secondary endpoints were pregnancy outcomes as well as maternal efficacy and safety outcomes.
ANCOVA=analysis of covariance.
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:
- Tresiba [package insert]. Plainsboro, NJ: Novo Nordisk Inc; July 2022.
- Jonassen I, Havelund S, Hoeg-Jensen T, Steensgaard DB, Wahlund PO, Ribel U. Design of the novel protraction mechanism of insulin degludec, an ultra-long-acting basal insulin. Pharm Res. 2012;29(8):2104-2114.
- Heise T, Korsatko S, Nosek L, et al. Steady state is reached within 2-3 days of once-daily administration of degludec, a basal insulin with an ultralong duration of action. J Diabetes. 2016;8(1):132-138.
- Heise T, Hermanski L, Nosek L, Feldman A, Rasmussen S, Haahr H. Insulin degludec: four times lower pharmacodynamic variability than insulin glargine under steady-state conditions in type 1 diabetes. Diabetes Obes Metab. 2012;14(9):859-864.
- Marso SP, McGuire DK, Zinman B, et al. Efficacy and safety of degludec versus glargine in type 2 diabetes. N Engl J Med. 2017;377(8):723-732.
- Data on file. Novo Nordisk Inc; July 2022.
- Managed Markets Insight & Technology, LLC (MMIT), September 2023.