Brand Name
Tresiba
Generic Name
Degludec
View Brand Information FDA approval date: September 25, 2015
Classification: Insulin Analog
Form: Injection
What is Tresiba (Degludec)?
Insulin Degludec is indicated to improve glycemic control in patients 1 year of age and older with diabetes mellitus. Limitations of Use Not recommended for the treatment of diabetic ketoacidosis. Insulin Degludec is a long-acting human insulin analog indicated to improve glycemic control in patients 1 year of age and older with diabetes mellitus . Limitations of Use:, Not recommended for the treatment of diabetic ketoacidosis.
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Brand Information
Tresiba (insulin degludec)
1INDICATIONS AND USAGE
TRESIBA is indicated to improve glycemic control in patients 1 year of age and older with diabetes mellitus.
Limitations of Use
- Not recommended for the treatment of diabetic ketoacidosis.
2DOSAGE FORMS AND STRENGTHS
Injection: Available as a clear and colorless solution:
- 100 units/mL (U-100): 3 mL single-patient-use FlexTouch prefilled pen
- 100 units/mL (U-100): 10 mL multiple-dose vial
- 200 units/mL (U-200): 3 mL single-patient-use FlexTouch prefilled pen
3CONTRAINDICATIONS
TRESIBA is contraindicated:
- During episodes of hypoglycemia
- In patients with hypersensitivity to insulin degludec or any of the excipients in TRESIBA
4ADVERSE REACTIONS
The following adverse reactions are also discussed elsewhere:
- Hypoglycemia
- Hypoglycemia due to Medication errors
- Hypersensitivity reactions
- Hypokalemia
4.1Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of TRESIBA in subjects with type 1 diabetes or type 2 diabetes was evaluated in nine trials of 6-12 month duration in adults and in one trial of 12-month duration in pediatric patients 1 year of age and older with type 1 diabetes. The cardiovascular safety of TRESIBA was evaluated in one double-blinded, event-driven trial of 2-year median duration in patients with type 2 diabetes at high risk of cardiovascular events
The data in Table 1 reflect the exposure of 1102 adults with type 1 diabetes to TRESIBA with a mean exposure duration to TRESIBA of 34 weeks in three open-label trials;
The data in Table 2 reflect the exposure of 2713 adults with type 2 diabetes to TRESIBA with a mean exposure duration to TRESIBA of 36 weeks in six open-label trials;
Common adverse reactions (excluding hypoglycemia) occurring in TRESIBA treated subjects during clinical trials in adult patients with type 1 diabetes mellitus and adults with type 2 diabetes mellitus are listed in Table 1 and Table 2, respectively. Common adverse reactions were defined as reactions occurring in ≥5% of the population studied. Hypoglycemia is not shown in these tables but discussed in a dedicated subsection below.
174 pediatric patients 1 year of age and older with type 1 diabetes were exposed to TRESIBA with a mean exposure to TRESIBA of 48 weeks. The mean age was 10 years: 25% were ages 1-5 years, 40% were ages 6-11 years, and 35% were ages 12-17 years. 55% were male, 78% were White, 3% were Black or African American and 4% were Hispanic. The mean body mass index (BMI) was 18.7 kg/m
Table 1: Adverse Reactions Occurring in ≥5% of TRESIBA-Treated Adult Patients with Type 1 Diabetes Mellitus
Table 2: Adverse Reactions Occurring in ≥5% of TRESIBA-Treated Adult Patients with Type 2 Diabetes Mellitus
Hypoglycemia
Hypoglycemia was the most commonly observed adverse reaction in patients treated with TRESIBA. The rates of reported hypoglycemia depend on the definition of hypoglycemia used, diabetes type, insulin dose, intensity of glucose control, background therapies, and other intrinsic and extrinsic patient factors. For these reasons, comparing rates of hypoglycemia in clinical trials for TRESIBA with the incidence of hypoglycemia for other products may be misleading and also, may not be representative of hypoglycemia rates that will occur in clinical practice.
In the open-label adult clinical trials of patients with type 1 and type 2 diabetes, and in the open-label pediatric clinical trial of patients with type 1 diabetes, percentages of adult and pediatric patients with type 1 diabetes randomized to TRESIBA who experienced at least one episode of hypoglycemia in clinical trials
Severe hypoglycemia in the open-label trials with adult patients was defined as an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Severe hypoglycemia in the pediatric trial was defined as an altered mental status where the child could not assist in his own care, was semiconscious or unconscious, or in a coma ± convulsions and may require parenteral therapy (glucagon or intravenous glucose). A hypoglycemia episode was defined as a severe hypoglycemia episode or an episode where a laboratory or a self-measured glucose calibrated to plasma was less than 56 mg/dL or where a whole blood glucose was less than 50 mg/dL (i.e., with or without the presence of hypoglycemic symptoms).
Table 3: Percent (%) of Type 1 Diabetes Patients Experiencing at Least One Episode of Severe Hypoglycemia or Hypoglycemia
*Severe hypoglycemia in pediatric patients: an episode with altered mental status, where the child could not assist in his own care, was semiconscious or unconscious, or in a coma ± convulsions and may require parenteral therapy (glucagon or intravenous glucose).
§Hypoglycemia: a severe hypoglycemia episode or an episode where a laboratory or a self-measured glucose calibrated to plasma was less than 56 mg/dL or where a whole blood glucose was less than 50 mg/dL (i.e., with or without the presence of hypoglycemic symptoms).
Table 4: Percent (%) of Patients with Type 2 Diabetes Experiencing at Least One Episode of Severe Hypoglycemia or Hypoglycemia
*OAD: oral antidiabetic agent,
Hypersensitivity Reactions
Severe, life-threatening, generalized allergy, including anaphylaxis, generalized skin reactions, angioedema, bronchospasm, hypotension, and shock have occurred with insulin, including TRESIBA and may be life threatening. Hypersensitivity (manifested with swelling of tongue and lips, diarrhea, nausea, tiredness, and itching) and urticaria were reported in 0.9% of patients treated with TRESIBA.
Lipodystrophy
Long-term use of insulin, including TRESIBA, can cause lipodystrophy at the site of repeated insulin injections. Lipodystrophy includes lipohypertrophy (thickening of adipose tissue) and lipoatrophy (thinning of adipose tissue) and may affect insulin absorption
Injection Site Reactions
Patients taking TRESIBA may experience injection site reactions, including injection site hematoma, pain, hemorrhage, erythema, nodules, swelling, discoloration, pruritus, warmth, and injection site mass. In the clinical program, injection site reactions occurred in 3.8% of patients treated with TRESIBA.
Weight Gain
Weight gain can occur with insulin therapy, including TRESIBA, and has been attributed to the anabolic effects of insulin. In the clinical program after 52 weeks of treatment, patients with type 1 diabetes treated with TRESIBA gained an average of 1.8 kg and patients with type 2 diabetes treated with TRESIBA gained an average of 3.0 kg.
Peripheral Edema
TRESIBA, may cause sodium retention and edema. In the clinical program, peripheral edema occurred in 0.9% of patients with type 1 diabetes mellitus and 3.0% of patients with type 2 diabetes mellitus treated with TRESIBA.
4.2Immunogenicity
As with all therapeutic proteins, insulin administration may cause anti-insulin antibodies to form. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay and may be influenced by several factors such as: assay methodology, sample handling, timing of sample collection, concomitant medication, and underlying disease. For these reasons, comparison of the incidence of antibodies to TRESIBA with the incidence of antibodies in other studies or to other products may be misleading.
In a 52-week trial of adult insulin-experienced type 1 diabetes patients, 68.9% of patients who received TRESIBA were positive at baseline for anti-insulin degludec antibodies and 12.3% of the patients developed anti-insulin degludec antibodies at least once during the trial. In a 52-week trial of pediatric insulin-experienced type 1 diabetes patients, 84.1% of patients who received TRESIBA were positive at baseline for anti-insulin degludec antibodies and 5.8% of patients developed anti-insulin degludec antibodies at least once during the trial. In a 52-week trial of adult insulin-naïve type 2 diabetes patients, 1.7% of patients who received TRESIBA were positive at baseline for anti-insulin degludec antibodies and 6.2% of patients developed anti-insulin degludec antibodies at least once during the trial. In these trials, between 96.7% and 99.7% of patients who were positive for anti-insulin degludec antibodies were also positive for anti-human insulin antibodies.
4.3Postmarketing Experience
The following additional adverse reactions have been identified during post-approval use of TRESIBA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Localized cutaneous amyloidosis at the injection site has occurred. Hyperglycemia has been reported with repeated insulin injections into areas of localized cutaneous amyloidosis; hypoglycemia has been reported with a sudden change to an unaffected injection site.
5DRUG INTERACTIONS
Table 5 includes clinically significant drug interactions with TRESIBA.
Table 5: Clinically Significant Drug Interactions with TRESIBA
6OVERDOSAGE
An excess of insulin relative to food intake, energy expenditure, or both may lead to severe and sometimes prolonged and life-threatening hypoglycemia and hypokalemia
7DESCRIPTION
Insulin degludec is a long-acting basal human insulin analog for subcutaneous injection produced by a process that includes expression of recombinant DNA in
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 C
Figure 1: Structural Formula of Insulin Degludec
TRESIBA (insulin degludec) injection is a sterile, aqueous, clear, and colorless solution available as 100 units/mL (U-100) or 200 units/mL (U-200) for subcutaneous use.
For the 100 units/mL solution, each mL contains 100 units of insulin degludec and glycerin (19.6 mg), metacresol (1.72 mg), phenol (1.5 mg), zinc (32.7 mcg), and Water for Injection, USP.
For the 200 units/mL solution, each mL contains 200 units of insulin degludec and glycerin (19.6 mg), metacresol (1.72 mg), phenol (1.5 mg), zinc (71.9 mcg), and Water for Injection, USP.
TRESIBA has a pH of approximately 7.6. Hydrochloric acid or sodium hydroxide may be added to adjust pH.
8CLINICAL STUDIES
The efficacy of TRESIBA administered once-daily either at the same time each day or at any time each day in patients with type 1 diabetes and used in combination with a mealtime insulin was evaluated in three randomized, open-label, treat-to-target, active-controlled trials in adults and one randomized, open-label, treat-to-target, active-controlled trial in pediatric patients 1 year of age and older. The efficacy of TRESIBA administered once-daily either at the same time each day or at any time each day in adult patients with type 2 diabetes and used in combination with a mealtime insulin or in combination with common oral anti-diabetic agents was evaluated in six randomized, open-label, treat-to-target active-controlled trials.
Adult patients treated with TRESIBA achieved levels of glycemic control similar to those achieved with LANTUS (insulin glargine 100 units/mL) and LEVEMIR (insulin detemir) and achieved statistically significant improvements compared to sitagliptin.
8.1Type 1 Diabetes – Adult
TRESIBA Administered at the Same Time Each Day in Combination with a Rapid-Acting Insulin Analog at Mealtimes in Adult Patients
Study A
The efficacy of TRESIBA was evaluated in a 52-week randomized, open-label, multicenter trial in 629 patients with type 1 diabetes mellitus (Study A). Patients were randomized to TRESIBA once-daily with the evening meal or insulin glargine U-100 once-daily according to the approved labeling. Insulin aspart was administered before each meal in both treatment arms.
The mean age of the trial population was 43 years and mean duration of diabetes was 19 years. 59% were male. 93% were White, 2% Black or African American. 5% were Hispanic. 9% of patients had eGFR<60 mL/min/1.73m
At week 52, the difference in HbA
Study B
The efficacy of TRESIBA was evaluated in a 26-week randomized, open-label, multicenter trial in 455 patients with type 1 diabetes mellitus (Study B). Patients were randomized to TRESIBA or insulin detemir once-daily in the evening. After 8 weeks, insulin detemir could be dosed twice-daily. 67% used insulin detemir once daily at end of trial. 33% used insulin detemir twice daily at end of trial. Insulin aspart was administered before each meal in both treatment arms.
The mean age of the trial population was 41 years and mean duration of diabetes was 14 years. 52% were male. 45% were White, 0.4% Black or African American. 4% were Hispanic. 4% of patients had eGFR<60 mL/min/1.73m
At week 26, the difference in HbA
Table 6: Results at Week 52 in a Trial Comparing TRESIBA to Insulin Glargine U-100 (Study A) and Week 26 in a Trial Comparing TRESIBA to Insulin Detemir (Study B) in Adult Patients with Type 1 Diabetes Mellitus Receiving Insulin Aspart at Mealtimes
- 1At Week 52
- 2At Week 26
- *The change from baseline to end of treatment visit in HbA1c was analyzed using ANOVA with treatment, region, sex, and anti-diabetic treatment at screening as fixed effects, and age and baseline HbA1c as covariates.
- In Study A, there were 14.8% of subjects in the TRESIBA and 11.5% Insulin glargine arms for whom data was missing at the time of the HbA
- In Study B, there were 6.3% of subjects in the TRESIBA and 9.8% Insulin detemir arms for whom data was missing at the time of the HbA
Study C: TRESIBA Administered at the Same Time Each Day or at Any Time Each Day in Combination with a Rapid-Acting Insulin Analog at Mealtimes in Adult Patients
The efficacy of TRESIBA was evaluated in a 26-week randomized, open-label, multicenter trial in 493 patients with type 1 diabetes mellitus. Patients were randomized to TRESIBA injected once-daily at the same time each day (with the main evening meal), to TRESIBA injected once daily at any time each day or to insulin glargine U-100 injected once-daily according to the approved labeling. The any time each day TRESIBA arm was designed to simulate a worst-case scenario injection schedule of alternating short and long, once daily, dosing intervals (i.e., alternating intervals of 8 to 40 hours between doses). TRESIBA in this arm was dosed in the morning on Monday, Wednesday, and Friday and in the evening on Tuesday, Thursday, Saturday, and Sunday. Insulin aspart was administered before each meal in all treatment arms.
The mean age of the trial population was 43.7 years and mean duration of diabetes was 19 years. 58% were male. 98% were White, 2% Black or African American. 3% were Hispanic. 7% of patients had eGFR<60 mL/min/1.73m
At week 26, the difference in HbA
Table 7: Results at Week 26 in a Trial Comparing TRESIBA Dosed Once Daily at the Same and at Alternating Times Each Day to Insulin Glargine U-100 in Adult Patients with Type 1 Diabetes Mellitus Receiving Insulin Aspart at Mealtimes
*The change from baseline to end of treatment visit in HbA1c was analyzed using ANOVA with treatment, region, sex, and anti-diabetic treatment at screening as fixed effects, and age and baseline HbA1c as covariates.
In Study C, there were 15.8% and 15.9% of subjects in the TRESIBA (same time and alternating times respectively) and 7.9% Insulin glargine arms for whom data was missing at the time of the HbA
8.2Type 1 Diabetes – Pediatric Patients 1 Year of Age and Older
Study J: TRESIBA Administered at the Same Time Each Day in Combination with a Rapid-Acting Insulin Analog at Mealtimes in Pediatric Patients 1 Year of Age and Older
The efficacy of TRESIBA was evaluated in a 26-week, randomized, open label, multicenter trial in 350 patients with type 1 diabetes mellitus (Study J). Patients were randomized to TRESIBA once-daily or insulin detemir once or twice-daily. Subjects on a twice-daily insulin detemir regimen were dosed at breakfast and in the evening either with the main evening meal or at bedtime. Insulin aspart was administered before each main meal in both treatment arms. At end of trial, 36% used insulin detemir once daily and 64% used insulin detemir twice daily.
The mean age of the trial population was 10 years; 24% were ages 1-5 years; 39% were ages 6-11 years and 36% were ages 12-17 years. The mean duration of diabetes was 4 years. 55% were male. 75% were White, 3% Black or African American. 3% were Hispanic. The mean z-score for body weight was 0.31.
At week 26, the difference in HbA
Table 8: Results at Week 26 in a Trial Comparing TRESIBA to Insulin Detemir in Pediatric Patients 1 Year of Age and Older with Type 1 Diabetes Mellitus Receiving Insulin Aspart at Mealtimes
- ±The change from baseline to end of treatment visit in HbA1c was analyzed using ANOVA with missing data imputed by multiple imputation carrying forward the baseline value and adding the error term, with treatment, region, sex, and age group as fixed factors, and baseline HbA1c as covariate.
- In Study J, there were 2.9% of subjects in TRESIBA and 6.3% Insulin detemir arms for whom data was missing at the 26-week HbA
8.3Type 2 Diabetes - Adult
Study D: TRESIBA Administered at the Same Time Each Day as an Add-on to Metformin with or without a DPP-4 Inhibitor in Insulin Naïve Adult Patients
The efficacy of TRESIBA was evaluated in a 52-week randomized, open-label, multicenter trial that enrolled 1030 insulin naïve patients with type 2 diabetes mellitus inadequately controlled on one or more oral antidiabetic agents (OADs). Patients were randomized to TRESIBA once-daily with the evening meal or insulin glargine U-100 once-daily according to the approved labeling. Metformin alone (83%) or in combination with a DPP-4 inhibitor (18%) was used as background therapy in both treatment arms.
The mean age of the trial population was 59 years and mean duration of diabetes was 9 years. 62% were male. 88% were White, 7% Black or African American. 17% were Hispanic. 10% of patients had eGFR<60 mL/min/1.73m
At week 52, the difference in HbA
Table 9: Results at Week 52 in a Trial Comparing TRESIBA to Insulin Glargine U-100 in Adult Patients with Type 2 Diabetes Mellitus on OAD(s)*
- *OAD: oral antidiabetic agent
- **The change from baseline to end of treatment visit in HbA1c was analyzed using ANOVA with treatment, region, sex, and anti-diabetic treatment at screening as fixed effects, and age and baseline HbA1c as covariates.
- In Study D, there were 20.6% of subjects in the TRESIBA and 22.2% Insulin glargine arms for whom data was missing at the time of the HbA
Study E: TRESIBA U-200 Administered at the Same Time Each Day as an Add-on to Metformin with or without a DPP-4 Inhibitor in Insulin Naïve Adult Patients
The efficacy of TRESIBA U-200 was evaluated in a 26-week randomized, open-label, multicenter trial in 457 insulin naïve patients with type 2 diabetes mellitus inadequately controlled on one or more oral antidiabetic agents (OADs) at baseline. Patients were randomized to TRESIBA U-200 once-daily with the evening meal or insulin glargine U-100 once-daily according to the approved labeling. Both treatment arms were receiving metformin alone (84%) or in combination with a DPP-4 inhibitor (16%) as background therapy.
The mean age of the trial population was 58 years and mean duration of diabetes was 8 years. 53% were male. 78% were White, 14% Black or African American. 8% were Hispanic. 8% of patients had eGFR <60 mL/min/1.73m
At week 26, the difference in HbA
Table 10: Results at Week 26 in a Trial Comparing TRESIBA U-200 to Insulin Glargine U-100 in Adult Patients with Type 2 Diabetes Mellitus on OAD(s)*
- *OAD: oral antidiabetic agent
- **The change from baseline to end of treatment visit in HbA1c was analyzed using ANOVA with treatment, region, sex, and anti-diabetic treatment at screening as fixed effects, and age and baseline HbA1c as covariates.
- In Study E, there were 12.3% of subjects in the TRESIBA and 12.7% Insulin glargine arms for whom data was missing at the time of the HbA
Study F: TRESIBA Administered at the Same Time Each Day in Insulin Naïve Adult Patients as an Add-on to One or More of the Following Oral Agents: Metformin, Sulfonylurea, Glinides or Alpha-Glucosidase Inhibitors
The efficacy of TRESIBA was evaluated in a 26-week randomized, open-label, multicenter trial in Asia in 435 insulin naïve patients with type 2 diabetes mellitus inadequately controlled on one or more oral antidiabetic agents (OADs) at baseline. Patients were randomized to TRESIBA once-daily in the evening or insulin glargine U-100 once-daily according to the approved labeling. Pre-trial oral antidiabetes agents were continued as background therapy except for DPP-4 inhibitors or thiazolidinediones in both treatment arms.
The mean age of the trial population was 59 years and mean duration of diabetes was 12 years. 54% were male. All patients were Asian. 11% of patients had eGFR<60 mL/min/1.73m
At week 26, the difference in HbA
Table 11: Results at Week 26 in a Trial Comparing TRESIBA to Insulin Glargine U-100 in Adult Patients with Type 2 Diabetes Mellitus on OAD(s)*
- *OAD: oral antidiabetic agent
- **The change from baseline to end of treatment visit in HbA1c was analyzed using ANOVA with treatment, region, sex, and anti-diabetic treatment at screening as fixed effects, and age and baseline HbA1c as covariates.
- In Study F, there were 10% of subjects in the TRESIBA and 6.8% Insulin glargine arms for whom data was missing at the time of the HbA
Study G: TRESIBA Administered at the Same Time Each Day or Any Time Each Day as an Add-on to One and up to Three of the Following Oral Agents: Metformin, Sulfonylurea or Glinides or Pioglitazone in Adult Patients
The efficacy of TRESIBA was evaluated in a 26-week randomized, open-label, multicenter trial in 687 patients with type 2 diabetes mellitus inadequately controlled on basal insulin alone, oral antidiabetic agents (OADs) alone or both basal insulin and OAD. Patients were randomized to TRESIBA injected once-daily at the same time each day (with the main evening meal), to TRESIBA injected once daily at any time each day or to insulin glargine U-100 injected once-daily according to the approved labeling. The any time each day TRESIBA arm was designed to simulate a worst-case scenario injection schedule of alternating short and long, once daily, dosing intervals (i.e., alternating intervals of 8 to 40 hours between doses). TRESIBA in this arm was dosed in the morning on Monday, Wednesday, and Friday and in the evening on Tuesday, Thursday, Saturday, and Sunday. Up to three of the following oral antidiabetes agents (metformin, sulfonylureas, glinides or thiazolidinediones) were administered as background therapy in both treatment arms.
The mean age of the trial population was 56 years and mean duration of diabetes was 11 years. 54% were male. 67% were White, 3% Black or African American. 11% were Hispanic. 6% of patients had eGFR<60 mL/min/1.73m
At week 26, the difference in HbA
Table 12: Results at Week 26 in a Trial Comparing TRESIBA at Same and Alternating Times to Insulin Glargine U-100 in Adult Patients with Type 2 Diabetes Mellitus on OAD(s)*
- *OAD: oral antidiabetic agent
- **The change from baseline to end of treatment visit in HbA1c was analyzed using ANOVA with treatment, region, sex, and anti-diabetic treatment at screening as fixed effects, and age and baseline HbA1c as covariates.
- In Study G, there were 11.4% subjects for TRESIBA (both same time and alternating times) and 11.7% Insulin glargine arms for whom data was missing at the time of the HbA
Study H: TRESIBA Administered at the Same Time Each Day in Combination with a Rapid-Acting Insulin Analog at Mealtimes in Adult Patients
The efficacy of TRESIBA was evaluated in a 52-week randomized, open-label, multicenter trial in 992 patients with type 2 diabetes mellitus inadequately controlled on premix insulin, bolus insulin alone, basal insulin alone, oral antidiabetic agents (OADs) alone or any combination thereof. Patients were randomized to TRESIBA once-daily with the main evening meal or insulin glargine U-100 once-daily according to the approved labeling. Insulin aspart was administered before each meal in both treatment arms. Up to two of the following oral antidiabetes agents (metformin or pioglitazone) were used as background therapy in both treatment arms.
The mean age of the trial population was 59 years and mean duration of diabetes was 14 years. 54% were male. 83% were White, 10% Black or African American. 12% were Hispanic. 12% of patients had eGFR<60 mL/min/1.73m
At week 52, the difference in HbA
Table 13: Results at Week 52 in a Trial Comparing TRESIBA to Insulin Glargine U-100 in Adult Patients with Type 2 Diabetes Mellitus Receiving Insulin Aspart at Mealtimes and OADs*
- *OAD: oral antidiabetic agent
- **The change from baseline to end of treatment visit in HbA1c was analyzed using ANOVA with treatment, region, sex, and anti-diabetic treatment at screening as fixed effects, and age and baseline HbA1c as covariates.
- In Study H, there were 16.1% of subjects in the TRESIBA and 14.5% Insulin glargine arms for whom data was missing at the time of the HbA
Study I: TRESIBA Administered at Any Time Each Day as an Add-on to One or Two of the Following Oral Agents: Metformin, Sulfonylurea, or Pioglitazone in Adult Patients
The efficacy of TRESIBA was evaluated in a 26-week randomized, open-label, multicenter trial in 447 patients with type 2 diabetes mellitus inadequately controlled on one or more oral antidiabetic agent (OADs) at baseline. Patients were randomized to TRESIBA once-daily at any time of day or sitagliptin once-daily according to the approved labeling. One or two of the following oral antidiabetes agents (metformin, sulfonylurea or pioglitazone) were also administered in both treatment arms.
The mean age of the trial population was 56 years and mean duration of diabetes was 8 years. 59% were male. 61% were White, 8% Black or African American. 21% were Hispanic. 6% of patients had eGFR<60 mL/min/1.73m
At the end of 26 weeks, TRESIBA provided greater reduction in mean HbA
Table 14: Results at Week 26 in a Trial Comparing TRESIBA to Sitagliptin in Adult Patients with Type 2 Diabetes Mellitus on OADs*
- *OAD: oral antidiabetic agent
- **The change from baseline to end of treatment visit in HbA1c was analyzed using ANOVA with treatment, region, sex, and anti-diabetic treatment at screening as fixed effects, and age and baseline HbA1c as covariates.
- In Study I, there were 20.9% of subjects in the TRESIBA and 22.5% Sitagliptin arms for whom data was missing at the time of the HbA
- 1p <0.001; 1-sided p-value evaluated at 2.5% level for superiority
8.4Safety Outcomes Trial
DEVOTE (NCT01959529) Cardiovascular Outcomes Trial of TRESIBA Administered Once-Daily Between Dinner and Bedtime in Combination with Standard of Care in Subjects with Type 2 Diabetes and Atherosclerotic Cardiovascular Disease
DEVOTE was a multi-center, multi-national, randomized, double-blinded, active-controlled, treat-to-target, event-driven trial. 7,637 patients with inadequately controlled type 2 diabetes and atherosclerotic cardiovascular disease were randomized to either TRESIBA or insulin glargine U-100. Each was administered once-daily between dinner and bedtime in addition to standard of care for diabetes and cardiovascular disease for a median duration of 2 years.
Patients eligible to enter the trial were; 50 years of age or older and had established, stable, cardiovascular, cerebrovascular, peripheral artery disease, chronic kidney disease or NYHA class II and III heart failure (85% of the enrolled population) or were 60 years of age or older and had other specified risk factors for cardiovascular disease (15% of the enrolled population).
At baseline, demographic and disease characteristics were balanced between treatment groups. The mean age of the trial population was 65 years and the mean duration of diabetes was 16 years. The population was 63% male, 76% White 11% Black or African American, 10% Asian. 15% had Hispanic ethnicity. The mean HbA
At baseline, patients treated their diabetes with oral antidiabetic drugs (72%) and with an insulin regimen (84%). Types of insulins included long acting insulin (60%), intermediate acting insulin (14%) short acting insulin (37%) and premixed insulin (10%). 16% of patients were insulin naive. The most common background oral antidiabetic drugs used at baseline were metformin (60%), sulfonylureas (29%) and DPP-4 inhibitors (12%).
During the trial, investigators could modify anti-diabetic and cardiovascular medications to achieve local standard of care treatment targets for lipids and blood pressure.
Cardiovascular Outcomes - Patients with T2DM and Atherosclerotic CVD
The incidence of major cardiovascular events with TRESIBA was evaluated in DEVOTE. Subjects treated with TRESIBA had a similar incidence of major adverse cardiovascular events (MACE) when compared to those treated with insulin glargine U-100.
The primary endpoint in DEVOTE was time from randomization to the first occurrence of a 3-component major adverse cardiovascular event (MACE): cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke. The trial was designed to exclude a pre-specified risk margin of 1.3 for the hazard ratio of MACE comparing TRESIBA to insulin glargine U-100. The primary outcome at end of trial was available for 98.2% of participants in each treatment group.
The time to first occurrence of MACE with TRESIBA as compared to insulin glargine U-100 was non-inferior (HR: 0.91; 95% CI [0.78;1.06]; see Figure 3). The results of the primary composite MACE endpoint and a summary of its individual components are shown in Table 15.
Table 15: Analysis of the Composite 3-point MACE and Individual Cardiovascular Endpoints in DEVOTE
* PYO = patient-years of observation until first MACE, death, or trial discontinuation
Figure 3: Cumulative Event Probability for Time to First MACE in DEVOTE
Hypoglycemia Outcomes - Patients with T2DM and Atherosclerotic CVD
The pre-specified secondary endpoints of event and incidence rates of severe hypoglycemia were sequentially tested.
Severe 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.
The incidence of severe hypoglycemia was lower in the TRESIBA group as compared to the insulin glargine U-100 group (Table 16). Glycemic control between the two groups was similar at baseline and throughout the trial.
Table 16: Severe Hypoglycemic Episodes in Patients Treated with TRESIBA or Insulin Glargine U-100 in DEVOTE
* Test for superiority evaluated at 5% level for significance, (2-sided p<0.001)
9PATIENT COUNSELING INFORMATION
Advise the patient and/or caregiver to read the FDA-approved patient labeling (Patient Information and Instructions for Use). There are separate Instructions for Use for the Vials and FlexTouch Pens.
Never Share a TRESIBA FlexTouch Pen, Needle, or Insulin Syringe Between Patients
Advise patients that they should never share a TRESIBA FlexTouch pen device with another person, even if the needle is changed. Advise patients using TRESIBA vials not to share needles or insulin syringes with another person. Sharing poses a risk for transmission of blood-borne pathogens
Hyperglycemia or Hypoglycemia
Inform patients that hypoglycemia is the most common adverse reaction with insulin. Inform patients of the symptoms of hypoglycemia(e.g., impaired ability to concentrate and react . This may present a risk in situations where these abilities are especially important, such as driving or operating other machinery. Advise patients who have frequent hypoglycemia or reduced or absent warning signs of hypoglycemia to use caution when driving or operating machinery
Advise patients that changes in insulin regimen can predispose to hyperglycemia or hypoglycemia and that changes in insulin regimen should be made under close medical supervision
Hypoglycemia Due to Medication Errors
Inform patients to always check the insulin label before each injection to reduce the risk of medication error
Hypersensitivity Reactions
Advise patients that hypersensitivity reactions have occurred with TRESIBA. Inform patients on the symptoms of hypersensitivity reactions
Version: 9
Novo Nordisk, TRESIBA, FlexTouch®, LEVEMIR®, NOVOLOG® and NovoFine are registered trademarks of Novo Nordisk A/S.
© 2015-2022 Novo Nordisk
PATENT Information:
Manufactured by:
Novo Nordisk Inc.
800 Scudders Mill Road
Plainsboro, NJ 08536
U.S. License Number 1261
For information about TRESIBA contact:
Novo Nordisk Inc.
800 Scudders Mill Road
Plainsboro, NJ 08536
1-800-727-6500
www.novonordisk-us.com
10Patient Information
TRESIBA® (tre–SI-bah)
(insulin degludec)
(insulin degludec)
injection, for subcutaneous use
Do not share your TRESIBA FlexTouch insulin delivery device with other people, even if the needle has changed. Do not share needles or syringes with another person. You may give other people a serious infection, or get a serious infection from them.
What is TRESIBA?
- TRESIBA is a man-made insulin that is used to control high blood sugar in adults and children who are 1 year of age and older with diabetes mellitus.
- TRESIBA is not for people with diabetic ketoacidosis (increased ketones in the blood or urine).
- It is not known if TRESIBA is safe and effective in children under 1 year of age.
- TRESIBA is available in 2 concentrations (U-100 and U-200):
Who should not take TRESIBA?
Do not take TRESIBA if you:
- are having an episode of low blood sugar (hypoglycemia).
- have an allergy to TRESIBA or any of the ingredients in TRESIBA.
Before taking TRESIBA, tell your healthcare provider about all your medical conditions including, if you are:
- pregnant, planning to become pregnant, or are breastfeeding.
- taking new prescription or over-the-counter medicines, vitamins, or herbal supplements.
Before you start taking TRESIBA, talk to your healthcare provider about low blood sugar and how to manage it.
How should I take TRESIBA?
- Read the Instructions for Use that come with your TRESIBA.
- Take TRESIBA exactly as your healthcare provider tells you to.
- Do not do any conversion of your dose. The dose counter always shows the selected dose in units. Both the 100 units/mL and 200 units/mL TRESIBA FlexTouch pens are made to deliver your insulin dose in units.
- Know the type and strength of insulin you take.
- For children who need less than 5 units of TRESIBA each day, use a TRESIBA U-100 vial.
- Adults: If you miss or are delayed in taking your dose of TRESIBA:
- If children miss a dose of TRESIBA:
- Check your blood sugar levels. Ask your healthcare provider what your blood sugars should be and when you should check your blood sugar levels.
- Do not reuse or share your needles with other people. You may give other people a serious infection or get a serious infection from them.
- Never inject TRESIBA into a vein or muscle.
- Never use a syringe to remove TRESIBA from the FlexTouch pen.
- TRESIBA can be injected under the skin (subcutaneously) of your upper legs (thighs), upper arms, or stomach area (abdomen).
- Change (rotate) your injection sites within the area you choose with each dose to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites.
- Do not use the exact same spot for each injection.
- Do not inject where the skin has pits, is thickened, or has lumps.
- Do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin.
What should I avoid while taking TRESIBA?
While taking TRESIBA do not:
- Drive or operate heavy machinery, until you know how TRESIBA affects you.
- Drink alcohol or use prescription or over-the-counter medicines that contain alcohol.
What are the possible side effects of TRESIBA?
TRESIBA may cause serious side effects that can lead to death, including:
- Low blood sugar (hypoglycemia). Signs and symptoms that may indicate low blood sugar include:
- dizziness or light-headedness
- blurred vision
- anxiety, irritability, or mood changes
- sweating
- slurred speech
- hunger
- confusion
- shakiness
- headache
- fast heartbeat
- Low potassium in your blood (hypokalemia).
- Heart failure. Taking certain diabetes pills called thiazolidinediones or “TZDs” with TRESIBA may cause heart failure in some people. This can happen even if you have never had heart failure or heart problems before. If you already have heart failure, it may get worse while you take TZDs with TRESIBA. Your healthcare provider should monitor you closely while you are taking TZDs with TRESIBA. Tell your healthcare provider if you have any new or worse symptoms of heart failure including shortness of breath, tiredness, swelling of your ankles or feet and sudden weight gain. Treatment with TZDs and TRESIBA may need to be adjusted or stopped by your healthcare provider if you have new or worse heart failure.
Your insulin dose may need to change because of:
- change in level of physical activity or exercise
- weight gain or loss
- increased stress
- illness
- change in diet
Common side effects of TRESIBA may include:
- serious allergic reactions (whole body reactions), reactions at the injection site, skin thickening or pits at the injection site (lipodystrophy), itching, rash, swelling of your hands and feet, and weight gain.
Get emergency medical help if you have:
- trouble breathing, shortness of breath, fast heartbeat, swelling of your face, tongue, or throat, sweating, extreme drowsiness, dizziness, confusion.
These are not all the possible side effects of TRESIBA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of TRESIBA.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your pharmacist or healthcare provider for information about TRESIBA that is written for health professionals. Do not use TRESIBA for a condition for which it was not prescribed. Do not give TRESIBA to other people, even if they have the same symptoms that you have. It may harm them.
What are the ingredients in TRESIBA?
Active Ingredient: insulin degludec
Inactive Ingredients: glycerin, metacresol, phenol, zinc, and Water for Injection, USP. Hydrochloric acid or sodium hydroxide may be added.
Manufactured by: Novo Nordisk Inc., Plainsboro, NJ 08536, U.S. License Number 1261
For more information, go to www.novonordisk-us.com or call 1-800-727-6500.
This Patient Information has been approved by the U.S. Food and Drug Administration.
Revised: 07/2022
11INSTRUCTIONS FOR USE
TRESIBA
(insulin degludec)
injection, for subcutaneous use
10 mL multiple-dose vial (100 units/mL, U-100)
Read this Instructions for Use before you start taking TRESIBA and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.
The vial is not recommended for use by the blind or visually impaired without the assistance of a person trained in the proper use of the product and insulin syringe.
Do not reuse or share syringes or needles with other people. You may give other people a serious infection or get a serious infection from them.
Supplies you will need to give your TRESIBA injection:
- a 10 mL TRESIBA vial
- a U-100 insulin syringe and needle
- 2 alcohol swabs
- 1 sharps container for throwing away used syringes and needles. See “Disposing of your used needles and syringes” at the end of these instructions.
Preparing your TRESIBA dose:
- Do not roll or shake the TRESIBA vial. Shaking the TRESIBA vial right before the dose is drawn into the syringe may cause bubbles or foam. This can cause you to draw up the wrong dose of insulin.
- The tamper-resistant cap should not be loose or damaged before the first use.
- Wash your hands with soap and water.
- Before you start to prepare your injection, check the TRESIBA label to make sure that you are taking the right type of insulin. This is especially important if you use more than 1 type of insulin.
- Check that the TRESIBA vial is not cracked or damaged.
- TRESIBA should look clear and colorless.
- Do not use TRESIBA past the expiration date printed on the label or 56 days after you start using the TRESIBA vial.
- Giving your TRESIBA injection:
- Inject your TRESIBA exactly as your healthcare provider has shown you. Your healthcare provider should tell you if you need to pinch the skin before injecting.
- TRESIBA can be injected under the skin (subcutaneously) of your upper legs (thighs), upper arms, or stomach area (abdomen). Do not inject TRESIBA into your muscle.
- Change (rotate) your injection sites within the area you choose for each dose to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites.
- Do not dilute or mix TRESIBA with any other type of insulin or solutions.
After your injection:
- Do not recap the needle. Recapping the needle can lead to needle stick injury.
Disposing of your used needles and syringes:
Put your used insulin needles and syringes in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles and syringes in your household trash.
If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
- made of a heavy-duty plastic
- can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out
- upright and stable during use
- leak-resistant
- properly labeled to warn of hazardous waste inside the container.
- When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. Do not reuse or share needles or syringes with another person. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at:
- Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.
How should I store TRESIBA?
Before use:
- Store unopened TRESIBA vials in the refrigerator at 36
- Do not freeze TRESIBA. Do not use TRESIBA if it has been frozen.
- Unused TRESIBA vials may be used until the expiration date printed on the label, if they are kept in the refrigerator.
- After 56 days, throw away TRESIBA vials that have been kept at room temperature (up to 86°F (30°C)).
Vial in use:
- Store the TRESIBA vial you are currently using in the refrigerator between 36
- Keep TRESIBA away from direct heat or light.
- The TRESIBA vial you are using should be thrown away after 56 days, even if it still has insulin left in it and the expiration date has not passed.
General information about the safe and effective use of TRESIBA
- Keep TRESIBA vials, syringes, and needles out of the reach of children.
- Always use a new syringe and needle for each injection to help ensure sterility and prevent blocked needles.
- Do not reuse or share syringes or needles with other people. You may give other people a serious infection or get a serious infection from them.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Manufactured by:
Novo Nordisk Inc.
800 Scudders Mill Road
Plainsboro, NJ 08536
U.S. License Number 1261
Novo Nordisk
Patent Information:
© 2015-2022 Novo Nordisk
For information contact:
- Novo Nordisk Inc.
Plainsboro, NJ 08536
1-800-727-6500 (Se habla español)
Revised: 07/2022
12INSTRUCTIONS FOR USE
TRESIBA
(insulin degludec)
injection, for subcutaneous use
FlexTouch
Please read the following instructions carefully before using your TRESIBA FlexTouch Pen.
- Do not share your TRESIBA FlexTouch Pen with other people, even if the needle is changed. You may give other people a serious infection, or get a serious infection from them.
- TRESIBA FlexTouch Pen 100 units/mL (“Pen”) is a prefilled disposable, single-patient-use insulin pen containing 300 units of insulin degludec. You can inject from 1 to 80 units in a single injection. The units can be increased by 1 unit at a time.
- This Pen is not recommended for use by the blind or visually impaired without the assistance of a person trained in the proper use of the product.
Supplies you will need to give your TRESIBA injection:
- TRESIBA FlexTouch Pen
- a new NovoFine or NovoTwist needle
- alcohol swab
- a sharps container for throwing away used Pens and needles.
Preparing your TRESIBA FlexTouch Pen:
- Wash your hands with soap and water.
- Before you start to prepare your injection, check the TRESIBA FlexTouch Pen label to make sure you are taking the right type of insulin. This is especially important if you take more than 1 type of insulin.
- TRESIBA should look clear and colorless.
- Do not use TRESIBA past the expiration date printed on the label or 56 days after you start using the Pen.
- Always use a new needle for each injection to help ensure sterility and prevent blocked needles. Do not reuse or share needles with another person. You may give other people a serious infection, or get a serious infection from them.
Step 1:
- Pull Pen cap straight off (See Figure B).
Step 2:
- Check the liquid in the Pen (See Figure C). TRESIBA should look clear and colorless. Do not use it if it looks cloudy or colored.
Step 3:
- Select a new needle.
- Pull off the paper tab from the outer needle cap (See Figure D).
Step 4:
- Push the capped needle straight onto the Pen and twist the needle on until it is tight (See Figure E).
Step 5:
- Pull off the outer needle cap.
Step 6:
- Pull off the inner needle cap and throw it away (See Figure G).
Priming your TRESIBA FlexTouch Pen:
Step 7:
- Turn the dose selector to select 2 units (See Figure H).
Step 8:
- Hold the Pen with the needle pointing up. Tap the top of the Pen gently a few times to let any air bubbles rise to the top (See Figure I).
Step 9:
- Hold the Pen with the needle pointing up. Press and hold in the dose button until the dose counter
shows “0”. The “0” must line up with the dose pointer.
- A drop of insulin should be seen at the needle tip (See Figure J).
Selecting your dose:
Step 10:
TRESIBA FlexTouch Pen 100 units/mL is made to deliver the number of insulin units that your healthcare provider prescribed.
Check to make sure the dose selector is set at 0.
- Turn the dose selector to select the number of units you need to inject. The dose pointer should line up
with your dose (See Figure K).
- If you select the wrong dose, you can turn the dose selector forwards or backwards to the correct dose.
- The
- The
- The TRESIBA FlexTouch Pen insulin scale will show you how much insulin is left in your Pen (See Figure L).
- To see how much insulin is left in your TRESIBA FlexTouch Pen:
- Turn the dose selector until it stops. The dose counter will line up with the number of units of insulin that is left in your Pen. If the dose counter shows 80, there are at least 80 units left in your Pen.
- If the dose counter shows less than 80, the number shown in the dose counter is the number of units left in your Pen.
Giving your injection:
- Inject your TRESIBA exactly as your healthcare provider has shown you. Your healthcare provider should tell you if you need to pinch the skin before injecting.
- TRESIBA can be injected under the skin (subcutaneously) of your upper legs (thighs), upper arms, or stomach area (abdomen).
- Change (rotate) your injection sites within the area you choose for each dose to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites.
Step 11:
- Choose your injection site (thighs, upper arms, or abdomen) and wipe the skin with an alcohol swab (See Figure M). Let the injection site dry before you inject your dose.
Step 12:
- Insert the needle into your skin (See Figure N).
- Make sure you can see the dose counter. Do not cover it with your fingers, this can stop your injection.
Step 13:
- Press and hold down the dose button until the dose counter shows “0” (See Figure O).
- The “0” must line up with the dose pointer. You may then hear or feel a click.
- Keep the needle in your skin after the dose counter has returned to “0” and slowly count to 6 (See Figure P).
- When the dose counter returns to “0”, you will not get your full dose until 6 seconds later.
- If the needle is removed before you count to 6, you may see a stream of insulin coming from the needle tip.
- If you see a stream of insulin coming from the needle tip you will not get your full dose. If this happens you should check your blood sugar levels more often because you may need more insulin.
Step 14:
- Pull the needle out of your skin (See Figure Q).
- If you see blood after you take the needle out of your skin, press the injection site lightly with a piece of gauze or an alcohol swab.
Step 15:
- Carefully remove the needle from the Pen and throw it away (See Figure R).
- Do not recap the needle. Recapping the needle can lead to needle stick injury.
- If you
- Do not store the Pen with the needle attached. Storing without the needle attached helps prevent leaking, blocking of the needle, and air from entering the Pen.
Step 16:
- Replace the Pen cap by pushing it straight on (See Figure T).
After your injection:
- The used TRESIBA FlexTouch Pen may be thrown away in your household trash after you have removed the needle.
- Put your used needles in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles in your household trash.
- If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
- When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. Do not reuse or share needles or syringes with another person. For more information about the safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at:
- Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.
How should I store my TRESIBA FlexTouch Pen?
Before use:
- Store unused TRESIBA FlexTouch Pens in the refrigerator at 36°F to 46°F (2°C to 8°C).
- Do not freeze TRESIBA. Do not use TRESIBA if it has been frozen.
- Unused Pens may be used until the expiration date printed on the label, if kept in the refrigerator.
Pen in use:
- Store the Pen you are currently using in the refrigerator between 36°F to 46°F (2°C to 8°C) or keep at room temperature up to 86°F (30°C).
- Keep TRESIBA away from heat or light.
- The TRESIBA FlexTouch Pen you are using should be thrown away after 56 days if it is refrigerated or kept at room temperature, even if it still has insulin left in it and the expiration date has not passed.
General Information about the safe and effective use of TRESIBA.
- Keep TRESIBA FlexTouch Pens and needles out of the reach of children.
- Always use a new needle for each injection.
- Do not share TRESIBA FlexTouch Pens or needles with other people. You may give other people a serious infection, or get a serious infection from them.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Manufactured by:
Novo Nordisk Inc.
Novo Nordisk Inc.
800 Scudders Mill Road
Plainsboro, NJ 08536
U.S. License Number 1261
Revised: 07/2022
For more information go to
© 2015-2022 Novo Nordisk
TRESIBA
FlexTouch
(insulin degludec) injection
100 units/mL
Read before first use
13INSTRUCTIONS FOR USE
TRESIBA
(insulin degludec)
injection, for subcutaneous use
FlexTouch
Please read the following instructions carefully before using your TRESIBA FlexTouch Pen.
- Do not share your TRESIBA FlexTouch Pen with other people, even if the needle is changed. You may give other people a serious infection, or get a serious infection from them.
- TRESIBA FlexTouch Pen 200 units/mL (“Pen”) is a prefilled disposable, single-patient-use insulin pen containing 600 units of insulin degludec. You can inject from 2 to 160 units in a single injection. The units can be increased by 2 units at a time.
- Do not use a syringe to remove insulin from your Pen. If you do, you will get too many units of insulin because the scale on most syringes is for measuring U-100 insulin doses only.
- This Pen is not recommended for use by the blind or visually impaired without the assistance of a person trained in the proper use of the product.
Supplies you will need to give your TRESIBA injection:
- TRESIBA FlexTouch Pen
- a new NovoFine or NovoTwist needle
- alcohol swab
- a sharps container for throwing away used Pens and needles.
Preparing your TRESIBA FlexTouch Pen:
- Wash your hands with soap and water.
- Before you start to prepare your injection, check the TRESIBA FlexTouch Pen label to make sure you are taking the right type of insulin. This is especially important if you take more than 1 type of insulin.
- TRESIBA should look clear and colorless. Do not use TRESIBA if it is cloudy or colored.
- Do not use TRESIBA past the expiration date printed on the label or 56 days after you start using the Pen.
- Always use a new needle for each injection to help ensure sterility and prevent blocked needles. Do not reuse or share needles with another person. You may give other people a serious infection, or get a serious infection from them.
(Figure A)
Step 1:
- Pull Pen cap straight off (See Figure B).
Step 2:
- Check the liquid in the Pen (See Figure C). TRESIBA should look clear and colorless. Do not use it if it looks cloudy or colored.
Step 3:
- Select a new needle.
- Pull off the paper tab from the outer needle cap (See Figure D).
Step 4:
- Push the capped needle straight onto the Pen and twist the needle on until it is tight (See Figure E).
Step 5:
- Pull off the outer needle cap. Do not throw it away (See Figure F).
Step 6:
- Pull off the inner needle cap and throw it away (See Figure G).
Priming your TRESIBA FlexTouch Pen:
Step 7:
- Turn the dose selector to
Step 8:
- Hold the Pen with the needle pointing up. Tap the top of the Pen gently a few times to let any air bubbles rise to the top (See Figure I).
Step 9:
- Hold the Pen with the needle pointing up. Press and hold in the dose button until the dose counter shows “0”. The “0” must line up with the dose pointer.
- A drop of insulin should be seen at the needle tip (See Figure J).
- If you
- If you
Selecting your dose:
Step 10:
TRESIBA FlexTouch Pen 200 units/mL is made to deliver the number of insulin units that your healthcare provider prescribed.
Check to make sure the dose selector is set at 0.
- Turn the dose selector to select the number of units you need to inject. The dose pointer should line up with your dose (See Figure K).
- If you select the wrong dose, you can turn the dose selector forwards or backwards to the correct dose.
- Each line on the dial is an even number.
- The TRESIBA FlexTouch Pen insulin scale will show you how much insulin is left in your Pen (See Figure L).
- To see how much insulin is left in your TRESIBA FlexTouch Pen:
- o Turn the dose selector until it stops. The dose counter will line up with the number of units of insulin that is
- left in your Pen. If the dose counter shows 160, there are
- o If the dose counter shows
- in your Pen.
Giving your injection:
- Inject your TRESIBA exactly as your healthcare provider has shown you. Your healthcare provider should tell you
- TRESIBA can be injected under the skin (subcutaneously) of your upper legs (thighs), upper arms, or stomach area (abdomen).
- Change (rotate) your injection sites within the area you choose for each dose to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites.
Step 11:
- Choose your injection site (thighs, upper arms, or abdomen) and wipe the skin with an alcohol swab (See Figure M). Let the injection site dry before you inject your dose.
Step 12:
- Insert the needle into your skin (See Figure N).
- Make sure you can see the dose counter.Do not cover it with your fingers, this can stop your injection.
Step 13:
- Press and hold down the dose button until the dose counter shows “0” (See Figure O).
- o The “0” must line up with the dose pointer. You may then hear or feel a click.
- Keep the needle in your skin after the dose counter has returned to “0” and slowly count to 6 (See Figure P).
- When the dose counter returns to “0”, you will not get your full dose until 6 seconds later.
- If the needle is removed before you count to 6, you may see a stream of insulin coming from the needle tip.
- If you see a stream of insulin coming from the needle tip you will not get your full dose. If this happens you should check your blood sugar levels more often because you may need more insulin.
Step 14:
- Pull the needle out of your skin (See Figure Q).
- If you see blood after you take the needle out of your skin, press the injection site lightly with a piece of gauze or an alcohol swab.
Step 15:
- Carefully remove the needle from the Pen and throw it away (See Figure R).
- Do not recap the needle. Recapping the needle can lead to needle stick injury.
- If you
- Do not store the Pen with the needle attached. Storing without the needle attached helps prevent leaking, blocking of the needle, and air from entering the Pen.
Step 16:
- Replace the Pen cap by pushing it straight on (See Figure T).
After your injection:
- The used TRESIBA FlexTouch Pen may be thrown away in your household trash after you have removed the needle.
- Put your used needles in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles in your household trash.
- If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
- made of a heavy-duty plastic
- can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out
- upright and stable during use
- leak-resistant
- properly labeled to warn of hazardous waste inside the container
- When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. Do not reuse or share needles or syringes with another person. For more information about the safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at:
- Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.
How should I store my TRESIBA FlexTouch Pen?
Before use:
- Store unused TRESIBA FlexTouch Pens in the refrigerator at 36°F to 46°F (2°C to 8°C).
- Do not freeze TRESIBA. Do not use TRESIBA if it has been frozen.
- Unused Pens may be used until the expiration date printed on the label, if kept in the refrigerator.
Pen in use:
- Store the Pen you are currently using in the refrigerator between 36°F to 46°F (2°C to 8°C) or keep at room temperature up to 86°F (30°C).
- Keep TRESIBA away from heat or light.
- The TRESIBA FlexTouch Pen you are using should be thrown away after 56 days if it is refrigerated or kept at room temperature, even if it still has insulin left in it and the expiration date has not passed.
General Information about the safe and effective use of TRESIBA.
- Keep TRESIBA FlexTouch Pens and needles out of the reach of children.
- Always use a new needle for each injection.
- Do not share TRESIBA FlexTouch Pens or needles with other people. You may give other people a serious infection, or get a serious infection from them.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Manufactured by:
Novo Nordisk Inc.
800 Scudders Mill Road
Plainsboro, NJ 08536
U.S. License Number 1261
Revised: 07/2022
For more information go to
© 2015-2022 Novo Nordisk
TRESIBA
FlexTouch
(insulin degludec) injection
200 units/mL
Read before first use
14PRINCIPAL DISPLAY PANEL U-100 Vial
- NDC 0169-2662-11 List 266211
TRESIBA
- (insulin degludec) injection
100 units/mL (U-100)
For subcutaneous use only
- Use only with a U-100 syringe.
- Rx Only
15PRINCIPAL DISPLAY PANEL U-100 FlexTouch
- NDC 0169-2660-15 List: 266015
TRESIBA
FlexTouch
(insulin degludec) injection
For Single Patient Use Only
100 units/mL (U-100)
5×3 mL Prefilled Pens
For subcutaneous use only
Recommended for use with NovoFine
Keep in a cold place until first use.
Store at 36°F to 46°F (2°C to 8°C).
Do not freeze.
After first use, store between 36°F to 86°F (2°C to 30°C) for up to 56 days.
Protect from light.
Rx Only
Dispense in this sealed carton.
16PRINCIPAL DISPLAY PANEL U-200 FlexTouch
- NDC 0169-2550-13 List: 255013
TRESIBA
FlexTouch
(insulin degludec) injection
For Single Patient Use Only
200 units/mL (U-200)
3×3 mL Prefilled Pens
For subcutaneous use only
Recommended for use with NovoFine
disposable needles.
disposable needles.
Keep in a cold place until first use.
Store at 36°F to 46°F (2°C to 8°C).
Do not freeze.
After first use, store between 36°F to 86°F (2°C to 30°C) for up to 56 days.
Protect from light.
Rx Only
Dispense in this sealed carton.
