Tresiba

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• See Full Prescribing Information for important administration instructions ( 2.1 ).
• Inject TRESIBA subcutaneously into the thigh, upper arm, or abdomen ( 2.1 ).
• Rotate injection sites to reduce risk of lipodystrophy and localized cutaneous amyloidosis ( 2.1 ).
• For pediatric patients requiring less than 5 units of TRESIBA each day, use a TRESIBA U-100 vial ( 2.1 ).
• In adults, inject subcutaneously once daily at any time of day ( 2.2 ).
• In pediatric patients inject subcutaneously once daily at the same time every day ( 2.2 ).
• Individualize dose based on type of diabetes, metabolic needs, blood glucose monitoring results and glycemic control goal ( 2.2 ).
• The recommended days between dose increases are 3 to 4 days ( 2.2 ).
• See Full Prescribing Information for recommended starting dose in insulin naïve patients and patients already on insulin therapy ( 2.3 , 2.4 ). 2.1 Important Administration Instructions
• Always check insulin labels before administration [see Warnings and Precautions ( 5.4 ) ] .
• Inspect visually for particulate matter and discoloration. Only use TRESIBA if the solution appears clear and colorless.
• Inject TRESIBA subcutaneously into the thigh, upper arm, or abdomen.
• Rotate injection sites within the same region from one injection to the next to reduce the risk of lipodystrophy and localized cutaneous amyloidosis. Do not inject into areas of lipodystrophy or localized cutaneous amyloidosis [see Warnings and Precautions ( 5.2 ), Adverse Reactions ( 6.1 , 6.3 )].
• During changes to a patient’s insulin regimen, increase the frequency of blood glucose monitoring [see Warnings and Precautions ( 5.2 )].
• For pediatric patients requiring less than 5 units of TRESIBA each day, use the TRESIBA U-100 vial.
• DO NOT administer TRESIBA intravenously or in an insulin infusion pump.
• DO NOT dilute or mix TRESIBA with any other insulin or solution.
• DO NOT transfer TRESIBA from the TRESIBA FlexTouch pen into a syringe for administration [see Warnings and Precautions ( 5.4 )].
• Use TRESIBA FlexTouch pens with caution in patients with visual impairment that may rely on audible clicks to dial their dose. 2.2 General Dosing Instructions
• TRESIBA is available in 2 concentrations (U-100 and U-200):
• o TRESIBA U-100 is available, as a single-patient use FlexTouch pen and multiple-dose vial.
• The FlexTouch pen delivers doses in 1 unit increments and can deliver up to 80 units in a single injection. o TRESIBA U-200 is available as a single-patient-use FlexTouch pen.
• The FlexTouch pen delivers doses in 2 unit increments and can deliver up to 160 units in a single injection.
• DO NOT perform dose conversion
• when using the TRESIBA U-100 or U-200 FlexTouch pens. The dose window shows the number of insulin units to be delivered and no conversion is needed.
• In adults, inject TRESIBA subcutaneously once-daily at any time of day.
• In pediatric patients inject TRESIBA subcutaneously once-daily at the same time every day.
• Individualize and titrate the dose of TRESIBA based on the patient’s metabolic needs, blood glucose monitoring results, and glycemic control goal .
• The recommended days between dose increases are 3 to 4 days.
• Dose adjustments may be needed with changes in physical activity, changes in meal patterns (i.e., macronutrient content or timing of food intake), changes in renal or hepatic function or during acute illness to minimize the risk of hypoglycemia or hyperglycemia [see Warnings and Precautions ( 5.3 )] .
• For adult patients, instruct patients who miss a dose of TRESIBA to inject their daily dose during waking hours upon discovering the missed dose. Instruct patients to ensure that at least 8 hours have elapsed between consecutive TRESIBA injections.
• For pediatric patients, instruct patients who miss a dose of TRESIBA to contact their healthcare provider for guidance and to monitor blood glucose levels more frequently until the next scheduled TRESIBA dose.
• In patients with type 1 diabetes, TRESIBA must be used concomitantly with short-acting insulin. 2.3 Starting Dose in Insulin Naïve Patients Recommended Starting Dosage in Patients with Type 1 Diabetes Mellitus:
• The recommended starting dose of TRESIBA in insulin naïve patients with type 1 diabetes is approximately one-third to one-half of the total daily insulin dose. The remainder of the total daily insulin dose should be administered as a short-acting insulin and divided between each daily meal. As a general rule, 0.2 to 0.4 units of insulin per kilogram of body weight can be used to calculate the initial total daily insulin dose in insulin naïve patients with type 1 diabetes. Recommended Starting Dosage in Patients with Type 2 Diabetes Mellitus:
• The recommended starting dose of TRESIBA in insulin naïve patients with type 2 diabetes mellitus is 10 units once daily. 2.4 Switching to TRESIBA from Other Insulin Therapies Dosage adjustments are recommended to lower the risk of hypoglycemia when switching patients to Insulin Degludec from another insulin therapy [see Warnings and Precautions ( 5.3 )].
• Adults with Type 1 or Type 2 Diabetes Mellitus:
• Start TRESIBA at the same unit dose as the total daily long or intermediate-acting insulin unit dose. Pediatric Patients 1 Year of Age and Older with Type 1 or Type 2 Diabetes Mellitus:
• Start TRESIBA at 80% of the total daily long or intermediate-acting insulin unit dose to minimize the risk of hypoglycemia [see Warnings and Precautions ( 5.2 )].

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Quoted from the official label, section “Overdosage”.

Use in children

• The safety and effectiveness of TRESIBA to improve glycemic control in pediatric patients 1 year of age and older with diabetes mellitus have been established.
• The use of TRESIBA for this indication is supported by evidence from an adequate and well-controlled trial and a pharmacokinetic study (trials included pediatric patients 1 year of age and older with type 1 diabetes mellitus) [ see Clinical Pharmacology ( 12.3 ) and Clinical Studies ( 14.2 )].
• The use of TRESIBA in pediatric patients 1 year of age and older with type 2 diabetes mellitus is also supported by evidence from adequate and well-controlled trials in
• adults with type 2 diabetes mellitus [see Clinical Studies ( 14.3 )] .
• In pediatric patients 1 year of age and older already on insulin therapy, start TRESIBA at a reduced dose to minimize the risk of hypoglycemia [see Dosage and Administration ( 2.4 )].
• The safety and effectiveness of TRESIBA have not been established in pediatric patients less than 1-year-old.

Quoted from the official label, section “Pediatric Use”.

Use in older people

• In controlled clinical trials [see Clinical Studies ( 14 )] a total of 77 (7%) of the 1102 TRESIBA-treated patients with type 1 diabetes were 65 years or older and 9 (1%) were 75 years or older.
• A total of 670 (25%) of the 2713 TRESIBA-treated patients with type 2 diabetes were 65 years or older and 80 (3%) were 75 years or older.
• Differences in safety or effectiveness were not suggested in subgroup analyses comparing subjects older than 65 years to younger subjects.
• In the safety outcomes trial (DEVOTE), a total of 1983 (52%) of the 3818 TRESIBA-treated patients with type 2 diabetes were 65 years or older and 381 (10%) were 75 years or older.
• Differences in safety or effectiveness were not observed in these subgroup analyses.
• Nevertheless, greater caution should be exercised when TRESIBA is administered to geriatric patients since greater sensitivity of some older individuals to the effects of TRESIBA cannot be ruled out.
• The initial dosing, dose increments, and maintenance dosage should be conservative to
• avoid hypoglycemia.
• Hypoglycemia may be more difficult to recognize in the geriatric patients.

Quoted from the official label, section “Geriatric Use”.

Side effects

• The following adverse reactions are also discussed elsewhere:
• Hypoglycemia [see Warnings and Precautions ( 5.3 )]
• Hypoglycemia due to Medication errors [see Warnings and Precautions ( 5.4 )]
• Hypersensitivity reactions [see Warnings and Precautions ( 5.5 )]
• Hypokalemia [see Warnings and Precautions ( 5.6 )] Adverse reactions commonly associated with TRESIBA are:
• hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, rash, edema and weight gain ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Novo Nordisk at 1-800-727-6500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical 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 [see Clinical Studies ( 14 )]. 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; Study A, B and C [see Clinical Studies (14.1)] . The mean age was 43 years and 1% were older than 75 years. Fifty-seven percent were male, 81% were White, 2% were Black or African American and 4% were Hispanic. The mean body mass index (BMI) was 26 kg/m 2 . The mean duration of diabetes was 18 years and the mean HbA 1c at baseline was 7.8%. A history of neuropathy, ophthalmopathy, nephropathy and cardiovascular disease at baseline was reported in 11%, 16%, 7% and 0.5% respectively. The mean eGFR at baseline was 87 mL/min/1.73 m 2 and 7% of the patients had an eGFR less than 60 mL/min/1.73 m 2 . 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; Study D, E, F, G, H and I [see Clinical Studies (14.3)] . The mean age was 58 years and 3% were older than 75 years. Fifty-eight percent were male, 71% were White, 7% were Black or African American and 13% were Hispanic. The mean BMI was 30 kg/m 2 . The mean duration of diabetes was 11 years and the mean HbA 1c at baseline was 8.3%. A history of neuropathy, ophthalmopathy, nephropathy and cardiovascular disease at baseline was reported for 14%, 10%, 6% and 0.6% of participants respectively. At baseline, the mean eGFR was 83 mL/min/1.73 m 2 and 9% had an eGFR less than 60 mL/min/1.73 m 2 . 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 2 . The mean duration of diabetes was 3.9 years and the mean HbA 1c at baseline was 8.2%. Common adverse reactions in TRESIBA treated pediatric patients with type 1 diabetes mellitus were similar to the adverse reactions listed in Table 1. Table 1:
• Adverse Reactions Occurring in ≥5% of TRESIBA-Treated Adult Patients with Type 1 Diabetes Mellitus Adverse Reaction TRESIBA (N=1,102) Nasopharyngitis 23.9 % Upper respiratory tract infection 11.9 % Headache 11.8 % Sinusitis 5.1 % Gastroenteritis 5.1 % Table 2:
• Adverse Reactions Occurring in ≥5% of TRESIBA-Treated Adult Patients with Type 2 Diabetes Mellitus Adverse Reaction TRESIBA (N=2,713) Nasopharyngitis 12.9 % Headache 8.8 % Upper respiratory tract infection 8.4 % Diarrhea 6.3 % 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 [see Clinical Studies ( 14 )] and
• adults with type 2 diabetes are shown in Tables 3 and 4, respectively. 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 § on TRESIBA in Open-Label Adult and Pediatric Clinical Trials Study A
• Adults + insulin aspart 52 weeks Study B
• Adults + insulin aspart 26 weeks Study C
• Adults + insulin aspart 26 weeks Study J Pediatrics + insulin aspart 52 weeks TRESIBA (N=472) TRESIBA (N=301) TRESIBA at the same time each day (N=165) TRESIBA at alternating times (N=164) TRESIBA (N=174) Severe hypoglycemia* Percent of patients 12.3% 10.6% 12.7% 10.4% 17.8% Hypoglycemia § Percent of patients 95.6% 93.0% 99.4% 93.9% 98.3% * 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 § on TRESIBA in Open-Label Adult Clinical Trials Study D + 1-2 OADs* insulin naïve 52 weeks Study E + 1-2 OADs* insulin naïve 26 weeks Study F ± 1-3 OADs* insulin naïve 26 weeks Study G T2DM ± 0-3 OADs* 26 weeks Study H T2DM ± 0-2 OADs* + insulin aspart 52 weeks Study I T2DM ± 1-2 OADs* insulin naïve 26 weeks TRESIBA (N=766) TRESIBA (N=228) TRESIBA (N=284) TRESIBA (N=226) TRESIBA (alternating time) (N=230) TRESIBA (N=753) TRESIBA (N=226) Severe Hypoglycemia Percent of patients 0.3% 0 0 0.9% 0.4% 4.5% 0.4% Hypoglycemia § Percent of patients 46.5% 28.5% 50% 43.8% 50.9% 80.9% 42.5% *OAD:
• oral antidiabetic agent, § 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). 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 [see Dosage and Administration ( 2.1 )] . In the clinical program, lipodystrophy, lipohypertrophy, or lipoatrophy was reported in 0.3% of patients treated with TRESIBA. 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. 6.2 Immunogenicity 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. 6.3 Postmarketing 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.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

• 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 [see Warnings and Precautions ( 5.1 )] .
• 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 [see Warnings and Precautions ( 5.3 )].
• 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 [see Warnings and Precautions ( 5.2 )] .
• Hypoglycemia Due to Medication Errors Inform patients to always check the insulin label before each injection to reduce the risk of medication error [see Warnings and Precautions ( 5.4 )] .
• Inform patients that the dose counter of TRESIBA FlexTouch pen shows the number of units of TRESIBA to be injected.
• NO dose re-calculation is required [see Dosage and Administration ( 2.2 )] .
• Instruct patients to never use a syringe to remove TRESIBA from the FlexTouch disposable insulin prefilled pen.
• Hypersensitivity Reactions Advise patients that hypersensitivity reactions have occurred with TRESIBA.
• Inform patients on the symptoms of hypersensitivity reactions [see Warnings and Precautions ( 5.5 )].
• Version:
• 9 Novo Nordisk ® , TRESIBA ® , FlexTouch ® , LEVEMIR ® , NOVOLOG ® and NovoFine ® are registered trademarks of Novo Nordisk A/S. © 2015-2022 Novo Nordisk PATENT Information:
• http://novonordisk-us.com/products/product-patents.html 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

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

• 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 Injection:
• Available as:
• 100 units/mL (U-100): 3 mL single-patient-use FlexTouch ® prefilled pen ( 3 ).
• 100 units/mL (U-100): 10 mL multiple-dose vial ( 3 ).
• 200 units/mL (U-200): 3 mL single-patient-use FlexTouch ® prefilled pen ( 3 ).

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

• 16.1 How Supplied TRESIBA (insulin degludec) injection is available as a clear and colorless solution as follows:
• Table 17:
• Presentations of TRESIBA TRESIBA Presentation Total volume Concentration Total units available in presentation NDC number Max dose per injection Dose increment Package Size U-100 single-patient-use FlexTouch Pen 3 mL 100 units/mL 300 Units 0169-2660-15 80 Units 1 Unit 5 pens/pack U-100 multiple-dose Vial 10 mL 100 units/mL 1,000 Units 0169-2662-11 _ _ 1 vial/pack U-200 single-patient-use FlexTouch Pen 3 mL 200 units/mL 600 Units 0169-2550-13 160 Units 2 Unit 3 pens/pack Additional Information about TRESIBA FlexTouch:
• TRESIBA U-100 FlexTouch pen dials in 1 unit increments.
• TRESIBA U-200 FlexTouch pen dials in 2 unit increments. 16.2 Recommended Storage Dispense in the original sealed carton with the enclosed Instructions for Use. Store TRESIBA vials in the original carton to protect from light. Store unused TRESIBA in a refrigerator (36ºF to 46ºF [2ºC to 8ºC]). Do not store in the freezer or directly adjacent to the refrigerator cooling element. Do not freeze.
• Do not use TRESIBA if it has been frozen. The storage conditions are summarized in Table 18:
• Table 18:
• Storage Conditions for TRESIBA Not in-use (unopened) In-use (opened) Refrigerated (36°F to 46°F [2°C to 8°C]) Room Temperature (up to 86°F [30°C]) Room Temperature (up to 86°F [30°C]) Refrigerated (36°F to 46°F [2°C to 8°C]) 3 mL single-patient-use TRESIBA U-100 FlexTouch Until expiration date 56 days (8 weeks) 56 days (8 weeks) 56 days (8 weeks) 10 mL multiple-dose TRESIBA U-100 Vial Until expiration date 56 days (8 weeks) 56 days (8 weeks) 56 days (8 weeks) 3 mL single-patient-use TRESIBA U-200 FlexTouch Until expiration date 56 days (8 weeks) 56 days (8 weeks) 56 days (8 weeks)

Quoted from the official label, section “How Supplied”.

What is in it

• Insulin degludec is a long-acting basal human insulin analog for subcutaneous injection produced by a process that includes expression of recombinant DNA in Saccharomyces cerevisiae followed by chemical modification.
• Insulin degludec differs from human insulin in that the amino acid threonine in position B30 has been omitted and a side-chain consisting of glutamic acid and a C16 fatty acid has been attached (chemical name:
• LysB29(Nε-hexadecandioyl-γ-Glu) des(B30) human insulin).
• Insulin degludec has a molecular formula of C 274 H 411 N 65 O 81 S 6 and a molecular weight of 6.104 kDa.
• It has the following structure:
• 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.
• Figure 1: Structural Formula of Tresiba

Quoted from the official label, section “Description”.

Ingredients people check for

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Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Same active substance

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