Insulin Degludec (insulin degludec)

Insulin Degludec is approved for: To improve glycemic control in adults with diabetes mellitus (US label of 2015); Current Tresiba labeling covers adults and children 1 year of age and older with diabetes - the manufacturer states it is the only long-acting insulin approved for both type 1 and type 2 diabetes in children as young as 1 year of age; Not recommended for the treatment of diabetic ketoacidosis; Used alone or in combination with oral antidiabetic medicines or bolus insulin. It is a insulin degludec (Ultra-long-acting), originally marketed as Tresiba (诺和达); an unbranded 'insulin degludec' biologic is also marketed by Novo Nordisk.

No biosimilar or generic of insulin degludec was found approved in the sources reviewed - the patents on the degludec molecule have kept copies off the market, so unlike insulin glargine or insulin aspart there is no interchangeable biosimilar to substitute. What exists instead is Novo Nordisk's own unbranded 'insulin degludec' biologic (FDA-approved July 2022 and launched at about 65% below the Tresiba list price): this is the same product made by the same manufacturer without the brand name on the label, not a copy made by a competitor. For a knowledge site this distinction matters: patients asking whether a cheaper 'generic Tresiba' exists are in fact being offered either an unbranded version of the same product or a switch to a different basal insulin (for example a glargine biosimilar), which requires clinical review rather than pharmacy substitution. Manufacturers supplying insulin degludec generic versions include Novo Nordisk. Brands registered in Bangladesh include Tresiba.

Insulin Degludec (Ultra-long-acting (basal) recombinant human insulin analog, available as 100 units/mL (U-100) and 200 units/mL (U-200), originally Tresiba (诺和达); an unbranded 'insulin degludec' biologic is also marketed by Novo Nordisk) Insulin degludec is a very long-acting background insulin. After injection it forms long chains in the tissue under the skin that break down slowly, releasing insulin steadily for more than 24 hours. This gives a flat, stable basal insulin level and allows the once-daily injection to be given at almost any time of day, while keeping blood sugar controlled between meals and overnight. Individualize and titrate the dose based on metabolic needs, blood glucose monitoring results and the glycemic control goal. Insulin-naive type 1 diabetes: start with approximately one-third to one-half of the total daily insulin dose, with the remainder divided between meals as a short-acting insulin; a general rule is 0.2 to 0.4 units/kg/day for the initial total daily dose. Insulin-naive type 2

Insulin Degludec (Ultra-long-acting (basal) recombinant human insulin analog, available as 100 units/mL (U-100) and 200 units/mL (U-200), originally Tresiba (诺和达); an unbranded 'insulin degludec' biologic is also marketed by Novo Nordisk) Insulin degludec is a very long-acting background insulin. After injection it forms long chains in the tissue under the skin that break down slowly, releasing insulin steadily for more than 24 hours. This gives a flat, stable basal insulin level and allows the once-daily injection to be given at almost any time of day, while keeping blood sugar controlled between meals and overnight. Individualize and titrate the dose based on metabolic needs, blood glucose monitoring results and the glycemic control goal. Insulin-naive type 1 diabetes: start with approximately one-third to one-half of the total daily insulin dose, with the remainder divided between meals as a short-acting insulin; a general rule is 0.2 to 0.4 units/kg/day for the initial total daily dose. Insulin-naive type 2

Storage: Before use: store unused Tresiba FlexTouch pens and vials in a refrigerator at 2 degrees C to 8 degrees C (36-46 degrees F); do not store in the freezer or directly adjacent to the refrigerator cooling element; do not freeze and do not use if it has been frozen. Unopened pens may be used until the expiration date printed on the label if kept refrigerated. An in-use (opened) pen should NOT be refrigerated but kept at room temperature below 30 degrees C (86 degrees F), away from direct heat and light, and it may be used for up to 56 days (8 weeks) after being opened. Always remove the needle and store the pen without a needle attached. The FDA approval letter for Tresiba granted a 30-month shelf life at 5 degrees C plus or minus 3 degrees C and a 56-day in-use period at up to 30 degrees C. Keep the product in its original packaging and check the expiry date printed on the pack.

Insulin Degludec (Ultra-long-acting (basal) recombinant human insulin analog, available as 100 units/mL (U-100) and 200 units/mL (U-200), originally Tresiba (诺和达); an unbranded 'insulin degludec' biologic is also marketed by Novo Nordisk) Insulin degludec is a very long-acting background insulin. After injection it forms long chains in the tissue under the skin that break down slowly, releasing insulin steadily for more than 24 hours. This gives a flat, stable basal insulin level and allows the once-daily injection to be given at almost any time of day, while keeping blood sugar controlled between meals and overnight. Individualize and titrate the dose based on metabolic needs, blood glucose monitoring results and the glycemic control goal. Insulin-naive type 1 diabetes: start with approximately one-third to one-half of the total daily insulin dose, with the remainder divided between meals as a short-acting insulin; a general rule is 0.2 to 0.4 units/kg/day for the initial total daily dose. Insulin-naive type 2

Standard dosing for insulin degludec: Individualize and titrate the dose based on metabolic needs, blood glucose monitoring results and the glycemic control goal. Insulin-naive type 1 diabetes: start with approximately one-third to one-half of the total daily insulin dose, with the remainder divided between meals as a short-acting insulin; a general rule is 0.2 to 0.4 units/kg/day for the initial total daily dose. Insulin-naive type 2 diabetes: 10 units once daily. Patients already on insulin: start at the same unit dose as the total daily long- or intermediate-acting insulin being replaced. Inject subcutaneously once daily at any time of day; the recommended interval between dose increases is 3 to 4 days, and at least 8 hours must elapse between consecutive injections. Do not administer intravenously, intramuscularly or in an insulin pump; do not dilute or mix; do not transfer Tresiba from the pen into a syringe (the markings will not measure the dose correctly). No dose conversion is needed between the U-100 and U-200 FlexTouch pens - both dose windows show units directly. Dose adjustments: Dose adjustments may be needed with changes in physical activity, changes in meal patterns (macronutrient content or timing), changes in renal or hepatic function, or during acute illness, to minimize the risk of hypoglycemia or hyperglycemia. Patients with renal or hepatic impairment may

Insulin Degludec (Ultra-long-acting (basal) recombinant human insulin analog, available as 100 units/mL (U-100) and 200 units/mL (U-200), originally Tresiba (诺和达); an unbranded 'insulin degludec' biologic is also marketed by Novo Nordisk) Insulin degludec is a very long-acting background insulin. After injection it forms long chains in the tissue under the skin that break down slowly, releasing insulin steadily for more than 24 hours. This gives a flat, stable basal insulin level and allows the once-daily injection to be given at almost any time of day, while keeping blood sugar controlled between meals and overnight. Individualize and titrate the dose based on metabolic needs, blood glucose monitoring results and the glycemic control goal. Insulin-naive type 1 diabetes: start with approximately one-third to one-half of the total daily insulin dose, with the remainder divided between meals as a short-acting insulin; a general rule is 0.2 to 0.4 units/kg/day for the initial total daily dose. Insulin-naive type 2

The most frequently reported side effects of insulin degludec are hypoglycemia - the most commonly observed adverse reaction with insulin, and may be life-threatening, allergic reactions, including severe, life-threatening generalized allergy and anaphylaxis, injection site reactions, lipodystrophy at injection sites, pruritus and rash, edema, weight gain. Routine monitoring: Blood glucose self-monitoring and HbA1c; increase monitoring frequency when changing the insulin regimen; Signs and symptoms of hypoglycemia, especially in patients with renal or hepatic impairment, in patients with hypoglycemia unawareness, and in those on beta-blockers or other anti-adrenergic drugs (which can mask warning signs); Potassium levels in patients at risk of hypokalemia. Report any new or worsening symptom to your treating physician — most adverse effects are managed by dose reduction rather than stopping treatment.

Recommended monitoring for insulin degludec: Blood glucose self-monitoring and HbA1c; increase monitoring frequency when changing the insulin regimen; Signs and symptoms of hypoglycemia, especially in patients with renal or hepatic impairment, in patients with hypoglycemia unawareness, and in those on beta-blockers or other anti-adrenergic drugs (which can mask warning signs); Potassium levels in patients at risk of hypokalemia; Injection sites for lipodystrophy; Signs and symptoms of heart failure in patients taking insulin with a thiazolidinedione (PPAR-gamma agonist); Timing of doses - at least 8 hours must elapse between consecutive injections