Insulin degludec

What is Insulin degludec?

• Insulin degludec (̈TRESIBA) is a long-acting human insulin analog used to improve blood sugar (glucose) control in adults with diabetes mellitus.

What are the uses of this medicine?

• This medicine 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.

Limitations of Use:

• Not recommended for treating diabetic ketoacidosis.

How does this medicine work?

• The primary activity of insulin, including TRESIBA, is regulation of glucose metabolism.
• Insulin and its analogs lower blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production.
• Insulin also inhibits lipolysis and proteolysis, and enhances protein synthesis.
• TRESIBA forms multi-hexamers when injected into the subcutaneous tissue resulting in a subcutaneous insulin degludec depot.
• The protracted time action profile of TRESIBA is predominantly due to delayed absorption of insulin degludec from the subcutaneous tissue to the systemic circulation and to a lesser extent due to binding of insulin-degludec to circulating albumin.

Who Should Not Use this medicine ?

This medicine caanot be used in patients:

• having an episode of low blood sugar (hypoglycemia).
• have an allergy to TRESIBA or any of the ingredients in TRESIBA.

What drug interactions can this medicine cause?

• Antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, propoxyphene, salicylates, somatostatin analog (e.g., octreotide), and sulfonamide antibiotics. These drugs may increase the risk of hypoglycemia. Dose reductions and increased frequency of glucose monitoring may be required when TRESIBA is co-administered with these drugs.
• Atypical antipsychotics (e.g., olanzapine and clozapine), corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens (e.g., in oral contraceptives), protease inhibitors, somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline), and thyroid hormones. These drugs may decrease the blood glucose lowering effect. Dose increases and increased frequency of glucose monitoring may be required when TRESIBA is co-administered with these drugs.
• Alcohol, beta-blockers, clonidine, lithium salts, and pentamidine may increase or decrease the blood glucose lowering effect. Dose adjustment and increased frequency of glucose monitoring may be required when TRESIBA is co-administered with these drugs.
• Beta-blockers, clonidine, guanethidine, and reserpine may blunt signs and symptoms of hypoglycemia. Increased frequency of glucose monitoring may be required when TRESIBA is co-administered with these drugs.

Is this medicine FDA approved?

• It was approved for use in the United States in 2015.

How should this medicine be used?

Recommended Dosage: Starting Dose in Insulin Naïve Patients 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.

Type 2 Diabetes Mellitus:

• The recommended starting dose of TRESIBA in insulin naïve patients with type 2 diabetes mellitus is 10 units once daily.

Starting Dose in Patients Already on Insulin Therapy Adults withType 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

Administration

• 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. Do not change the type of insulin you take unless your healthcare provider tells you to. The amount of insulin and the best time for you to take your insulin may need to change if you take different types of insulin.
• 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:
• Take your dose as soon as you remember then continue with your regular dosing schedule.
• Make sure there are at least 8 hours between your doses.

If children miss a dose of TRESIBA:

• Call the healthcare provider for information and instructions about checking blood sugar levels more often until the next scheduled 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 are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As 100 units/mL (U-100): 3 mL single-patient-use FlexTouch®.
• 200 units/mL (U-200): 3 mL single-patient-use FlexTouch®.
• 100 units/mL (U-100): 10 mL multiple-dose vial

This medicine is available in fallowing brand namesː

• TRESIBA

What side effects can this medication cause?

The most common side effects of this medicine 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
• weight gain

TRESIBA may cause serious side effects that can lead to death, including:

• Low blood sugar (hypoglycemia)
• Low potassium in your blood (hypokalemia)
• Heart failure

What special precautions should I follow?

• TRESIBA FlexTouch disposable prefilled pens should never be shared between patients, even if the needle is changed.
• Changes in an insulin regimen (e.g., insulin strength, manufacturer, type, injection site or method of administration) may affect glycemic control and predispose to hypoglycemia. Make changes to a patient’s insulin regimen (e.g., insulin strength, manufacturer, type, injection site or method of administration) under close medical supervision with increased frequency of blood glucose monitoring.
• Hypoglycemia is the most common adverse reaction of insulin, including TRESIBA. May be life-threatening. Increase monitoring with changes to: insulin dosage, co-administered glucose lowering medications, meal pattern, physical activity; and in patients with renal impairment or hepatic impairment or hypoglycemia unawareness.
• Accidental mix-ups between basal insulin products and other insulins, particularly rapid-acting insulins, have been reported. Accidental mix-ups between insulin products can occur. Instruct patients to check insulin labels before injection. DO NOT transfer TRESIBA into a syringe for administration as overdosage and severe hypoglycemia can result.
• Severe, life-threatening, generalized allergy, including anaphylaxis, can occur. Discontinue TRESIBA, monitor and treat if indicated.
• All insulin products, including TRESIBA, cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia. May be life-threatening. Monitor potassium levels in patients at risk for hypokalemia and treat if indicated.
• Thiazolidinediones (TZDs), which are peroxisome proliferator-activated receptor (PPAR)-gamma agonists can cause dose related fluid retention, particularly when used in combination with insulin. Observe for signs and symptoms of heart failure; consider dosage reduction or discontinuation if heart failure occurs.

What to do in case of emergency/overdose?

• 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.

Management of Overdosage

• Mild episodes of hypoglycemia usually can be treated with oral glucose.
• Adjustments in drug dosage, meal patterns, or exercise may be needed.
• More severe episodes of hypoglycemia with coma, seizure, or neurologic impairment may be treated with intramuscular/subcutaneous glucagon or concentrated intravenous glucose. After apparent clinical recovery from hypoglycemia, continued observation and additional carbohydrate intake may be necessary to avoid reoccurrence of hypoglycemia.
• Hypokalemia must be corrected appropriately.

Can this medicine be used in pregnancy?

• There are no available data with TRESIBA or insulin degludec in pregnant women to inform a drug-associated risk for major birth defects and miscarriage.

Can this medicine be used in children?

• The safety and effectiveness of TRESIBA to improve glycemic control in type 1 and type 2 diabetes mellitus have been established in pediatric patients 1 year of age and older.
• The safety and effectiveness of TRESIBA have not been established in pediatric patients less than 1-year-old.

What are the active and inactive ingredients in this medicine?

• Active Ingredient: insulin degludec
• Inactive Ingredients: glycerol, metacresol, phenol, water for injection, and zinc. Hydrochloric acid or sodium hydroxide may be added.

Who manufactures and distributes this medicine?

Manufactured by: Novo Nordisk A/S DK-2880 Bagsværd, Denmark

What should I know about storage and disposal of this medication?

Before use:

• Store unopened TRESIBA vials in the refrigerator at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light.
• 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 (below 86°F (30°C)).

Vial in use:

• Store the TRESIBA vial you are currently using in the refrigerator between 36°F to 46°F (2°C to 8°C) or keep at room temperature below 86°F (30°C) in the original carton to protect from light.
• 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.

• Dailymed label info on Insulin degludec
• FDA Insulin degludec

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