Insulin degludec is a long-acting basal human insulin analog that is used to improve glycemic control in people with diabetes.

Insulin is a hormone produced by your body that helps you to lower your blood glucose (blood sugar) levels.

People with type 1 diabetes and some people with type 2 diabetes need to administer man-made forms of insulin. This is because they don't produce enough insulin themselves or their body doesn't respond well enough to the insulin they produce.

Basal insulin analogs like insulin degludec, work to keep your blood glucose levels stable during times when you're fasting, such as at night when you're asleep. Insulin degludec provides a 'background', slow-acting supply of insulin.

Insulin degludec was approved by the US Food and Drug Administration (FDA) in 2015. The Tresiba brand of insulin degludec is the only version of this medication currently available.

What is insulin degludec used for?

• Insulin degludec is used to control high blood sugar in adults and children who are 1 year of age and older with diabetes mellitus.
• Insulin degludec is not for people with diabetic ketoacidosis (increased ketones in the blood or urine).
• It is not known if insulin degludec is safe and effective in children under 1 year of age.
• Insulin degludec is available in 2 concentrations (U-100 and U-200):
  • U-100 concentration is available in pen and vial
    • The 100 units/mL pen can be injected from 1 to 80 units in a single injection, in increments of 1 unit.
    • The 100 units/mL vial should be used with a U-100 insulin syringe only.
  • U-200 concentration is only available in pen
    • The 200 units/mL pen can be injected from 2 to 160 units in a single injection, in increments of 2 units.

Do not share your insulin degludec FlexTouch insulin delivery device (pen) 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.

• Read the Instructions for Use that come with your insulin degludec.
• Take insulin degludec 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 insulin degludec 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 insulin degludec each day, use a insulin degludec U-100 vial.
• 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 insulin degludec into a vein or muscle.
• Never use a syringe to remove insulin degludec from the FlexTouch pen.
• Insulin degludec 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.

• Inject insulin degludec subcutaneously into the thigh, upper arm, or abdomen.
• Rotate injection sites to reduce risk of lipodystrophy and localized cutaneous amyloidosis.
• For pediatric patients requiring less than 5 units of insulin degludec each day, use a U-100 vial.
• In adults, inject subcutaneously once daily at any time of day.
• In pediatric patients inject subcutaneously once daily at the same time every day.
• Individualize dose based on type of diabetes, metabolic needs, blood glucose monitoring results and glycemic control goal.
• The recommended days between dose increases are 3 to 4 days.

Starting dose in patients who are not taking insulin:

• Type 1 diabetes
  The recommended starting dose of insulin degludec in insulin naive 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 naive patients with type 1 diabetes.
• Type 2 diabetes
  The recommended starting dose of insulin degludec in insulin naïve patients with type 2 diabetes mellitus is 10 units once daily.

Starting dose in patients already taking insulin:

• Adults with type 1 or type 2 diabetes
  Start insulin degludec at the same unit dose as the total daily long or intermediate-acting insulin unit dose.
• Pediatric patients (≥ 1 year of age) with type 1 or type 2 diabetes
  Start insulin degludec at 80 percent of the total daily long or intermediate-acting insulin unit dose to minimize the risk of hypoglycemia

See full prescribing information for additional important information about insulin degludec dosing.

Do not take insulin degludec if you:

• are having an episode of low blood sugar (hypoglycemia).
• have an allergy to insulin degludec or any of the ingredients in insulin degludec. See below for a complete list of ingredients.

What should I tell my doctor before taking insulin degludec?

Before taking insulin degludec, 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 insulin degludec, talk to your healthcare provider about low blood sugar and how to manage it.

• Adults: If you miss or are delayed in taking your dose of insulin degludec:
  • 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 insulin degludec:
  • Call the healthcare provider for information and instructions about checking blood sugar levels more often until the next scheduled dose of insulin degludec.

While taking insulin degludec do not:

• Drive or operate heavy machinery, until you know how insulin degludec affects you.
• Drink alcohol or use prescription or over-the-counter medicines that contain alcohol.

Insulin degludec 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 insulin degludec 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 insulin degludec. Your healthcare provider should monitor you closely while you are taking TZDs with insulin degludec. 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 insulin degludec 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 insulin degludec 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
• 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 insulin degludec. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Especially tell your doctor if you take medications that may:

• increase your risk of hypoglycemia (low blood sugar)
• increase or decrease how well insulin degludec works
• make it hard to tell if your blood sugar is getting too low

Ask your healthcare provider or pharmacist if you are not sure if you take one of these medications.