Insulin degludec

Generic name: Insulin Degludec
Brand names: Tresiba
Dosage form: pen and vial for subcutaneous injection
Drug class: Insulin

Usage of Insulin degludec

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.

Insulin degludec side effects

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.

    Before taking Insulin degludec

    Tell your doctor if you are pregnant or plan to become pregnant. There is a risk to mother and fetus associated with poorly controlled diabetes in pregnancy. However, there is a lack of data available to determine whether insulin degludec is safe in pregnancy.

    Tell your doctor if you are breastfeeding or plan to breastfeed. There is a lack of data available to determine whether insulin degludec is safe to use while breastfeeding. Talk to your doctor about whether the benefits of taking insulin degludec while breastfeeding outweigh any possible risks. Talk to your doctor about the best way to feed your baby while taking insulin degludec.

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    How to use Insulin degludec

  • 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.

    Warnings

    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.

    What other drugs will affect Insulin degludec

    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.

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