Tresiba

What is Tresiba?

• Tresiba 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.
• Tresiba is not for people with diabetic ketoacidosis (increased ketones in the blood or urine).
• It is not known if Tresiba is safe and effective in children under 1 year of age.
• Tresiba 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.

What is the most important information I should know about Tresiba?

Do not share your Tresiba FlexTouch insulin delivery device 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.

Who should not take Tresiba?

Do not take Tresiba if you:

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

What should I tell my healthcare provider before taking Tresiba?

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

How should I take Tresiba?

• Read the Instructions for Use that come with your Tresiba.
• 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 should I avoid while taking Tresiba?

While taking Tresiba do not:

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

What are the possible side effects of Tresiba?

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

General information about the safe and effective use of Tresiba

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your pharmacist or healthcare provider for information about Tresiba that is written for health professionals. Do not use Tresiba for a condition for which it was not prescribed. Do not give Tresiba to other people, even if they have the same symptoms that you have. It may harm them.

How should I store Tresiba?

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.

What are the ingredients in Tresiba?

Active Ingredient: insulin degludec

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