Tresiba^® Important Safety Information

Do not share your Tresiba^® FlexTouch^® with other people, even if the needle has been 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^® 

Before taking Tresiba^®, tell your health care 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

Talk to your health care provider about low blood sugar and how to manage it.

How should I take Tresiba^®?

• Read the Instructions for Use and take Tresiba^® exactly as your health care provider tells you to
• Do not do any conversion of your dose. The dose counter always shows the selected dose in units
• Know the type and strength of insulin you take. Do not change the type of insulin you take unless your health care provider tells you to
• 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 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^®
•  For children who need less than 5 units of Tresiba^® each day, use a Tresiba^® U-100 vial
• Check your blood sugar levels. Ask your health care provider what your blood sugar levels should be and when you should check them
• Do not reuse or share your needles or syringes with other people. You may give them 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 injection 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^®?

• Do not drive or operate heavy machinery, until you know how Tresiba^® affects you
• Do not 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 be life-threatening, including:

• Low blood sugar (hypoglycemia). Signs and symptoms that may indicate low blood sugar include dizziness, light-headedness, sweating, confusion, headache, blurred vision, slurred speech, shakiness, fast heart beat, anxiety, irritability, mood changes, and hunger.
• Low potassium in your blood (hypokalemia)
• Heart failure in some people if taken with thiazolidinediones (TZDs). This can happen even if you have never had heart failure or heart problems. If you already have heart failure, it may get worse while you take TZDs with Tresiba^®. Tell your health care 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 

Your insulin dose may need to change because of change in level of physical activity or exercise, increased stress, change in diet, weight gain or loss, or illness. 

• Common side effects 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, or confusion.