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TRESIBA is a man-made insulin that is used to control high blood sugar in adults with diabetes mellitus.
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TRESIBA is not for people with diabetic ketoacidosis (increased ketones in the blood or urine).
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TRESIBA is available in 2 concentrations: The 100 units/mL pen can be injected from 1 to 80 units in a single injection, in increments of 1 unit. The 200 units/mL pen can be injected from 2 to 160 units in a single injection, in increments of 2 units.
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It is not known if TRESIBA is safe and effective in children under 18 years of age.
Who should not take TRESIBA?

Do not take TRESIBA if you:

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are having an episode of low blood sugar (hypoglycemia).
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have an allergy to TRESIBA or any of the ingredients in TRESIBA.
Before taking TRESIBA, tell your healthcare provider about all your medical conditions including, if you are:

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pregnant, planning to become pregnant, or are breastfeeding.
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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?

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Read the Instructions for Use that come with your TRESIBA.
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Take TRESIBA exactly as your healthcare provider tells you to.
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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.
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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.
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If you miss or are delayed in taking your dose of TRESIBA:
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Take your dose as soon as you remember then continue with your regular dosing schedule.
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Make sure there are at least 8 hours between your doses.
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Check your blood sugar levels. Ask your healthcare provider what your blood sugars should be and when you should check your blood sugar levels.
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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.
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Never inject TRESIBA into a vein or muscle.
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Never use a syringe to remove TRESIBA from the FlexTouch pen.
What should I avoid while taking TRESIBA?

While taking TRESIBA do not:

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Drive or operate heavy machinery, until you know how TRESIBA affects you.
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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:

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Low blood sugar (hypoglycemia). Signs and symptoms that may indicate low blood sugar include:
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dizziness or light -headedness
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sweating
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confusion
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fast heartbeat
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blurred vision
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slurred speech
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shakiness
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anxiety, irritability, or mood changes
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hunger
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headache
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Low potassium in your blood (hypokalemia).
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Heart failure. Taking certain diabetes pills called thiazolidinediones or “TZDs”