Brief Summary

information about TRESIBA® (insulin degludec injection)

Rx Only

This information is not comprehensive. • Talk to your healthcare provider or pharmacist • Visit to obtain FDA-approved product labeling • Call 1-800-727-6500

Do not share your TRESIBA® FlexTouch®


• TRESIBA® • TRESIBA® blood or urine). ?

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.

is not for people with diabetic ketoacidosis (increased ketones in the is not for children who need less than 5 units of TRESIBA®

• It is not known if TRESIBA® • TRESIBA®

each day. is safe and effective in children under 1 year of age.

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.

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®

Before taking TRESIBA® or any of the ingredients in TRESIBA®

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.

• Adults: If you miss or are delayed in taking your dose of TRESIBA: o Take your dose as soon as you remember then continue with your regular dosing schedule.

o Make sure there are at least 8 hours between your doses. • If children miss a dose of TRESIBA®


o 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® 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.

from the FlexTouch® ?


For information contact: Novo Nordisk Inc. 800 Scudders Mill Road

Plainsboro, New Jersey 08536, USA 1-800-727-6500

Novo Nordisk® , TRESIBA® , and FlexTouch® registered trademarks of Novo Nordisk A/S.

© 2017 Novo Nordisk USA16TSM05267 1/2017

are . . , tell your healthcare provider about all your ? insulin delivery device with

other people, even if the needle has changed. You may give other people a serious infection, or get a serious infection from them.

What are the possible side effects of TRESIBA® TRESIBA®


• Low blood sugar (hypoglycemia). Signs and symptoms that may indicate low blood sugar include: o dizziness or light-headedness

o anxiety, irritability, or mood changes o slurred speech o confusion o headache

o blurred vision o sweating o hunger

o shakiness o 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

. 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®

healthcare provider should monitor you closely while you are taking TZDs with 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 • increased stress • change in diet • illness

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® TRESIBA®

that is written for health professionals. Do not use 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. What are the ingredients in TRESIBA®

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

Manufactured by: Novo Nordisk A/S DK-2880 Bagsvaerd, Denmark For more information, go to or call 1-800-727-6500.

This Patient Information has been approved by the U.S. Food and Drug Administration Revised: 12/2016

More detailed information is available upon request. Available by prescription only.

• weight gain or loss

? may cause serious side effects that can lead to death,

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