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Answers to common questions about Tresiba®

About Tresiba®

Tresiba® is a long-acting insulin used to control high blood sugar in adults and children as young as 1 year of age with diabetes.

Tresiba® is not for people with diabetic ketoacidosis.

Adults can take once-daily Tresiba® at any time of day, if needed, so they can decide on a time and place that work best. Children must take their dose at the same time every day.

Adults who miss or delay a dose should take Tresiba® as soon as they remember, then continue with their regular dosing schedule, making sure there are at least 8 hours between doses. If children miss a dose, their health care provider should be contacted and blood glucose levels monitored more frequently until the next scheduled dose.

Tell your health care provider about all medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Your Tresiba® dose may change if you take other medicines. Dosages of other medicines may change, too.

Heart failure may occur 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.

Other medicines also may interact with Tresiba®. See the Prescribing Information for more details.

Tresiba® can be used in combination with diabetes pills or fast-acting insulins.

Heart failure may occur 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.

Other medicines also may interact with Tresiba®. See the Prescribing Information for more details.

Tresiba® is taken by injection once daily. Your health care provider will tell you how to take Tresiba® based on your individual needs. If you think you need to adjust your insulin dose because of illness, new medicine, stress, change in diet, or change in activity level, make sure to talk to your health care provider.

Do not make any changes to your dose or the type of insulin you use unless you are told to do so by your health care provider.

Tresiba® is the only long-acting insulin approved for both type 1 and type 2 diabetes in children as young as 1 year of age.

Tresiba® is approved for adults and children as young as 1 year of age with diabetes.

Tresiba® is available from pharmacies in the following ways:

  • 100 units/milliliter (U-100): Tresiba® FlexTouch® (5 pens/pack)
  • 200 units/milliliter (U-200): Tresiba® FlexTouch® (3 pens/pack)
  • 100 units/milliliter (U-100): Tresiba® multiple-dose, 10-mL vial (1 vial/pack)

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.

About Tresiba® FlexTouch® and vial

Tresiba® FlexTouch® is our latest advancement in prefilled insulin devices from Novo Nordisk. Tresiba® FlexTouch® has been designed with no push-button extension and offers an audible click when your dose is delivered.a

aAfter dose counter has returned to 0, keep needle in skin for 6 seconds before the needle is removed. If you do not, you may not have received your full dose and you should check your blood sugar levels more often because you may need more insulin. You may or may not hear an audible click at end of dose.

For children who need fewer than 5 units a day or adults who prefer vials.

For Tresiba® FlexTouch® U-100, the minimum dose is 1 unit and the maximum dose is 80 units in a single injection.

For Tresiba® FlexTouch® U-200, the minimum dose is 2 units and the maximum dose is 160 units in a single injection.

Other prefilled injection pens have a push button that extends when the dose is dialed up. Tresiba® FlexTouch® has a spring-loaded mechanism that allows the push button to stay in place at any dose.

Tresiba® FlexTouch® is compatible with all universal fit needles. We recommend NovoTwist®, NovoFine®, and NovoFine® Plus needles, including NovoFine® Autocover®.

Do not reuse or share your needles with other people. You may give them a serious infection or get a serious infection from them.

Store unused Tresiba® FlexTouch® pens and vials in the refrigerator at 36oF to 46oF (2oC to 8oC).

Tresiba® lasts up to 8 weeks once in use, if it is refrigerated (36°F to 46°F) or kept at room temperature below 86oF (30ºC) away from direct heat and light.

Once in use, Tresiba® FlexTouch® pens and vials can last up to 8 weeks at room temperature (below 86oF) or refrigerated (36oF to 46oF).

Used needles or syringes and any empty Tresiba® FlexTouch® pens should be discarded in a sharps container or some type of hard plastic or metal container with a tight-fitting, puncture-resistant lid, such as an empty detergent bottle. Disposal requirements may vary locally. Check with your health care provider about the right way to throw away used needles.

If you have any additional questions, ask your health care provider or call Novo Nordisk at 1-800-727-6500.

Tresiba® support

Our Questions for Your Doctor guide can help prepare you for a conversation with your health care provider about taking Tresiba®. Download the guide, print it out, and bring it to your next appointment.

You can sign up to receive helpful emails with information and updates about Tresiba®. You’ll also have access to one-on-one calls with a Certified Diabetes Educator and personalized diabetes management tools through Cornerstones4Care®, an online support program that features diabetes information, videos, downloadable books, recipes, interactive trackers, a digital coaching program, and more.

Sign up for the Tresiba® Savings Card. If eligible, you can use this card to pay as little as $15 per 30-day supply of Tresiba® for up to 24 months®.b

bMaximum savings of $500 per prescription. Eligibility and other restrictions apply.

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Selected 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
  • are allergic 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

What is Tresiba®?

  • Prescription Tresiba® is a long-acting insulin used to control high blood sugar in adults and children who are 1 year of age and older with diabetes
  • Tresiba® is not for people with diabetic ketoacidosis
  • It is not known if Tresiba® is safe and effective in children under 1 year of age
  • Tresiba® is available in 2 concentrations: 200 units/mL and 100 units/mL

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
  • are allergic 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

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 anxiety, irritability, mood changes, dizziness, sweating, confusion, and headache
  • 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 reactions at the injection site, itching, rash, serious allergic reactions (whole body reactions), skin thickening or pits at the injection site (lipodystrophy), weight gain, and swelling of your hands and feet.

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.

Please click here for Tresiba® Prescribing Information.

Look up your cost and a savings offer at MyTresibaCost.com.

Tresiba® is a prescription medication.

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch, or call 1‑800-FDA-1088.

If you need assistance with prescription costs, help may be available. Visit www.pparx.org or call 1‑888-4PPA-NOW.

Talk to your health care provider about your diabetes management plan, including diet and exercise.