What is Tresiba®?

Prescription Tresiba ® is a long-acting insulin used to control high blood sugar in adults with diabetes

is a long-acting insulin used to control high blood sugar in adults with diabetes Tresiba ® is not for people with diabetic ketoacidosis

is not for people with diabetic ketoacidosis Tresiba ® is available in 2 concentrations: 200 units/mL and 100 units/mL

is available in 2 concentrations: 200 units/mL and 100 units/mL It is not known if Tresiba® is safe and effective in children under 18 years of age

Important Safety Information

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

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

change the type of insulin you take unless your health care provider tells you to 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

: Check your blood sugar levels. Ask your health care provider what your blood sugar levels should be and when you should check them

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 with other people. You may give them a serious infection, or get a serious infection from them

You may give them a serious infection, or get a serious infection from them Never inject Tresiba ® into a vein or muscle

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

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

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.