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Please scroll down for Important Safety Information and Prescribing Information.
Once-daily Tresiba® is a long-acting basal insulin that can help control high blood sugar in adults with diabetes, along with diet and exercise. Once-daily Tresiba® provides blood sugar control for more than 24 hours.a You can take Tresiba® at any time of day, and still stay in control. If you miss or delay a dose, take Tresiba® as soon as you remember, then continue with your regular dosing schedule. Make sure there are at least 8 hours between doses. Tresiba® FlexTouch® is available in the U-100 or U-200 formulation. For more information on Tresiba®, FlexTouch®, and a money-saving offer, please visit www.tresiba.com.
a In studies, Tresiba® has been shown to work effectively beyond 42 hours,
after 8 once-daily injections.
What is Tresiba®?
- Prescription Tresiba® is a long-acting insulin used to control high blood sugar in adults with diabetes
- Tresiba® is not for people with diabetic ketoacidosis
- Tresiba® 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
- 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
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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
- Do not reuse or share your needles 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.
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.
Please scroll down for Important Safety Information and Prescribing Information.
Levemir® is a long-acting insulin analog that can help control high blood sugar for up to 24 hours in adults with type 1 or type 2 diabetes. Levemir® can be dosed once or twice daily and is the first and only long-acting insulin analog that has been approved for use in children with type 1 diabetes as young as 2 years of age. Levemir® is also the first and only man-made long-acting insulin to receive a Pregnancy Category B classification. Levemir® is available in 10 mL vials, and in FlexTouch®. Levemir® FlexTouch® is the first prefilled insulin pen with no push-button extension and is covered by most health insurance plans and Medicare part D plans. Ask your doctor if Levemir® FlexTouch® is right for you. For more information on Levemir® FlexTouch® and a money-saving offer, please visit www.levemir.com.
What is Levemir® (insulin detemir [rDNA origin] injection)?
- Levemir® is a man-made insulin used to control high blood sugar in adults and children with diabetes mellitus.
- Levemir® is not meant for use to treat diabetic ketoacidosis.
Important Safety Information
Do not share your Levemir 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 Levemir®?
Do not take Levemir® if:
- you have an allergy to Levemir® or any of the ingredients in Levemir®.
Before taking Levemir®, tell your health care provider about all your medical conditions including, if you are:
- pregnant, plan to become pregnant, or are breastfeeding.
- taking new prescription or over-the-counter medicines, including supplements.
Talk to your health care provider about how to manage low blood sugar.
How should I take Levemir®?
- Read the Instructions for Use and take exactly as directed.
- Know the type and strength of your insulin. Do not change your insulin type unless your health care provider tells you to.
- 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 other people a serious infection, or get a serious infection from them.
- Never inject Levemir® into a vein or muscle.
What should I avoid while taking Levemir®?
- Do not drive or operate heavy machinery, until you know how it affects you.
- Do not drink alcohol or use medicines that contain alcohol.
What are the possible side effects of Levemir®?
Serious side effects can lead to death, including:
Low blood sugar. Some signs and symptoms include:
- anxiety, irritability, mood changes, dizziness, sweating, confusion, and headache.
Your insulin dose may need to change because of:
- change in level of physical activity, weight gain or loss, increased stress, illness, or change in diet.
Other 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, swelling of your hands and feet and if taken with thiazolidinediones (TZDs) possible heart failure.
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.
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.