What is Levemir?
Levemir is a man-made insulin that is used to control high blood sugar in adults and children with diabetes mellitus.
Levemir is not meant for use to treat diabetic ketoacidosis.
What is the most important information I should know about Levemir?
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.
What should I tell my healthcare provider before taking Levemir?
Before taking Levemir, tell your healthcare 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.
Before you start taking Levemir, talk to your healthcare provider about low blood sugar and how to manage it.
How should I take Levemir?
- Read the Instructions for Use that come with your Levemir.
- Take Levemir exactly as your healthcare provider tells you to.
- 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.
- 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 or syringes with other people. You may give other people a serious infection, or get a serious infection from them.
- Levemir is injected under the skin (subcutaneously) of your upper legs (thighs), upper arms, or stomach area (abdomen).
- Never inject Levemir into a vein or muscle.
- Change (rotate) your injection sites within the area you choose with each dose to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites.
- Do not use the exact same spot for each injection.
- Do not inject where the skin has pits, is thickened, or has lumps.
- Do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin.
What should I avoid while taking Levemir?
While taking Levemir do not:
- Drive or operate heavy machinery, until you know how Levemir affects you.
- Drink alcohol or use prescription or over-the-counter medicines that contain alcohol.
What are the possible side effects of Levemir?
Levemir may cause serious side effects that can lead to death, including:
Low blood sugar (hypoglycemia). Signs and symptoms that may indicate low blood sugar include:
- dizziness or light-headedness
- blurred vision
- slurred speech
- fast heart beat
- anxiety, irritability, or mood changes
Your insulin dose may need to change because of:
- change in level of physical activity or exercise
- weight gain or loss
- increased stress
- change in diet
Other common side effects of Levemir 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
Get emergency medical help if you have:
- trouble breathing
- shortness of breath
- fast heartbeat
- swelling of your face, tongue, or throat
- extreme drowsiness
These are not all the possible side effects of Levemir. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store Levemir?
- Do not freeze Levemir. Do not use Levemir if it has been frozen.
- Keep Levemir away from heat or light.
- All unopened vials:
- Store unopened Levemir vials in the refrigerator at 36°F to 46°F (2°C to 8°C).
- Unopened vials may be used until the expiration date printed on the label, if they have been stored in the refrigerator.
- Unopened vials should be thrown away after 42 days, if they are stored at room temperature below 86°F (30°C).
- After vials have been opened:
- Opened Levemir vials can be stored in the refrigerator at 36°F to 46°F (2°C to 8°C) or at room temperature below 86°F (30°C).
- Throw away all opened Levemir vials after 42 days, even if they still have insulin left in them.
Keep out of sight and reach of children.
What are the ingredients in Levemir?
Active Ingredient: insulin detemir
Inactive Ingredients: zinc, m-cresol, glycerol, phenol, disodium phosphate dihydrate, sodium chloride and water for injection. Hydrochloric acid or sodium hydroxide may be added.
For more information, go to www.novonordisk-US.com or call 1-800-727-6500.