• Levemir^® is a man-made insulin used to control high blood sugar in adults and children with diabetes mellitus.
• Levemir^® is not for people with diabetic ketoacidosis (increased ketones in the blood or urine).

Do not share your Levemir^® FlexPen^® 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.

Do not take Levemir^® if:

• you are having an episode of low blood sugar (hypoglycemia).
• you have an allergy to Levemir^® or any of the ingredients in Levemir^®.

Before taking Levemir^®, tell your healthcare provider about all your medical conditions including, if you:

• take any other medicines, especially medicines commonly called TZDs (thiazolidinediones)
• are pregnant, plan to become pregnant, or are breastfeeding.

Tell your healthcare provider all the medicines you take, including prescription and 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.

• 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 healthcare provider tells you to.
• Check your blood sugar levels. Ask your healthcare provider what your blood sugar levels 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.
• Do not inject Levemir^® into a vein or muscle.
• Change (rotate) your injection sites within the area you choose with each injection 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.

• Do not drive or operate heavy machinery, until you know how it affects you.
• Do not drink alcohol or use medicines that contain alcohol.

Serious side effects can lead to death, including:

• low blood sugar (hypoglycemia). Low blood sugar can be a serious, but common side effect of Levemir^®. Signs and symptoms that may indicate low blood sugar include dizziness, light-headedness, sweating, confusion, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, mood changes, and hunger.
• severe allergic reactions. Severe allergic reactions are a potential side effect of Levemir^®. Get emergency medical help if you have trouble breathing, shortness of breath, fast heartbeat, swelling, swelling of your face, tongue, or throat, sweating, extreme drowsiness, dizziness, or confusion.
• low potassium in your blood (hypokalemia)
• heart failure. Taking certain diabetes pills called TZDs (thiazolidinediones) with Levemir^® 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 Levemir^®. Tell your healthcare provider if you have new or worse symptoms of heart failure including shortness of breath, swelling of ankles or feet, and sudden weight gain. Treatment with TZDs and Levemir^® may need to be changed or stopped by your healthcare provider if you have new or worse heart failure.

Other common side effects include:

• injection site reactions, skin thickening or pits at the injection site (lipodystrophy), weight gain, swelling of your hands and feet, rash, and itching.

Your insulin dose may need to change because of:

• change in level of physical activity or exercise, weight gain or loss, increased stress, illness, or change in diet.

Please see Prescribing Information for Levemir^®.

Levemir^® 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.