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Levemir® FlexPen®

> Can be used by children as young as 2 years old with type 1 diabetes
> Is Pregnancy Category B
> Can be used in combination with a GLP-1 therapy and diabetes pill

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Safety Information

Please read the Patient Information that comes with Levemir® FlexPen® before you start taking it and each time you get a refill. Also, be sure to talk to your doctor about your diabetes and your treatment plan.

Possible side effects of Levemir® FlexPen®

  • Low blood sugar (hypoglycemia). Symptoms may include: sweating, dizziness, lightheadedness, shakiness, hunger, fast heart beat, tingling of lips and tongue, trouble concentrating or confusion, blurred vision, slurred speech, anxiety, irritability or mood changes and headache. Severe low blood sugar can cause unconsciousness (passing out), seizures, and death. Know your symptoms of low blood sugar. Follow your healthcare provider’s instructions for treating low blood sugar. Talk to your healthcare provider if low blood sugar is a problem for you.
  • Serious allergic reaction (whole body reaction). Get medical help right away, if you develop a rash over your whole body, have trouble breathing, a fast heartbeat, or sweating.
  • Reactions at the injection site (local allergic reaction). You may get redness, swelling, and itching at the injection site. If you keep having skin reactions or they are serious, talk to your doctor. You may need to stop using Levemir® FlexPen® and use a different insulin. Do not inject insulin into skin that is red, swollen, or itchy.
  • Skin thickness or pits at the injection site (lipodystrophy). Change (rotate) where you inject your insulin to help prevent these skin changes from happening. Do not inject insulin into this type of skin.
  • Swelling of your hands and feet.
  • Vision changes.
  • Low potassium in your blood (hypokalemia).

These are not all the possible side effects from Levemir® FlexPen®. For more, please see Levemir® Patient Information.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Selected Important Safety Information

What are the possible side effects of Levemir®?

• Low blood sugar (hypoglycemia), including when too much is taken. Some symptoms include sweating, shakiness, confusion, and headache. Severe low blood sugar can cause unconsciousness, seizures, and death.

• Other side effects include injection site reactions (like redness, swelling, and itching), skin thickening or pits at the injection site, if taken with thiazolidinediones (TZDs) possible heart failure, and weight gain.

Please click here for additional Important Safety Information