Selected Important Safety Information

Do not share your Fiasp® 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 Fiasp®?

Do not take Fiasp® if:

  • your blood sugar is too low (hypoglycemia) or you are allergic to any of its ingredients.

Before taking Fiasp®, tell your health care provider about all your medical conditions including, if you:

  • have kidney or liver problems
  • are pregnant or breastfeeding or plan to become pregnant or breastfeed. It is not known if Fiasp® passes into your breast milk.
  • are taking new prescription or over-the-counter medicines, including supplements.

Talk to your health care provider about low blood sugar and how to manage it.
 

Indications and Usage

What is Fiasp® (insulin aspart injection) 100 U/mL?
  • Fiasp® is a man-made insulin used to control high blood sugar in adults with diabetes mellitus. It is not known if Fiasp® is safe and effective in children.

Important Safety Information

Do not share your Fiasp® 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 Fiasp®?

Do not take Fiasp® if:

  • your blood sugar is too low (hypoglycemia) or you are allergic to any of its ingredients.

Before taking Fiasp® tell your health care provider about all your medical conditions including, if you:

  • have kidney or liver problems
  • are pregnant or breastfeeding or plan to become pregnant or breastfeed. It is not known if Fiasp® passes into your breast milk.
  • are taking new prescription or over-the-counter medicines, including supplements.

Talk to your health care provider about low blood sugar and how to manage it.

How should I take Fiasp®?
  • Read the Instructions for Use and take Fiasp® exactly as your health care provider tells you to.
  • Fiasp® starts acting fast. You should take your dose of Fiasp® at the beginning of the meal or within 20 minutes after starting a meal.
  • Know the type and strength of your insulin. Do not change your insulin type unless your health care provider tells you to.
  • If you miss a dose of Fiasp® monitor your blood sugar levels to decide if an insulin dose is needed. Continue with your regular dosing schedule at the next meal.
  • 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 other people a serious infection or get a serious infection from them.
What should I avoid while taking Fiasp®?
  • Do not drive or operate heavy machinery, until you know how Fiasp® affects you.
  • Do not drink alcohol or use medicines that contain alcohol.
What are the possible side effects of Fiasp®?
Serious side effects can lead to death, including:

Low blood sugar (hypoglycemia). Some signs and symptoms include:

  • anxiety, irritability, mood changes, dizziness or light-headedness, sweating, confusion, and headache.

Your insulin dose may need to change because of:

  • weight gain or loss, increased stress, illness, or change in diet or level of physical activity.
  • low potassium in your blood (hypokalemia).
  • serious allergic reactions (whole body reactions). Get emergency medical help right away if you have a rash over your whole body; trouble breathing; a fast heartbeat; swelling of your face, tongue or throat; sweating; extreme drowsiness; dizziness, or confusion.
  • heart failure. Taking certain diabetes pills called TZDs (thiazolidinediones) with Fiasp® 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 Fiasp®. Your health care provider should monitor you closely while you are taking TZDs with Fiasp®. Tell your health care provider if you have any new or worse symptoms of heart failure including shortness of breath, swelling of your ankles or feet, or sudden weight gain.

Common side effects of Fiasp® may include:

  • skin problems such as eczema, rash, itching, redness and swelling of your skin (dermatitis), reactions at the injection site such as itching, rash, skin thickening or pits at the injection site (lipodystrophy), or weight gain.

Fiasp® and NovoLog® are prescription medications.

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.

If you need assistance with prescription costs, help may be available. Visit www.pparx.org or call 1-888-4PPA-NOW.