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New Fast-Acting Mealtime Insulin Receives FDA Approval

The U.S. Food and Drug Administration (FDA) has recently approved Fiasp® (insulin aspart injection) as a fast-acting mealtime insulin to improve glycemic control in adults with type 1 and type 2 diabetes. Manufactured by Novo Nordisk, Fiasp is a reformulation of NovoLog® with the addition of niacinamide (vitamin B3). Niacinamide helps increase how quickly the insulin is absorbed, allowing for Fiasp to take effect rapidly. The intention of rapid-acting insulins like Fiasp is to mimic how the body typically responds to meal in order to best control blood sugar.1

What are the ingredients in Fiasp?

The active ingredient in Fiasp is insulin aspart, a human insulin analog. Inactive ingredients in Fiasp are glycerol, phenol, metacresol, zinc, disodium phosphate dehydrate, arginine hydrochloride, niacinamide and water.2

What are the possible side effects of Fiasp?

Fiasp may cause serious side effects that can lead to death, including low blood sugar. If you are experiencing low blood sugar, it is important to take action right away. Other serious side effects that are possible with Fiasp are low potassium (hypokalemia), serious allergic reactions, and heart failure.1,2

The most common side effects experienced by people taking Fiasp in clinical trials were:

  • Skin problems, including eczema, rash, itching, redness and swelling (dermatitis)
  • Reactions at the injection site (like itching or rash)
  • Skin thickening or pits at the injection site (lipodystrophy)
  • Weight gain1,2

Things to know about Fiasp

Fiasp should not be shared with other people, as there is a risk of infection when sharing drugs like insulin between different people.1,2

Fiasp should not be used during an episode of low blood sugar (hypoglycemia).1,2

Do not use Fiasp if you have an allergy to insulin aspart or any of the ingredients in Fiasp.1,2

Before using Fiasp, talk to your doctor about all health conditions you may have, especially:

  • Any kidney problems
  • Any liver problems
  • Pregnancy or plans to become pregnant
  • Breastfeeding or plans to breastfeed
  • Any new prescription or over-the-counter medications, vitamins, or herbal supplements1,2

When starting on Fiasp, do not drive or operate heavy machinery until you know how Fiasp affects you.1,2

People on Fiasp should not drink alcohol or use medications that contain alcohol.1,2

Dosing information

Fiasp can be taken at the start of a meal or within 20 minutes of beginning a meal. The dose of Fiasp is determined by a healthcare professional and is based on the individual patient’s metabolic needs, blood glucose monitoring, and glycemic control goal.2

Dosing may need to be adjusted when switching from another insulin, with changes in physical activity, changes in other medications, changes in meal patterns, changes in kidney or liver function, or during acute illness.2

Fiasp is available in a pre-filled delivery device (FlexTouch® pen) and a 10-mL vial. Fiasp should be injected subcutaneously (under the skin) into the abdomen, upper arm, or thigh. Injection sites should be rotated with each injection.2

  1. Novo Nordisk press release. Available at Accessed 10/2/17.
  2. Fiasp prescribing information. Available at Accessed 10/2/17.