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FDA Approves Fiasp for Glycemic Control

Novo Nordisk news release; 2017 Sep 29

The FDA has approved Fiasp (insulin aspart injection) 100 units/mL, a fast-acting mealtime insulin indicated to improve glycemic control in adults with types 1 and 2 diabetes.

Indications: Fiasp is a rapid-acting human insulin analog indicated to improve glycemic control in adults with diabetes mellitus.

Dosage and administration:

  • Individualize and adjust the dosage of Fiasp based on route of administration, individual’s metabolic needs, blood glucose monitoring results, and glycemic control goal.
  • Subcutaneous injection: Inject at the start of a meal or within 20 minutes after starting a meal into the abdomen, upper arm, or thigh.
  • Intravenous infusion: Administer only under medical supervision after diluting to concentrations from 0. 5 to 1 unit/mL insulin aspart in infusion systems using polypropylene infusion bags.

Efficacy and safety: Approval is based on results from a trial showing that participants taking Fiasp reduced A1C levels.

Side effects/risks: The most common adverse reactions are hypoglycemia, allergic reactions, hypersensitivity, injection site reactions, lipodystrophy, and weight gain.

Citation:

Novo Nordisk receives FDA approval for Fiasp, a new fast-acting mealtime insulin [news release]. Plainsboro, NJ: Novo Nordisk Inc. September 29, 2017. http://press.novonordisk-us.com/2017-09-29-Novo-Nordisk-Receives-FDA-App.... Accessed October 4, 2017.

Fiasp [package insert]. Plainsboro, NJ: Novo Nordisk Inc. 2017. http://www.novo-pi.com/fiasp.pdf Accessed October 4, 2017.

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