Demonstrated Glycemic Control in Adults With Diabetes Mellitus With Fiasp (insulin aspart injection) 100 U/mL

May 31, 2018
Fiasp® (insulin aspart injection) 100 U/mL is a rapid-acting insulin analog indicated to improve glycemic control in adults with diabetes mellitus.

Fiasp® contains 2 excipients that are added to insulin aspart: vitamin B3 (niacinamide) and amino acid (L-arginine). The addition of niacinamide increases the proportion of insulin aspart molecules in the monomeric state once injected, which increases the rate of initial insulin absorption. The addition of L-arginine aids in stabilizing the formulation.2

With a fast initial absorption into the bloodstream, the onset of appearance of Fiasp® is approximately two and half minutes.1

There are two dosing options for Fiasp®. It can be administered at the start of a meal, or patients can also inject up to 20 minutes after the start of a meal.


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Important Safety Information
Contraindications  

Fiasp® is contraindicated during episodes of hypoglycemia and in patients hypersensitive to Fiasp® or one of its excipients. 

Warnings and Precautions 
  • Never share a Fiasp® FlexTouch® Pen between patients, even if the needle is changed. Patients using Fiasp® vials must never share needles or syringes with another person. Sharing poses a risk for transmission of blood-borne pathogens.
  • Changes in insulin strength, manufacturer, type, or method of administration may affect glycemic control and predispose to hypoglycemia or hyperglycemia. These changes should be made cautiously under close medical supervision and the frequency of blood glucose monitoring should be increased.
Fiasp® (insulin aspart injection) 100 U/ml Indications and Usage

Fiasp® (insulin aspart Injection) 100 U/mL is a rapid-acting insulin analog indicated to improve glycemic control in adults with diabetes mellitus.

Important Safety Information (cont'd)

Warnings and Precautions (cont'd) 
  • Hypoglycemia Is the most common adverse reaction of insulin, including Fiasp®, and may be life threatening. Increase glucose monitoring with changes to: insulin dosage, co-administered glucose lowering medications, meal pattern, physical activity; and in patients with renal impairment or hepatic impairment or hypoglycemia unawareness.  
  • To avoid medication errors and accidental mix-ups between Fiasp® and other insulin products, instruct patients to always check the insulin label before injection.
  • As with all insulins, Fiasp® use can lead to life threatening hypokalemia, which then may cause respiratory paralysis, ventricular arrhythmia, and death. Monitor potassium levels in patients at risk for hypokalemia and treat if indicated.
  • Severe, life-threatening, generalized allergy, including anaphylaxis, may occur with insulin products, including Fiasp®.
  • Fluid retention and heart failure can occur with concomitant use of thiazolidinediones (TZDs), which are PPAR-gamma agonists, and insulin, including Fiasp®. Patients should be observed for signs and symptoms of heart failure. If heart failure occurs, dosage reduction or discontinuation of the TZD must be considered.
Adverse Reactions 
  • Adverse reactions observed with Fiasp® include hypoglycemia, allergic reactions, hypersensitivity, injection site reactions, lipodystrophy, and weight gain. Use in Specific Populations 
  • The safety and effectiveness of Fiasp® in pediatric patients have not been established,
  • Like all insulins Fiasp® requirements may be reduced in patients with renal impairment or hepatic impairment. These patients may require more frequent blood glucose monitoring and dose adjustments.
Use in Specific Populations
  • The safety and effectiveness of Fiasp® in pediatric patients have not been established.
  • Like all insulins, Fiasp® requirements may be reduced in patients with renal impairment or hepatic impairment. These patients may require more frequent blood glucose monitoring and dose adjustments. 
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References             
1. Fiasp [package insert]. Plainsboro, NJ: Novo Nordisk Inc; September 2017.
2. Heise T, Pieber TR, Danne T, Erichsen L, Haahr H. A pooled analysis of clinical pharmacology trials investigation the pharmacokinetic and pharacodynamic characteristics of fast-acting insulin aspart in adults with type 1 diabetes. Clin Pharmacokinet. 2017 May;56(5):551-559.


Fiasp®, FlexPen®,  and FlexTouch® are registered trademarks and NovoMedLinkTM is a trademark of Novo Nordisk A/S.
Novo Nordisk is a registered trademark of Novo Nordisk A/S.
®2018 Novo Nordisk. All rights reserved. US18FSP00048 05/18
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