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NOW APPROVED: Fiasp® is now indicated to improve glycemic control in pediatric patients with diabetes

Headline

Three ways to deliver Fiasp®

Fiasp® is approved for use in pumps

Refer to the insulin infusion pump user manual to see if Fiasp® can be used. Use in accordance with the insulin pump's instructions for use.

Three ways to deliver Fiasp®

Fiasp® is approved for use in pumps

Refer to the insulin infusion pump user manual to see if Fiasp® can be used. Use in accordance with the insulin pump's instructions for use.


Fiasp® 3-mL FlexTouch® insulin pen
3-mL Fiasp® FlexTouch®

3-mL Fiasp® FlexTouch®

A prefilled insulin pen with no push-button extension

Dosing from 1 to 80 units in 1-unit increments1,a

See how Fiasp® FlexTouch® works

Fiasp® FlexTouch® Instructions For Use


The Fiasp® FlexTouch®

Fiasp® FlexTouch® Insulin Pen
Fiasp® FlexTouch® doesn't have a push-button extension

No push-button extension

No matter what dose is dialed, the Fiasp® FlexTouch® push button doesn’t extend

Fiasp® FlexTouch® provides accurate dosing from 1 to 80 units

Dosing from 1‑80 units2,3

Patients may hear or feel a click when the FlexTouch® dose is delivereda

aAfter the dose display has returned to zero, the needle should be kept under the skin for at least 6 seconds to ensure the full dose is delivered. Refer to complete Instructions For Use on how to properly administer your patients’ insulin.

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Fiasp® 10-mL insulin vial
Fiasp® 10-mL insulin vial

10-mL vial

Available for patients who prefer conventional insulin injection.

Allows for half-unit dosing1

Fiasp® PenFill® cartridge
Fiasp® PenFill® cartridge

PenFill® cartridge

Designed for use with Novo Nordisk insulin delivery devices, such as NovoPen Echo®

Allows for half-unit dosing4

NovoPen Echo®—an option for patients

Half-unit dosing for smaller and more precise dosing

Short button distance to reduce injection movement

A customizable pen skin with 12 patterns to choose from

How to store Fiasp®

How to store Fiasp®

Fiasp® FlexTouch®


Not in use (unopened): If unopened, Fiasp® FlexTouch® should be stored in a refrigerator (36°F to 46°F [2°C to 8°C]) until expiration date. If unopened but improperly stored outside of refrigerated conditions, begin in-use storage for a maximum of 4 weeks.1

In use (opened): After first use, Fiasp® FlexTouch® can be stored at room temperature (below 86°F [30°C]) or in the refrigerator (36°F to 46°F [2°C to 8°C]) without the needle attached for a maximum of 4 weeks (28 days).1

Fiasp® vial


Not in use (unopened): If unopened, Fiasp® vials should be stored in a refrigerator (36°F to 46°F [2°C to 8°C]) until expiration date. If unopened but improperly stored outside of refrigerated conditions, begin in-use storage for a maximum of 4 weeks.1

In use (opened): After first use, Fiasp® vials can be stored at room temperature (below 86°F [30°C]) or in the refrigerator (36°F to 46°F [2°C to 8°C]) for a maximum of 4 weeks (28 days).1

Fiasp® PenFill®


Not in use (unopened): If unopened, Fiasp® PenFill® should be stored in a refrigerator (36°F to 46°F [2°C to 8°C]) until expiration date. If unopened but improperly stored outside of refrigerated conditions, begin in-use storage for a maximum of 4 weeks.1

In use (opened): After first use, Fiasp® PenFill® can be stored at room temperature (below 86°F [30°C]) for a maximum of 4 weeks (28 days).1 Do not refrigerate Fiasp® PenFill® cartridges after first use.

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See how to start prescribing Fiasp®

Selected 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, PenFill® cartridge or PenFill® cartridge device 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 an insulin regimen (e.g., insulin strength, manufacturer, type, injection site or method of administration) may affect glycemic control and predispose to hypoglycemia or hyperglycemia. Repeated insulin injections into areas of lipodystrophy or localized cutaneous amyloidosis have been reported to result in hyperglycemia; and a sudden change in the injection site (to an unaffected area) has been reported to result in hypoglycemia. Make any changes to a patient’s insulin regimen under close medical supervision with increased frequency of blood glucose monitoring. Advise patients who have repeatedly injected into areas of lipodystrophy or localized cutaneous amyloidosis to change the injection site to unaffected areas and closely monitor for hypoglycemia. Adjustments in concomitant anti-diabetic treatment may be needed.

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 adult and pediatric patients with diabetes mellitus.

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, PenFill® cartridge or PenFill® cartridge device 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.
  • Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen: Changes in an insulin regimen (e.g., insulin strength, manufacturer, type, injection site or method of administration) may affect glycemic control and predispose to hypoglycemia or hyperglycemia. Repeated insulin injections into areas of lipodystrophy or localized cutaneous amyloidosis have been reported to result in hyperglycemia; and a sudden change in the injection site (to an unaffected area) has been reported to result in hypoglycemia. Make any changes to a patient’s insulin regimen under close medical supervision with increased frequency of blood glucose monitoring. Advise patients who have repeatedly injected into areas of lipodystrophy or localized cutaneous amyloidosis to change the injection site to unaffected areas and closely monitor for hypoglycemia. Adjustments in concomitant anti-diabetic treatment may be needed.
  • 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.
  • Pump or infusion set malfunctions can lead to a rapid onset of hyperglycemia and ketoacidosis. Prompt identification and correction of the cause of hyperglycemia or ketosis is necessary. Interim therapy with subcutaneous injection of Fiasp® may be required. Patients using continuous subcutaneous insulin infusion pump therapy must be trained to administer insulin by injection and have alternate insulin therapy available in case of pump failure. 

Adverse Reactions

  • Adverse reactions observed with Fiasp® include hypoglycemia, allergic reactions, hypersensitivity, injection site reactions, lipodystrophy, and weight gain.

Use in Specific Populations

  • Pediatric patients with type 1 diabetes treated with mealtime and postmeal Fiasp® reported a higher rate of blood glucose confirmed hypoglycemic episodes compared to patients treated with NovoLog® (insulin aspart injection); the imbalance was greater during the nocturnal period. Monitor blood glucose levels closely in pediatric patients.
  • 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.

Please click here for Prescribing Information.

References:

  1. Fiasp [package insert]. Plainsboro, NJ: Novo Nordisk Inc; December 2019.
  2. Wielandt JO, Niemeyer M, Hansen MR, Bucher D, Thomsen NB. An assessment of dose accuracy and injection force of a novel prefilled insulin pen: comparison with a widely used prefilled insulin pen. Expert Opin Drug Deliv. 2011;8(10):1271-1276.
  3. Wielandt JO, Niemeyer M, Hansen MR, et al. FlexTouch: a prefilled insulin pen with a novel injection mechanism with consistent high accuracy at low- (1 U), medium- (40 U), and high- (80 U) dose settings. J Diabetes Sci Technol. 2011;5:1195–1199.
  4. NovoPen Echo. User guide. Plainsboro, NJ: Novo Nordisk Inc; 2018.