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

Talking to patients about their Fiasp® prescription

Patients may have questions when they pick up their prescription of Fiasp®. Here are some things you may want to discuss with them.

People with diabetes

Talking to patients about their Fiasp® prescription

Patients may have questions when they pick up their prescription of Fiasp®. Here are some things you may want to discuss with them.

Fiasp® FlexTouch® insulin pen and vial

What is Fiasp®?

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

Dose timing is different for Fiasp® vs NovoLog® (insulin aspart injection) 100 U/mL1,3

NovoLog®

NovoLog® one dosing option

Fiasp®

One plate showing start of a meal dosing and one plate showing after 20 minutes of a meal dosing

Instruct patients on basal-bolus treatment who forget a mealtime dose to monitor their blood glucose level to decide if an insulin dose is needed, and to resume their usual dosing schedule at the next meal.

Fiasp® Trade Unit Product Information

Fiasp® and NovoLog® have the same generic name, insulin aspart 100 U/mL, so be sure to confirm the brand name if it isn’t specified on the written script or in the ePrescribing system.

3 mL single-patient use Fiasp® FlexTouch® pen


NDC number

0169-3204-15

Form/strength

100 units/mL

Pens per package

5

Units of insulin per pen

300

Units of insulin per package

1500

Max dose per injection

80

Dose increment

1 unit

Fiasp® FlexTouch® insulin pen

10 mL multiple-dose vials


NDC number

0169-3201-11

Form/strength

100 units/mL

Fiasp® 10-mL insulin vial

PenFill® cartridge


NDC number

0169-3205-15

Form/strength

100 units/mL

Fiasp® PenFill®

See how FlexTouch® works with the Instructions For Use

Fiasp® FlexTouch® Instructions For Use

Show patients the illustrated step-by-step Instructions For Use. Patients can learn more about Fiasp® by viewing this video on MyFiasp.com.

See the features of FlexTouch®, the latest pen technology from Novo Nordisk.

How to store Fiasp® FlexTouch®

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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Help patients save

Help patients save

Eligible patients can save on prescriptions of Fiasp® with a Savings Card.

Personalized patient support

Personalized patient support

Cornerstones4Care® is a free support program for patients to help them manage their diabetes.

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.

 

NovoLog® (insulin aspart injection) 100 U/mL Indications and Usage

NovoLog® (insulin aspart injection) 100 U/mL is an insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus.

Important Safety Information

Contraindications

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

Warnings and Precautions

  • Never Share a NovoLog® FlexPen, NovoLog® FlexTouch®, PenFill® Cartridge, or PenFill® Cartridge Device Between Patients, even if the needle is changed. Patients using NovoLog® 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, or 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 effect of insulin therapy. The timing of hypoglycemia may reflect the time-action profile of the insulin formulation. Glucose monitoring is recommended for all patients with diabetes and is particularly important for patients using external pump infusion therapy.
  • To avoid medication errors and accidental mix-ups between NovoLog® and other insulin products, instruct patients to always check the insulin label before injection.
  • Severe, life-threatening, generalized allergy, including anaphylaxis, may occur with insulin products, including NovoLog®.
  • As with all insulins, NovoLog® 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.
  • Fluid retention and heart failure can occur with concomitant use of thiazolidinediones (TZDs), which are PPAR-gamma agonists, and insulin, including NovoLog®. 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.
  • Malfunction of the insulin pump or insulin infusion set or insulin degradation can rapidly lead to hyperglycemia and ketoacidosis. Patients using insulin infusion pump therapy must be trained to administer insulin by injection and have alternate insulin therapy available in case of pump failure.

NovoLog® continuous subcutaneous infusion route (insulin pump): Do not mix NovoLog® with any other insulin or diluent.

Adverse Reactions

  • Adverse reactions observed with NovoLog®include hypoglycemia, allergic reactions, local injection site reactions, lipodystrophy, rash, and pruritus.

Use in Specific Populations

  • NovoLog® has not been studied in children with type 2 diabetes or in children with type 1 diabetes who are younger than 2 years of age.
  • Like all insulins, NovoLog® 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. Heise T, Pieber TR, Danne T, Erichsen L, Haahr H. A pooled analysis of clinical pharmacology trials investigating the pharmacokinetic and pharmacodynamic characteristics of fast-acting insulin aspart in adults with type 1 diabetes. Clin Pharmacokinet. 2017;56(5):551-559.
  3. NovoLog [package insert]. Plainsboro, NJ: Novo Nordisk Inc; November 2019.