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

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

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

• 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.