atic function or during acute illness to minimize the risk ofhypoglycemia or hyperglycemia [see Warnings and Precautions(5.2, 5.3) and Drug Interactions (7)].
Subcutaneous Injection:
• Inject FIASP® at the start of a meal or within 20 minutes after
starting a meal subcutaneously into the abdomen, upper arm, orthigh.
• Rotate injection sites within the same region from one injectionto the next to reduce the risk of lipodystrophy [see AdverseReactions (6.1)].
• FIASP® given by subcutaneous injection should generally beused in regimens with intermediate or long-acting insulin [seeWarnings and Precautions (5.2)].
• Instruct patients on basal-bolus treatment who forget a mealtimedose to monitor their blood glucose level to decide if an insulindose is needed, and to resume their usual dosing schedule at thenext meal.
• The FIASP® FlexTouch® pen dials in 1 unit increments.Intravenous Administration:
• Administer FIASP® intravenously only under medicalsupervision with close monitoring of blood glucose andpotassium levels to avoid hypoglycemia and hypokalemia [see
Warnings and Precautions (5.3, 5.5)].
• Dilute FIASP® to concentrations from 0.5 unit/mL to 1 unit/mLinsulin aspart in infusion systems using polypropylene infusionbags.
• FIASP® is stable at room temperature for 24 hours in 0.9%sodium chloride or 5% dextrose infusion fluids [see HowSupplied/Storage and Handling (16.2)]
2.3 Converting to FIASP® from Other Insulins inPatients with Either Type 1 or Type 2 DiabetesIf converting from another mealtime insulin to FIASP®, the changecan be done on a unit-to-unit basis [see Clinical Studies (14)].
3 DOSAGE FORMS AND STRENGTHS
Injection: 100 units of insulin aspart per mL (U-100) is available asa clear and colorless solution in:
• 10 mL multiple-dose vial
• 3 mL single-patient-use FIASP® FlexTouch® pen
• 3 mL single-patient-use PenFill® cartridges for use in a PenFill®cartridge delivery device
4 CONTRAINDICATIONS
FIASP® is contraindicated
• During episodes of hypoglycemia [see Warnings and Precautions(5.3)].
• In patients with known hypersensitivity to insulin aspart or one ofthe excipients in FIASP® [see Warnings and Precautions (5.6)].
5 WARNINGS AND PRECAUTIONS
5.1 Never Share a FIASP® FlexTouch® Pen, PenFill®
Cartridge or PenFill® Cartridge Device Between
Patients
FIASP® FlexTouch® disposable prefilled pen, PenFill® cartridge andPenFill® cartridge devices should never be shared between patients,even if the needle is changed. Patients using FIASP® vials shouldnever share needles or syringes with another person. Sharing posesa risk for transmission of blood-borne pathogens.
5.2 Hyperglycemia or Hypoglycemia with Changes in
Insulin Regimen
Changes in insulin, insulin strength, manufacturer, type, or methodof administration may affect glycemic control and predispose tohypoglycemia or hyperglycemia. These changes should be madecautiously and only under close medical supervision and thefrequency of blood glucose monitoring should be increased. Forpatients with type 2 diabetes, dosage adjustments in concomitantoral anti-diabetic treatment may be needed.
5.3 Hypoglycemia
Hypoglycemia is the most common adverse reaction of all insulintherapies, including FIASP® [see Adverse Reactions |
