HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information
needed to use FIASP® safely and effectively. See full
prescribing information for FIASP®.
FIASP(insulin aspart injection)for subcutaneous orintravenous use
Initial U.S. Approval: 2000
INDICATIONS AND USAGE
• FIASP® is a rapid-acting human insulin analog indicated toimprove glycemic control in adults with diabetes mellitus (1).
DOSAGE AND ADMINISTRATION
• Individualize and adjust the dosage of FIASP® based on routeof administration, individual’s metabolic needs, blood glucosemonitoring results and glycemic control goal.
• Dosage adjustments may be needed when switching fromanother insulin, with changes in physical activity, changes inconcomitant medications, changes in meal patterns, changes inrenal or hepatic function or during acute illness.
• Subcutaneous injection:
o Inject at the start of a meal or within 20 minutes afterstarting a meal into the abdomen, upper arm, or thigh.
o Rotate injection sites within the same region.
o Should generally be used in regimens with anintermediate- or long-acting insulin.
• Intravenous Infusion: Administer only under medical supervisionafter diluting to concentrations from 0.5 to 1unit/mL insulinaspart in infusion systems using polypropylene infusion bags.
DOSAGE FORMS AND STRENGTHSInjection: 100 units/mL (U-100):
• 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 device
CONTRAINDICATIONS
• During episodes of hypoglycemia.
• Hypersensitivity to insulin aspart or one of the excipients inFIASP®.
WARNINGS AND PRECAUTIONS
• Never share a FIASP® FlexTouch® pen, PenFill® cartridge orPenFill® cartridge device between patients, even if the needle ischanged.
• Hyper- or hypoglycemia with changes in insulin regimen: Carryout under close medical supervision and increase frequency ofblood glucose monitoring.
• Hypoglycemia: May be life-threatening. Increase frequencyof glucose monitoring with changes to: insulin dosage,co-administered glucose lowering medications, meal pattern,physical activity; and in patients with renal impairment orhepatic impairment or hypoglycemia unawareness.
• Hypoglycemia due to medication errors: Accidental mix-upsbetween insulin products can occur. Instruct patients to checkinsulin labels before injection.
• Hypokalemia: May be life-threatening. Monitor potassium levelsin patients at risk for hypokalemia and treat if indicated.
• Hypersensitivity reactions: Severe, life-threatening, generalizedallergy, including anaphylaxis, can occur. Discontinue FIASP®,monitor and treat if indicated.
• Fluid retention and heart failure with concomitant use ofthiazolidinediones (TZDs): Observe for signs and symptoms ofheart failure; consider dosage reduction or discontinuation ifheart failure occurs.
ADVERSE REACTIONS
Adverse reactions observed with FIASP® include: hypoglycemia,allergic reactions, hypersensitivity, injection site reactions,lipodystrophy, and weight gain.
To report SUSPECTED ADVERSE REACTIONS, contactNovo Nordisk Inc. at 1-800-727-6500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERAC |
