Fiasp

FIASP- insulin aspart injection, solution
Novo Nordisk

1 INDICATIONS AND USAGE

FIASP is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.

2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Instructions

Always check insulin label before administration [see Warnings and Precautions (5.4)].
Inspect FIASP visually before use. It should appear clear and colorless. Do not use FIASP if particulate matter or coloration is seen.
Do not mix FIASP with any other insulin.

2.2 Route of Administration Instructions

Subcutaneous Injection:

Inject FIASP at the start of a meal or within 20 minutes after starting a meal subcutaneously into the abdomen, upper arm, or thigh.
Rotate injection sites within the same region from one injection to the next to reduce the risk of lipodystrophy and localized cutaneous amyloidosis. Do not inject into areas of lipodystrophy or localized cutaneous amyloidosis [see Adverse Reactions (6.1, 6.3)].
FIASP given by subcutaneous injection should generally be used in regimens with intermediate or long-acting insulin [see Warnings and Precautions (5.2)].
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.
The FIASP FlexTouch pen dials in 1 unit increments.
Use FIASP FlexTouch pen with caution in patients with visual impairment that may rely on audible clicks to dial their dose.

Continuous Subcutaneous Infusion (Insulin Pump):

Refer to the continuous subcutaneous insulin infusion pump user manual to see if FIASP can be used with the insulin pump. Use FIASP in accordance with the insulin pump system’s instructions for use.
Administer FIASP by continuous subcutaneous infusion in a region recommended in the instructions from the pump manufacturer. Rotate infusion sites within the same region to reduce the risk of lipodystrophy and localized cutaneous amyloidosis. Do not inject into areas of lipodystrophy or localized cutaneous amyloidosis [see Adverse Reactions ( 6.1 )].
Train patients using continuous subcutaneous insulin infusion therapy to administer insulin by injection and have alternate insulin therapy available in case of insulin pump failure [see Warnings and Precautions ( 5.8 )].
Change FIASP in the pump reservoir at least every 6 days, or according to the pump user manual, whichever is shorter. Follow the FIASP-specific information for in-use time because FIASP-specific information may differ from general insulin pump user manual instructions.
Change the infusion sets and the infusion set insertion site according to the manufacturers user manual.
Do not mix with other insulins or diluents in the insulin pump.
Do not expose FIASP in the pump reservoir to temperatures greater than 98.6°F (37°C).

Intravenous Administration:

Administer FIASP intravenously only under medical supervision with close monitoring of blood glucose and potassium 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/mL insulin aspart in infusion systems using polypropylene infusion bags.
FIASP is stable at room temperature for 24 hours in 0.9% sodium chloride or 5% dextrose infusion fluids [see How Supplied/Storage and Handling (16.2)]

2.3 Dosage Information

Individualize the dosage of FIASP based on the patient’s metabolic needs, blood glucose monitoring results, and glycemic control goal.
If converting from another mealtime insulin to FIASP, the initial change can be done on a unit-to-unit basis.
Dose adjustments may be needed when switching from another insulin, with changes in physical activity, changes in concomitant medications, changes in meal patterns (i.e., macronutrient content or timing of food intake), changes in renal or hepatic function or during acute illness to minimize the risk of hypoglycemia or hyperglycemia [see Warnings and Precautions (5.2, 5.3) and Drug Interactions (7)].
Closely monitor blood glucose when converting insulins used in insulin pumps as individualization of insulin pump parameters may be necessary to minimize the risk of hypoglycemia and hyperglycemia [see Warnings and Precautions (5.2, 5.3) and Adverse Reactions (6.1)]
During changes to a patient’s insulin regimen, increase the frequency of blood glucose monitoring [see Warnings and Precautions ( 5.2 )].
Dosage adjustment may be needed when FIASP is coadministered with certain drugs [see Drug Interactions ( 7 )].

3 DOSAGE FORMS AND STRENGTHS

Injection: 100 units of insulin aspart per mL (U-100) is available as a 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 of the 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 pen, PenFill cartridge and PenFill cartridge devices should never be shared between patients, even if the needle is changed. Patients using FIASP vials should never share needles or syringes with another person. Sharing poses a risk for transmission of blood-borne pathogens.

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