Fiasp (Page 7 of 9)

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

FIASP (insulin aspart injection) 100 units of insulin aspart per mL (U-100) is available as a clear and colorless solution in the following presentations and packaging configurations:

Carton of one 10 mL multiple-dose vials NDC 0169-3201-11
Carton of five 3 mL single-patient-use FIASP FlexTouch pens NDC 0169-3204-15
Carton of five 3 mL single-patient-use PenFill cartridges* NDC 0169-3205-15
The FIASP FlexTouch pen dials in 1 unit increments.
* FIASP PenFill cartridges are designed for use with Novo Nordisk insulin delivery devices.

16.2 Recommended Storage

Dispense in the original sealed carton with the enclosed Instructions for Use.

Unused FIASP vials should be stored between 2° to 8°C (36° to 46°F) in a refrigerator, but not in or near a freezing compartment. FIASP should not be exposed to excessive heat or light and must never be frozen. Do not use FIASP if it has been frozen. FIASP should not be drawn into a syringe and stored for later use.

Keep the cap on the pen in order to protect from light. Remove the needle from the FIASP FlexTouch pen after each injection and store without a needle attached. Use a new needle for each injection. Keep unused vials, FIASP FlexTouch and PenFill Cartridges in the carton so they will stay clean and protected from light.

The storage conditions for vials, FIASP FlexTouch pens, and 3 mL PenFill cartridges are summarized in Table 12:

Table 12. Storage Conditions for Vial, FIASP FlexTouch, and PenFill Cartridges

FIASPpresentation

Not in-use (unopened)

In-use (opened)

Room Temperature (below 30°C)

Refrigerated

(2°C to 8°C)

Room Temperature (below 30°C)

Refrigerated

(2°C to 8°C)

10 mL multiple-dose vial

28 days

Until expiration date

28 days*

28 days*

3 mL single-patient-use FIASP FlexTouch pen

28 days

Until expiration date

28 days

28 days

3 mL single-patient-use PenFill cartridges

28 days

Until expiration date

28 days

Do not refrigerate

*For insulin pump use, the total in-use time is 28 days, including 6 days pump in-use time

Storage of FIASP in Insulin Pump:

FIASP in the pump reservoir should be replaced at least every 6 days, or according to the pump user manual, whichever is shorter, to avoid insulin degradation or after exposure to temperatures that exceed 37°C (98.6°F). The infusion set and infusion set insertion sites should be changed according to the manufacturers’ user manual.

Storage of FIASP in Intravenous Infusion Fluids:
Infusion bags prepared as indicated under Dosage and Administration (2.2) are stable at room temperature for 24 hours.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-Approved Patient Labeling (Patient Information and Instructions for Use).

Never Share a FIASP FlexTouch Pen Device, PenFill Cartridge or PenFill Cartridge Device Between Patients

Advise patients that they should never share a FIASP FlexTouch pen device, PenFill cartridge or PenFill cartridge devices with another person, even if the needle is changed, because doing so carries a risk for transmission of blood-borne pathogens. Advise patients using FIASP vials not to share needles or syringes with another person. Sharing poses a risk for transmission of blood-borne pathogens [see Warnings and Precautions (5.1)].

Hyperglycemia or Hypoglycemia

Inform patients that hypoglycemia is the most common adverse reaction with insulin. Instruct patients on self-management procedures including glucose monitoring, proper injection technique, and management of hypoglycemia and hyperglycemia, especially at initiation of FIASP therapy. Instruct patients on handling of special situations such as intercurrent conditions (illness, stress, or emotional disturbances), an inadequate or skipped insulin dose, inadvertent administration of an increased insulin dose, inadequate food intake, and skipped meals. Instruct patients on the management of hypoglycemia [see Warnings and Precautions (5.3)].

Inform patients that their ability to concentrate and react may be impaired as a result of hypoglycemia. Advise patients who have frequent hypoglycemia or reduced or absent warning signs of hypoglycemia to use caution when driving or operating machinery.

Advise patients that changes in insulin regimen can predispose to hyperglycemia or hypoglycemia and that changes in insulin regimen should be made under close medical supervision [see Warnings and Precautions (5.2)].

Hypersensitivity Reactions

Advise patients that hypersensitivity reactions have occurred with FIASP. Inform patients on the symptoms of hypersensitivity reactions [see Warnings and Precautions (5.6)].

Hypoglycemia due to Medication Errors

Instruct patients to always check the insulin label before each injection to avoid mix-ups between insulin products.

Patients Using Continuous Subcutaneous Insulin Pumps

Train patients in intensive insulin therapy with multiple injections and in the function of their pump and pump accessories.
Instruct patients to follow healthcare provider recommendations when setting basal and meal time infusion rate.
Refer to the continuous subcutaneous infusion pump user manual to see if FIASP can be used with the pump. See recommended reservoir and infusion sets in the insulin pump user manual.
Instruct patients to replace insulin in the reservoir at least every 6 days, or according to the pump user manual, whichever is shorter; infusion sets and infusion set insertion sites should be changed in accordance with the manufacturers’ user manual. By following this schedule, patients avoid insulin degradation, infusion set occlusion, and loss of the insulin preservative.
Instruct patients to discard insulin exposed to temperatures higher than 37°C (98.6°F).
Instruct patients to inform physician and select a new site for infusion if infusion site becomes erythematous, pruritic, or thickened.
Instruct patients on the risk of rapid hyperglycemia and ketosis due to pump malfunction, infusion set occlusion, leakage, disconnection or kinking, and degraded insulin. Instruct patients on the risk of hypoglycemia from pump malfunction. If these problems cannot be promptly corrected, instruct patients to resume therapy with subcutaneous insulin injection and contact their physician [see Warnings and Precautions (5) and How Supplied/Storage and Handling (16.2)].

Date of Issue: 12/2019

Version: 6

Novo Nordisk® , FIASP® , NovoLog® , FlexTouch® , and PenFill® are registered trademarks of Novo Nordisk A/S.

PATENT Information: http://novonordisk-us.com/patients/products/product-patents.html

© 2019 Novo Nordisk A/S

Manufactured by:
Novo Nordisk A/S
DK-2880 Bagsvaerd, Denmark

For information about FIASP contact:
Novo Nordisk Inc.
800 Scudders Mill Road
Plainsboro, New Jersey 08536
1-800-727-6500
www.novonordisk-us.com

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