Fiasp insulin aspart 100 [iU]/mL Injection, Solution, 5 cartridges — NDC 0169-3206-95 (Billing 00169-3206-95)

1 INDICATIONS AND USAGE FIASP is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. • FIASP is a rapid-acting human insulin analog indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus ( 1 ).

2 DOSAGE AND ADMINISTRATION • Individualize and adjust the dosage of FIASP based on route of administration, individual’s metabolic needs, blood glucose monitoring results and glycemic control goal ( 2.3 ). • Dosage adjustments may be needed when switching from another insulin, with changes in physical activity, changes in concomitant medications, changes in meal patterns, changes in renal or hepatic function or during acute illness ( 2.3 ). • Subcutaneous injection ( 2.2 ): o Inject at the start of a meal or within 20 minutes after starting a meal into the abdomen, upper arm, or thigh. o Rotate injection sites within the same region to reduce the risk of lipodystrophy and localized cutaneous amyloidosis. o Should generally be used in regimens with an intermediate- or long-acting insulin. • Continuous Subcutaneous Infusion (Insulin Pump) ( 2.2 ): o Refer to the insulin infusion pump user manual to see if FIASP can be used.

Use in accordance with the insulin pumps’ instructions for use. o Administer by continuous subcutaneous infusion using an insulin pump 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. • Intravenous Infusion: Administer only under medical supervision after diluting to concentrations from 0.5 to 1 unit/mL insulin aspart in infusion systems using polypropylene infusion bags ( 2.2 ).

2.1Important Preparation and 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. • Use FIASP FlexTouch pen with caution in patients with visual impairment who may rely on audible clicks to dial their dose. • Use PenFill cartridges with caution in patients with visual impairment. • Do not mix FIASP with any other insulin.

2.2Route 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 , 6.2 )]. • FIASP given by subcutaneous injection should generally be used in regimens with intermediate or long-acting insulin. • 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.

Continuous Subcutaneous Infusion (Insulin Pump): • Refer to the continuous subcutaneous insulin infusion pump user manual to see if FIASP or FIASP PumpCart can be used with the insulin pump. Use FIASP and FIASP PumpCart 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 infuse into areas of lipodystrophy or localized cutaneous amyloidosis [see Warnings and Precautions ( 5.2 ) 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 replace the PumpCart cartridge at least every 4 days, or according to the pump user manual, whichever is shorter.

Follow the FIASP-specific information for in-use time because FIASP-specific informa… [Excerpted — this section continues on DailyMed.]

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 • 1.6 mL single-patient-use PumpCart cartridges for use in a compatible insulin pump. Injection: 100 units/mL (U-100) available as: • 10 mL multiple-dose vial ( 3 ) • 3 mL single-patient-use FIASP FlexTouch ® pen ( 3 ) • 3 mL single-patient-use PenFill ® cartridges for use in a PenFill cartridge device ( 3 ) • 1.6 mL single-patient-use PumpCart ® cartridges for use in a compatible insulin pump ( 3 )

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 change FIASP in the pump reservoir at least every 6 days, or replace the PumpCart cartridge at least every 4 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 )] . Version: 8 Novo Nordisk ® , FIASP ® , NovoLog ® , FlexTouch ® , PenFill ® and PumpCart ® are registered trademarks of Novo Nordisk A/S.

PATENT Information: http://novonordisk-us.co… [Excerpted — this section continues on DailyMed.]

INSTRUCTIONS FOR USE FIASP (fee’ asp) (insulin aspart) injection 10 mL multiple-dose vial (100 units/mL, U-100) Read this Instructions for Use before you start taking FIASP and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

The vial is not recommended for use by the blind or visually impaired without the assistance of a person trained in the proper use of the product and insulin syringe. Do not reuse or share syringes or needles with other people. You may give other people a serious infection or get a serious infection from them.

Supplies you will need to give your FIASP injection: • a 10 mL FIASP vial • a U-100 insulin syringe and needle • 2 alcohol swabs • 1 sharps container for throwing away used needles and syringes. See “Disposing of your used needles and syringes” at the end of these instructions. Preparing your FIASP dose: • Do not roll or shake the FIASP vial.

Shaking the FIASP vial right before the dose is drawn into the syringe may cause bubbles or foam. This can cause you to draw up the wrong dose of insulin. • The tamper-resistant cap should not be loose or damaged before the first use. Do not use if the tamper-resistant cap is loose or damaged before using FIASP for the first time. • Wash your hands with soap and water. • Before you start to prepare your injection, check the FIASP label to make sure that you are taking the right type of insulin.

This is especially important if you use more than 1 type of insulin. • Check that the FIASP vial is not cracked or damaged. Do not use if the FIASP vial is cracked or damaged. • FIASP should look clear and colorless. Do not use FIASP if it is thick, cloudy, or is colored. • Do not use FIASP past the expiration date printed on the label.

Step 1: Pull off the tamper-resistant cap (See Figure A). Step 2: Wipe the rubber stopper with an alcohol swab (See Figure B). (Figure A Figure B) Step 3: Hold the syringe with the needle pointing up.

Pull down on the plunger until the tip of the plunger reaches the line for the number of units for your prescribed dose (See Figure C). (Figure C) Step 4: Push the needle through the rubber stopper of the FIASP vial (See Figure D). (Figure D) Step 5: Push the plunger all the way in.

This puts air into the FIASP vial (See Figure E). (Figure E) Step 6: Turn the FIASP vial and syringe upside down and slowly pull the plunger down until the tip of the plunger is a few units past the line for your dose (See Figure F). If there are air bubbles, tap the syringe gently a few times to let any air bubbles rise to the top (See Figure G).

(Figure F) (Figure G) Step 7: Slowly push the plunger up until the tip of the plunger reaches the line for your prescribed FIASP dose (See Figure H). (Figure H) Step 8: Check the syringe to make sure you have the right dose of FIASP. Step 9: Pull the syringe out of the rubber stopper on the vial (See Figure I).

(Figure I) Giving your FIASP injection: • Inject your FIASP exactly as your healthcare provider has shown you. Your healthcare provider should tell you if you need to pinch the skin before injecting. • You should take your dose of FIASP at the start of a meal or within 20 minutes after starting a meal. • FIASP can be injected under the skin (subcutaneously) of your stomach area, upper legs, or upper arms, infused in an insulin pump into an area of your body recommended in the instructions that come with your insulin pump, or given through a needle in your arm (intravenously) by your healthcare provider.

Do not inject FIASP into your muscle. • If you use FIASP in an insulin pump, you should change the infusion sets and the infusion set insertion site according to the pump manufacturers’ user manual. The insulin in the reservoir should be changed at least every 6 days even if you have not used all of the insulin. • If you use FIASP in an insulin pump, see your insulin pump manual… [Excerpted — this section continues on DailyMed.]