Fiasp (Page 9 of 13)

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

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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:

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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.

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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.

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Wash your hands with soap and water.

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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.

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Check that the FIASP vial is not cracked or damaged. Do not use if the FIASP vial is cracked or damaged.

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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:

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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.

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You should take your dose of FIASP at the start of a meal or within 20 minutes after starting a meal.

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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.

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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.

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If you use FIASP in an insulin pump, see your insulin pump manual for instructions or talk to your healthcare provider. Your healthcare provider should provide recommendations for appropriate basal and meal time infusion rates.

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Change (rotate) your injection sites within the area you choose for each dose to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites. Do not use the same injection site for each injection. Do not inject where the skin has pits, is thickened, or has lumps. Do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin.

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Do not dilute or mix FIASP with any other type of insulin products or solutions.

Step 10: Choose your injection site (thighs, upper arms, or abdomen) and wipe the skin with an alcohol swab (See Figure J). Let the injection site dry before you inject your dose.	(Figure J)
Step 11: Insert the needle into your skin. Push down on the plunger to inject your dose (See Figure K). Make sure you have injected all the insulin in the syringe.	(Figure K)
Step 12: Pull the needle out of your skin. After your injection you may see a drop of FIASP at the needle tip. This is normal and does not affect the dose you just received (See Figure L). • If you see blood after you take the needle out of your skin, press the injection site lightly with a piece of gauze or an alcohol swab. Do not rub the area.	(Figure L)

After your injection:

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Do not recap the needle. Recapping the needle can lead to needle stick injury.

Disposing of your used needles and syringes:

Put your used insulin needles and syringes in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles and syringes in your household trash.

If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:

o

made of a heavy-duty plastic;

o

can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out;

o

upright and stable during use;

o

leak-resistant, and

o

properly labeled to warn of hazardous waste inside the container.

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When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. Do not reuse or share needles or syringes with another person. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposal.

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Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.

How should I store FIASP?

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Do not freeze FIASP. Do not use FIASP if it has been frozen.

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Keep FIASP away from excessive heat or light.

All unopened vials:

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Store unopened FIASP vials in the refrigerator at 36^° F to 46^° F (2^° C to 8^° C) or at room temperature below 86^° F (30^° C).

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If unopened vials have been stored in the refrigerator, vials may be used until the expiration date printed on the label.

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If unopened vials have been stored at room temperature, vials should be thrown away after 28 days.

After vials have been opened:

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Opened FIASP vials can be stored in the refrigerator at 36^° F to 46^° F (2^° C to 8^° C) or at room temperature below 86^° F (30^° C).

•

Throw away all opened FIASP vials after 28 days (including 6 days pump in-use time), even if they still have insulin left in them.

General information about the safe and effective use of FIASP

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Always use a new syringe and needle for each injection to help ensure sterility and prevent blocked needles.

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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.

•

Keep FIASP vials, syringes, and needles out of the reach of children.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Manufactured by:

Novo Nordisk Inc.

800 Scudders Mill Road

Plainsboro, NJ 08536

1-800-727-6500

U.S. License No. 1261

FIASP^® is a registered trademark of Novo Nordisk A/S.

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

© 2023 Novo Nordisk

For information about FIASP^® contact:

Novo Nordisk Inc.

800 Scudders Mill Road

Plainsboro, New Jersey 08536

1-800-727-6500

www.novonordisk-us.com

Revised: 06/2023