Garzulys (Insulin aspart): Uses, Side Effects and Dosage

What is Garzulys?

• Garzulys is a man-made insulin that is used to control high blood sugar in adults and children with diabetes mellitus.

Who should not take Garzulys?

Do not take Garzulys if you:

• are having an episode of low blood sugar (hypoglycemia).
• have an allergy to insulin aspart products or any of the ingredients in Garzulys.

Before taking Garzulys, tell your healthcare provider about all your medical conditions including, if you are:

• pregnant, planning to become pregnant, or are breastfeeding.

Tell your healthcare provider about all the medicines you take, including new prescriptions or over-the-counter medicines, vitamins, or herbal supplements.

Before you start taking Garzulys, talk to your healthcare provider about low blood sugar and how to manage it.

How should I take Garzulys?

• Read the Instructions for Use that come with your Garzulys.
• Take Garzulys exactly as your healthcare provider tells you to.
• Garzulys starts acting fast. You should eat a meal within 5 to 10 minutes after you take your dose of Garzulys.
• Know the type and strength of insulin you take. Do not change the type of insulin you take unless your healthcare provider tells you to. The amount of insulin and the best time for you to take your insulin may need to change if you take different types of insulin.
• Check your blood sugar levels. Ask your healthcare provider what your blood sugars should be and when you should check your blood sugar levels.
• Do not reuse or share your needles with other people. You may give other people a serious infection or get a serious infection from them.
• Garzulys can be injected under the skin (subcutaneously) of your stomach area (abdomen), buttocks, upper legs (thighs) or upper arms, or by continuous infusion under the skin (subcutaneously) through an insulin pump into an area of your body recommended in the instructions that come with your insulin pump.

• Change (rotate) your injection sites within the area you choose with 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 exact same spot 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.

What should I avoid while taking Garzulys?

While taking Garzulys do not:

• Drive or operate heavy machinery, until you know how Garzulys affects you.
• Drink alcohol or use prescription or over-the-counter medicines that contain alcohol.

What are the possible side effects of Garzulys?

Garzulys may cause serious side effects that can lead to death, including:

Low blood sugar (hypoglycemia). Signs and symptoms that may indicate low blood sugar include:

• dizziness or light-headedness
• sweating
• confusion
• headache

• blurred vision
• slurred speech
• shakiness
• fast heart beat

• anxiety, irritability, or mood changes
• hunger

Your insulin dose may need to change because of:

• change in level of physical activity or exercise
• weight gain or loss

• increased stress
• illness

• change in diet

Other common side effects of Garzulys may include:

• low potassium in your blood (hypokalemia), reactions at the injection site, itching, rash, serious allergic reactions (whole body reactions), skin thickening or pits at the injection site (lipodystrophy), weight gain, and swelling of your hands and feet.

Get emergency medical help if you have:

• trouble breathing, shortness of breath, fast heartbeat, swelling of your face, tongue, or throat, sweating, extreme drowsiness, dizziness, confusion.

These are not all the possible side effects of Garzulys. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of Garzulys.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your pharmacist or healthcare provider for information about Garzulys that is written for health professionals. Do not use Garzulys for a condition for which it was not prescribed. Do not give Garzulys to other people, even if they have the same symptoms that you have. It may harm them.

What are the ingredients in Garzulys?

Active Ingredient: insulin aspart-fsan

Inactive Ingredients: dibasic sodium phosphate, glycerin, metacresol, phenol, sodium chloride, zinc, and Water for Injection, USP. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH.

Additional Patient Information Leaflets are available at http://www.meithealpharma.com or call 1-844-824-8426.

Brands listed are the trademarks of their respective owners.

meitheal_®

Manufactured for: Meitheal Pharmaceuticals

Chicago, IL 60631 (USA)

©2026 Meitheal Pharmaceuticals Inc.

Manufactured by: Emerge Bioscience Pte. Ltd.

Singapore 069535

U.S. License Number 2395

Garzulys™ is a registered trademark of Emerge Bioscience Pte. Ltd.

July 2026

This Patient Information has been approved by the U.S. Food and Drug Administration.

INSTRUCTIONS FOR USE

GARZULYS™ [gar-zoo'-lis]

(insulin aspart-fsan)

injection, for subcutaneous use

10 mL Multiple Dose Vial (100 Units/mL, U-100)

Read this Instructions for Use before you start taking Garzulys 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.

Supplies you will need to give your Garzulys injection:

• 10 mL Garzulys vial
• insulin syringe and needle
• alcohol swabs

Preparing your Garzulys dose:

• Wash your hands with soap and water.
• Before you start to prepare your injection, check the Garzulys 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.
• Garzulys should look clear and colorless. Do not use Garzulys if it is thick, cloudy, or is colored.
• Do not use Garzulys 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 black tip 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 Garzulys vial (See Figure D).	(Figure D)
Step 5: Push the plunger all the way in. This puts air into the Garzulys vial (See Figure E).	(Figure E)
Step 6: Turn the Garzulys vial and syringe upside down and slowly pull the plunger down until the black tip 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 black tip reaches the line for your Garzulys dose (See Figure H).	(Figure H)
Step 8: Check the syringe to make sure you have the right dose of Garzulys.
Step 9: Pull the syringe out of the vial's rubber stopper (See Figure I).	(Figure I)

Giving your Injection:

• Inject your Garzulys exactly as your healthcare provider has shown you. Your healthcare provider should tell you if you need to pinch the skin before injecting.
• Garzulys can be injected under the skin (subcutaneously) of your stomach area, buttocks, upper legs or upper arms, infused in an insulin pump (continuous subcutaneous infusion 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.
• If you inject Garzulys, 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.
• If you use Garzulys in an insulin pump, you should change your infusion set and insertion site according to the manufacturer’s user manual. Garzulys can be used with the continuous subcutaneous insulin infusion pumps labeled for use with Garzulys or NOVOLOG. Read the insulin pump user manual to see if Garzulys or NOVOLOG can be used. Garzulys should be given into an area of your body recommended in the instructions that come with your insulin pump. Change (rotate) your insertion sites within the area you choose for each insertion to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the insertion sites. Do not insert into the exact same spot for each insertion. Do not insert where the skin has pits, is thickened, or has lumps. Do not insert where the skin is tender, bruised, scaly or hard, or into scars or damaged skin. The insulin in the reservoir should be changed at least every 7 days or according to the pump user manual, whichever is shorter, even if you have not used all of the insulin.
• If you use Garzulys in an insulin pump, see your insulin pump manual for instructions or talk to your healthcare provider.
• NPH insulin is the only type of insulin that can be mixed with Garzulys. Do not mix Garzulys with any other type of insulin.
• Garzulys should only be mixed with NPH insulin if it is going to be injected right away under your skin (subcutaneously).
• Garzulys should be drawn up into the syringe before you draw up your NPH insulin.
• Talk to your healthcare provider if you are not sure about the right way to mix Garzulys and NPH insulin.

Step 10: Choose your injection site (stomach area, buttocks, upper legs or upper arms) and wipe the skin with an alcohol swab. Let the injection site dry before you inject your dose (See Figure J).	(Figure J)
Step 11: Insert the needle into your skin. Push down on the plunger to inject your dose (See Figure K). The needle should remain in the skin for at least 6 seconds to make sure you have injected all the insulin.	(Figure K)
Step 12: Pull the needle out of your skin. After that, you may see a drop of Garzulys 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:

• Do not recap the needle. Recapping the needle can lead to a needle stick injury.
• Put the empty insulin vials, used needles and syringes in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles and syringes and needles in your household trash.

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

  • made of a heavy-duty plastic,
  • can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
  • upright and stable during use,
  • leak-resistant, and properly labeled to warn of hazardous waste inside the container.
• 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. For more information about the 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.

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 Garzulys?

• Do not freeze Garzulys. Do not use Garzulys if it has been frozen.
• Keep Garzulys away from heat or light.

• All unopened vials:

  • Store unopened Garzulys vials in the refrigerator at 36^°F to 46^°F (2^°C to 8^°C).
  • Unopened vials may be used until the expiration date printed on the label, if they have been stored in the refrigerator.
  • Unopened vials should be thrown away after 28 days, if they are stored at room temperature.

• After vials have been opened:

  • Opened Garzulys 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 Garzulys vials after 28 days, even if they still have insulin left in them.
  • If using Garzulys in a pump, throw away all opened Garzulys vials after 19 days.

General information about the safe and effective use of Garzulys

• Always use a new syringe and needle for each injection.
• Do not share syringes or needles.
• Keep Garzulys 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.

Additional Instructions for Use are available at http://www.meithealpharma.com or call 1-844-824-8426.

Brands listed are the trademarks of their respective owners.

meitheal_®

Manufactured for: Meitheal Pharmaceuticals

Chicago, IL 60631 (USA)

©2026 Meitheal Pharmaceuticals Inc.

Manufactured by: Emerge Bioscience Pte. Ltd

Singapore 069535

U.S. License Number 2395

Garzulys™ is a registered trademark of Emerge Bioscience Pte. Ltd.

Issued: July 2026

INSTRUCTIONS FOR USE

GARZULYS™ [gar-zoo’-lis]

(insulin aspart-fsan)

injection, for subcutaneous use

3 mL Single-Patient-Use Prefilled Pen (100 units/mL, U-100)

Introduction

Please read the following instructions carefully before using your Garzulys prefilled pen.

Do not share your Garzulys prefilled pen with other people, even if the needle has been changed. You may give other people a serious infection or get a serious infection from them.

Garzulys prefilled pen is a disposable, single-patient-use, dial-a-dose insulin pen. You can select doses from 1 to 80 units in increments of 1 unit. Garzulys prefilled pen is designed to be used with needles, such as, NovoFine or NovoFine Plus.

Δ People who are blind or have vision problems should not use this Pen without help from a person trained to use the Pen.

Getting ready

Make sure you have the following items:

• Garzulys prefilled pen
• New NovoFine or NovoFine Plus needle
• Alcohol swabs

Preparing your Garzulys prefilled pen

Wash your hands with soap and water. Before you start to prepare your injection, check the label to make sure that you are taking the right type of insulin. This is especially important if you take more than 1 type of insulin. Garzulys should look clear and colorless. Do not use your Garzulys prefilled pen if the liquid contains particles or is colored.

A. Pull off the pen cap (see diagram A).

Wipe the rubber stopper with an alcohol swab.

B. Attaching the needle

Remove the protective tab from a disposable needle.

Screw the needle tightly onto your prefilled pen. It is important that the needle is put on straight (see diagram B).

Never place a disposable needle on your Garzulys prefilled pen until you are ready to take your injection.

C. Pull off the big outer needle cap (see diagram C).

D. Pull off the inner needle cap and throw it away (dispose of it) (see diagram D).

Δ Always use a new needle for each injection to make sure the needle is free of germs (sterile) and to prevent blocked needles. Do not reuse or share your needles with other people. You may give other people a serious infection or get a serious infection from them.

Δ Be careful not to bend or damage the needle before use.

Δ To reduce the risk of unexpected needle sticks, never put the inner needle cap back on the needle.

Giving the airshot before each injection

Always check for fluid from the needle before each dose. Failure to check for fluid may result in an incomplete dose.

Before each injection small amounts of air may collect in the cartridge during normal use. To avoid injecting air and to ensure proper dosing:

E. Rotate the dose selector to select 2 units (see diagram E). You will hear a click for each unit you dial.

F. Hold your Garzulys prefilled pen with the needle pointing up. Tap the cartridge gently with your finger a few times to make any air bubbles collect at the top of the cartridge (see diagram F).

G. Keep the needle pointing upwards, press the push-button all the way in (see diagram G). The dose selector returns to 0.

A drop of insulin should appear at the needle tip. If not, change the needle and repeat the procedure no more than 6 times.

If you do not see a drop of insulin after 6 times, do not use the Garzulys prefilled pen and contact Meitheal Pharmaceuticals at 1-844-824-8426.

A small air bubble may remain at the needle tip, but it will not be injected.

Selecting your dose

Check and make sure that the dose selector is set at 0.

H. Turn the dose selector to the number of units you need to inject. The pointer should line up with your dose.

The dose can be corrected either up or down by turning the dose selector in either direction until the correct dose lines up with the pointer (see diagram H). When turning the dose selector, be careful not to press the push-button as insulin will come out.

You cannot select a dose larger than the number of units left in the cartridge.

You will hear a click for every single unit dialed. Do not set the dose by counting the number of clicks you hear because you may get an incorrect dose.

Δ Do not use the cartridge scale printed on the cartridge to measure your dose of insulin.

Giving the injection

Give the injection exactly as shown to you by your healthcare provider. Your healthcare provider should tell you if you need to pinch the skin before injecting. Wipe the skin with an alcohol swab and let the area dry.

Garzulys can be injected under the skin (subcutaneously) of your stomach area, buttocks, upper legs (thighs), or upper arms.

For each injection, 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.

I. Insert the needle into your skin.

Inject the dose by pressing the push-button all the way in until the 0 lines up with the pointer (see diagram I). Be careful only to push the button when injecting.

Turning the dose selector will not inject insulin.

J. Keep the needle in the skin for at least 6 seconds and keep the push-button pressed all the way in until the needle has been pulled out from the skin (see diagram J). This will make sure that the full dose has been given.

You may see a drop of insulin at the needle tip. This is normal and has no effect on the dose you just received. If blood appears after you take the needle out of your skin, press the injection site lightly with an alcohol swab. Do not rub the area.

After the injection

Do not recap the needle. Recapping can lead to a needle stick injury. Remove the needle from the Garzulys prefilled pen after each injection and dispose of it. This helps to prevent infection, leakage of insulin, and will help to make sure you inject the right dose of insulin.

If you do not have a sharps disposal container, carefully slip the needle into the outer needle cap. Safely remove the needle and throw it away as soon as you can.

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

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

  • made of a heavy-duty plastic,
  • can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
  • upright and stable during use,
  • leak-resistant, and
  • properly labeled to warn of hazardous waste inside the container.
• 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. 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 .

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.

• When there is not enough medicine left in your Garzulys prefilled pen for your prescribed dose, the Garzulys prefilled pen may be thrown away in your household trash after you have removed the needle.

The Garzulys prefilled pen prevents the cartridge from being completely emptied. It is designed to deliver 300 units.

K. Put the pen cap on the Garzulys prefilled pen and store the Garzulys prefilled pen without the needle attached (see diagram K). Storing without the needle attached helps prevent leaking, blocking of the needle, and air from entering the Pen.

How should I store Garzulys prefilled pen?

• Do not freeze Garzulys. Do not use Garzulys if it has been frozen.
• Keep Garzulys away from heat or light.
• Store the Garzulys prefilled pen without the needle attached.

• Until first use:

  • Store unused Garzulys prefilled pen in the refrigerator at 36°F to 46°F (2°C to 8°C).
  • Unused Garzulys prefilled pen may be used until the expiration date printed on the label, if kept in the refrigerator.
  • Unused Garzulys prefilled pen stored at room temperature should be thrown away after 28 days.

• In-use:

  • Store the prefilled pen you are currently using out of the refrigerator at room temperature below 86°F (30°C) for up to 28 days.
  • The Garzulys prefilled pen you are using should be thrown away after 28 days, even if it still has insulin left in it.

Maintenance

For the safe and proper use of your prefilled pen be sure to handle it with care. Avoid dropping your prefilled pen as it may damage it. If you are concerned that your prefilled pen is damaged, use a new one. You can clean the outside of your prefilled pen by wiping it with a damp cloth. Do not soak or wash your prefilled pen as it may damage it. Do not refill your prefilled pen.

Δ Remove the needle from the Garzulys prefilled pen after each injection. This helps to ensure sterility, prevent leakage of insulin, and will help to make sure you inject the right dose of insulin for future injections.

Δ Be careful when handling used needles to avoid needle sticks and transfer of infectious diseases.

Δ Keep your Garzulys prefilled pen and needles out of the reach of children.

Δ Use Garzulys prefilled pen as directed to treat your diabetes.

Δ Do not share your Garzulys prefilled pen or needles with other people. You may give other people a serious infection or get a serious infection from them.

Δ Always use a new needle for each injection.

Δ Meitheal Pharmaceuticals is not responsible for harm due to using this insulin pen with products not recommended by Meitheal Pharmaceuticals.

Δ As a precautionary measure, always carry a spare insulin delivery device in case your Garzulys prefilled pen is lost or damaged.

Δ Remember to keep the disposable Garzulys prefilled pen with you. Do not leave it in a car or other location where it can get too hot or too cold.

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

Additional Instructions for Use are available at http://www.meithealpharma.com or call 1-844-824-8426.

Brands listed are the trademarks of their respective owners.

meitheal_®

Manufactured for: Meitheal Pharmaceuticals

Chicago, IL 60631 (USA)

©2026 Meitheal Pharmaceuticals Inc.

Manufactured by Emerge Bioscience Pte. Ltd.

Singapore 069535

U.S. License Number 2395

Garzulys™ is a registered trademark of Emerge Bioscience Pte. Ltd.

Issued: July 2026