Patient information: uses, side effects, how to take - Voyxact

What is VOYXACT?

VOYXACT is a prescription medicine used to reduce protein in the urine (proteinuria) in adults with a kidney disease called primary immunoglobulin A nephropathy (IgAN) who are at risk for their disease getting worse.

It is not known if VOYXACT is safe and effective in children.

Do not take VOYXACT if you:

are allergic to any of the ingredients in VOYXACT. See the end of this Patient Information for a complete list of ingredients in VOYXACT. Stop using VOYXACT and get emergency help if you develop signs and symptoms of an allergic reaction, including:

breathing problems
swelling of the face, lips, mouth, tongue or throat
dizziness or feel lightheaded

itching
hives
skin rash

Before taking VOYXACT, tell your healthcare provider about all of your medical conditions, including if you:

have an infection.
have received or plan to receive therapy that can lower the ability of your immune system to fight infections (immunosuppressive therapy).
have recently received or are scheduled to receive an immunization (vaccine). VOYXACT may affect your immune system response to vaccines and increase your risk of infection from live vaccines.
are pregnant or plan to become pregnant. It is not known if VOYXACT will harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known if VOYXACT passes into your breast milk or if it will affect your baby. Talk to your healthcare provider about the best way to feed your baby during treatment with VOYXACT.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I take VOYXACT?

Read the detailed "Instructions for Use" that comes with VOYXACT for information about how to prepare and inject VOYXACT, and how to properly store and throw away (dispose of) used VOYXACT prefilled syringes.
Use VOYXACT exactly as your healthcare provider tells you to.
VOYXACT is given as an injection under the skin (subcutaneous injection).
Inject VOYXACT under the skin (subcutaneous injection) in the front of your upper legs (thighs) or stomach area (abdomen), avoiding the area 2 inches around the belly button. The back of the upper arms may also be used if a caregiver gives the injection.
If you miss a dose of VOYXACT, inject the missed dose as soon as possible. Then take your next dose in 4 weeks.

What are the possible side effects of VOYXACT?

VOYXACT can cause serious side effects, including:

immunosuppression and increased risk of infections. VOYXACT weakens your immune system, which may increase your risk of infections. Your healthcare provider will check you for signs and symptoms of infections before you start and during treatment with VOYXACT. Tell your healthcare provider right away if you develop any signs and symptoms of infection during treatment with VOYXACT, including:

fever
chills
feeling tired
cough

flu-like symptoms
aches and pain
warm, red, or painful skin

The most common side effects of VOYXACT include: upper respiratory tract infection and skin redness at your injection site.

These are not all of the possible side effects of VOYXACT.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store VOYXACT?

Store VOYXACT in the refrigerator between 36°F to 46°F (2°C to 8°C).
Keep the VOYXACT prefilled syringe in its original box to protect it from light.
Let the VOYXACT prefilled syringe come to room temperature up to 77°F (25°C) for 15 to 30 minutes before giving the injection.
When the VOYXACT prefilled syringe has reached room temperature, do not put it back in the refrigerator.
Do not use VOYXACT if it has been at room temperature for 7 days or longer.
Do not freeze the VOYXACT prefilled syringe.
Do not shake the VOYXACT prefilled syringe.
Keep the VOYXACT prefilled syringe away from heat and direct sunlight.
Do not use past the expiration date printed on the box.

Keep VOYXACT and all medicines out of the reach of children.

General information about the safe and effective use of VOYXACT.

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

What are the ingredients in VOYXACT?

Active ingredient: sibeprenlimab-szsi

Inactive ingredients: arginine, glutamic acid, histidine, L-histidine hydrochloride monohydrate, polysorbate 80, sorbitol, and Water for Injection.

VOYXACT prefilled syringe is not made with natural rubber latex.

Manufactured by:

Otsuka Pharmaceutical Company, Ltd., Tokyo, 101-8535 Japan

U.S. License No 2387

Distributed by:

Otsuka America Pharmaceutical, Inc.

Rockville, MD 20850, USA

For more information, call 1-833-869-9228 or visit www.VOYXACT.com.

INSTRUCTIONS FOR USE

VOYXACT^®(VOY-ZAKT)

(sibeprenlimab-szsi)

injection, for subcutaneous use

Single-Dose Prefilled Syringe

This Instructions for Use contains information on how to inject VOYXACT. Read and follow this Instructions for Use before you inject VOYXACT prefilled syringe for the first time and each time you get a refill. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. Your healthcare provider should show you or your caregiver how to prepare and inject VOYXACT the right way before you use or give it for the first time.

Important Information You Need to Know Before Injecting VOYXACT Prefilled Syringe

VOYXACT prefilled syringe is for injection under the skin (subcutaneous injection) use only.
Do not remove the grey needle cap from the prefilled syringe until you are ready to inject.
Each prefilled syringe has a needle guard. It will automatically cover the needle after the injection is completed.
Do not pull back on the plunger at any time.
Do not use if the VOYXACT prefilled syringe has been damaged.
Do not use if the VOYXACT prefilled syringe has been dropped after removing the needle cap.

Storing VOYXACT Prefilled Syringe

Store your VOYXACT prefilled syringe in a refrigerator between 36°F to 46°F (2°C to 8°C). Keep the prefilled syringe in its original box to protect it from light.
Let the VOYXACT prefilled syringe come to room temperature up to 77°F (25°C) for 15 to 30 minutes before giving an injection.
When the VOYXACT prefilled syringe has reached room temperature, do not put it back in the refrigerator.
Do not use the VOYXACT prefilled syringe if it has been at room temperature for 7 days or longer.
Do not freeze the VOYXACT prefilled syringe.
Do not shake the VOYXACT prefilled syringe.
Keep the VOYXACT prefilled syringe away from heat and direct sunlight.
Throw away (dispose of) any VOYXACT prefilled syringe if it is expired. See Step 11 for instructions on how to throw away (dispose of) the VOYXACT prefilled syringe.
Keep VOYXACT prefilled syringe and all medicines out of the reach of children.

Your VOYXACT Single-Dose Prefilled Syringe

Getting Your Supplies Ready

Step 1: Remove the VOYXACT prefilled syringe box from the refrigerator

Take the box containing VOYXACT prefilled syringe out of the refrigerator and check the expiration date (EXP) on the side of the box.

Do not use the prefilled syringe if the seals on the box have been broken.
Do not use the prefilled syringe if the expiration date (EXP) printed on the box has passed.

Step 2: Wait 15 to 30 minutes before use

Wait 15 to 30 minutes to let the prefilled syringe come to room temperature naturally (see Figure A ).

Do not warm the prefilled syringe any other way.
Do not let the prefilled syringe sit in direct sunlight.

Figure A

Step 3: Gather supplies

Gather supplies that are not included in the VOYXACT prefilled syringe box:

Alcohol swabs
Cotton balls or gauze
Adhesive bandages
Sharps disposal container (see Step 11 )

Preparing to Inject the VOYXACT Prefilled Syringe

Step 4: Take the VOYXACT prefilled syringe out of the box

Hold the middle of the prefilled syringe (near the viewing window) to carefully lift the prefilled syringe out of the box (see Figure B ).

Do not lift the prefilled syringe by the plunger.
Do not shake or roll the prefilled syringe.
Do not remove the grey needle cap from the prefilled syringe until Step 8 and you are ready to inject.

Figure B

Step 5: Inspect the VOYXACT Prefilled Syringe

Make sure that VOYXACT appears on the labels.
Check the expiration date (EXP) printed on the prefilled syringe (see Figure C ).
Check the medicine in the prefilled syringe through the viewing window. It is normal to see air bubbles. The medicine inside should be clear to slightly pearly and colorless to yellow (see Figure C ).
Do not use VOYXACT prefilled syringe if:
- the expiration date printed on the prefilled syringe label has passed.
- the medicine is cloudy, discolored, or has particles floating in it.
- any part of the prefilled syringe is damaged, broken, or the needle guard has been activated.
Do not try to remove air bubble(s) from the prefilled syringe.

Figure C

Step 6: Choose the injection site

Choose an injection site on your bare skin from 1 of the following areas (see Figure D ):

front of upper thigh
stomach area (abdomen), avoiding the area 2 inches around the belly button.
For caregiver only: back of the upper arm may also be used.
Do not inject into the same spot you used for your last injection.
Do not inject into moles, scars, or bruises or skin that is tender, damaged, hard or red.

Figure D

Step 7: Clean the injection site

Wash your hands with soap and clean water (see Figure E ).

Figure E

Clean the injection site with an alcohol swab and let the skin dry (see Figure F ).
Do not touch the area again before injecting.
Do not fan or blow on the injection site after you have cleaned it.

Figure F

Injecting VOYXACT

Step 8: Remove the needle cap

When you are ready to inject, hold the prefilled syringe with 1 hand, pull the needle cap straight off with the other hand (see Figure G ).

You may see a drop of liquid at the end of the needle. This is normal.
Do not touch or recap the needle or let it touch any surface.
Do not touch or pull back the plunger.
Do not use a prefilled syringe with a bent or broken needle.

Figure G

Step 9: Pinch the skin and insert needle

With the needle cap off, hold the prefilled syringe in 1 hand. With your other hand, gently pinch the skin at the injection site (see Figure H ).

It is important to pinch enough skin to inject under the skin and not into the muscle.

Insert the entire needle at a 45-degree angle into the pinched skin using a dart-like motion (see Figure H ).

Avoid touching the plunger until the needle is inserted.

Figure H

Step 10: Complete the Injection

Push the plunger as far as it will go and it stops, and all the medicine is injected (see Figure I ).

Figure I

Take your thumb off the plunger to allow the needle guard to automatically cover the exposed needle (see Figure J ).

Figure J

Gently lift the syringe away from the injection site (see Figure K ).

There may be a small amount of blood or liquid at the injection site. Hold pressure over your skin with a cotton ball or gauze until any bleeding stops.
Apply an adhesive bandage, if needed.
Do not rub or massage the injection site.

Figure K

Disposing of the VOYXACT Prefilled Syringe

Step 11: Throw away (dispose of) the VOYXACT prefilled syringe

Throw away (dispose of) the used prefilled syringe in a FDA-cleared sharps disposal container right away after use (see Figure L ). Do not recycle or throw away the prefilled syringe in your household trash.

Figure L

Throw away the remaining supplies in your household trash or sharps container.
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 local or state laws about how to throw away 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 recycle your used sharps disposal container.

If you have questions or concerns about your VOYXACT prefilled syringe, please call your healthcare provider. You can also call 1-800-441-6763 or visit www.VOYXACT.com for more information.

Manufactured by:

Otsuka Pharmaceutical Company, Ltd.

Tokyo 101-8535 Japan

U.S. License No 2387

Distributed by:

Otsuka America Pharmaceutical, Inc.

Rockville, MD 20850 USA

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

Issued: Nov 2025