Vyvgart Hytrulo: Uses, Side Effects and Dosage

What is VYVGART HYTRULO?

VYVGART HYTRULO is a prescription medicine used to treat adults with:

• generalized myasthenia gravis (gMG).
• chronic inflammatory demyelinating polyneuropathy (CIDP).

It is not known if VYVGART HYTRULO is safe and effective in children.

Do not take VYVGART HYTRULO if you:

• are allergic to efgartigimod alfa, hyaluronidase, or any of the ingredients in VYVGART HYTRULO. See the end of this leaflet for a complete list of ingredients in VYVGART HYTRULO. VYVGART HYTRULO can cause serious allergic reactions and a decrease in blood pressure leading to fainting.

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

• have an infection or fever.
• have recently received or are scheduled to receive any vaccinations.
• have any history of allergic reactions.
• have kidney (renal) problems.

• are pregnant or plan to become pregnant. It is not known whether VYVGART HYTRULO will harm your unborn baby.

  • Pregnancy Exposure Registry. There is a pregnancy exposure registry for women who use VYVGART HYTRULO during pregnancy. The purpose of this registry is to collect information about your health and your baby. Your healthcare provider can enroll you in this registry. You may also enroll yourself or get more information about the registry by calling 1-855-272-6524 or going to https://www.Vyvgartpregnancy.com
• are breastfeeding or plan to breastfeed. It is not known if VYVGART HYTRULO passes into your breast milk.

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 VYVGART HYTRULO?

• Take VYVGART HYTRULO exactly as your healthcare provider tells you to take it.
• VYVGART HYTRULO is injected under your skin (subcutaneously) only. Do not inject into a vein (intravenously).
• For gMG, VYVGART HYTRULO is injected 1 time weekly for 4 weeks (treatment cycle).Your healthcare provider will tell you when to administer your future treatment cycles.
• For CIDP, VYVGART HYTRULO is injected 1 time weekly.
• VYVGART HYTRULO comes in a single-dose prefilled syringe and single-dose vial.
• Only a healthcare provider should inject VYVGART HYTRULO using the single-dose vial.
• If you are prescribed the VYVGART HYTRULO prefilled syringe, you or your caregiver should receive training on the right way to prepare and inject VYVGART HYTRULO prefilled syringe.
• Do not try to inject VYVGART HYTRULO prefilled syringe until you have been shown the right way by a healthcare provider. See the detailed Instructions for Use that comes with VYVGART HYTRULO prefilled syringe.
• Monitor for signs and symptoms of an allergic reaction for at least 30 minutes after administration. See " What are the possible side effects of VYVGART HYTRULO?"
• If you miss a dose of VYVGART HYTRULO, you may give the injection for up to 3 days after the missed dose. After that, continue with the normal time between doses (dosing schedule).

What are the possible side effects of VYVGART HYTRULO?

VYVGART HYTRULO can cause side effects which can be serious, including:

• Infection. VYVGART HYTRULO may increase the risk of infection. If you have an active infection, your healthcare provider should delay your treatment with VYVGART HYTRULO until your infection is gone. Tell your healthcare provider right away if you get any of the following signs and symptoms of an infection:

• fever
• chills
• frequent and painful urination
• cough

• pain and blockage of nasal passages
• wheezing
• shortness of breath

• sore throat
• excess phlegm
• nasal discharge

• Allergic reactions (hypersensitivity reactions). VYVGART HYTRULO can cause allergic reactions that can be severe. These reactions can happen during, shortly after, or weeks after your VYVGART HYTRULO injection. Tell your healthcare provider or get emergency help right away if you have any of the following symptoms of an allergic reaction:

• rash
• swelling of the face, lips, throat, or tongue
• shortness of breath
• hives

• trouble breathing
• low blood pressure
• fainting

• Infusion or injection-related reactions. VYVGART HYTRULO can cause infusion or injection-related reactions. These reactions can happen during or shortly after your VYVGART HYTRULO injection. Tell your healthcare provider if you have any of the following symptoms of an infusion or injection-related reaction:

• high blood pressure
• chills

• shivering
• chest, stomach, or back pain

The most common side effects of VYVGART HYTRULO include:

• respiratory tract infection
• injection site reactions

• headache

• urinary tract infection

These are not all the possible side effects of VYVGART HYTRULO. 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 VYVGART HYTRULO?

Refrigerated

• Store VYVGART HYTRULO in the refrigerator between 36°F to 46°F (2°C to 8°C).
• Warm VYVGART HYTRULO by letting it sit on a flat surface for at least 30 minutes for the prefilled syringe and 15 minutes for the vial. Do not warm VYVGART HYTRULO any other way (e.g., with an external heat source).
• Store VYVGART HYTRULO in the original carton to protect from light until you are ready to use it.
• Do not freeze VYVGART HYTRULO.
• Do not shake VYVGART HYTRULO.
• Do not use VYVGART HYTRULO past the expiration date.
• VYVGART HYTRULO is for one-time use only (single-dose).
• Remove from the refrigerator only the dose you are preparing to inject. Future doses should remain refrigerated until ready to use.

Room temperature

• If needed, VYVGART HYTRULO may be stored at room temperature. Record the date you removed VYVGART HYTRULO from the refrigerator.

• Single-dose prefilled syringe may be stored at room temperature (up to 86°F (30°C)) for up to 30 days. When removed from the refrigerator and brought to room temperature VYVGART HYTRULO must be used within 30 days or thrown away.

• Single-dose vial may be stored at room temperature (between 68°F to 77°F (20°C to 25°C)) for up to 3 days. When removed from the refrigerator and brought to room temperature, VYVGART HYTRULO must be used within 3 days or thrown away.

• Do not put VYVGART HYTRULO back into the refrigerator after it has warmed to room temperature.

Keep VYVGART HYTRULO and all medicines out of the reach of children.

General information about the safe and effective use of VYVGART HYTRULO.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use VYVGART HYTRULO for a condition for which it was not prescribed. Do not give VYVGART HYTRULO 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 VYVGART HYTRULO that is written for health professionals.

What are the ingredients in VYVGART HYTRULO?

Active ingredients: efgartigimod alfa and hyaluronidase (human recombinant)

Inactive ingredients:

• single-dose prefilled syringe: arginine hydrochloride, histidine, L-histidine hydrochloride monohydrate, methionine, polysorbate 80, sodium chloride, sucrose, and water for injection, USP
• single-dose vial: arginine hydrochloride, histidine, L-histidine hydrochloride monohydrate, methionine, polysorbate 80, sodium chloride, sucrose and water for injection, USP

Manufactured by:

• argenx BV Industriepark 7, 9052 Zwijnaarde, Belgium, U.S. License No. 2217
• Halozyme, Inc. 12390 El Camino Real, San Diego, CA 92130, U.S. License No. 2187

Distributed by: argenx US, Inc. 33 Arch Street, Boston, MA 02110

VYVGART HYTRULO is a registered trademark of argenx BV.

© 2026 argenx BV

INSTRUCTIONS FOR USE

VYVGART HYTRULO [viv' gart hye troo' loe]

(efgartigimod alfa and hyaluronidase-qvfc)

injection, for subcutaneous use

1,000 mg and 10,000 units/5 mL

This Instructions for Use contains information on how to inject VYVGART HYTRULO.

Important Information You Need to Know Before Injecting VYVGART HYTRULO

• VYVGART HYTRULO is for under the skin (subcutaneous) injection only.
• Be sure to read and understand this Instructions for Use before injecting VYVGART HYTRULO. Your healthcare provider should show you or your caregiver how to prepare and inject VYVGART HYTRULO the correct way before using it for the first time. Ask your healthcare provider if you have any questions.
• The prefilled syringe is for one-time-use only and cannot be reused.
• Do not use VYVGART HYTRULO if it has been at room temperature for longer than 30 days.
• Do not use the prefilled syringe if it is expired.
• Do not use the prefilled syringe if it is cracked, broken, or damaged. Return damaged prefilled syringes to the specialty pharmacy.
• Do not use a prefilled syringe if the liquid medicine is discolored or contains particles. The liquid medicine should look clear to yellowish in color. A little cloudiness is normal.
• Do not shake the prefilled syringe.
• You will need supplies that are not provided with VYVGART HYTRULO (see Figure J).

Storing VYVGART HYTRULO Prefilled Syringe

Store VYVGART HYTRULO in the refrigerator between 36°F to 46°F (2°C to 8°C) (see Figure A). Keep the prefilled syringes in the original carton to protect them from light until ready to use. Keep VYVGART HYTRULO and all medicines out of the reach of children.
Do not freeze the prefilled syringes or store them in direct sunlight. Do not use a prefilled syringe that has been frozen or left in direct sunlight.

Prefilled Syringe Parts

Safety Needle (not provided with VYVGART HYTRULO prefilled syringe) that is 25G, 5/8 inch length, thin wall

Gather and Check the Prefilled Syringe

1 Remove the carton from the refrigerator
1.1 Remove the carton containing the prefilled syringe from the refrigerator (see Figure C).
1.2 Remove 1 prefilled syringe from the carton (see Figure D) and place any remaining prefilled syringes back into the refrigerator for later use.
1.3 Remove the prefilled syringe from the tray (see Figure E).
2 Check the prefilled syringe before use
2.1 Check the expiration date on the prefilled syringe label (see Figure F).
Do not use the prefilled syringe if the expiration date has passed.
2.2 Check the condition of the prefilled syringe and the prefilled syringe cap (see Figure G).
Do not use the prefilled syringe if it is cracked, broken, damaged, or if the prefilled syringe cap is missing.
2.3 Check the appearance of the liquid medicine in the prefilled syringe (see Figure H). The liquid medicine should look clear to yellowish in color. A little cloudiness is normal.
Do not use the prefilled syringe if the liquid medicine is discolored or contains particles.

Prepare for the Injection

3 Allow the prefilled syringe to warm to room temperature
3.1 Place the prefilled syringe on a clean flat surface and let it sit for at least 30 minutes, to allow it to warm to room temperature (see Figure I).
Do not attempt to warm the prefilled syringe in any other way. Do not use the VYVGART HYTRULO prefilled syringe if it has been at room temperature for longer than 30 days.
4 Gather supplies and wash your hands
4.1 Gather the following supplies that are not provided with the prefilled syringe (see Figure J).
4.2 Wash your hands with soap and water (see Figure K).
5 Snap off the prefilled syringe cap and attach the safety needle
5.1 Carefully open the safety needle package and remove the needle (see Figure L). Throw away the packaging into household trash.
5.2 Bend the prefilled syringe cap to one side to snap it off and remove it from the prefilled syringe (see Figure M). Throw away the prefilled syringe cap into the household trash.
Do not touch the tip of the prefilled syringe after the prefilled syringe cap has been removed.
5.3 Hold the prefilled syringe by the syringe body in one hand, and attach the safety needle to the prefilled syringe by twisting it to the right (clockwise) until you feel resistance (see Figure N).
The safety needle is now attached to the prefilled syringe (see Figure O).
6 Choose and clean the injection site on the stomach (abdomen)
6.1 Choose an injection site on the stomach (abdomen) at least 2 inches away from the belly button (navel) (see Figure P). Change (rotate) the injection site the next time you inject VYVGART HYTRULO.
Do not inject into skin that is irritated, red, bruised, infected, or tender. Do not inject into skin that is hard, scarred, or has moles. Do not inject into a vein. VYVGART HYTRULO is for under the skin (subcutaneous) injection only.
6.2 Clean the chosen injection site with an alcohol swab and let it air dry (see Figure Q).
Do not blow on or touch the injection site after it has been cleaned.

Inject VYVGART HYTRULO

7 Pull back the needle shield and remove the clear needle cap
7.1 Pull the needle shield back (see Figure R). Note: The needle shield will be used after the injection to cover the needle and protect from needle-stick injuries.
7.2 Hold the prefilled syringe body and remove the clear needle cap by pulling it straight off of the needle (see Figure S). Throw away the clear needle cap into the household trash.
Do not recap the needle.
8 Give the injection
8.1 Pinch the cleaned injection site (Figure T).
While pinching the skin, insert the needle at a 45 to 90 degree angle all the way into the pinched skin (see Figure U). Then release the pinched skin.
Do not pinch the skin too tightly as this can cause bruising.
8.2 Slowly press the thumb pad down all the way until it stops to inject the liquid medicine (see Figure V). It will take about 20 to 30 seconds to inject all of the liquid medicine. You will feel resistance as you press down. Inject more slowly in case there is discomfort. It is ok if you need to pause or change your grip during the injection.
Do not try to force the thumb pad down quickly as this will make the thumb pad harder to press.
8.3 After all the liquid medicine is injected, remove the needle from the skin by pulling it straight out without changing the angle that it was inserted (see Figure W).

Throw away (dispose of) the Used Prefilled Syringe

9 Cover the needle and throw away the used prefilled syringe
9.1 Carefully push the needle shield over the needle until it snaps into place and covers the needle (see Figure X). This helps to prevent needle-stick injuries.
Do not recap the needle using the clear needle cap. Only use the needle shield to cover the needle.
9.2 Throw away the used prefilled syringe, with the needle still attached, into an FDA-cleared sharps disposal container right away after use (see Figure Y).
Do not throw away (dispose of) loose needles and syringes in your household trash.
10 Treat the injection site
10.1 If there is a small amount of blood or liquid at the injection site, press a sterile gauze over the injection site until the bleeding stops (see Figure Z). If needed, you may apply a small adhesive bandage.

Additional Disposal Information

Additional Information