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Efgartigimod alfa and hyaluronidase

Pronunciation: EF-gar-TIG-i-mod AL-fa and HYE-al-ure-ON-i-dase
Generic name: efgartigimod alfa and hyaluronidase-qvfc
Brand name: Vyvgart Hytrulo
Dosage form: single-dose prefilled syringe for subcutaneous injection (efgartigimod alfa 1000 mg/hyaluronidase 10,000 units), single-dose vial for subcutaneous injection (efgartigimod alfa 1008 mg/ hyaluronidase 11,200 units)
Drug class: Immune globulins

Medically reviewed by Carmen Pope, BPharm. Last updated on Jul 8, 2025.

What is efgartigimod alfa and hyaluronidase?

Efgartigimod alfa and hyaluronidase (Vyvgart Hytrulo) is an injection used to treat generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) antibody-positive, and for adults with chronic inflammatory demyelinating polyneuropathy (CIDP). It is given subcutaneously (under the skin) once a week and can be self-administered or administered by a caregiver or healthcare provider. 

Efgartigimod alfa works by blocking the neonatal Fc receptor (FcRn), a protein that normally extends the lifespan of antibodies in the body. By blocking these receptors, harmful IgG antibodies remain unattached and are naturally removed. This mechanism helps treat CIDP and gMG, conditions where harmful antibodies cause disease. Efgartigimod alfa belongs to the drug class called neonatal Fc receptor (FcRn) inhibitors. The hyaluronidase component allows this medicine to be given subcutaneously. Hyaluronidase is an enzyme that temporarily increases the permeability of subcutaneous tissue by depolymerizing a critical component of the skin's structure called hyaluronan, allowing larger injection quantities to be given subcutaneously. The integrity of the subcutaneous tissue is restored within 24 to 48 hours.

Efgartigimod alfa + hyaluronidase (Vyvgart Hytrulo) first gained FDA approval on June 20, 2023, for gMG, and approval was extended on June 21, 2024, to cover chronic inflammatory demyelinating polyneuropathy (CIDP). There is no generic or biosimilar.

Side effects

The most common side effects of efgartigimod alfa and hyaluronidase are:

Serious side effects and warnings

Efgartigimod alfa + hyaluronidase can cause the following serious side effects.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Before receiving this medicine

Do not receive efgartigimod alfa + hyaluronidase if you are allergic to efgartigimod alfa, hyaluronidase, Vyvgart, Vyvgart Hytrulo, or any of the inactive ingredients in the preparation. Efgartigimod alfa can cause serious allergic reactions and a decrease in blood pressure leading to fainting.

To make sure efgartigimod alfa + hyaluronidase is safe for you, tell your doctor if you:

Pregnancy

It is not known whether efgartigimod alfa + hyaluronidase will harm your unborn baby.

Pregnancy Exposure Registry. There is a pregnancy exposure registry for women who use efgartigimod alfa + hyaluronidase 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

Breastfeeding

It is not known if efgartigimod alfa + hyaluronidase passes into your breast milk.  

How is efgartigimod alfa + hyaluronidase administered?

Administer efgartigimod alfa + hyaluronidase exactly as your healthcare provider tells you to.

Efgartigimod alfa + hyaluronidase comes in a single-dose prefilled syringe and single-dose vial.

Efgartigimod alfa + hyaluronidase is given as a slow and steady injection.

Dosing information

Dose of efgartigimod alfa + hyaluronidase for gMG in adults

Subsequent treatment cycles may be administered based on clinical evaluation.

Dose of efgartigimod alfa + hyaluronidase for CIDP in adults

What happens if I miss a dose?

If you miss a dose, ring your healthcare provider to reschedule. The injection may be administered up to 3 days after the scheduled time. Resume the original dosing schedule until the treatment cycle is completed.

What happens if I overdose?

An overdose is unlikely because efgartigimod alfa + hyaluronidase is administered by a healthcare provider.

What should I avoid while receiving efgartigimod alfa?

You should avoid receiving live vaccines, such as chickenpox, measles, or mumps while you are being treated with this medicine.

What other drugs will affect efgartigimod alfa?

Efgartigimod alfa + hyaluronidase may interact with other prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use, and when you start, stop, or change a dose of any medicine.

Care should be taken when using efgartigimod alfa + hyaluronidase with other medications that bind to the human neonatal Fc receptor (FcRn) (such as immunoglobulin products, monoclonal antibodies, or antibody derivates containing the human Fc domain of the IgG subclass) because it may reduce the effectiveness of these medications.

Does Efgartigimod alfa/hyaluronidase interact with my other drugs?

Enter medications to view a detailed interaction report using our Drug Interaction Checker.

Storage

Refrigerator

Store Vyvgart Hytrulo in the refrigerator between 36°F to 46°F (2°C to 8°C).

Only warm Vyvgart Hytrulo just before use 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 (eg, with an external heat source).

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.

Keep  Vyvgart Hytrulo and all medicines out of the reach of children.

Ingredients

Available as Vyvgart Hytrulo 

Active ingredients: efgartigimod alfa and hyaluronidase (human recombinant)

Inactive ingredients:

Vyvgart Hytrulo is available as:

Preservative-free.

Manufacturer

Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) is manufactured by:

It is distributed by argenx US, Inc. 33 Arch Street, Boston, MA 02110.

Efgartigimod alfa/hyaluronidase Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for efgartigimod alfa/hyaluronidase.

Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) - Argenx BV
Formulation type Strength
Pre-Filled Syringe 1,000 mg/5 mL;10,000 units/5 mL (200 mg/2,000 units/mL)
Single-Dose Vial 1,008 mg/5.6 mL; 11,200 units/5.6 mL (180 mg/2,000 units/mL)

View Vyvgart Hytrulo information in detail.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.