Vyvgart Hytrulo

Pronunciation: VIV-gart hy-TRUE-lo
Generic name: efgartigimod alfa and hyaluronidase-qvfc
Dosage form: subcutaneous injection
Drug class: Immune globulins

Medically reviewed by Carmen Pope, BPharm. Last updated on Nov 28, 2024.

What is Vyvgart Hytrulo?

Vyvgart Hytrulo is used to treat generalized myasthenia gravis (gMG) or chronic inflammatory demyelinating polyneuropathy (CIDP) in adults.

• Vyvgart Hytrulo is given as a subcutaneous (SC; under the skin) injection over 30 to 90 seconds.
• Vyvgart Hytrulo contains a combination of efgartigimod alfa and hyaluronidase.

Vyvgart Hytrulo's mechanism of action involves attaching to and blocking a protein called neonatal Fc receptor (FcRn) which binds circulating IgG antibodies. When antibodies, including harmful ones, attach to FcRN, their time in the body is extended but those that remain unattached are removed by the body. Harmful IgG antibodies are thought to play a role in CIDP and gMG. Vyvgart Hytrulo is a fragment of an IgG antibody that keeps some FcRn receptors occupied, so more IgG antibodies, including harmful ones, remain unattached and are removed from the body. 

The hyaluronidase component of Vyvgart Hytrulo allows it to be given subcutaneously. Hyaluronidase momentarily increases the permeability of the subcutaneous tissue by depolymerizing a critical component of the skin's structure called hyaluronan. The integrity of the subcutaneous tissue is restored within 24 to 48 hours.

Vyvgart Hytrulo first gained FDA approval on June 20, 2023, for gMG and approval was extended on June 21, 2024 to cover CIDP. Vyvgart, an IV formulation of efgartigimod, received FDA approval on December 17, 2021. 

Vyvgart and Vyvgart Hytrulo both contain the same active ingredient, efgartigimod, but there are differences in their uses and the way they are given, see What is the difference between Vyvgart and Vyvgart Hytrulo?

What is Vyvgart Hytrulo used for?

Vyvgart Hytrulo is used for gMG in adults who are anti-acetylcholine receptor (AChR) antibody positive.

Vyvgart Hytrulo is also used to treat CIDP in adults.

Vyvgart Hytrulo side effects

The most common side effects of Vyvgart Hytrulo are:

• respiratory tract infections
• headache
• urinary tract infections
• red, pain, itching, bruising, or swelling at the site where the injection was given.

Serious side effects

Vyvgart Hytrulo can cause the following serious side effects.

Vyvgart Hytrulo can increase your risk of infection and should not be administered if you currently have an infection. The most common infections for Vyvgart Hytrulo-treated patients were urinary tract and respiratory tract infections. Call your healthcare provider if you develop signs or symptoms of an infection such as fever, chills, frequent and/or painful urination, cough, pain and blockage of nasal passages/sinus, wheezing, shortness of breath, fatigue, sore throat, excess phlegm, nasal discharge, back pain, and/or chest pain.

Allergic reactions (hypersensitivity reactions). These have occurred in some patients treated with Vyvgart Hytrulo. Most were mild or moderate and occurred within one hour to three weeks of medicine administration. Symptoms included rashes, swelling under the skin, and trouble breathing. Hives and serious allergic reactions, such as trouble breathing and a decrease in blood pressure leading to fainting have also been reported in patients treated with Vyvgart Hytrulo. Your doctor will monitor you during your infusion for hypersensitivity reactions. Get emergency medical help if you have signs of an allergic reaction such as hives; difficulty breathing; or swelling of your face, lips, tongue, or throat.

Infusion-related reactions. Vyvgart Hytrulo can cause infusion-related reactions. The most frequent
symptoms and signs reported were high blood pressure, chills, shivering, and chest, abdominal, and back pain.

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.

Related/similar drugs

Before receiving this medicine

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

To make sure Vyvgart Hytrulo is safe for you, tell your doctor if you:

• have any allergies
• currently have an infection or have had any infections recently
• have received or are scheduled to receive a vaccine (immunization). You should have received all your age-appropriate immunizations before starting Vyvgart Hytrulo 
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

How is Vyvgart Hytrulo administered?

Vyvgart Hytrulo is administered subcutaneously (under the skin) by a healthcare provider in their clinic.

• Vyvgart Hytrulo is given into your abdominal area but within 2 inches of your navel.
• It takes around 30 to 90 seconds for Vyvgart Hytrulo to be administered.
• After administration, you will be monitored for hypersensitivity reactions for 30 minutes.

Vyvgart Hytrulo dosage

Dosage of Vyvgart Hytrulo for gMG in adults

• Vyvgart Hytrulo 1,008 mg/11,200 units SC 1 time a week for 4 weeks.
• Subsequent treatment cycles may be administered based on clinical evaluation.
• It is unknown if it is safe to administer a subsequent treatment cycle within 50 days of the first treatment cycle.

Dosage of Vyvgart Hytrulo for CIDP in adults

• Vyvgart Hytrulo 1,008 mg / 11,200 units SC 1 time a week.

What happens if I miss a dose?

If you miss a dose, ring your healthcare provider to reschedule. The infusion 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?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while receiving Vyvgart Hytrulo?

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 Vyvgart Hytrulo?

Vyvgart Hytrulo 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 Vyvgart Hytrulo 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.

Vyvgart Hytrulo ingredients

Active ingredients: 1,008 mg efgartigimod alfa and 11,200 units hyaluronidase (human recombinant) in each 5.6 mL single-dose vial (the equivalent of 180 mg/mL efgartigimod alfa, 2,000 units/mL of hyaluronidase (human recombinant).

Inactive (per mL): histidine 1.4 mg, L-histidine hydrochloride monohydrate 2.2 mg, methionine 1.5 mg, polysorbate 20 (0.4 mg), sodium chloride 5.8 mg, sucrose 20.5 mg, and water for injection, USP, at a pH of 6.0.

Vyvgart Hytrulo is preservative-free and a yellowish, clear to opalescent solution, in a single-dose vial.

Who makes Vyvgart Hytrulo

Argenx BV manufactures Vyvgart Hytrulo.

Vyvgart hytrulo 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 Vyvgart Hytrulo.

Popular FAQ

Further information

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

Medical Disclaimer