Vyvgart Hytrulo

Generic name: efgartigimod alfa and hyaluronidase-QVFC
Dosage form: injection (1,008 mg efgartigimod alfa and 11,200 units hyaluronidase per 5.6 mL)
Drug class: Immune globulins

Medically reviewed by Carmen Pope, BPharm. Last updated on Jun 25, 2024.

What is Vyvgart Hytrulo?

Vyvgart Hytrulo infusion is used to treat generalized myasthenia gravis (gMG) to improve muscle strength and for chronic inflammatory demyelinating polyneuropathy (CIDP) to slow symptom deterioration in adults. Vyvgart Hytrulo contains a combination of efgartigimod alfa and hyaluronidase. 

Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase) works by attaching to and blocking a protein called neonatal Fc receptor (FcRn) which is involved in regulating levels of autoantibodies. Autoantibodies are produced by the immune system of people with generalized myasthenia gravis that damage acetylcholine receptors, which prevents acetylcholine from activating them. For a muscle to contract, acetylcholine released from the end of a nerve must be able to attach to acetylcholine receptors.  If autoantibodies damage these receptors then the muscles are not able to contract as well as normal, leading to muscle weakness and difficulty moving.

The hyaluronidase component allows Vyvgart Hytrulo to be given subcutaneously. Hyaluronidase is an endoglycosidase that releases oligosaccharides from glycoproteins or glycolipids. It transiently increases the permeability of the subcutaneous tissue by depolymerizing hyaluronan, a critical component of the extracellular matrix that regulates normal structural integrity and development. Permeability of the subcutaneous tissue is restored within 24 to 48 hours.

Generalized myasthenia gravis is a rare disease characterized by severe, life-threatening, muscular weakness that can cause symptoms such as difficulty breathing, double vision, drooping eyelids, and difficulty swallowing, chewing, and talking. The global prevalence is 100–350 cases per every 1 million people and it can occur in any race, gender or age.

Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) is an autoimmune disorder caused by the body's immune system attacking the myelin that insulates and protects the body’s nerves. It is a slowly developing disorder with symptoms of gradual weakness or sensation changes in the arms or legs. Symptoms may get worse over time, or they might come and go

Related/similar drugs

azathioprine, pyridostigmine, Imuran, Mestinon, Hizentra, neostigmine, Gammagard Liquid

What is Vyvgart Hytrulo used for?

Vyvgart Hytrulo received FDA approval on June 20, 2023, for adults with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive. The approval was expanded to include adults with chronic inflammatory demyelinating polyneuropathy (CIDP).

Vyvgart Hytrulo side effects

Common Vyvgart Hytrulo side effects include respiratory tract infections, headache, urinary tract infections, and injection site reactions, which occurred in 10% or more patients.

Serious Vyvgart Hytrulo side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• signs of infection--fever, chills, sore throat, body aches, unusual tiredness, loss of appetite, bruising, or bleeding.

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 FDA at 1-800-FDA-1088.

Warnings

Vyvgart Hytrulo can increase your risk of infection and should not be administered if you currently have an infection. Call your doctor at once if you develop fever, chills, sore throat, body aches, unusual tiredness, loss of appetite, bruising, or bleeding.

Hypersensitivity reactions 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. Your doctor will monitor you during your infusion for hypersensitivity reactions. Seek medical attention if you develop any allergic reactions.

Infusion-related reactions have been reported with intravenous efgartigimod alfa-fcab in postmarketing experience.

Before taking this medicine.

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

• currently have an infection or have had any infections recently
• have received or are scheduled to receive a vaccine (immunization). All age-appropriate immunizations should be completed before starting Vyvgart Hytrulo. Administration of live or live-attenuated vaccines is not recommended during treatment
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

How is Vyvgart Hytrulo given?

Vyvgart Hytrulo will be administered by your healthcare provider in their clinic. It will be given subcutaneously (this means under the skin) in your abdominal area but not close to your navel, over 30 to 90 seconds. You will be monitored for hypersensitivity reactions for 30 minutes afterward.

Vyvgart Hytrulo dosage

Generalized myasthenia gravis dosage

• The recommended dosage is 1,008 mg/11,200 units (1,008 mg efgartigimod alfa and 11,200 units hyaluronidase).
• One treatment cycle usually consists of 4 injections given once weekly 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.

Chronic inflammatory demyelinating polyradiculoneuropathy dosage

• The recommended Vyvgart Hytrulo dosage is 1,008 mg / 11,200 units (1,008 mg efgartigimod alfa and 11,200 units hyaluronidase) 
• administered subcutaneously once weekly injections.

What happens if I miss a dose?

If a scheduled dose is missed,  the infusion may be administered up to 3 days after the scheduled time point. Thereafter, resume the original dosing schedule until the treatment cycle is completed. Call your doctor for instructions if you miss an appointment for your infusion.

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 while you are being treated with this medicine.

What other drugs will affect Vyvgart Hytrulo?

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 may have interactions 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.

Storage

Store vials of Vyvgart Hytrulo in the refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light until the time of use. Do not freeze. Do not shake.

Unopened vials may be stored in the original carton for up to 3 days at room temperature at 20°C to 25°C (68°F to 77°F) for a single period before administration or returned to refrigeration. Do not store the vial at room temperature more than one time.

Ingredients

Injection: 1,008 mg efgartigimod alfa and 11,200 units hyaluronidase per 5.6 mL (180 mg/2,000 units per mL) as yellowish, clear to opalescent solution, in a single-dose vial.

Preservative free.

Company

Manufactured by: argenx BV, argenx BV, Industriepark 7, 9052 Zwijnaarde, Belgium

U.S. License No. 2217 Halozyme Therapeutics, 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 

Further information

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

Medical Disclaimer