Vyvgart Hytrulo is a combination subcutaneous infusion that contains efgartigimod alfa and hyaluronidase which may be used to improve muscle weakness in adults with generalized myasthenia gravis who are anti-AChR antibody positive.

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.

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.

Vyvgart Hytrulo was FDA approved on June 20, 2023.

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-type reactions.

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.

• 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.

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.

• 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.

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.

Call your doctor for instructions if you miss an appointment for your infusion.

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

You should avoid receiving live vaccines while you are being treated with this medicine.

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.

Common Vyvgart Hytrulo side effects include:

• respiratory tract infections
• headache
• urinary tract infections
• injection site reactions.

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.

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.