Vyvgart
Pronunciation: VIV-gart
Generic name: efgartigimod alfa
Dosage form: injection for intravenous infusion (400 mg/20 mL)
Drug class: Immune globulins
What is Vyvgart?
Vyvgart is used to treat generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) antibody positive. It is given as an intravenous infusion once a week for 4 weeks.
Vyvgart works by attaching to and blocking a protein called neonatal Fc receptor (FcRn), which binds circulating IgG antibodies. By occupying these receptors, Vyvgart prevents harmful antibodies from binding, allowing the body to naturally remove them faster. This helps conditions such as gMG, where harmful antibodies damage nerves and muscles.
This medication guide covers Vyvgart, which first gained FDA approval on December 17, 2021, for gMG. Vyvgart Hytrulo is a formulation of Vyvgart containing hyaluronidase that can be given subcutaneously (see Vyvgart Hytrulo for more information).
Side effects
The most common side effects of Vyvgart 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 and warnings
Vyvgart can cause the following serious side effects:
- An increased risk of infection. Vyvgart should not be administered if you currently have an infection. The most common infections seen in Vyvgart-treated patients are 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, or chest pain.
- Allergic reactions (hypersensitivity reactions). These have occurred in some patients treated with Vyvgart. 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. 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 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 if you are allergic to efgartigimod alfa, Vyvgart, Vyvgart Hytrulo, or any of the inactive ingredients in the preparation. Vyvgart can cause serious allergic reactions and a decrease in blood pressure leading to fainting.
To make sure Vyvgart 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
- are pregnant or plan to become pregnant
- are breastfeeding or plan to breastfeed.
How is Vyvgart administered?
Vyvgart is administered intravenously (into a vein) by a healthcare provider in their clinic.
- Vyvgart takes about an hour to be administered.
- After administration, you will be monitored for hypersensitivity reactions for 30 minutes.
Dosing information
Dose of Vyvgart for gMG in adults
- 10 mg/kg administered as an IV infusion over 1 hour.
- Administer once 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.
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 should I avoid while receiving Vyvgart?
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?
Vyvgart 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 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.
Ingredients
Active ingredients: efgartigimod alfa 20 mg/mL
Inactive ingredients: Arginine hydrochloride, polysorbate 80, sodium chloride, sodium phosphate, dibasic, anhydrous, sodium phosphate, monobasic, monohydrate, and water for injection.
Vyvgart is available as a 400 mg in 20 mL (20 mg/mL) injection in a single-dose vial.
Manufacturer
Vyvgart is made by Argenx BV, Industriepark 7, 9052 Zwijnaarde, Belgium, and distributed by Argenx US, Inc., 33 Arch Street, Boston, MA 02110.
Vyvgart 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.
Vyvgart (efgartigimod alfa-fcab) - Argenx BV
Formulation type | Strength |
---|---|
Single-Dose Vial | 400 mg/20 mL (20 mg/mL) |
Popular FAQ
What is the difference between Vyvgart and Vyvgart Hytrulo?
Vyvgart and Vyvgart Hytrulo both contain the same active ingredient, efgartigimod, but there are differences in their uses and the way they are given, for example Vyvgart Hytrulo can be self-administered using a prefilled syringe for subcutaneous (SC) injection, whereas Vyvgart must be given by intravenous (IV) infusion by a healthcare provider.
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Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.