Frequently asked questions about VYVGART

What is VYVGART?

VYVGART uses a fragment of an IgG antibody to treat adults with anti-AChR antibody positive gMG. VYVGART is pronounced VIV-gart.

AChR=acetylcholine receptor; IgG=immunoglobulin G.

How is VYVGART given?

VYVGART Hytrulo for subcutaneous injection is given by delivering medicine into the layer beneath the skin. You can self-inject in about 20-30 seconds using the VYVGART Hytrulo prefilled syringe, or a caregiver can do it for you.* You can also get a subcutaneous injection from your healthcare professional. Learn about the prefilled syringe and how self-injection works.

VYVGART for intravenous (IV) infusion is given by inserting a needle into a vein so the medicine enters the bloodstream. Your infusion may take approximately 1 hour. A doctor or nurse will monitor you for allergic reactions during and for 1 hour after your infusion. Get more details about IV infusions, including a downloadable infusion guide.

Do I have to get any vaccines before taking VYVGART?

No specific vaccines are required to start treatment. Tell your doctor if you have recently received or are scheduled to receive any vaccinations.

Do I need regular blood tests while on VYVGART?

No. Routine lab monitoring isn’t required, but your doctor will still monitor your response to treatment and look out for possible side effects.

Is VYVGART right for me?

Talk to your neurologist to see if VYVGART is right for you. Use the VYVGART Doctor Discussion Guide to talk to your doctor about your current gMG symptoms, your treatment goals, and whether VYVGART Hytrulo for subcutaneous injection or VYVGART for IV infusion could be a fit for you.

Is VYVGART intended to be taken with other medications?

Yes, in the studies, patients stayed on their current oral gMG treatments while receiving VYVGART Hytrulo or VYVGART for IV infusion. Talk to your doctor about the medications you are taking as part of your treatment plan.

How often do I need to get VYVGART?

VYVGART is given in treatment cycles with a personalized break between each cycle. Each treatment cycle is 4 treatments, 1 given each week. You’ll work with your doctor to personalize your breaks between cycles based on your symptoms and side effects. When your symptoms start to return, talk to your doctor to help them decide when you need another cycle.

For example: Your doctor may start you with a 4-week break after each of your first 3 treatment cycles. Your doctor will continue to adjust your time between additional cycles, based on your symptoms and side effects.

The safety of starting the next treatment cycle sooner than 4 weeks from the end of the previous treatment cycle has not been established.

What should I do if I miss a treatment? 

If you miss a treatment, VYVGART may be given up to 3 days after the missed treatment. After that, continue with the normal time between treatments (dosing schedule). Talk to your doctor if you have any questions about your dosing schedule.

How does VYVGART work?

VYVGART is specifically designed to attach to and block FcRn receptors, resulting in the reduction of IgG antibodies, including the harmful AChR antibodies that cause gMG symptoms. See how VYVGART works in the body.

FcRn=neonatal Fc receptor.

What results were seen in clinical studies?

VYVGART Hytrulo and VYVGART for IV infusion can improve daily abilities and reduce muscle weakness when added to your current oral gMG treatment.^†‡ See more data from the 2 VYVGART studies.

What are the side effects of VYVGART?

In the VYVGART Hytrulo study, the most common side effects of VYVGART Hytrulo-treated patients were injection site reactions, 38% (21 of 55), and headache. Injection site reactions included injection site rash, redness of the skin, itching sensation, bruising, pain, and hives.

In the VYVGART for IV infusion study, the most common side effects included respiratory tract infection (33% vs. 29%), headache (32% vs. 29%), urinary tract infection (10% vs. 5%), tingling sensation (7% vs. 5%), and muscle pain (6% vs. 1%).^§ Most infections in patients on VYVGART for IV infusion were mild to moderate. Additionally, more patients on VYVGART for IV infusion vs. placebo had lower white blood cell counts that were mild to moderate in severity.

VYVGART or VYVGART Hytrulo can cause allergic reactions such as rash, swelling of the face, lips, throat, or tongue, and shortness of breath. VYVGART Hytrulo can also cause hives. VYVGART or VYVGART Hytrulo can also increase the risk of serious allergic reactions such as trouble breathing, low blood pressure, and fainting, as well as infusion or injection-related reactions including high blood pressure, chills, shivering, and chest, stomach, or back pain. These reactions can happen during, shortly after, or weeks after treatment and can cause doctors to pause or, in some cases, stop treatment.

Learn more about the safety profiles for VYVGART Hytrulo and VYVGART for IV infusion.

*Please see Patient Information. Follow appropriate administration steps in the Instructions for Use. Monitor for signs and symptoms of an allergic reaction for at least 30 minutes after injection. If an allergic reaction occurs, you should seek medical attention.
†Defined as a decrease of 2 or more points on the Myasthenia Gravis Activities of Daily Living (MG-ADL) scale, which measures the severity of 8 common symptoms of gMG, maintained for at least 4 weeks. A lower MG-ADL score means less severe symptoms.
‡Defined as a decrease of 3 or more points on the Quantitative Myasthenia Gravis (QMG) scale, which assesses muscle weakness based on 13 items, maintained for at least 4 weeks. A lower QMG score means less muscle weakness.
§In ≥5% treated with VYVGART for IV infusion and more frequently than placebo. 

What is the VYVGART Hytrulo prefilled syringe?

VYVGART Hytrulo is a prescription medicine for adults with anti-AChR antibody positive gMG.

The prefilled syringe contains 1 dose of VYVGART Hytrulo. It’s approved for self-injection—which means that VYVGART Hytrulo can be self-injected or injected by a caregiver. It is injected under your skin (subcutaneously). Learn about the prefilled syringe.

How do I learn to self-inject?

You and/or your caregiver will receive in-person training at home or in your doctor’s office until you're ready to inject on your own. You’ll also get a demonstration kit to help you practice. Learn about self-injecting with the VYVGART Hytrulo prefilled syringe.

Where can I get the VYVGART Hytrulo prefilled syringe?

After your doctor prescribes VYVGART Hytrulo, your specialty pharmacy will contact you to discuss next steps. You can ask them if delivery to your home or doctor’s office is an option for you.^||

How long does it take to inject with the VYVGART Hytrulo prefilled syringe?

It takes about 20-30 seconds to inject with the prefilled syringe. Please see Patient Information. Follow appropriate administration steps in the Instructions for Use. Monitor for signs and symptoms of an allergic reaction for at least 30 minutes after injection. If an allergic reaction occurs, you should seek medical attention.

Do I always have to be at home to inject VYVGART Hytrulo?

The prefilled syringe can go where you go. For example, you can inject at your kitchen table or a hotel room with a view.^¶

I’m already on VYVGART Hytrulo. Is injection with the prefilled syringe different from what I’m used to?

Yes, the prefilled syringe is different from what you’re used to being given by your doctor or nurse. Injections with the prefilled syringe can be done by you or a caregiver.

In both cases, VYVGART Hytrulo works the same way in your body. If you have further questions, please talk to your doctor.

What should I ask my doctor if I want to start a conversation about self-injection with the VYVGART Hytrulo prefilled syringe?

Talk to your neurologist and ask if self-injection with VYVGART Hytrulo is right for you.

GET THE DISCUSSION GUIDE

What makes VYVGART Hytrulo different from VYVGART for IV infusion?

VYVGART Hytrulo contains 2 active ingredients: efgartigimod alfa, which is the same active ingredient in VYVGART for IV infusion, and hyaluronidase (human recombinant). Hyaluronidase helps to increase the distribution and absorption of ingredients into the body. Learn about what efgartigimod alfa does.

||A specialty pharmacy provides medications that require special handling, storage, and delivery.
¶Please see Patient Information. Follow appropriate administration steps and storage and handling guidance in the Instructions for Use.

How do I track my symptoms?

Download the MG-ADL assessment tool to start tracking your symptoms. You can also use this interactive tool to get your total MG-ADL symptom score.

If you are enrolled in My VYVGART Path, a physical journal will be mailed to you and a Nurse Case Manager can show you how to use it as you get started.

How often do I need to track my symptoms?

Track your symptoms regularly. If you track them weekly, try to do it at the same time each week. Be sure to share this information with your neurologist, as it may help them determine your next VYVGART treatment cycle.

Why is it helpful to track my symptoms?

Breaks between VYVGART treatment cycles are personalized to you, based on your symptoms and side effects. Tracking your symptoms helps your neurologist determine your next treatment cycle.

What is My VYVGART Path?

My VYVGART Path is a patient support program that provides personalized support from a Nurse Case Manager and committed support team.

How do I join the My VYVGART Path program?

After your neurologist prescribes VYVGART Hytrulo for subcutaneous injection or VYVGART for IV infusion, you can enroll in My VYVGART Path at EnrollMVP.com or have your doctor’s office enroll you. Then, a Nurse Case Manager will call, welcome you to the program, and offer assistance as you start your treatment journey.

How can a Nurse Case Manager help me during treatment with VYVGART?

Nurse Case Managers are knowledgeable about gMG and VYVGART and are dedicated to listening to you and helping you navigate your VYVGART treatment journey. They can help you understand your VYVGART treatment, feel empowered with resources and information, navigate the insurance process, and understand potential financial assistance programs.