I can get answers to frequently asked questions

What is VYVGART?

VYVGART is a fragment of an IgG antibody used to treat adults with gMG who are triple seronegative, or anti-AChR, anti-LRP4, or anti-MuSK antibody positive. VYVGART is pronounced VIV-gart.

AChR=acetylcholine receptor; IgG=immunoglobulin G; LRP4=low-density lipoprotein receptor-related protein 4; MuSK=muscle-specific tyrosine kinase. Triple seronegative means a person does not show anti-AChR, anti-LRP4, or anti-MuSK antibodies when tested.

How is VYVGART given?

There are 3 ways to receive treatment:

• Self-injection with the VYVGART Hytrulo prefilled syringe by you or a caregiver.*^† Learn about the prefilled syringe and how self-injection works.
• Injection by your doctor with VYVGART Hytrulo for subcutaneous injection at an infusion center, doctor’s office, or at home.
• Intravenous (IV) infusion with VYVGART at an infusion center, doctor’s office, or at home.^‡ Get more details about IV infusions, including a downloadable infusion guide.

Do I have to get any vaccines before starting 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. Regular blood tests aren’t required, but your doctor will still monitor your response to treatment and look out for possible side effects.

Is VYVGART right for me?

Use the VYVGART Doctor Discussion Guide at your next appointment to talk about your symptoms, treatment goals, and whether VYVGART is a fit for you.

Get the guide

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 and your doctor will decide together when to schedule your next treatment cycle, taking into account your symptoms and any side effects. If you notice a change in your symptoms during your break between cycles, reach out to your doctor to discuss adjusting your dosing schedule. You don’t have to wait to start the conversation.

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.

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 attaches to FcRn receptors, so some IgG antibodies cannot attach. These include harmful anti-AChR, anti-LRP4, and anti-MuSK antibodies. Harmful IgG antibodies that do not attach to FcRn receptors are removed. With fewer harmful IgG antibodies, gMG symptoms are reduced.

People with triple seronegative gMG may have these harmful IgG antibodies, but at levels so low, they are undetected.

What results were seen in clinical studies?

VYVGART Hytrulo and VYVGART for IV infusion can help improve daily abilities when added to your current oral gMG treatment.^§ See more data from the VYVGART studies:

• Anti-AChR antibody positive gMG
• Triple seronegative, anti-LRP4 antibody positive, and anti-MuSK antibody positive gMG

What are the side effects of VYVGART?

The safety profile of VYVGART for adults with gMG was established across 3 studies.

In the ADAPT study, the most common side effects for patients on VYVGART for IV infusion plus current oral gMG treatment vs. placebo 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%).

These side effects were reported in at least 5% of patients on VYVGART plus their current oral gMG treatment, and more frequently than in patients on placebo plus their current oral gMG treatment.

• Most infections in patients on VYVGART plus their current oral gMG treatment were mild to moderate
• Additionally, more patients on VYVGART compared to placebo plus current oral gMG treatment had lower white blood cell counts that were mild to moderate in severity

Patients in the ADAPT SERON study with triple seronegative, anti-LRP4 antibody positive, or anti-MuSK antibody positive gMG had consistent side effects to those seen in the earlier ADAPT study, with the main difference being nausea. 7% of patients on VYVGART plus their current oral gMG treatment experienced nausea compared to 5% of patients on placebo plus their current oral gMG treatment.

In the ADAPT-SC study, the overall safety of VYVGART Hytrulo for subcutaneous injection was similar to the safety profile of VYVGART for IV infusion, except patients on VYVGART Hytrulo plus their current oral gMG treatment experienced more injection site reactions.

In the ADAPT-SC 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.

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

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, 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.

*If you are prescribed the VYVGART Hytrulo prefilled syringe, 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.
†Do not try to inject the VYVGART Hytrulo prefilled syringe until you have been shown the right way by a healthcare provider. See the detailed Instructions for Use that come with the VYVGART Hytrulo prefilled syringe.
‡In some cases, VYVGART for IV infusion may also be given at home by a trained nurse.
§Based on the Myasthenia Gravis Activities of Daily Living (MG-ADL) scale, which measures daily abilities.

What is the VYVGART Hytrulo prefilled syringe?

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 doctor 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 doctor, 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 doctor 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 doctor 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.