The VYVGART Doctor Discussion Guide can be used to help you discuss with your neurologist current anti-AChR antibody positive gMG symptoms you have and how they impact your daily abilities.
About VYVGART
What is VYVGART?
VYVGART is the first FDA-approved treatment that uses a fragment of an IgG antibody to treat adults with anti-AChR antibody positive generalized myasthenia gravis (gMG). VYVGART is given in treatment cycles of a 1-hour infusion each week for 4 weeks (4 infusions total). Your neurologist will work with you to help determine if and when you need another treatment cycle, with the aim to help manage your symptoms.*
AChR=acetylcholine receptor; IgG=immunoglobulin G
*If additional cycles are needed.
How is VYVGART pronounced?
VYVGART is pronounced VIV-gart.
How does VYVGART work?
VYVGART is specifically designed to attach to and block the neonatal Fc receptor (FcRn), resulting in the reduction of IgG antibodies, including the harmful AChR antibodies that cause gMG symptoms.
Is VYVGART right for me?
Talk to your neurologist to see if VYVGART is right for you. The VYVGART Doctor Discussion Guide can be used to help you discuss with your neurologist current anti-AChR antibody positive gMG symptoms you have and how they impact your daily abilities.
Is VYVGART intended to be taken with other medications?
Yes, in the clinical trial, participants stayed on their current gMG treatment while receiving VYVGART. Talk to your doctor about the medications you are taking as part of your treatment plan.
What results did people see with VYVGART?
When added to their current gMG treatment, VYVGART helped clinical trial participants with anti-AChR antibody positive gMG achieve improved daily abilities. 68% (44 of 65) of participants on VYVGART achieved significant improvement in their ability to perform daily activities.†
†Improvement maintained for 4 or more weeks was measured by a decrease of 2 or more points on the Myasthenia Gravis Activities of Daily Living (MG-ADL) scale, with the first reduction occurring no later than 1 week after the last infusion of treatment cycle 1. The MG-ADL scale assesses the impact of gMG on daily functions by measuring 8 signs or symptoms that are commonly affected in gMG. Each item is measured on a 4-point scale, where a score of 0 represents normal function and a score of 3 represents the loss of ability to perform that function. Total scores range from 0 to 24 points, with a higher score showing more severe gMG.
What are the most common side effects of VYVGART?
In 84 clinical trial participants treated with VYVGART, the most common side effects included respiratory tract infection (33%), headache (32%), urinary tract infection (10%), tingling sensation (7%), and muscle pain (6%).‡
Most infections in participants on VYVGART were mild to moderate. Additionally, more patients on VYVGART vs placebo had blood side effects that were mild to moderate.
‡In ≥5% treated with VYVGART and more frequently than placebo.
Do I have to get any vaccines before taking VYVGART?
Discuss with your doctor when you need to receive age-appropriate vaccines before starting a new treatment cycle with VYVGART. Some types of vaccines are not recommended while taking VYVGART. Be sure to talk to your doctor about vaccines before starting any treatment cycle of VYVGART.
How many of the trial participants continued on to the extended safety study?
After the clinical trial, 91% of the clinical trial participants who were eligible chose to enter a 3-year extension safety study where they would receive VYVGART. These participants could have received, in addition to their current gMG treatment, either VYVGART or placebo in the original trial.
Dosing and infusions
How is VYVGART administered?
VYVGART is an infusion treatment, meaning it goes through an intravenous (IV) line put into a vein in your arm. Learn more about infusion treatment
How often do I need to get VYVGART?
VYVGART is given in treatment cycles with a break between each cycle.§ A treatment cycle consists of a 1-hour infusion each week for 4 weeks (4 infusions total). Your neurologist will work with you to help determine if and when you need another treatment cycle, with the aim to help manage your symptoms.§ In the clinical trial, the average time between the first infusion of the first treatment cycle and the first infusion of the second treatment cycle was 94 days.‖
§If additional cycles are needed.
‖The minimum time between treatment cycles in the clinical study was 50 days.
How long is a VYVGART infusion?
Your infusion may take approximately 1 hour. During this time, a doctor or nurse will monitor you for any reactions.
What should I do if I miss an infusion?
If you miss a scheduled infusion, VYVGART may be administered up to 3 days after the scheduled infusion day. Work with your neurologist to reschedule your next infusion.
Symptom tracking
Why do I need to track my symptoms?
Track your symptoms to help your neurologist determine your next treatment cycle. After starting VYVGART, track your symptoms each week and keep your neurologist up to date. See how symptom tracking works
How do I track my symptoms?
Download the MG-ADL assessment tool to start tracking your symptoms. 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.
Patient support
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.
Find out how we can help
How do I join the My VYVGART Path program?
After you and your neurologist decide on VYVGART, your doctor’s office will be able to enroll you in My VYVGART Path. Then, a Nurse Case Manager will call, welcome you to the program, and offer assistance as you get started with VYVGART on 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.
See how Nurse Case Managers can help
Additional resources
Infusion centers in your area
Enter your zip code to look up infusion centers in your area.¶
gMG terms and definitions
This list of commonly used terms can help you and your loved ones better understand gMG.
¶Your neurologist and insurance company will determine where you can receive your infusions.
What is the most important information I should know about VYVGART® (efgartigimod alfa-fcab)?
VYVGART may cause serious side effects, including:
- Infection. VYVGART may increase the risk of infection. In a clinical study, the most common infections were urinary tract and respiratory tract infections. More patients on VYVGART vs placebo had below normal levels for white blood cell counts, lymphocyte counts, and neutrophil counts. The majority of infections and blood side effects were mild to moderate in severity. Your health care provider should check you for infections before starting treatment, during treatment, and after treatment with VYVGART. Tell your health care provider if you have any history of infections. Tell your health care provider right away if you have signs or symptoms of an infection during treatment with VYVGART 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, and/or chest pain.
- Undesirable immune reactions (hypersensitivity reactions). VYVGART can cause the immune system to have undesirable reactions such as rashes, swelling under the skin, and shortness of breath. In clinical studies, the reactions were mild or moderate and occurred within 1 hour to 3 weeks of administration, and the reactions did not lead to VYVGART discontinuation. Your health care provider should monitor you during and after treatment and discontinue VYVGART if needed. Tell your health care provider immediately about any undesirable reactions.
Before taking VYVGART, tell your health care provider about all of your medical conditions, including if you:
- Have a history of infection or you think you have an infection
- Have received or are scheduled to receive a vaccine (immunization). Discuss with your health care provider whether you need to receive age-appropriate immunizations before initiation of a new treatment cycle with VYVGART. The use of vaccines during VYVGART treatment has not been studied, and the safety with live or live-attenuated vaccines is unknown. Administration of live or live-attenuated vaccines is not recommended during treatment with VYVGART.
- Are pregnant or plan to become pregnant and are breastfeeding or plan to breastfeed.
Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
What are the common side effects of VYVGART?
The most common side effects of VYVGART are respiratory tract infection, headache, and urinary tract infection.
These are not all the possible side effects of VYVGART. Call your doctor for medical advice about side effects. You may report side effects to the US Food and Drug Administration at 1-800-FDA-1088.
What is VYVGART?
VYVGART is a prescription medicine used to treat a condition called generalized myasthenia gravis, which causes muscles to tire and weaken easily throughout the body, in adults who are positive for antibodies directed toward a protein called acetylcholine receptor (anti-AChR antibody positive).
Please see the full Prescribing Information for VYVGART and talk to your doctor.
Important Safety Information
What is the most important information I should know about VYVGART® (efgartigimod alfa-fcab)?
VYVGART may cause serious side effects, including:
- Infection. VYVGART may increase the risk of infection. In a clinical study, the most common infections were urinary tract and respiratory tract infections. More patients on VYVGART vs placebo had below normal levels for white blood cell counts, lymphocyte counts, and neutrophil counts. The majority of infections and blood side effects were mild to moderate in severity. Your health care provider should check you for infections before starting treatment, during treatment, and after treatment with VYVGART. Tell your health care provider if you have any history of infections. Tell your health care provider right away if you have signs or symptoms of an infection during treatment with VYVGART 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, and/or chest pain.
- Undesirable immune reactions (hypersensitivity reactions). VYVGART can cause the immune system to have undesirable reactions such as rashes, swelling under the skin, and shortness of breath. In clinical studies, the reactions were mild or moderate and occurred within 1 hour to 3 weeks of administration, and the reactions did not lead to VYVGART discontinuation. Your health care provider should monitor you during and after treatment and discontinue VYVGART if needed. Tell your health care provider immediately about any undesirable reactions.
Before taking VYVGART, tell your health care provider about all of your medical conditions, including if you:
- Have a history of infection or you think you have an infection
- Have received or are scheduled to receive a vaccine (immunization). Discuss with your health care provider whether you need to receive age-appropriate immunizations before initiation of a new treatment cycle with VYVGART. The use of vaccines during VYVGART treatment has not been studied, and the safety with live or live-attenuated vaccines is unknown. Administration of live or live-attenuated vaccines is not recommended during treatment with VYVGART.
- Are pregnant or plan to become pregnant and are breastfeeding or plan to breastfeed.
Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
What are the common side effects of VYVGART?
The most common side effects of VYVGART are respiratory tract infection, headache, and urinary tract infection.
These are not all the possible side effects of VYVGART. Call your doctor for medical advice about side effects. You may report side effects to the US Food and Drug Administration at 1-800-FDA-1088.
What is VYVGART?
VYVGART is a prescription medicine used to treat a condition called generalized myasthenia gravis, which causes muscles to tire and weaken easily throughout the body, in adults who are positive for antibodies directed toward a protein called acetylcholine receptor (anti-AChR antibody positive).
Please see the full Prescribing Information for VYVGART and talk to your doctor.
Questions? Call 1-833-VYVGART (1-833-898-4278)
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VYVGART is a registered trademark of argenx.
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US-EFG-21-00184 V6 11/2022
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