About VYVGART
What is VYVGART?
VYVGART uses a fragment of an IgG antibody to treat adults with anti-AChR antibody positive generalized myasthenia gravis (gMG).
AChR=acetylcholine receptor; IgG=immunoglobulin G
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. 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 gMG treatment while receiving VYVGART for IV infusion or VYVGART Hytrulo for subcutaneous injection. Talk to your doctor about the medications you are taking as part of your treatment plan.
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 often do I need to get VYVGART?
VYVGART is given in treatment cycles with a personalized break between cycles.* 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 last treatment of the previous treatment cycle has not been established. If you miss a scheduled treatment, VYVGART may be given up to 3 days after the scheduled treatment day.
*If additional cycles are needed.
How is VYVGART given?
VYVGART can be given in 1 of 2 ways:
As an intravenous (IV) infusion—given by inserting a needle into a vein so the medicine enters the bloodstream. Learn more about IV infusions.
As a subcutaneous injection—given by delivering medicine into the layer beneath the skin. VYVGART Hytrulo for subcutaneous injection 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.
What are the most common side effects of VYVGART?
Of the 84 patients in the study treated with VYVGART for IV infusion compared to the 83 patients on placebo, 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 for IV infusion may increase the risk of allergic reactions including rash, swelling under the skin, and shortness of breath. It may also increase the risk of serious allergic reactions such as trouble breathing and decrease in blood pressure leading to fainting, as well as infusion-related reactions including increase in blood pressure, chills, shivering, and chest, abdominal, and back pain. These reactions can occur during or after treatment and can cause doctors to pause or, in some cases, stop treatment.
The overall safety of VYVGART Hytrulo for subcutaneous injection was consistent with the safety profile of VYVGART for IV infusion, except patients on VYVGART Hytrulo for subcutaneous injection experienced more injection site reactions.
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 Hytrulo study and its long-term safety study, all injection site reactions were mild to moderate and didn’t lead to treatment discontinuation. The majority occurred within 24 hours of injection and resolved on their own. The majority occurred during the first treatment cycle and decreased with each subsequent cycle.
VYVGART Hytrulo may increase the risk of allergic reactions including rash, swelling under the skin, shortness of breath, and hives. It may also increase the risk of serious allergic reactions such as trouble breathing and decrease in blood pressure leading to fainting, as well as infusion-related reactions including increase in blood pressure, chills, shivering, and chest, abdominal, and back pain. These reactions can occur during or after treatment and can cause doctors to pause or, in some cases, stop treatment.
†In ≥5% treated with VYVGART for IV infusion and more frequently than placebo.
About VYVGART for IV infusion
How long does it take to receive VYVGART for IV 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 for IV infusion may be given up to 3 days after the scheduled infusion day. Work with your neurologist to reschedule your next infusion.
What results did people see with VYVGART for IV infusion?
When added to their current gMG treatment, VYVGART for IV infusion helped patients in the study with anti-AChR antibody positive gMG achieve improved daily abilities. 68% (44 of 65) of patients on VYVGART for IV infusion achieved a significant improvement in their ability to perform daily activities, compared to 30% (19 of 64) of patients on placebo plus current treatment.‡
63% (41 of 65) of patients on VYVGART for IV infusion achieved a significant reduction in muscle weakness, compared to 14% (9 of 64) of patients who were on placebo plus current treatment.§
‡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.
§Improvement maintained for 4 or more weeks was measured by a decrease of 3 or more points on the Quantitative Myasthenia Gravis (QMG) scale, with the first reduction occurring no later than 1 week after the last infusion of treatment cycle 1. The QMG scale assesses muscle weakness in gMG based on 13 items. Each item is assessed on a 4-point scale, where a score of 0 represents no muscle weakness and a score of 3 represents severe muscle weakness. Total scores range from 0 to 39, with a higher score meaning muscle weakness is more severe.
How many of the patients in the VYVGART for IV infusion study continued to the extended safety study?
After the study, 91% of the patients in the study who were eligible chose to enter a 3-year extension safety study where they would receive VYVGART for IV infusion.
About VYVGART Hytrulo for subcutaneous injection
How long does it take to receive VYVGART Hytrulo?
VYVGART Hytrulo usually takes ~30 to 90 seconds to inject and is given at an infusion center, doctor’s office, or at home.|| For at least 30 minutes after your injection, a healthcare professional will monitor you for reactions.
||In some cases, VYVGART Hytrulo may also be given at home by a trained nurse.
What should I do if I miss an injection?
If you miss a scheduled injection, VYVGART Hytrulo may be given up to 3 days after the scheduled injection day.
What is hyaluronidase?
VYVGART Hytrulo for subcutaneous injection 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.
Symptom tracking
Why is it helpful to track my symptoms?
Track your symptoms to help your neurologist determine your next treatment cycle. After starting VYVGART for IV infusion or VYVGART Hytrulo for subcutaneous injection, 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.
How do I join the My VYVGART Path program?
After you and your neurologist decide on VYVGART for IV infusion or VYVGART Hytrulo for subcutaneous injection, 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 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.
Who can I talk to for more information about VYVGART?
You can call 1-833-VYVGART (1-833-898-4278) to speak with an educator about gMG, how VYVGART works, study data, cost and coverage, and more.
Support and resources
Talk to your neurologist
Use this 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.
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.
Do not take VYVGART if you are allergic to efgartigimod alfa or any of the ingredients in VYVGART. Do not take VYVGART HYTRULO if you are allergic to efgartigimod alfa, hyaluronidase, or any of the ingredients in VYVGART HYTRULO. VYVGART or VYVGART HYTRULO can cause serious allergic reactions and a decrease in blood pressure leading to fainting.
Before taking VYVGART or VYVGART HYTRULO, tell your healthcare provider about all of your medical conditions, including if you:
- have an infection or fever.
- have recently received or are scheduled to receive any vaccinations.
- have any history of allergic reactions.
- have kidney (renal) problems.
- are pregnant or plan to become pregnant. It is not known whether VYVGART or VYVGART HYTRULO will harm your unborn baby.
- Pregnancy Exposure Registry. There is a pregnancy exposure registry for women who use VYVGART or VYVGART HYTRULO during pregnancy. The purpose of this registry is to collect information about your health and your baby. Your healthcare provider can enroll you in this registry. You may also enroll yourself or get more information about the registry by calling 1-855-272-6524 or going to VYVGARTPregnancy.com
- are breastfeeding or plan to breastfeed. It is not known if VYVGART or VYVGART HYTRULO passes into your breast milk.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
VYVGART or VYVGART HYTRULO can cause side effects which can be serious, including:
- Infection. VYVGART or VYVGART HYTRULO may increase the risk of infection. If you have an active infection, your healthcare provider should delay your treatment with VYVGART or VYVGART HYTRULO until your infection is gone. Tell your healthcare provider right away if you get any of the following signs and symptoms of an infection:
- fever
- chills
- frequent and painful urination
- cough
- pain and blockage of nasal passages
- wheezing
- shortness of breath
- sore throat
- excess phlegm
- nasal discharge
- Allergic reactions (hypersensitivity reactions). VYVGART or VYVGART HYTRULO can cause allergic reactions that can be severe. These reactions can happen during, shortly after, or weeks after your VYVGART infusion or VYVGART HYTRULO injection. Tell your healthcare provider or get emergency help right away if you have any of the following symptoms of an allergic reaction with VYVGART or VYVGART HYTRULO:
- rash
- swelling of the face, lips, throat, or tongue
- shortness of breath
- trouble breathing
- low blood pressure
- fainting
An additional symptom of an allergic reaction with VYVGART HYTRULO can include hives.
- Infusion or injection-related reactions. VYVGART can cause infusion-related reactions. VYVGART HYTRULO can cause infusion or injection-related reactions. These reactions can happen during or shortly after your VYVGART infusion or VYVGART HYTRULO injection. Tell your healthcare provider if you have any of the following symptoms of an infusion or injection-related reaction:
- high blood pressure
- chills
- shivering
- chest, stomach, or back pain
The most common side effects of VYVGART or VYVGART HYTRULO include respiratory tract infection, headache, and urinary tract infection. An additional common side effect with VYVGART HYTRULO includes injection site reactions.
These are not all the possible side effects of VYVGART or VYVGART HYTRULO. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is VYVGART® (efgartigimod alfa-fcab) for intravenous (IV) infusion and what is VYVGART HYTRULO® (efgartigimod alfa and hyaluronidase-qvfc) for subcutaneous injection?
VYVGART and VYVGART HYTRULO are both prescription medicines used to treat adults with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive.
It is not known if VYVGART or VYVGART HYTRULO is safe and effective in children.
Please see full Prescribing and Patient Information for VYVGART HYTRULO for subcutaneous injection and full Prescribing Information for VYVGART for IV infusion.
IMPORTANT SAFETY INFORMATION
Do not take VYVGART if you are allergic to efgartigimod alfa or any of the ingredients in VYVGART. Do not take VYVGART HYTRULO if you are allergic to efgartigimod alfa, hyaluronidase, or any of the ingredients in VYVGART HYTRULO. VYVGART or VYVGART HYTRULO can cause serious allergic reactions and a decrease in blood pressure leading to fainting.
Before taking VYVGART or VYVGART HYTRULO, tell your healthcare provider about all of your medical conditions, including if you:
- have an infection or fever.
- have recently received or are scheduled to receive any vaccinations.
- have any history of allergic reactions.
- have kidney (renal) problems.
- are pregnant or plan to become pregnant. It is not known whether VYVGART or VYVGART HYTRULO will harm your unborn baby.
- Pregnancy Exposure Registry. There is a pregnancy exposure registry for women who use VYVGART or VYVGART HYTRULO during pregnancy. The purpose of this registry is to collect information about your health and your baby. Your healthcare provider can enroll you in this registry. You may also enroll yourself or get more information about the registry by calling 1-855-272-6524 or going to VYVGARTPregnancy.com
- are breastfeeding or plan to breastfeed. It is not known if VYVGART or VYVGART HYTRULO passes into your breast milk.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
VYVGART or VYVGART HYTRULO can cause side effects which can be serious, including:
- Infection. VYVGART or VYVGART HYTRULO may increase the risk of infection. If you have an active infection, your healthcare provider should delay your treatment with VYVGART or VYVGART HYTRULO until your infection is gone. Tell your healthcare provider right away if you get any of the following signs and symptoms of an infection:
- fever
- chills
- frequent and painful urination
- cough
- pain and blockage of nasal passages
- wheezing
- shortness of breath
- sore throat
- excess phlegm
- nasal discharge
- Allergic reactions (hypersensitivity reactions). VYVGART or VYVGART HYTRULO can cause allergic reactions that can be severe. These reactions can happen during, shortly after, or weeks after your VYVGART infusion or VYVGART HYTRULO injection. Tell your healthcare provider or get emergency help right away if you have any of the following symptoms of an allergic reaction with VYVGART or VYVGART HYTRULO:
- rash
- swelling of the face, lips, throat, or tongue
- shortness of breath
- trouble breathing
- low blood pressure
- fainting
An additional symptom of an allergic reaction with VYVGART HYTRULO can include hives.
- Infusion or injection-related reactions. VYVGART can cause infusion-related reactions. VYVGART HYTRULO can cause infusion or injection-related reactions. These reactions can happen during or shortly after your VYVGART infusion or VYVGART HYTRULO injection. Tell your healthcare provider if you have any of the following symptoms of an infusion or injection-related reaction:
- high blood pressure
- chills
- shivering
- chest, stomach, or back pain
The most common side effects of VYVGART or VYVGART HYTRULO include respiratory tract infection, headache, and urinary tract infection. An additional common side effect with VYVGART HYTRULO includes injection site reactions.
These are not all the possible side effects of VYVGART or VYVGART HYTRULO. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is VYVGART® (efgartigimod alfa-fcab) for intravenous (IV) infusion and what is VYVGART HYTRULO® (efgartigimod alfa and hyaluronidase-qvfc) for subcutaneous injection?
VYVGART and VYVGART HYTRULO are both prescription medicines used to treat adults with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive.
It is not known if VYVGART or VYVGART HYTRULO is safe and effective in children.
Please see full Prescribing and Patient Information for VYVGART HYTRULO for subcutaneous injection and full Prescribing Information for VYVGART for IV infusion.
Do not take VYVGART if you are allergic to efgartigimod alfa or any of the ingredients in VYVGART. Do not take VYVGART HYTRULO if you are allergic to efgartigimod alfa, hyaluronidase, or any of the ingredients in VYVGART HYTRULO. VYVGART or VYVGART HYTRULO can cause serious allergic reactions and a decrease in blood pressure leading to fainting.
Before taking VYVGART or VYVGART HYTRULO, tell your healthcare provider about all of your medical conditions, including if you:
- have an infection or fever.
- have recently received or are scheduled to receive any vaccinations.
- have any history of allergic reactions.
- have kidney (renal) problems.
- are pregnant or plan to become pregnant. It is not known whether VYVGART or VYVGART HYTRULO will harm your unborn baby.
- Pregnancy Exposure Registry. There is a pregnancy exposure registry for women who use VYVGART or VYVGART HYTRULO during pregnancy. The purpose of this registry is to collect information about your health and your baby. Your healthcare provider can enroll you in this registry. You may also enroll yourself or get more information about the registry by calling 1-855-272-6524 or going to VYVGARTPregnancy.com
- are breastfeeding or plan to breastfeed. It is not known if VYVGART or VYVGART HYTRULO passes into your breast milk.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
VYVGART or VYVGART HYTRULO can cause side effects which can be serious, including:
- Infection. VYVGART or VYVGART HYTRULO may increase the risk of infection. If you have an active infection, your healthcare provider should delay your treatment with VYVGART or VYVGART HYTRULO until your infection is gone. Tell your healthcare provider right away if you get any of the following signs and symptoms of an infection:
- fever
- chills
- frequent and painful urination
- cough
- pain and blockage of nasal passages
- wheezing
- shortness of breath
- sore throat
- excess phlegm
- nasal discharge
- Allergic reactions (hypersensitivity reactions). VYVGART or VYVGART HYTRULO can cause allergic reactions that can be severe. These reactions can happen during, shortly after, or weeks after your VYVGART infusion or VYVGART HYTRULO injection. Tell your healthcare provider or get emergency help right away if you have any of the following symptoms of an allergic reaction with VYVGART or VYVGART HYTRULO:
- rash
- swelling of the face, lips, throat, or tongue
- shortness of breath
- trouble breathing
- low blood pressure
- fainting
An additional symptom of an allergic reaction with VYVGART HYTRULO can include hives.
- Infusion or injection-related reactions. VYVGART can cause infusion-related reactions. VYVGART HYTRULO can cause infusion or injection-related reactions. These reactions can happen during or shortly after your VYVGART infusion or VYVGART HYTRULO injection. Tell your healthcare provider if you have any of the following symptoms of an infusion or injection-related reaction:
- high blood pressure
- chills
- shivering
- chest, stomach, or back pain
The most common side effects of VYVGART or VYVGART HYTRULO include respiratory tract infection, headache, and urinary tract infection. An additional common side effect with VYVGART HYTRULO includes injection site reactions.
These are not all the possible side effects of VYVGART or VYVGART HYTRULO. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is VYVGART® (efgartigimod alfa-fcab) for intravenous (IV) infusion and what is VYVGART HYTRULO® (efgartigimod alfa and hyaluronidase-qvfc) for subcutaneous injection?
VYVGART and VYVGART HYTRULO are both prescription medicines used to treat adults with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive.
It is not known if VYVGART or VYVGART HYTRULO is safe and effective in children.
Please see full Prescribing and Patient Information for VYVGART HYTRULO for subcutaneous injection and full Prescribing Information for VYVGART for IV infusion.
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US-VYV-23-00232 V6 12/2024
