A woman stands in the bleachers of a soccer field with her husband and daughter. She is cheering joyfully for her team.
A woman stands in the bleachers of a soccer field with her husband and daughter. She is cheering joyfully for her team.

Generalized 
myasthenia gravis
doesn’t get to stop this cheering section


VYVGART for intravenous (IV) infusion is an FDA-approved treatment for adults with anti‑AChR antibody positive generalized myasthenia gravis (gMG).


AChR=acetylcholine receptor; gMG=generalized myasthenia gravis; IV=intravenous

Sign up to get the latest information about VYVGART

The ADAPT study explored the effectiveness and safety of VYVGART for IV infusion in patients with gMG

Two main goals of the study were to see how VYVGART for IV infusion improved daily abilities and reduced muscle weakness among patients with gMG vs. those who were on placebo.

VYVGART for IV infusion improved daily abilities and reduced muscle weakness among patients with anti-AChR antibody positive gMG

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.

VYVGART for IV infusion reduced gMG symptoms compared to placebo

Average reduction in MG-ADL score during treatment cycle 1

aPatients did not come in for an evaluation at week 9.
MG-ADL=Myasthenia Gravis Activities of Daily Living

 Average change in MG-ADL score
WeekVYVGART for IV infusion
+ current treatment
Placebo + 
current treatment
000
1-2.2-1.1
2-3.7-1.4
3-4.1-1.4
4-4.6-1.8
5-4.4-1.8
6-4.1-1.4
7-3.4-1.7
8-2.2-1.7
9a--
10-1.6-1.0

aPatients did not come in for an evaluation at week 9.

VYVGART for IV infusion was determined to be effective if a patient’s MG-ADL score decreased by 2 or more points and stayed at that level for 4 weeks or more in a row, with the first improvement occurring no later than 1 week after the last infusion of treatment cycle 1.

Learn more about MG-ADL and symptom tracking

DOWNLOAD NOW

Reduced muscle weakness

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 on placebo plus current treatment.

The ADAPT study:
VYVGART for IV infusion was evaluated in a global study of adults with anti-AChR antibody positive gMG. The primary goals of the study were to examine effectiveness (improved daily abilities and reduced muscle weakness) and safety for FDA approval of VYVGART for IV infusion. The study examined the effectiveness and safety of VYVGART for IV infusion in 167 adults (18 years or older) with gMG. In addition to their current treatment, patients received either VYVGART for IV infusion or placebo.

*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.

‡Patients in Japan were 20 years or older.
QMG=Quantitative Myasthenia Gravis

VYVGART for IV infusion was evaluated in a global study of adults with anti-AChR antibody positive gMG. 

The study examined the effectiveness and safety of VYVGART for IV infusion in 167 adults (18 years or oldera) with gMG. In addition to their current treatment, patients received either VYVGART for IV infusion or placebo.

aPatients in Japan were 20 years or older. 

Patients in this study needed to meet the following criteria:

  • Adult (18 or older)
  • Myasthenia Gravis Foundation of America (MGFA) clinical classification class II to IV
  • MG-ADL score of 5 or more
  • On a stable dose of their current gMG treatment throughout the study

Patients represented a range of adults with gMG:

  • Median time since gMG diagnosis was 9 years
  • MGFA class ranged from II to IV at the start of the study

The MG-ADL scale was used to measure gMG symptoms.

  • The MG-ADL scale assesses the impact of gMG on daily functions by measuring 8 signs or symptoms that are commonly affected in gMG: the ability to speak, chew, swallow, breathe, brush teeth or comb hair, and get out of a chair, as well as the frequency of double vision and eyelid droop
  • 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
  • VYVGART for IV infusion was determined to be effective if an anti-AChR antibody positive patient’s MG-ADL score decreased by 2 or more points and stayed at that level for 4 weeks or more in a row, with the first improvement occurring no later than 1 week after the last infusion of treatment cycle 1

MGFA=Myasthenia Gravis Foundation of America

Additional data


The data in this section is presented as potentially useful information. However, this data was not a main goal of the study, nor does it carry the same weight as the main goals of the study. For this reason, no reliable conclusions can be drawn about the effectiveness or safety of VYVGART for IV infusion based on this additional data. Talk to your neurologist if you have any questions.


Patients on VYVGART for IV infusion plus current treatment were observed to have an MG-ADL score of 0 or 1 (minimal or no symptoms) at any visit during treatment cycle 1: 40% (26 of 65).§

Compared to 11% (7 of 63) of patients in the study who received placebo plus their current gMG treatment.

§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 score of 0 or 1 meaning minimal or no symptoms.

The safety of VYVGART for IV infusion among patients with gMG was a main goal of the ADAPT study

VYVGART for IV infusion was safe in treating most patients

The following side effects were reported in at least 5% of patients on VYVGART for IV infusion and more frequently than in patients on placebo

Side effectVYVGART for IV infusion
84 patients
Placebo
83 patients
Respiratory tract infection33%29%
Headache32%29%
Urinary tract infection10%5%
Tingling sensation7%5%
Muscle pain6%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.

VYVGART is available in 2 forms


For IV infusion—given by inserting a needle into a vein so the medicine enters the bloodstream.


For subcutaneous injection—given by delivering medicine into the layer beneath the skin.

  

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.

Getting started with VYVGART

How VYVGART works

Because of VYVGART, IgG antibodies are reduced, including the harmful AChR antibodies that cause gMG symptoms.

VYVGART dosing

Your neurologist will work with you to help determine when you need another treatment cycle, with the aim to help manage your symptoms.||

Real Stories on VYVGART for IV infusion

This video series features real people who speak about the impact of living with anti-AChR antibody positive gMG—and their experiences with VYVGART for IV infusion.

||If additional cycles are needed.

IgG=immunoglobulin G

Get the latest VYVGART updates

Sign up to get the latest information about VYVGART sent straight to your inbox. 

VYVGART (efgartigimod alfa-fcab) Injection for Intravenous Use 400 mg/20 mL vial; VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) Subcutaneous Injection 180 mg/mL and 2000 U/mL vial
VYVGART (efgartigimod alfa-fcab) Injection for Intravenous Use 400 mg/20 mL vial; VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) Subcutaneous Injection 180 mg/mL and 2000 U/mL vial

Still have questions? 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.

Do not use VYVGART if you have a serious allergy to efgartigimod alfa or any of the other ingredients in VYVGART. Do not use VYVGART HYTRULO if you have a serious allergy to efgartigimod alfa, hyaluronidase, or any of the other ingredients in VYVGART HYTRULO. VYVGART and VYVGART HYTRULO can cause serious allergic reactions and a decrease in blood pressure leading to fainting.

VYVGART and VYVGART HYTRULO may cause serious side effects, including:

  • Infection. VYVGART and VYVGART HYTRULO may increase the risk of infection. The most common infections for efgartigimod alfa-fcab-treated patients were urinary tract and respiratory tract infections. Signs or symptoms of an infection may include 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.
  • Allergic Reactions (hypersensitivity reactions). VYVGART and VYVGART HYTRULO can cause allergic reactions such as rashes, swelling under the skin, and shortness of breath. Hives were also observed in patients treated with VYVGART HYTRULO. Serious allergic reactions, such as trouble breathing and decrease in blood pressure leading to fainting have been reported with efgartigimod alfa-fcab.
  • Infusion-Related Reactions. VYVGART and VYVGART HYTRULO can cause infusion-related reactions. The most frequent symptoms and signs reported with efgartigimod alfa-fcab were high blood pressure, chills, shivering, and chest, abdominal, and back pain.

Tell your doctor if you have signs or symptoms of an infection, allergic reaction, or infusion-related reaction. These can happen while you are receiving your VYVGART or VYVGART HYTRULO treatment or afterward. Your doctor may need to pause or stop your treatment. Contact your doctor immediately if you have signs or symptoms of a serious allergic reaction.

Before taking VYVGART or VYVGART HYTRULO, tell your doctor if you:

  • take any medicines, including prescription and non-prescription medicines, supplements, or herbal medicines,
  • have received or are scheduled to receive a vaccine (immunization), or
  • have any allergies or medical conditions, including if you are pregnant or planning to become pregnant, or are breastfeeding.

What are the common side effects of VYVGART and VYVGART HYTRULO?

The most common side effects in efgartigimod-alfa-fcab-treated patients were respiratory tract infection, headache, and urinary tract infection. Additional common side effects with VYVGART HYTRULO are injection site reactions, including rash, redness of the skin, itching sensation, bruising, pain, and hives.

These are not all the possible side effects of VYVGART and VYVGART HYTRULO. 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® (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, each 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 the full Prescribing Information for VYVGART HYTRULO, and talk to your doctor.

Do not use VYVGART if you have a serious allergy to efgartigimod alfa or any of the other ingredients in VYVGART. Do not use VYVGART HYTRULO if you have a serious allergy to efgartigimod alfa, hyaluronidase, or any of the other ingredients in VYVGART HYTRULO. VYVGART and VYVGART HYTRULO can cause serious allergic reactions and a decrease in blood pressure leading to fainting.

VYVGART and VYVGART HYTRULO may cause serious side effects, including:

  • Infection. VYVGART and VYVGART HYTRULO may increase the risk of infection. The most common infections for efgartigimod alfa-fcab-treated patients were urinary tract and respiratory tract infections. Signs or symptoms of an infection may include 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.
  • Allergic Reactions (hypersensitivity reactions). VYVGART and VYVGART HYTRULO can cause allergic reactions such as rashes, swelling under the skin, and shortness of breath. Hives were also observed in patients treated with VYVGART HYTRULO. Serious allergic reactions, such as trouble breathing and decrease in blood pressure leading to fainting have been reported with efgartigimod alfa-fcab.
  • Infusion-Related Reactions. VYVGART and VYVGART HYTRULO can cause infusion-related reactions. The most frequent symptoms and signs reported with efgartigimod alfa-fcab were high blood pressure, chills, shivering, and chest, abdominal, and back pain.

Tell your doctor if you have signs or symptoms of an infection, allergic reaction, or infusion-related reaction. These can happen while you are receiving your VYVGART or VYVGART HYTRULO treatment or afterward. Your doctor may need to pause or stop your treatment. Contact your doctor immediately if you have signs or symptoms of a serious allergic reaction.

Before taking VYVGART or VYVGART HYTRULO, tell your doctor if you:

  • take any medicines, including prescription and non-prescription medicines, supplements, or herbal medicines,
  • have received or are scheduled to receive a vaccine (immunization), or
  • have any allergies or medical conditions, including if you are pregnant or planning to become pregnant, or are breastfeeding.

What are the common side effects of VYVGART and VYVGART HYTRULO?

The most common side effects in efgartigimod-alfa-fcab-treated patients were respiratory tract infection, headache, and urinary tract infection. Additional common side effects with VYVGART HYTRULO are injection site reactions, including rash, redness of the skin, itching sensation, bruising, pain, and hives.

These are not all the possible side effects of VYVGART and VYVGART HYTRULO. 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® (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, each 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 the full Prescribing Information for VYVGART HYTRULO, and talk to your doctor.