GENERALIZED MYASTHENIA GRAVIS

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VYVGART is the first FDA-approved treatment of its kind for adults with anti-AChR antibody positive generalized myasthenia gravis (gMG).

AChR=acetylcholine receptor; gMG=generalized myasthenia gravis

Antibody
Fragment
VYVGART is the first treatment that uses a fragment of an IgG antibody to treat adults with anti-AChR antibody positive gMG. VYVGART is a fragment of an IgG antibody.

IgG=immunoglobulin G

Results with VYVGART for intravenous (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.

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.

Find out more about VYVGART for IV infusion, including safety results from the study

VYVGART for IV infusion was evaluated in a global study of adults with anti-AChR antibody positive gMG. The study examined the safety and efficacy 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.

IV=intravenous; MG-ADL=Myasthenia Gravis Activities of Daily Living; QMG= Quantitative Myasthenia Gravis

Choose the VYVGART option that is best for you


Learn about the proven effectiveness, safety, and additional data of VYVGART for IV infusion.


Learn about the effectiveness and safety of VYVGART Hytrulo for subcutaneous injection.

  

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.

My VYVGART Path
My VYVGART Path
My PRODUCT Y Path

Help at every step in understanding your VYVGART treatment

My VYVGART Path is a Patient Support Program that provides personalized support from a Nurse Case Manager and committed support team.

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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.