Terms and definitions

Here's a list of commonly used terms related to generalized myasthenia gravis (gMG) that may help you and your loved ones better understand gMG.

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  • Acetylcholine (ACh)
    Acetylcholine helps carry messages from the brain to different parts of the body, including muscles. In gMG, harmful AChR antibodies damage the receptors for acetylcholine on muscles, which causes muscle weakness.
  • Acetylcholine receptor (AChR)
    A type of receptor (message receiver) found on muscles. These receptors receive messages from nerves that tell muscles what to do. Patients with gMG who have antibodies that damage AChR receptors are called anti-AChR antibody positive gMG patients. Anti-AChR antibody positive is the most common type of gMG.
  • Acetylcholine receptor (AChR) antibody
    Sometimes the immune system mistakenly makes IgG antibodies that target AChR receptors. These are known as harmful AChR antibodies. gMG patients with harmful AChR antibodies have anti-AChR antibody positive gMG.
  • Anti-AChR antibody positive gMG
    The most common type of gMG. People with gMG who have harmful antibodies that damage acetylcholine receptors (AChR) are called anti-AChR antibody positive gMG patients.
  • Antibody fragment
    An antibody fragment is only part of a whole antibody. For example, the bottom section of the Y-shaped antibody is a fragment.
  • Autoimmune
    Autoimmune means that the immune system, which normally protects you, is mistakenly attacking itself.
  • Biologics
    Biologics treat disease by using substances made from living organisms. These substances may naturally occur in the body or may be artificially created. A biologic must be approved by the Food and Drug Administration (FDA) to be used as a treatment in the United States.
  • Immunoglobulin G (IgG) antibody
    A Y-shaped protein made by the immune system. Antibodies attach to different things to let the immune system know that there is a potential threat that it will need to destroy or neutralize. Antibodies can attach to disease-causing substances like bacteria and viruses.
  • Immunosuppressive therapy (IST)
    A type of medication used to reduce the strength of the body’s immune system. It is often used to treat conditions where the immune system is overactive, like in autoimmune diseases.
  • Intravenous (IV) infusion
    Given by inserting a needle into a vein so that the medication immediately enters the bloodstream. 
  • Myasthenia Gravis Activities of Daily Living (MG-ADL) scale
    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.
  • Neonatal Fc receptor (FcRn)
    A receptor that attaches to IgG antibodies and helps them stay in the body longer. In gMG, the IgG antibodies and harmful AChR antibodies can both attach to FcRns to stay in the body longer.
  • Placebo
    An inactive substance used in a study that looks like the medicine being tested.
  • Quantitative Myasthenia Gravis (QMG) scale
    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.
  • Study

    A study, also known as a clinical trial, is a type of research that tests the safety and effectiveness of a treatment in people. The FDA reviews the results of studies to determine if a treatment is safe and effective for use in a specific condition.
  • Subcutaneous injection
    Given by delivering medicine into the layer beneath the skin.

  

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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.