VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) | VYVGART (efgartigimod alfa-fcab) VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) | VYVGART (efgartigimod alfa-fcab)
Prescription medicines for adults with anti-AChR antibody positive generalized myasthenia gravis (gMG)
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Questions? Call 1-833-VYVGART (1-833-898-4278)

Prescription medicines for adults with anti-AChR antibody positive generalized myasthenia gravis (gMG)
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Questions? Call 1-833-VYVGART (1-833-898-4278)

How VYVGART works
in the body

VYVGART helps reduce harmful AChR antibodies, the main cause of gMG symptoms.

AChR=acetylcholine receptor.

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See how
VYVGART works

Learn how VYVGART Hytrulo for subcutaneous injection and VYVGART for intravenous (IV) infusion work in the body of adults with anti-AChR antibody positive gMG.

VYVGART Hytrulo for subcutaneous injection works in a similar way to VYVGART for IV infusion once in your body

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.

The body has many “characters” that influence how your muscles and brain work together to help you move. Expand below to learn more about some of the characters that play a role in the VYVGART treatment journey.

ACh

Acetylcholine (ACh) helps carry messages from the brain to different parts of the body, including muscles.

AChR

Acetylcholine receptor (AChR) is a type of receptor (message receiver) found on muscles. These receptors receive messages from nerves that tell muscles what to do. 

IgG

Immunoglobulin G (IgG) antibody is a Y-shaped protein made by the immune system. Antibodies—like IgG—play a vital role in helping protect your body from infection and disease.  

Harmful AChR antibody

Harmful acetylcholine receptor (AChR) antibodies disrupt communication between muscles and nerves.

Hyaluronidase

Hyaluronidase helps to increase the distribution and absorption of ingredients into the body.

FcRn

Neonatal Fc receptor (FcRn) is a receptor (yellow) that attaches to IgG antibodies (green) and helps IgG antibodies stay in the body longer.

VYVGART uses a fragment of an IgG antibody to treat adults with anti-AChR antibody positive gMG

IgG=immunoglobulin G.

Antibody

Image of the fragment
Image of the fragment

Fragment

VYVGART is specifically designed to attach to and block FcRn receptors, resulting in the reduction of IgG antibodies, including the harmful AChR antibodies that cause gMG symptoms

Receptors called FcRn extend the life of IgG antibodies.

In gMG, this allows harmful AChR antibodies to continue causing gMG symptoms. But IgG antibodies, including harmful AChR antibodies, that cannot attach to FcRn receptors are removed by the body.

When harmful AChR antibodies that cause gMG symptoms are removed, they can no longer disrupt nerve-muscle communication.

FcRn=neonatal Fc receptor.

In the study, patients on VYVGART for IV infusion who had anti-AChR antibody positive gMG saw a reduction in total IgG antibody levels, which included a reduction in the levels of harmful AChR antibodies that cause gMG symptoms

VYVGART for IV infusion has a demonstrated safety profile.

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%).a 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 can cause allergic reactions such as rash, swelling of the face, lips, throat, or tongue, and shortness of breath. It can also increase the risk of serious allergic reactions such as trouble breathing, low blood pressure, and fainting, as well as infusion-related reactions including high blood pressure, chills, shivering, and chest, stomach, or back pain. These reactions can happen during, shortly after, or weeks after treatment and can cause doctors to pause or, in some cases, stop treatment.

a In ≥5% treated with VYVGART for IV infusion and more frequently than placebo.

In the VYVGART Hytrulo study, VYVGART Hytrulo for subcutaneous injection had a similar reduction in the harmful AChR antibodies that cause gMG symptoms as VYVGART for IV infusion

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 of injection site reactions occurred within 24 hours of injection and resolved on their own
  • The majority of injection site reactions occurred during the first treatment cycle and decreased with each subsequent cycle

VYVGART Hytrulo can cause allergic reactions such as rash, swelling of the face, lips, throat, or tongue, shortness of breath, and hives. It can also increase the risk of serious allergic reactions such as trouble breathing, low blood pressure, and fainting, as well as infusion or injection-related reactions including high blood pressure, chills, shivering, and chest, stomach, or back pain. These reactions can happen during, shortly after, or weeks after treatment and can cause doctors to pause or, in some cases, stop treatment.

Be sure to discuss your symptoms and any side effects with your doctor. This information can help your doctor determine your next treatment cycle.

Talk to your doctor to see if VYVGART is right for you

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.

GET THE GUIDE

Getting started with VYVGART

Learn more at VYVGART (You)niversity

Watch a video, or attend a virtual or in-person event across the U.S. for an opportunity to learn more about VYVGART from an expert.

Find out more

Learn about the 2 VYVGART studies

Learn about the studies for VYVGART for IV infusion and VYVGART Hytrulo for subcutaneous injection.

See the data

Frequently asked questions

Find answers to common questions about VYVGART treatment and support.

Get answers

Still have questions? Call 1-833-VYVGART (1-833-898-4278) to speak with an educator about gMG, how VYVGART works in the body, study data, cost and coverage, and more.

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.

Dosage forms and strengths:

VYVGART Hytrulo is available as a single-dose subcutaneous injection containing: 200 mg/mL of efgartigimod alfa and 2,000 U/mL of hyaluronidase per prefilled syringe, or 180 mg/mL of efgartigimod alfa and 2,000 U/mL of hyaluronidase per vial. VYVGART is available as a single-dose injection for intravenous use containing 400 mg/20 mL of efgartigimod alfa-fcab per vial.

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.

Dosage forms and strengths:

VYVGART Hytrulo is available as a single-dose subcutaneous injection containing: 200 mg/mL of efgartigimod alfa and 2,000 U/mL of hyaluronidase per prefilled syringe, or 180 mg/mL of efgartigimod alfa and 2,000 U/mL of hyaluronidase per vial. VYVGART is available as a single-dose injection for intravenous use containing 400 mg/20 mL of efgartigimod alfa-fcab per vial.

Questions? Call 1-833-VYVGART
(1-833-898-4278)

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Patient and Prescribing Information
VYVGART Hytrulo Patient Information VYVGART Hytrulo Prescribing Information VYVGART Hytrulo Prefilled Syringe Instructions for Use VYVGART for IV Infusion Prescribing Information

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