NOW APPROVED—VYVGART Hytrulo prefilled syringe for self‑injection

(Subcutaneous injection: 200 mg/mL of efgartigimod alfa and 2,000 U/mL of hyaluronidase)

GENERALIZED MYASTHENIA GRAVIS

isn’t canceling this weekend getaway

VYVGART Hytrulo for subcutaneous injection and VYVGART for IV infusion are first-of-their-kind treatments for adults with anti-AChR antibody positive generalized myasthenia gravis (gMG)

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

VYVGART Hytrulo for subcutaneous injection and VYVGART for intravenous (IV) infusion can improve daily abilities and reduce muscle weakness when added to your current oral gMG treatment*

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Learn about the data from 2 studies.

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It’s a ~30 to 90–second subcutaneous injection that can be 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 allergic reactions.

VYVGART and VYVGART Hytrulo may increase the risk of infection and can cause allergic and infusion-related reactions. The most common side effects of VYVGART and VYVGART Hytrulo are respiratory and urinary tract infections and headache, as well as injection site reactions for VYVGART Hytrulo. See safety data.

*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 8 activities of daily living.
†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 is a strength scoring system developed specifically for MG.
‡In some cases, VYVGART Hytrulo may be given at home by a trained nurse.
IV=intravenous; MG-ADL=Myasthenia Gravis Activities of Daily Living; QMG=Quantitative Myasthenia Gravis

MY gMG treatment, MY way

NOW APPROVED—VYVGART Hytrulo prefilled syringe for self-injection

(Subcutaneous injection: 200 mg/mL of efgartigimod alfa and 2,000 U/mL of hyaluronidase)


Get the latest info about the prefilled syringe and stay tuned for more coming soon.

VYVGART for IV infusion is the #1 prescribed FDA-approved biologic treatment for adults with anti-AChR antibody positive gMG§

VYVGART for IV infusion has been FDA approved for more than 3 years.

VYVGART is widely available


90%

of commercial and Medicare insured patients have coverage for VYVGART for IV infusion or VYVGART Hytrulo for subcutaneous injection||

Multiple treatment cycles are possible with the first prescription


90%

of commercial and Medicare insured patients have coverage allowing for an initial authorization of VYVGART for IV infusion or VYVGART Hytrulo for subcutaneous injection for at least 6 months.|| This can allow for multiple treatment cycles with the first prescription

§Based on IQVIA LAAD data from January 2023 to April 2024. Data is based on validated claims of VYVGART for IV infusion and other biologics that have been approved by the FDA for the treatment of adults with anti-AChR antibody positive gMG. All claims are associated with patients who received 2 confirmed diagnoses of anti-AChR antibody positive gMG. Patients who were prescribed more than one of the biologics in this data set were counted for each biologic prescribed.
||Based on published policies from Policy Reporter as of August 2024.
LAAD=Longitudinal Access and Adjudication Data

My VYVGART Path
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Get personalized support for every step of your journey

My VYVGART Path is a Patient Support Program that pairs you with a dedicated Nurse Case Manager and committed support team to help you:

  • Navigate the insurance process
  • Find resources to help you understand your treatment
  • Get answers to your questions
Doctor Discussion Guide Doctor Discussion Guide Doctor Discussion Guide

Talk to your neurologist 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.

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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; VYVGART (efgartigimod alfa-fcab) Injection for Intravenous Use 400 mg/20 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 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.