Tennis legend Monica Seles joins members of the gMG community for a picnic.
Tennis legend Monica Seles joins members of the gMG community for a picnic.

With VYVGART, I can do more with MY days

Clinical studies for adults with
anti-AChR antibody positive gMG.

Learn about other gMG antibody subtypes here.

AChR=acetylcholine receptor.

Listen to this page

Two proven treatments, for MY gMG

ADAPT study:
VYVGART for intravenous (IV) infusion

Improved daily abilities and reduced muscle weakness in adults with anti-AChR antibody positive gMG.

Learn more about the ADAPT study

ADAPT-SC study:
VYVGART Hytrulo for subcutaneous injection

Had a similar effect on harmful anti-AChR antibodies that cause gMG symptoms compared to VYVGART for IV infusion.

Learn more about the ADAPT-SC study

Making the days count with VYVGART

Results from the ADAPT study of VYVGART for IV infusion

Improved daily abilities.
Improved daily abilities.

Significantly improved daily abilities*

  • 68% of patients (44 of 65) who added VYVGART for IV infusion to their current oral gMG treatment significantly improved their daily abilities
  • Compared to 30% of patients (19 of 64) who added placebo to their current oral gMG treatment
  • Results measured by the Myasthenia Gravis Activities of Daily Living (MG-ADL) scale in treatment cycle 1 (by week 8)
David.
David.
With VYVGART, I noticed improvement in my vision and swallowing.”

David

Living with gMG

David started on VYVGART for IV infusion in 2022 and was not part of the clinical studies.

That’s more than 2x as many
patients vs placebo

*Defined as a decrease of 2 or more points on the MG-ADL scale, which measures the severity of 8 common symptoms of gMG, maintained for at least 4 weeks. A lower MG-ADL score means less severe symptoms.

Results from the ADAPT study of VYVGART for IV infusion

Reduced muscle weakness.
Reduced muscle weakness.

Significantly reduced muscle weakness†

  • 63% of patients (41 of 65) who added VYVGART for IV infusion to their current oral gMG treatment significantly reduced their muscle weakness
  • Compared to 14% of patients (9 of 64) who added placebo to their current oral gMG treatment
  • Results were measured by the Quantitative Myasthenia Gravis (QMG) scale in treatment cycle 1 (by week 8)
Niki.
Niki.
With VYVGART, I’m able to play with my kids and have fun with my family.”

Niki

Living with gMG

Niki started on VYVGART for IV infusion in 2022 and was not part of the clinical studies.

That’s more than 4x as many
patients vs placebo

†Defined as a decrease of 3 or more points on the QMG scale, which assesses muscle weakness based on 13 items, maintained for at least 4 weeks. A lower QMG score means less muscle weakness.

David and Niki are paid spokespeople taking VYVGART for IV infusion.

Average change in symptoms during treatment cycle 1

Patients had an average improvement of 4.6 points on their MG-ADL score at 4 weeks while on VYVGART for IV infusion + current oral gMG treatment compared to a 1.8-point improvement on placebo + current oral gMG treatment.

Average change in symptoms during treatment cycle 1.

Swipe to see full graph

a Patients did not come in for an evaluation at week 9.

 

Average change in MG-ADL score

Week

VYVGART for IV infusion
+ current oral gMG treatment

Placebo
+ current oral gMG treatment

0

0

0

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

a Patients did not come in for an evaluation at week 9.

Additional data from the ADAPT study

The following data points were not the main goals of the study and do not carry the same weight as the main goals of the study. No reliable conclusions can be drawn about the effectiveness or safety of VYVGART for IV infusion based on these data points.

Percentage of patients observed to have minimal to no symptoms during at least 1 visit in treatment cycle 1

Minimal to no symptoms means having an MG-ADL score of 0 or 1.

VYVGART for
IV infusion

+ current oral
gMG treatment

Placebo

+ current oral
gMG treatment

VYVGART dosing.

Learn about safety for my treatment

Read about safety and side effects for VYVGART for IV infusion and VYVGART Hytrulo for subcutaneous injection.

VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) | VYVGART (efgartigimod alfa-fcab)
VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) | VYVGART (efgartigimod alfa-fcab)

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).

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).

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)

This site is intended for patients and caregivers.

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Patient and Prescribing Information
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