Downloadable resources

Discover resources that you and your patients may need during their VYVGART treatment journey. 

Important forms, guides, and other helpful information about VYVGART

ABOUT VYVGART

VYVGART Overview Brochure

Key data and information about VYVGART for healthcare professionals.

Frequently Asked Questions

A resource for HCPs that provides answers to commonly asked questions about VYVGART.

VYVGART Dosing Calculator

A tool for HCPs to help calculate the appropriate weight-based dose of VYVGART.

TALKING WITH PATIENTS

VYVGART Brochure

An introduction to VYVGART for your patients, including information about how to get started.

MG-ADL Scale

A simple 8-question survey of MG symptoms.

Doctor Discussion Guide

Informative guide to help patients talk about their current symptoms and their treatment goals.

ENROLLMENT & PATIENT SUPPORT

Enrollment Form

Downloadable version of VYVGART enrollment form to fill out and fax to get patients started on VYVGART and enrolled in My VYVGART® Path.

My VYVGART Path Brochure

An overview of the patient support offerings available through the My VYVGART Path program.

HCP PSP Overview Brochure

An overview of support offerings for you and your patients through the My VYVGART Path program.

Infusion Center Locator

Link to identify the nearest infusion center for patients to receive VYVGART.

Spanish Enrollment Form

Downloadable Spanish-language version of the VYVGART enrollment form to fill out and fax to get patients started on VYVGART and enrolled in My VYVGART Path.

ACCESS SUPPORT

VYVGART Savings Program HCP Brochure

An overview of the co-pay assistance program available to eligible patients with commercial insurance.

VYVGART Savings Program Patient Brochure

An overview of the co-pay assistance program available to eligible patients with commercial insurance that you can share with patients.

Billing and Coding Guide

A guide to help your office submit claims for VYVGART with an assigned J-Code: J9332.

VYVGART Acquisition Guide

A guide to help your office staff work with specialty distributors and specialty pharmacies to get VYVGART for your patients.

VYVGART Prior Authorization Checklist

A checklist for you and office staff regarding common prior authorization requirements for VYVGART. 

VYVGART Letter of Medical Necessity

A sample letter of medical necessity explaining why you have prescribed VYVGART with patient-specific information that health plans can use to assess your request. 

Infection

VYVGART may increase the risk of infection. The most common infections observed in Study 1 were urinary tract infection (10% for VYVGART vs 5% for placebo) and respiratory tract infection (33% for VYVGART vs 29% for placebo). Patients on VYVGART vs placebo had below normal levels for white blood cell counts (12% vs 5%, respectively), lymphocyte counts (28% vs 19%, respectively), and neutrophil counts (13% vs 6%, respectively). The majority of infections and hematologic abnormalities were mild to moderate in severity. Delay VYVGART administration in patients with an active infection until the infection is resolved; monitor for clinical signs and symptoms of infections. If serious infection occurs, administer appropriate treatment and consider withholding VYVGART until the infection has resolved.

Immunization

Immunization with vaccines during VYVGART treatment has not been studied; the safety with live or live-attenuated vaccines and the response to immunization with any vaccine are unknown. Because VYVGART causes a reduction in immunoglobulin G (IgG) levels, vaccination with live-attenuated or live vaccines is not recommended during VYVGART treatment. Evaluate the need to administer age-appropriate vaccines according to immunization guidelines before initiation of a new treatment cycle with VYVGART.

Hypersensitivity Reactions

Hypersensitivity reactions, including rash, angioedema, and dyspnea, were observed with VYVGART. In clinical trials, hypersensitivity reactions were mild or moderate, occurred within 1 hour to 3 weeks of administration, and did not lead to treatment discontinuation. Monitor patients during administration and for 1 hour thereafter for clinical signs and symptoms of hypersensitivity reactions. If a hypersensitivity reaction occurs during administration, discontinue VYVGART infusion and institute appropriate supportive measures if needed.

ADVERSE REACTIONS

The most common (≥10%) adverse reactions with VYVGART were respiratory tract infection, headache, and urinary tract infection.

USE IN SPECIFIC POPULATIONS

Pregnancy

As VYVGART is expected to reduce maternal IgG antibody levels, reduction in passive protection to the newborn is anticipated. Risks and benefits should be considered prior to administering live or live-attenuated vaccines to infants exposed to VYVGART in utero.

Lactation

There is no information regarding the presence of VYVGART in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for VYVGART and any potential adverse effects on the breastfed infant from VYVGART or from the underlying maternal condition.

INDICATION

VYVGART® (efgartigimod alfa-fcab) is indicated for the treatment of generalized myasthenia gravis in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.

Please see the full Prescribing Information.

You may report side effects to the US Food and Drug Administration by visiting http://www.fda.gov/medwatch or calling 1-800-FDA-1088. You may also report side effects to argenx US, Inc, at 1-833-argx411 (1-833-274-9411).

Infection

VYVGART may increase the risk of infection. The most common infections observed in Study 1 were urinary tract infection (10% for VYVGART vs 5% for placebo) and respiratory tract infection (33% for VYVGART vs 29% for placebo). Patients on VYVGART vs placebo had below normal levels for white blood cell counts (12% vs 5%, respectively), lymphocyte counts (28% vs 19%, respectively), and neutrophil counts (13% vs 6%, respectively). The majority of infections and hematologic abnormalities were mild to moderate in severity. Delay VYVGART administration in patients with an active infection until the infection is resolved; monitor for clinical signs and symptoms of infections. If serious infection occurs, administer appropriate treatment and consider withholding VYVGART until the infection has resolved.

Immunization

Immunization with vaccines during VYVGART treatment has not been studied; the safety with live or live-attenuated vaccines and the response to immunization with any vaccine are unknown. Because VYVGART causes a reduction in immunoglobulin G (IgG) levels, vaccination with live-attenuated or live vaccines is not recommended during VYVGART treatment. Evaluate the need to administer age-appropriate vaccines according to immunization guidelines before initiation of a new treatment cycle with VYVGART.

Hypersensitivity Reactions

Hypersensitivity reactions, including rash, angioedema, and dyspnea, were observed with VYVGART. In clinical trials, hypersensitivity reactions were mild or moderate, occurred within 1 hour to 3 weeks of administration, and did not lead to treatment discontinuation. Monitor patients during administration and for 1 hour thereafter for clinical signs and symptoms of hypersensitivity reactions. If a hypersensitivity reaction occurs during administration, discontinue VYVGART infusion and institute appropriate supportive measures if needed.

ADVERSE REACTIONS

The most common (≥10%) adverse reactions with VYVGART were respiratory tract infection, headache, and urinary tract infection.

USE IN SPECIFIC POPULATIONS

Pregnancy

As VYVGART is expected to reduce maternal IgG antibody levels, reduction in passive protection to the newborn is anticipated. Risks and benefits should be considered prior to administering live or live-attenuated vaccines to infants exposed to VYVGART in utero.

Lactation

There is no information regarding the presence of VYVGART in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for VYVGART and any potential adverse effects on the breastfed infant from VYVGART or from the underlying maternal condition.

INDICATION

VYVGART® (efgartigimod alfa-fcab) is indicated for the treatment of generalized myasthenia gravis in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.

Please see the full Prescribing Information.

You may report side effects to the US Food and Drug Administration by visiting http://www.fda.gov/medwatch or calling 1-800-FDA-1088. You may also report side effects to argenx US, Inc, at 1-833-argx411 (1-833-274-9411).