Downloadable resources

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

Important forms, guides, and other helpful information

KEY

  • VYVGART
  • VYVGART Hytrulo
  • VYVGART & VYVGART Hytrulo

ABOUT VYVGART & VYVGART Hytrulo

VYVGART Overview Brochure

Key data and information about VYVGART for healthcare professionals (HCPs).

VYVGART 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.

VYVGART Hytrulo Overview Brochure

A brochure detailing important information about VYVGART Hytrulo.

VYVGART Hytrulo Injection Site Reaction Card

A resource for your VYVGART Hytrulo patients to learn about injection site reactions and ways to help prevent them.

VYVGART Hytrulo Frequently Asked Questions

Answers to common questions about treatment with VYVGART Hytrulo for your patients.

Patient Profiles

Use these profiles to identify appropriate patients in your practice who may be right for VYVGART.

TALKING WITH PATIENTS

Patient Brochure

An introduction to VYVGART and VYVGART Hytrulo 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

VYVGART Infusion Center Locator

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

VYVGART Hytrulo Specialty Pharmacy Journey Handout

A resource for you and your patients to understand the steps involved when starting VYVGART Hytrulo.

VYVGART Hytrulo What to Expect Handout

A resource for patients to understand what to expect after being prescribed VYVGART Hytrulo.

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.

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.

HCP PSP Overview Brochure

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

My VYVGART Path Brochure

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

Field Reimbursement Manager Guide 

A resource for you to learn more about Field Reimbursement Managers and how they can help your office.

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.

ACCESS SUPPORT

VYVGART Billing & 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.

VYVGART Letter of Claims Appeal

This document provides guidance for appealing a denied or underpaid VYVGART claim.

VYVGART Office Order Form

Standardized form for your office to use when ordering VYVGART from a specialty pharmacy.

VYVGART Insurance Cost & Coverage Guide

A guide to help patients understand the insurance process when navigating their VYVGART journey.

VYVGART Hytrulo Billing & Coding Guide

A guide to help your office submit claims for VYVGART Hytrulo when no product code is available.

VYVGART Hytrulo Acquisition Guide

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

VYVGART Hytrulo Prior Authorization

A guide to help you navigate the common requirements for prior authorization when starting patients on VYVGART Hytrulo.

CONTRAINDICATIONS

VYVGART and VYVGART HYTRULO are contraindicated in patients with serious hypersensitivity to efgartigimod alfa products or to any of the excipients of VYVGART or VYVGART HYTRULO, respectively. VYVGART HYTRULO is also contraindicated in patients with serious hypersensitivity to hyaluronidase. Reactions have included anaphylaxis and hypotension leading to syncope.

WARNINGS AND PRECAUTIONS
Infection

VYVGART and VYVGART HYTRULO may increase the risk of infection. The most common infections observed in Study 1 were urinary tract infection (10% of efgartigimod alfa-fcab-treated patients vs 5% of placebo-treated patients) and respiratory tract infection (33% of efgartigimod alfa-fcab-treated patients vs 29% of placebo-treated patients). Patients on efgartigimod alfa-fcab 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 the administration of VYVGART or VYVGART HYTRULO in patients with an active infection until the infection has resolved; monitor for clinical signs and symptoms of infections. If serious infection occurs, administer appropriate treatment and consider withholding treatment with VYVGART or VYVGART HYTRULO until the infection has resolved.

Immunization

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

Hypersensitivity Reactions

In clinical trials, hypersensitivity reactions, including rash, angioedema, and dyspnea were observed in patients treated with VYVGART or VYVGART HYTRULO. Urticaria was also observed in patients treated with VYVGART HYTRULO. Hypersensitivity reactions were mild or moderate, occurred within 1 hour to 3 weeks of administration, and did not lead to treatment discontinuation. Anaphylaxis and hypotension leading to syncope have been reported in postmarketing experience with intravenous efgartigimod alfa-fcab. Anaphylaxis and hypotension occurred during or within an hour of administration and led to infusion discontinuation and in some cases to permanent treatment discontinuation. Healthcare professionals should monitor patients during and for 1 hour after VYVGART administration, or for at least 30 minutes after VYVGART HYTRULO administration, for clinical signs and symptoms of hypersensitivity reactions. If a hypersensitivity reaction occurs, the healthcare professional should institute appropriate measures if needed or the patient should seek medical attention.

Infusion-Related Reactions

Infusion-related reactions have been reported with intravenous efgartigimod alfa-fcab in postmarketing experience. The most frequent symptoms and signs were hypertension, chills, shivering, and thoracic, abdominal, and back pain. Infusion-related reactions occurred during or within an hour of administration and led to infusion discontinuation. If a severe infusion-related reaction occurs during administration, discontinue VYVGART infusion and initiate appropriate therapy. If a severe infusion-related reaction occurs with VYVGART HYTRULO, initiate appropriate therapy. Consider the risks and benefits of readministering VYVGART or VYVGART HYTRULO following a severe infusion-related reaction. If a mild to moderate infusion-related reaction occurs, patients may be rechallenged with close clinical observation, slower infusion rates, and pre-medications.

ADVERSE REACTIONS

In Study 1, the most common (≥10%) adverse reactions in efgartigimod alfa-fcab-treated patients were respiratory tract infection, headache, and urinary tract infection. In Study 2, the most common (≥10%) adverse reactions in VYVGART HYTRULO-treated patients were injection site reactions and headache. Injection site reactions occurred in 38% of VYVGART HYTRULO-treated patients, including injection site rash, erythema, pruritus, bruising, pain, and urticaria. In Study 2 and its open-label extension, all injection site reactions were mild to moderate in severity and did not lead to treatment discontinuation. The majority occurred within 24 hours after administration and resolved spontaneously. Most injection site reactions occurred during the first treatment cycle, and the incidence decreased with each subsequent cycle.

USE IN SPECIFIC POPULATIONS
Pregnancy

As VYVGART and VYVGART HYTRULO are 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 or VYVGART HYTRULO in utero.

Lactation

There is no information regarding the presence of efgartigimod alfa-fcab from administration of VYVGART, or efgartigimod alfa or hyaluronidase from administration of VYVGART HYTRULO, 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 or VYVGART HYTRULO, and any potential adverse effects on the breastfed infant from VYVGART or VYVGART HYTRULO or from the underlying maternal condition.

INDICATION

VYVGART® (efgartigimod alfa-fcab) for intravenous infusion and VYVGART® HYTRULO (efgartigimod alfa and hyaluronidase-qvfc) for subcutaneous injection are each 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 for VYVGART and the full Prescribing Information for VYVGART HYTRULO.

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).

CONTRAINDICATIONS

VYVGART and VYVGART HYTRULO are contraindicated in patients with serious hypersensitivity to efgartigimod alfa products or to any of the excipients of VYVGART or VYVGART HYTRULO, respectively. VYVGART HYTRULO is also contraindicated in patients with serious hypersensitivity to hyaluronidase. Reactions have included anaphylaxis and hypotension leading to syncope.

WARNINGS AND PRECAUTIONS
Infection

VYVGART and VYVGART HYTRULO may increase the risk of infection. The most common infections observed in Study 1 were urinary tract infection (10% of efgartigimod alfa-fcab-treated patients vs 5% of placebo-treated patients) and respiratory tract infection (33% of efgartigimod alfa-fcab-treated patients vs 29% of placebo-treated patients). Patients on efgartigimod alfa-fcab 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 the administration of VYVGART or VYVGART HYTRULO in patients with an active infection until the infection has resolved; monitor for clinical signs and symptoms of infections. If serious infection occurs, administer appropriate treatment and consider withholding treatment with VYVGART or VYVGART HYTRULO until the infection has resolved.

Immunization

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

Hypersensitivity Reactions

In clinical trials, hypersensitivity reactions, including rash, angioedema, and dyspnea were observed in patients treated with VYVGART or VYVGART HYTRULO. Urticaria was also observed in patients treated with VYVGART HYTRULO. Hypersensitivity reactions were mild or moderate, occurred within 1 hour to 3 weeks of administration, and did not lead to treatment discontinuation. Anaphylaxis and hypotension leading to syncope have been reported in postmarketing experience with intravenous efgartigimod alfa-fcab. Anaphylaxis and hypotension occurred during or within an hour of administration and led to infusion discontinuation and in some cases to permanent treatment discontinuation. Healthcare professionals should monitor patients during and for 1 hour after VYVGART administration, or for at least 30 minutes after VYVGART HYTRULO administration, for clinical signs and symptoms of hypersensitivity reactions. If a hypersensitivity reaction occurs, the healthcare professional should institute appropriate measures if needed or the patient should seek medical attention.

Infusion-Related Reactions

Infusion-related reactions have been reported with intravenous efgartigimod alfa-fcab in postmarketing experience. The most frequent symptoms and signs were hypertension, chills, shivering, and thoracic, abdominal, and back pain. Infusion-related reactions occurred during or within an hour of administration and led to infusion discontinuation. If a severe infusion-related reaction occurs during administration, discontinue VYVGART infusion and initiate appropriate therapy. If a severe infusion-related reaction occurs with VYVGART HYTRULO, initiate appropriate therapy. Consider the risks and benefits of readministering VYVGART or VYVGART HYTRULO following a severe infusion-related reaction. If a mild to moderate infusion-related reaction occurs, patients may be rechallenged with close clinical observation, slower infusion rates, and pre-medications.

ADVERSE REACTIONS

In Study 1, the most common (≥10%) adverse reactions in efgartigimod alfa-fcab-treated patients were respiratory tract infection, headache, and urinary tract infection. In Study 2, the most common (≥10%) adverse reactions in VYVGART HYTRULO-treated patients were injection site reactions and headache. Injection site reactions occurred in 38% of VYVGART HYTRULO-treated patients, including injection site rash, erythema, pruritus, bruising, pain, and urticaria. In Study 2 and its open-label extension, all injection site reactions were mild to moderate in severity and did not lead to treatment discontinuation. The majority occurred within 24 hours after administration and resolved spontaneously. Most injection site reactions occurred during the first treatment cycle, and the incidence decreased with each subsequent cycle.

USE IN SPECIFIC POPULATIONS
Pregnancy

As VYVGART and VYVGART HYTRULO are 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 or VYVGART HYTRULO in utero.

Lactation

There is no information regarding the presence of efgartigimod alfa-fcab from administration of VYVGART, or efgartigimod alfa or hyaluronidase from administration of VYVGART HYTRULO, 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 or VYVGART HYTRULO, and any potential adverse effects on the breastfed infant from VYVGART or VYVGART HYTRULO or from the underlying maternal condition.

INDICATION

VYVGART® (efgartigimod alfa-fcab) for intravenous infusion and VYVGART® HYTRULO (efgartigimod alfa and hyaluronidase-qvfc) for subcutaneous injection are each 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 for VYVGART and the full Prescribing Information for VYVGART HYTRULO.

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).