VYVGART Hytrulo prefilled syringe for self-injection (single-dose subcutaneous injection: 200 mg/mL of efgartigimod alfa and 2,000 U/mL of hyaluronidase) has been approved by the U.S. FDA for the treatment of adults with anti-AChR antibody-positive generalized myasthenia gravis (gMG). The VYVGART Hytrulo prefilled syringe is a self-injection that takes about 20-30 seconds.* It is injected under the skin (subcutaneously). Patients and/or their caregivers will receive in-person training at home or in their doctor’s office until they’re ready to inject on their own. They’ll also get a demonstration kit to help them practice.

*Please see Patient Information [links to: https://argenx.com/content/dam/argenx-corp/products/vyvgart-hytrulo-patient-information.pdf]. Follow appropriate administration steps in the Instructions for Use [links to: https://argenx.com/content/dam/argenx-corp/products/vyvgart-hytrulo-IFU.pdf]. Monitor for signs and symptoms of an allergic reaction for at least 30 minutes after injection. If an allergic reaction occurs, you should seek medical attention.
AChR=acetylcholine receptor.

argenx will provide support and educational resources to patients who are prescribed VYVGART Hytrulo through our My VYVGART Path Patient Support Program. Resources are available throughout the entire treatment journey and include: disease and product education, access to support and benefits verification, and financial assistance programs for eligible patients. If patients are self-injecting with the VYVGART Hytrulo prefilled syringe, a Nurse Case Manager can also provide additional educationalresources on self-injection.

On behalf of all of us at argenx, I personally want to thank you for your support. Your organization’s continued partnership has helped us bring this milestone to fruition for the gMG community. We are so honored to have you as an argenx advocacy partner.

To learn more about the VYVGART Hytrulo prefilled syringe, click here [links to: https://www.VYVGARTHytrulo.com/PFS].

[VYVGART Hytrulo for self-injection ISI]

IMPORTANT SAFETY INFORMATION

Do not take VYVGART HYTRULO if you are allergic to efgartigimod alfa, hyaluronidase, or any of the ingredients in VYVGART HYTRULO. VYVGART HYTRULO can cause serious allergic reactions and a decrease in blood pressure leading to fainting.

Before taking 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 HYTRULO will harm your unborn baby.

o Pregnancy Exposure Registry. There is a pregnancy exposure registry for women who use 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 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 HYTRULO can cause side effects which can be serious, including:

• Infection. VYVGART HYTRULO may increase the risk of infection. If you have an active infection, your healthcare provider should delay your treatment with 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:

Allergic reactions (hypersensitivity reactions). VYVGART HYTRULO can cause allergic reactions that can be severe. These reactions can happen during, shortly after, or weeks after your 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:

Infusion or injection-related reactions. VYVGART HYTRULO can cause infusion or injection-related reactions. These reactions can happen during or shortly after your VYVGART HYTRULO injection. Tell your healthcare provider if you have any of the following symptoms of an infusion or injection-related reaction:

The most common side effects of VYVGART HYTRULO include respiratory tract infection, headache, urinary tract infection, and injection site reactions. 

These are not all the possible side effects of 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 HYTRULO® (efgartigimod alfa and hyaluronidase-qvfc)?

VYVGART HYTRULO is a prescription medicine used to treat adults with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive.

It is not known if VYVGART HYTRULO is safe and effective in children.

Please see full Prescribing [links to: https://argenx.com/content/dam/argenx-corp/products/vyvgart-hytrulo-prescribing-information.pdf] and Patient Information [links to: https://argenx.com/content/dam/argenx-corp/products/vyvgart-hytrulo-patient-information.pdf] for VYVGART HYTRULO.

By Raghav Govindarajan, Neurologist and Conquer MG Medical Advisory Board Member 

What is a vaccine? 

Vaccination is a safe, and effective way of protecting you or your loved one against harmful diseases. It uses your body’s natural defenses to build resistance to specific infections and makes your immune system stronger.  

How do vaccines work? 

Vaccines train your immune system to create antibodies, just as it does when it’s exposed to a disease. However, because vaccines contain only killed or weakened forms of germs like viruses or bacteria, they do not cause the disease or put you at risk of its complications. 

Do MG patients need to get vaccinated? 

Getting vaccinated is an important aspect of MG care. With a weakened immune system, illnesses that other people can fight, like the flu, or pneumonia, can become life-threatening. Preventing sickness from happening in the first place through vaccination helps keep people with MG healthier overall. Further, preventing respiratory infections in people with generalized MG can reduce the risk of exacerbation.  

Which vaccines are safe and recommended for MG patients? 

Most vaccines are safe for people with myasthenia gravis. Age-appropriate vaccination is recommended for MG patients. These include TdaP (tetanus, diphtheria, and pertussis), HPV (human papillomavirus), Hepatitis B, inactivated varicella (chickenpox and shingles). In patients on complement inhibitors, meningococcal vaccine is also recommended. Also recommended are pneumonia vaccine along with inactivated flu and COVID vaccine for MG patients.  

What vaccines to avoid with MG? 

MG patients taking immunosuppressants should not be given live vaccines. This includes nasal flu spray, certain type of shingles vaccine, yellow fever vaccine, measles, mumps, rubella (MMR) vaccine. However, non-live versions of the flu shot, and shingles vaccine are safe and recommended for people with MG. 

Flu vaccine and MG-Is it safe? 

Some people believe that the flu vaccine may cause flares or flu in people with MG. However, multiple studies have found the flu vaccine safe in people with mild to moderate MG. Flu vaccine is even safe in severe MG. There is a greater chance of having MG related complications from flu than the flu vaccine. 

Can I get COVID vaccine if I have MG? 

In patients with well-controlled myasthenia gravis (MG), the 2-dose mRNA COVID-19 vaccines have been shown to be safe and well tolerated. These are the findings of a study published in the journal Muscle & Nerve. Clinical outcome scores demonstrated no exacerbation of symptoms of MG. Overall, COVID-19 vaccination did not induce clinical exacerbation in stable patients with MG, regardless of their age, sex, history of myasthenic crisis, or whether they were taking immunosuppressant. 

Rare Disease Week is a multi-day event, hosted by the Rare Disease Legislative Advocates (a program of the EveryLife Foundation for Rare Diseases), that brings together rare disease advocates from across the country to make their voices heard. Participants are educated on policy proposals impacting the rare disease community and provided opportunities to advocate for policy changes directly to their members of Congress.  

From our Conquer MG community, three of our ambassadors are attending to advocate for you! Ahead of their journey, we asked them to tell us what motivated them to get involved and participate in Rare Disease Week in Washington, DC. Here are their responses.  

Gary Jackson: Forest Park, IL 

I am a 61-year-old male living with the rare disease, myasthenia gravis, which currently has no known cure. I am eager to learn about policy proposals that can and will affect the rare disease community. I look forward to meeting with members of Congress to advocate for policy changes for rare diseases and connecting with other advocates from across the country. This is a great opportunity for me to share my story and hear from others with lived experiences of rare diseases. I aim to build awareness around treatment options and the need for increased education of physicians about rare diseases. I want elected officials to support legislation that makes getting approved for disability benefits easier than it is today. 

Kelly Aiken: Springfield, IL

This is my first time participating in this national effort to improve the lives of people who live with rare diseases. As I have faced my own struggles with myasthenia gravis (MG), it is my community that helped me through some of the worst days of this disease. MG has led me to lean on support groups, and eventually, I began leading a group and volunteering for the MG community in other ways.

One of our greatest challenges in the rare disease space is building awareness of local support and resources. Living with a rare disease can come with a long list of struggles including working with insurance to get life-saving medications covered, getting disability approval and obtaining the necessary assistive equipment for the home. Nobody should struggle for life-saving care.

I want to help lessen these struggles. By sharing my story, I hope to raise awareness about MG and advocate for bills that support our community. The adage “knowledge is power” takes on a new meaning with MG—knowledge can be lifesaving.

Tammy Carter: Munster, Indiana 

I have always been an advocate for my children as well as foster children. It was my job to ensure that all my children received the best education possible. Now, it’s time to advocate for issues that touch my life and to educate others who can pull the levers of change to improve the lives of people living with myasthenia gravis (MG) and rare diseases. I am excited to put my story to work for the greater good of those living with a rare disease. 

As someone diagnosed with Seronegative MG, my treatment options are quite limited. I hope that with greater awareness more research will be conducted to expand the available therapies. Struggles with the affordability of treatment is a topic I plan to weave into my story when I meet with my elected officials. I am all too familiar with the stress that comes with the burden of this disease, particularly for those like me who have had multiple hospitalizations and rehabilitation stays. The topic of affordability deserves greater attention.