Introductions, please...
What does VYVGART treat, and how do I know if it is right for me?
VYVGART is a prescription medicine used to treat a condition called generalized myasthenia gravis, which causes muscles to tire and weaken easily throughout the body in adults who have antibodies directed toward proteins called acetylcholine receptors. Speak with your doctor to see if VYVGART is the right treatment for you.
What are the most common side effects of VYVGART?
The most common side effects with VYVGART for IV infusion are respiratory tract infection, headache, and urinary tract infection. Additional common side effects with VYVGART HYTRULO are injection site reactions, including rash, redness of the skin, itching sensation, bruising, pain, and hives.
What is My VYVGART Path?
My VYVGART Path is a Patient Support Program that provides personalized support from a Nurse Case Manager and a committed support team, so you’ll have resources and support available to you during your VYVGART treatment journey. With My VYVGART Path, a Nurse Case Manager can help you: • Navigate the insurance process • Understand potential financial assistance programs • Understand your VYVGART treatment • Access the My VYVGART App to help you track your MG-ADL digitally, create personalized medication and doctor appointment reminders, and receive customized tips and information
There are 2 ways in enroll; you can talk with your doctor and ask to be enrolled in My VYVGART Path, or you can download the patient enrollment form on VYVGART.com/gmg. It is located on the website under the “savings and support” tab.
What is generalized myasthenia gravis?
Generalized myasthenia gravis is a rare neuromuscular illness that causes muscle weakness and fatigue. Muscle weakness and fatigue from generalized myasthenia gravis can make daily life more challenging and may limit one’s ability to do everyday activities.
How is VYVGART given?
VYVGART can be administered two different ways, either as an intravenous infusion or as a subcutaneous injection. Your doctor will work with you to help determine which administration method is right for you. [VYVGART for IV infusion:] If you are prescribed VYVGART for IV infusion it is given by inserting a needle into a vein so that medicine immediately enters the bloodstream. [VYVGART HYTRULO for subcutaneous injection:] If you are prescribed VYVGART HYTRULO for subcutaneous injection it is delivered as an injection to the layer beneath the skin.
Does VYVGART work in all types of generalized myasthenia gravis?
VYVGART is indicated for the treatment of generalized myasthenia gravis in adult patients who are anti-acetylcholine receptor antibody positive. It is important to talk to your doctor to see if VYVGART for IV infusion or VYVGART Hytrulo is right for you.
What should I tell my healthcare provider before taking VYVGART?
: Tell your doctor if are taking any medications, including prescription and nonprescription medicines, supplements, or herbal medicines. Tell your doctor if you have received or are scheduled to receive a vaccine (immunization) or if you have any allergies or medical conditions, including if you are pregnant or planning to become pregnant or are breastfeeding. Track your symptoms regularly. If you track them weekly, try to do it at the same time each week for consistency. Be sure to share this information with your doctor as it may help them determine your VYVGART for IV infusion treatment cycle. If you are interested, there is an online resource that can help with tracking your gMG symptoms located at [VYVGART.com/gmg/support-and-resources/downloadable-resources]. Having tools such as the symptom tracker can help when having discussions with your doctor.
What is the VYVGART (You)niversity program about?
The program is about VYVGART, a treatment for adults with anti-acetylcholine receptor antibody positive gMG. During the program you will hear from a healthcare professional and possibly a person with gMG. There are in-person programs as well as virtual programs to fit your schedule. Whether you’re newly diagnosed or further along on your treatment journey, this program is a great way to learn more about VYVGART. Caregivers and family members are also welcome.
What are the symptoms of generalized myasthenia gravis?
Serious muscle weakness is the main symptom of generalized myasthenia gravis. This muscle weakness often shows up in the face, with drooping eyelids being an early sign. Double or blurred vision caused by weakness in the eye muscles is another common symptom. Muscle weakness can extend to arms and legs. Smiling, chewing, swallowing, and breathing can also be affected.
How many doses or treatment cycles of VYVGART are given?
VYVGART is given in treatment cycles with a break between each cycle. A treatment cycle consists of a dose each week for 4 weeks, so 4 treatments per cycle. There is an individualized break between cycles. The length of the break between cycles is different for each person because it is based on an evaluation of your gMG symptoms and side effects. The safety of starting the next treatment cycle sooner than 4 weeks from the last treatment of the previous treatment cycle has not been established. It is important to keep track of your symptoms and share this information with your neurologist as it may help them determine your next VYVGART treatment cycle.
How does VYVGART work?
VYVGART helps remove IgG antibodies, which includes harmful acetylcholine receptor (AChR) antibodies that cause gMG symptoms. Sometimes the immune system mistakenly makes harmful IgG antibodies that target acetylcholine receptors and cause gMG symptoms. In patients with generalized myasthenia gravis that have harmful A-C-h-R antibodies, harmful A-C-h-R antibodies attach to receptors called neonatal Fc receptors to avoid being removed from the body. VYVGART is specifically designed to attach to and block the neonatal Fc receptor, resulting in the reduction of IgG antibodies, including the harmful A-C-h-R antibodies that cause generalized myasthenia gravis symptoms. In the VYVGART for IV infusion study, participants who had anti-A-C-h-R antibody positive generalized myasthenia gravis saw a reduction in total immunoglobulin G antibody levels. A similar reduction was seen in harmful acetylcholine receptor antibodies that cause generalized myasthenia gravis symptoms. In the VYVGART Hytrulo study, VYVGART Hytrulo for subcutaneous injection had a similar reduction in the harmful AChR antibodies that cause gMG symptoms as VYVGART for IV infusion.
Is VYVGART intended to be taken with other medications?
Yes, in the studies, participants stayed on their current gMG treatment while receiving VYVGART. Talk to your doctor about the medications you are taking as part of your gMG treatment plan.
What is the mentor program?
My VYVGART Journey is a mentor program that connects adults living antiacetylcholine receptor antibody positive gMG and their supporters with adult mentors who have received treatment with VYVGART for IV infusion and VYVGART Hytrulo for subcutaneous injection. When you sign up, you’ll have the opportunity to talk one-on-one with an adult mentor who understands the anti-AChR antibody positive gMG journey. You’ll also get to learn and ask questions about their treatment experience with VYVGART for IV infusion and VYVGART Hytrulo for subcutaneous injection. You can choose to connect by phone or video call.
How does someone get generalized myasthenia gravis?
The reasons some people get it aren’t fully understood. Generalized myasthenia gravis is an autoimmune disease. It is caused by the immune system mistakenly targeting healthy cells in the body. Generalized myasthenia gravis is not genetic, meaning it is not inherited, and it’s not contagious, so you cannot catch it from someone else. It affects people of all ages and races, but it is slightly more common in women 20 to 30 years old and men 50 to 60 years old.
Can I have another treatment cycle in less than 4 weeks?
The safety of starting the next treatment cycle sooner than 4 weeks from the previous treatment cycle has not been established. Your doctor will work with you to determine if or when you need another treatment cycle, with the aim of helping to manage your symptoms.
How well does VYVGART work?
[VYVGART for IV infusion:] When added to their current generalized myasthenia gravis treatment, VYVGART for IV infusion helped patients in the study with anti-acetylcholine receptor antibody positive generalized myasthenia gravis achieve improved daily abilities and reduced muscle weakness: • Improved daily abilities: 68% (44 of 65) of participants on VYVGART for IV infusion achieved significant improvement in their ability to perform daily activities compared to 30% (19 of 64) of participants on placebo plus current gMG treatment. • Reduced muscle weakness: 63% (41 of 65) of participants on VYVGART for IV infusion achieved a significant reduction in muscle weakness compared to 14% (9 of 64) of participants on placebo plus current gMG treatment.
[VYVGART HYTRULO for subcutaneous injection:] VYVGART HYTRULO was found to be effective for adults with anti-AChR antibody positive gMG. The effectiveness of VYVGART HYTRULO was established in 2 studies: 1) In the VYVGART HYTRULO study, VYVGART HYTRULO for subcutaneous injection had a similar reduction in the harmful anti-acetylcholine receptor antibodies that cause gMG symptoms as VYVGART for IV infusion. 2) In the VYVGART for IV infusion study, a reduction in harmful AChR antibodies was associated with improved daily abilities (reduction in total Myasthenia Gravis Activities of Daily Living [MG-ADL] score). 68% (44 of 65) of participants on VYVGART for IV infusion achieved significant improvement in their ability to perform daily activities compared to 30% (19 of 64) of participants on placebo plus current gMG treatment
Is there anyone who shouldn’t take VYVGART?
[VYVGART for IV infusion:] Do not use VYVGART if you have a serious allergy to efgartigimod alfa or any of the other ingredients in VYVGART. It is important to talk to your doctor to see if VYVGART is right for you. [VYVGART HYTRULO for subcutaneous injection:] Do not use VYVGART HYTRULO if you have a serious allergy to efgartigimod alfa, hyaluronidase, or any of the other ingredients in VYVGART HYTRULO. It is important to talk to your doctor to see if VYVGART HYTRULO is right for you.
What is the Patient Ambassador Program?
The Patient Ambassador Program is a volunteer opportunity where you may share your story at patient events and in promotional materials about how you were diagnosed and your treatment journey with VYVGART for IV infusion or VYVGART Hytrulo for subcutaneous injection. I can ask a recruitment specialist to get in touch with you to provide you with more information and answer any of your questions.
What causes generalized myasthenia gravis?
Antibodies are produced by the immune system to help protect the body from infection and disease. Sometimes the immune system mistakenly makes harmful acetylcholine receptor antibodies. Acetylcholine helps carry messages from the brain to different parts of the body, including muscles, by attaching to acetylcholine receptors. In generalized myasthenia gravis, harmful acetylcholine receptor antibodies disrupt nerve-muscle communication, preventing muscles from getting some messages which leads to generalized myasthenia gravis symptoms.
How is VYVGART supplied?
[VYVGART for IV infusion:]. A dose of VYVGART for IV infusion is 400 mg in 20 mL (20 mg/mL) and is packaged as a single-dose vial.
[VYVGART HYTRULO for subcutaneous injection:] VYVGART HYTRULO for subcutaneous injection is supplied as 1,008 mg efgartigimod alfa and 11,200 units hyaluronidase per 5.6 mL (180 mg/2,000 units per mL) and is packaged as a single-dose vial.
Can I continue my current immune therapy if I start VYVGART?
Talk to your doctor as they are able to provide medical information specific to your situation. For the patients in the clinical studies, VYVGART was added to their current gMG treatment.
What if I miss my dose during my cycle?
If you miss a scheduled dose, VYVGART may be administered up to 3 days after the scheduled day. You should work with your neurologist to reschedule your next dose.
What resources are available on VYVGART.com/gmg?
VYVGART.com/gmg contains many resources that you might find valuable, such as information about: • Understanding generalized myasthenia gravis • Understanding how VYVGART works in adults with anti-acetylcholine receptor antibody positive gMG • Getting started with VYVGART • VYVGART(You)niversity, where you can sign up for in-person and virtual educational programs • My VYVGART Journey, a Mentor Program where you can sign up to speak with someone who has treatment experience with VYVGART for IV infusion • Additional support and resources available to you: o Doctor Discussion Guide o Intravenous Infusion Guides and Subcutaneous Injection Guides o Symptom Assessment Guide MG Activities of Daily Living tool to assess your symptoms o Goal-Setting Worksheet o VYVGART Co-pay program brochure o My VYVGART Path brochure o An infusion center finder o FAQs o An opportunity to sign up to receive emails about VYVGART
Are there different types of generalized myasthenia gravis?
For ~85% of people with generalized myasthenia gravis, their immune system creates immunoglobulin G antibodies known as harmful acetylcholine receptor antibodies that target the acetylcholine receptor. This type of generalized myasthenia gravis is called antiacetylcholine receptor antibody positive.
What are the ingredients in VYVGART?
: [VYVGART for IV infusion:] Each 20 mL single-dose vial of VYVGART contains 400 mg of efgartigimod alfa-fcab at a concentration of 20 mg/mL. The inactive ingredients in each mL of solution are L-arginine hydrochloride (31.6 mg), polysorbate 80 (0.2 mg), sodium chloride (5.8 mg), sodium phosphate dibasic anhydrous (2.4 mg), sodium phosphate monobasic monohydrate (1.1 mg), and water for injection, USP, at a pH of 6.7 or Larginine hydrochloride (10.5 mg), L-histidine (1.4 mg), L-histidine hydrochloride monohydrate (2.2 mg), L-methionine (1.5 mg), polysorbate 80 (0.4 mg), sodium chloride (4.1 mg), sucrose (20.5 mg), and water for injection, USP, at a pH of 6.0.
[VYVGART HYTRULO for subcutaneous injection:] VYVGART HYTRULO contains two active ingredients: one is called efgartigimod alfa which is the same active ingredient in VYVGART for IV infusion, and the other is called hyaluronidase. Hyaluronidase helps to increase the absorption of these ingredients into the body. Each 5.6 mL single-dose vial contains 1,000 mg of efgartigimod alfa at a concentration of 180 mg/mL and 11,200 units of hyaluronidase at a concentration of 2,000 units/mL. The inactive ingredients in each mL of solution are histidine (1.4 mg), L-histidine hydrochloride monohydrate (2.2 mg), methionine (1.5 mg), polysorbate 20 (0.4 mg), sodium chloride (5.8 mg), sucrose (20.5 mg), and water for injection, USP, at a pH of 6.0.