Vyvgart (efgartigimod alfa-fcab) is a prescription medicine for certain types of generalized myasthenia gravis (gMG). It is a protein substance made in the lab for humans (monoclonal antibody). The FDA approved Vyvgart in 2021 for the treatment of gMG in adults who have antibodies against a protein called the acetylcholine receptor (AChR). A health care provider injects it into your vein (IV infusion) at their office or in a clinic. It is given once a week in four-week cycles.
How Does Vyvgart Work in gMG?
gMG is an autoimmune disease where the immune system mistakenly damages the connections between your nerves and muscles. This weakens your muscles and affects how they work. In people with gMG, the immune system blocks a protein called AChR, which is important for connecting nerves and muscles. The immune system does this using a group of immune proteins (antibodies).
Vyvgart attaches to a part of these antibodies, called neonatal Fc receptors (FcRn), which protects them from being destroyed. This lowers the amount of the antibodies in the blood and helps restore the connection between nerves and muscles.
Is Vyvgart Right for Me?
Vyvgart may be the right choice for you if:
- You are an adult with gMG.
- You have antibodies for AChR.
Your doctor will test you for AChR antibodies and review your medical history to decide if Vyvgart is right for you.
How Was Vyvgart Studied for Treating gMG?
One clinical study, the ADAPT trial, was done to look at the benefits and risks of Vyvgart in people with advanced gMG.
The main question the study wanted to answer was: How well does Vyvgart work to improve symptoms in people with gMG who have antibodies for AChR?
To learn this, the researchers measured the effect of Vyvgart using a test called the Myasthenia Gravis-Specific Activities of Daily Living scale (MG-ADL), which shows how gMG affects daily activities. A higher score means gMG has a bigger impact on those activities.
What medicines did the people in the study take?
People in the study were randomly selected to take either Vyvgart or a placebo. The placebo looked like Vyvgart but didn’t contain any medicine. Neither the people in the study nor the doctors knew who received Vyvgartand who got the placebo.
Who was included in the study?
To take part in the study, people had to:
- Be at least 18 years old
- Have class 2 to 4 myasthenia gravis that affects the muscles all over the body
- Have a score of 5 or higher on the MG-ADL test
- Be on other medicines for myasthenia gravis for a period of time before the study
Who was excluded from the study?
People could not be in this study if they:
- Had gotten other medicines that affected their immune system within six months of the study
- Had hepatitis B or antibodies for hepatitis C or HIV
What was the study population?
- 167 people were in the study.
- 84 people got Vyvgart, and 83 people got the placebo.
- About 71% were female.
- Most of the people in the study (77%) had antibodies for AChR.
- The average age of the people in the study was 46 years (from 19 to 81 years).
- Among the people who got Vyvgart, about 82% were White, 11% Asian, 4% Black, and 4% Other.
How long was the study?
People got Vyvgart or the placebo for about 6.5 months (26 weeks).
What was the main benefit of Vyvgart?
Vyvgart was much more effective at improving gMG symptoms compared to the placebo. About 68% of the people who took Vyvgart could perform their daily activities better, compared to about 30% of those who got the placebo.
What Are the Serious Side Effects of Vyvgart That I Should Be Aware Of?
Serious side effects that may happen when you get your Vyvgart infusion are:
Allergic reactions (hypersensitivity reactions). You may have allergic reactions to Vyvgart, like rashes, swelling under the skin, and shortness of breath. These reactions are usually mild and can happen within one hour to three weeks after a Vyvgart infusion.
Some people have had serious allergic reactions, including trouble breathing or a drop in blood pressure that caused them to faint.
Infusion reactions. You may have reactions during or after your Vyvgart infusion, including high blood pressure, chills, shivering, and pain in your chest, stomach, or back.
Your health care provider will watch you for signs of an allergic reaction or an infusion reaction during the infusion and for one hour afterward. They will treat any symptoms or stop the infusion if needed.
Contact your health care provider right away if you have symptoms of an allergic reaction or infusion reaction when you are outside the clinic.
Infections. Vyvgart may cause you to get more infections.
The most common side effects of Vyvgart are:
Infections in your sinuses, throat, airways, or lungs (respiratory tract infections). If you have a fever, chills, cough, runny nose, sinus pain, or headache, drink plenty of fluids and get some rest. Your pharmacist may recommend nonprescription pain medicines, like acetaminophen, or cough and cold medicines. Avoid being around people who are sick, and stay away from crowded places, especially during cold and flu season. Wear a well-fitting mask in busy areas for added safety.
Headache. You may get headaches, including migraines. Your pharmacist may recommend nonprescription painkillers like ibuprofen or acetaminophen.
Tell your health care provider if you have a fever, chills, an ongoing cough, or a headache that won’t go away.
Bladder (urinary tract) infection. Drink plenty of water to help keep bladder infections away.
Tell your health care provider if you have bladder pain, blood in your urine, need to urinate frequently, or if you feel burning or pain when you urinate.
You may also feel muscle pain or have numbness or tingling in your body, including your mouth. These side effects are usually mild and will go away as your body gets used to Vyvgart. Tell your health care provider if they don’t go away or become bothersome.
You can also report side effects to the drugmaker at 833-argx411 (833-274-9411), or to the FDA at 800-FDA-1088 (800-332-1088) or www.fda.gov/medwatch.
How Do I Know if Vyvgart Is Working?
Your doctor will regularly check how well Vyvgart is working for your gMG by tracking your progress in performing your daily activities. They may ask you to write down your gMG symptoms after each infusion and let them know if anything changes.
Do not stop your Vyvgart infusions or change your infusion schedule unless your health care provider tells you to do so.
How Do Other Medicines Interact With Vyvgart?
Vyvgart affects your immune system. Tell your health care providers and pharmacist about all the other prescription and nonprescription medicines, vitamins, supplements, and herbal products you take before starting Vyvgart.
Vaccines: Tell your health care provider you are on Vyvgart before getting any vaccines during a Vyvgart cycle. Vyvgart may affect how your body reacts to vaccines.
Non-live vaccines. It is not known if Vyvgart makes non-live vaccines less effective. Some examples of these vaccines are tetanus, pneumonia, flu, hepatitis A, and polio.
Live vaccines. Getting live vaccines during a Vyvgart cycle is not recommended. Some examples of live vaccines are measles, mumps, rubella, smallpox, chickenpox, and yellow fever.
How Can I Get Vyvgart?
You will need a prescription from a neurologist, a health care provider who is an expert on the nervous system. Your neurologist will either offer you Vyvgart infusions in their office or arrange for you to get Vyvgart at a clinic.
If you need support with payment for Vyvgart, the drugmaker may be able to help you. Check out https://www.vyvgart.com/gmg/support-and-resources/cost-and-coverageto learn more about their copay program or to ask your questions about insurance. You can also contact the drugmaker at 833-Vyvgart (833-898-4278).
