Vyvgart
Vyvgart (efgartigimod alfa or efgartigimod alfa-fcab) is an FDA-approved IV injection that's used to treat certain adults with generalized myasthenia gravis (gMG). It belongs to a drug class called neonatal Fc receptor blockers, which work by lowering harmful antibodies that interferes with communication between your nerves and muscles. The medication is given IV, typically at an infusion center, your prescriber's office, or at home. Common side effects include respiratory tract infections, headache, and urinary tract infection (UTIs).
What is Vyvgart (efgartigimod alfa)?
What is Vyvgart (efgartigimod alfa) used for?
- Generalized myasthenia gravis (gMG) in adults with anti-AChR antibodies
How Vyvgart (efgartigimod alfa) works
Vyvgart (efgartigimod alfa) is a neonatal Fc receptor (FcRn) blocker, which means it works by targeting a protein in your body called FcRn. This protein normally helps protect antibodies from being broken down. In people with gMG, some of these antibodies, called anti-acetylcholine receptor (anti-AChR) antibodies, are harmful because they interrupt signals between the nerves and muscles. These signals are what allow your muscles to move.
By blocking FcRn, Vyvgart (efgartigimod alfa) helps your body remove more of these harmful anti-AChR antibodies. This allows your nerves and muscles to communicate better, which helps reduce muscle weakness and makes it easier to move, talk, chew, and breathe.
Drug facts
Side effects of Vyvgart (efgartigimod alfa)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Respiratory tract infection (33%)
- Headache (32%)
- Urinary tract infection (10%)
Less Common Side Effects
- Tingling sensation
- Muscle pain
Vyvgart (efgartigimod alfa) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Allergic reaction: swelling of the face or throat, trouble breathing, rash, fainting
The following Vyvgart (efgartigimod alfa) side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions or angioedema—skin rash, itching or hives, swelling of the face, eyes, lips, tongue, arms, or legs, trouble swallowing or breathing
- Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
- Infusion reactions—chest pain, shortness of breath or trouble breathing, feeling faint or lightheaded
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
- Burning or tingling sensation in hands or feet
- Headache
- Muscle pain
Pros and cons of Vyvgart (efgartigimod alfa)
Pros
- Starts to work within 1 to 2 weeks
- Only injected once a week per treatment cycle
- Treatment cycles can lasts several weeks
Cons
- Must be given by IV infusion
- Can raise the risk of infections
- Only approved for people with gMG who have anti-AChR antibodies
Pharmacist tips for Vyvgart (efgartigimod alfa)
- You’ll most often get Vyvgart (efgartigimod alfa) at an infusion center or your prescriber’s office. Each IV infusion takes about an hour to complete.
- Plan to stay a little longer after your Vyvgart (efgartigimod alfa) treatment. Your care team will monitor you for allergic reactions during the infusion and for about one hour afterward. Tell them right away if you notice a rash, shortness of breath, or swelling of your tongue or throat.
- Try to get your Vyvgart (efgartigimod alfa) infusions on the same day each week. If you miss an appointment, contact your prescriber to reschedule. You can usually make up the dose within 3 days, but if you wait longer, you might need to restart the treatment cycle.
- Tell your prescriber if you’ve had any recent or ongoing infections before starting Vyvgart (efgartigimod alfa). Also, let them know right away if you develop fever, chills, cough, or a runny nose. This medication can raise your risk of infections, and some might be serious.
- Be aware that Vyvgart (efgartigimod alfa) can sometimes cause infusion-related reactions such as chills, shaking, or chest, stomach, or back pain. Tell your care team right away if you experience any of these symptoms.
- Avoid getting live vaccines while receiving Vyvgart (efgartigimod alfa). It isn't known whether live vaccines are safe or work well while you're taking this medication.
- There isn't enough information to know if Vyvgart (efgartigimod alfa) is safe during pregnancy. If you're pregnant and taking this medication, you can join a pregnancy registry to help monitor your and your baby’s health. For more information, call 1-855-272-6524 or visit https://www.Vyvgartpregnancy.com.
Common questions about Vyvgart (efgartigimod alfa)
After one 4-week treatment cycle, Vyvgart (efgartigimod alfa) usually lasts for several weeks. But this can vary depending on how your body responds. In studies, some people started another cycle in less than 6 weeks, while others waited 9 weeks or longer. Starting another cycle sooner than 7 weeks hasn’t been fully studied for safety. Your prescriber will decide when it’s time for your next treatment based on how well your symptoms improve or return.
Vyvgart (efgartigimod alfa) was approved by the FDA in December 2021.
Vyvgart (efgartigimod alfa) typically starts working within 1 to 2 weeks. Keep in mind that you might not see the full benefits until 4 weeks after starting this medication.
In clinical studies, Vyvgart (efgartigimod alfa) showed a success rate of about 68% in people with gMG and anti-AChR antibodies. This means around 68% of people taking the medication showed improvement on the Myasthenia Gravis Activities of Daily Living (MG‑ADL) scale. This scale checks how well you can do everyday activities like eating, talking, and walking.
An infusion of Vyvgart (efgartigimod alfa) is usually given over 1 hour. But after it's over, your healthcare professional will monitor you for another hour for allergic reactions.
If you miss your Vyvgart (efgartigimod alfa) infusion, call your prescriber right away. This medication can be given up to 3 days after your missed infusion. If it's been more than 3 days, your care team will give you further instructions.
Diarrhea wasn't a commonl side effect of Vyvgart (efgartigimod alfa) in studies. But if you have diarrhea that doesn't get better or becomes severe, contact your care team.
Vyvgart (efgartigimod alfa) and Vyvgart Hytrulo (efgartigimod alfa / hyaluronidase) both contain the same active ingredient (efgartigimod alfa), but Vyvgart Hytrulo also includes hyaluronidase. Hyaluronidase is a protein that helps the medication absorb better into your body when it’s injected under the skin. Vyvgart (efgartigimod alfa) is given as an IV infusion, while Vyvgart Hytrulo is injected under the skin. Follow up with your prescriber to learn about other differences between these two medications.
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Risks and warnings for Vyvgart (efgartigimod alfa)
Vyvgart (efgartigimod alfa) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Infections
- Risk factor: Active, long-term, or recurrent infection
Vyvgart (efgartigimod alfa) can lower your body's ability to fight infections. In studies, the most common infections were urinary tract infections (UTIs) and respiratory tract infections like colds or sinus infections. Most of these infections were mild to moderate, but some can be serious. Tell your care team right away if you notice fever, chills, cough, or any other signs of infection.
Before starting a new cycle of Vyvgart (efgartigimod alfa), your prescriber might recommend that you get any vaccines you're due for. But you shouldn’t get live vaccines while being treated since it’s not known if they’re safe or effective during this time.
Allergic reactions
In rare cases, some people who received Vyvgart (efgartigimod alfa) had allergic reactions. Your care team will watch out for these reactions during the infusion and for 1 hour afterward to make sure the medication is safe for you. But sometimes, allergic reactions can happen up to 3 weeks after treatment. Let your care team know if you experience signs and symptoms of allergic reactions like shortness of breath, chills, rash, or swelling of the face or throat.
Infusion-related reactions
Some people have experienced infusion-related reactions while receiving Vyvgart (efgartigimod alfa). The most common symptoms include high blood pressure, chills, shivering, and pain in the chest, stomach, or back. These reactions can happen during the infusion or within an hour afterward. If you have a reaction during treatment, your care team will decide whether to pause or stop the infusion and provide treatment needed to help you feel better.
Vyvgart (efgartigimod alfa) dosage
Typical dosage for Vyvgart (efgartigimod alfa)
Vyvgart (efgartigimod alfa) is an intravenous (IV) infusion that's given by a healthcare professional. Your dose is based on your body weight.
The typical dose is 10 mg/kg of body weight injected into a vein, once a week for 4 weeks (this is one treatment cycle). The maximum dose is 1,200 mg per infusion.
After you finish one cycle, your prescriber will decide if and when you need another round of treatment based on your symptoms.
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