Vyvgart is a brand-name IV infusion prescribed for generalized myasthenia gravis. Vyvgart contains the active ingredient efgartigimod alfa-fcab.

Drug details

You’ll find key information about Vyvgart below.

  • Drug class: neonatal Fc receptor blocker
  • Drug form: solution given as an intravenous (IV) infusion
  • Generic or biosimilar available? no
  • Prescription required? yes
  • Controlled substance? no
  • Year of FDA approval: 2021

Vyvgart vs. Vyvgart Hytrulo

A drug called Vyvgart Hytrulo is available, which is a subcutaneous injection. This drug is approved to treat myasthenia gravis and chronic inflammatory demyelinating polyneuropathy. It contains the same active ingredient as Vyvgart and another active ingredient called hyaluronidase-qvfc.

This article focuses on Vyvgart, not Vyvgart Hytrulo. But for details about Vyvgart Hytrulo, you can refer to the drug’s prescribing information.

Vyvgart is a brand-name medication that contains the active drug efgartigimod alfa-fcab.* It’s a biologic drug that isn’t available in biosimilar form.

Traditional drugs are made using chemicals, while biologics are made using parts of living cells. A generic drug is an exact copy of the active drug in a brand-name medication. However, it’s not possible to make exact copies of biologics. Instead of generics, biologic drugs have biosimilars.

Like generics, biosimilars are considered to be as safe and effective as the original brand-name drug.

* The reason “-fcab” appears at the end of the drug’s name is to show that the drug is distinct from similar medications that may be created in the future.

As with all medications, the cost of Vyvgart can vary. The actual price you’ll pay depends on your insurance plan and your location.

Financial and insurance assistance: If you need financial support to pay for Vyvgart, or if you need help understanding your insurance coverage, help is available.

The Vyvgart Copay Program and My Vyvgart Path program are available for Vyvgart. These resources might help you save on Vyvgart and help you understand what your insurance covers. For more information and to find out if you’re eligible for support, call 833-VYVGART (833-898-4278) or visit the drug manufacturer’s website.

Biosimilar form: Vyvgart is not available in a biosimilar form. It’s a biologic drug made using parts of living cells. Instead of generics, biologic drugs have biosimilars. A generic drug is an exact copy of the active drug in a brand-name medication. However, it’s not possible to make exact copies of biologics.

Like generics, biosimilars are considered to be as safe and effective as the original brand-name drug. And they may cost less than brand-name drugs.

To learn more, you can refer to this Vyvgart cost article. Also, for more information about saving money on prescriptions, check out this article.

The Food and Drug Administration (FDA) approves prescription drugs such as Vyvgart to treat certain conditions.

Vyvgart for generalized myasthenia gravis

Vyvgart is FDA-approved to treat generalized myasthenia gravis. This is a rare autoimmune condition that causes muscle weakness. “Generalized” means the condition affects muscles throughout the body.

For this use, Vyvgart is prescribed for adults who have certain antibodies in their blood. These antibodies target a protein called acetylcholine receptor (AChR), which is found on muscle cells. Antibodies against AChR are thought to cause the symptoms of myasthenia gravis. Examples of these symptoms include weakness in your arms and legs and trouble standing, walking, chewing, or swallowing.

Vyvgart and children

Vyvgart is not FDA-approved for use in children. It’s not known for sure whether the drug is safe or effective for children.

The Vyvgart dosage your doctor prescribes will depend on several factors. These include:

  • the severity of the condition you’re using Vyvgart to treat
  • your body weight

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.

Drug forms and strengths

Vyvgart comes as a solution in a single-use vial. It’s available in one strength of 400 milligrams (mg) in 20 milliliters (mL) of solution. This is also written as 20 mg/mL.

Dosage for generalized myasthenia gravis

For generalized myasthenia gravis, Vyvgart is given in treatment cycles. Each cycle is 4 weeks long.

The usual dosing schedule for Vyvgart is one infusion each week of the treatment cycle. You’ll receive a total of four infusions each cycle. Your doctor will advise you on how many treatment cycles you’ll receive.

For a person weighing under 120 kilograms (kg), which equals about 264 pounds (lb), each dose of Vyvgart is 10 mg/kg. For example, if you weigh 80 kg (about 176 lb), you’ll receive 800 mg of the drug per infusion.

For a person weighing at least 120 kg (about 264 lb), each dose of Vyvgart is 1,200 mg per infusion.

How Vyvgart is administered

Vyvgart is given as an intravenous infusion. Each infusion takes 1 hour.

A healthcare professional will give Vyvgart infusions in a hospital, clinic, or infusion center. In some cases, a healthcare professional may be able to give the infusions in your home.

For more information about what to expect with Vyvgart infusions, visit the drug manufacturer’s website.

About taking Vyvgart

Below you’ll find information about key dosage issues.

  • When is the drug administered: You’ll receive one infusion of Vyvgart each week of your treatment cycle.
  • If you miss a dose: If you miss an appointment to receive your Vyvgart infusion, call your doctor. They’ll help you reschedule your appointment as soon as possible.
  • Length of use: How long you’ll receive Vyvgart depends on how your condition responds to treatment. Talk with your doctor about how long you’ll receive Vyvgart.

Note: To learn more, you can refer to this Vyvgart dosage article.

Vyvgart can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Vyvgart. These lists do not include all possible side effects.

For more information about the possible side effects of Vyvgart, talk with your doctor or pharmacist. They can give you tips on how to manage any side effects that may be concerning or bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Vyvgart, you can do so through MedWatch.

Mild side effects

Below is a partial list of mild side effects of Vyvgart. To learn about other mild side effects, talk with your doctor or pharmacist, or view Vyvgart’s prescribing information.

Mild side effects of Vyvgart can include:

Most of these side effects may go away within a few days to a couple of weeks. However, if they become more severe or don’t go away, talk with your doctor or pharmacist.

Serious side effects

Serious side effects from Vyvgart aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or you think you’re having a medical emergency.

Serious side effects of Vyvgart may include a severe allergic reaction. For details about this side effect, see “Allergic reaction” below.

Serious side effects of Vyvgart may also include:

  • an infusion reaction, which can be mild or severe, potentially causing:
    • chills and shivering
    • pain in your chest, abdomen, or back
    • high blood pressure
  • an allergic reaction (see below for details)

You can refer to this Vyvgart side effects article for more details.

ALLERGIC REACTION

As with most drugs, some people can have an allergic reaction after taking Vyvgart. This was a rare side effect in clinical trials of this drug.

Symptoms of a mild allergic reaction can include:

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

  • swelling under your skin, typically in your eyelids, lips, hands, or feet
  • swelling of your tongue, mouth, or throat
  • trouble breathing

Call your doctor right away if you have an allergic reaction to Vyvgart, as the reaction could become severe. Call 911 or your local emergency number if your symptoms feel life threatening or you think you’re having a medical emergency.

Here are answers to some frequently asked questions about Vyvgart.

What is Vyvgart’s mechanism of action?

Vyvgart’s mechanism of action (how it works) is to lower the amount of antibodies in your body. This includes antibodies that target a protein called acetylcholine receptor (AChR), which is found on muscle cells. Antibodies against AChR proteins are thought to cause symptoms of myasthenia gravis.

Vyvgart specifically blocks a different protein that protects antibodies. By blocking this protein, Vyvgart lowers the level of antibodies in your body, which can help with communication between your nerves and muscles. This can ease symptoms of myasthenia gravis.

Is Vyvgart similar to Soliris or IVIg?

Yes, in some ways. For example, each drug has similar uses and is given by a healthcare professional as an intravenous (IV) infusion.

Vyvgart and eculizumab (Soliris) are prescribed to treat generalized myasthenia gravis in adults who have certain antibodies in their blood. Intravenous immunoglobulin (IVIg) is used off-label to treat episodes of worsened myasthenia gravis symptoms. With off-label use, a drug is prescribed for a purpose other than what it’s approved for.

Vyvgart, Soliris, and IVIg work differently in the body. And each drug has different dosages and side effects. For more details about how Vyvgart, Soliris, and IVIg are alike and different, talk with your doctor.

Does Vyvgart cause weight gain?

No, Vyvgart isn’t known to cause weight gain. This side effect wasn’t reported in clinical trials of the drug.

Other treatments for myasthenia gravis, such as corticosteroids, are known to cause weight gain. Examples of corticosteroids include prednisone (Rayos) and methylprednisolone (Medrol). However, Vyvgart isn’t known to cause this side effect.

If you have questions about Vyvgart and weight gain, talk with your doctor.

Can Vyvgart cause long-term side effects?

It’s not likely. Long-term side effects weren’t reported in clinical trials of Vyvgart. Most of the drug’s side effects are temporary, lasting only a few days or weeks. Many will likely go away soon after starting or stopping the drug.

If you have questions about Vyvgart and long-term side effects, talk with your doctor or pharmacist.

Vyvgart can interact with a few other medications. It’s not known to interact with supplements or foods.

Before taking Vyvgart, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

Interactions with medications

Below is a list of medications that can interact with Vyvgart. This list does not contain all drugs that may interact with Vyvgart. If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Medications that can interact with Vyvgart• intravenous immunoglobulin (IVIg)
• monoclonal antibodies, such as rituximab (Rituxan) and belimumab (Benlysta)
Vaccines that can interact with Vyvgart• live vaccines, such as the nasal spray flu vaccine (FluMist) and the measles, mumps, and rubella (MMR) vaccine

Alcohol interaction

Alcohol is not known to interact with Vyvgart. It’s likely safe to consume alcohol while taking Vyvgart. If you have questions about how much alcohol is safe to drink while taking Vyvgart, talk with your doctor or pharmacist.

Other drugs are available that can treat your condition. Some may be a better fit for you than others. If you’re interested in finding an alternative to Vyvgart, talk with your doctor. They can tell you about other medications that may work well for you.

The following drugs are similar to Vyvgart:

If you can become pregnant, consider the following information about pregnancy and breastfeeding.

Vyvgart and pregnancy

It’s not known whether Vyvgart should be used during pregnancy. If you’re planning a pregnancy or can become pregnant, talk with your doctor before using this medication.

If you take Vyvgart during pregnancy, you could consider joining the drug’s pregnancy registry. Pregnancy registries help gather information about how certain drugs affect pregnancy. To learn more you can call 855-272-6524 or visit the registry website.

Vyvgart and breastfeeding

It’s not known whether Vyvgart should be used while breastfeeding. If you’re currently breastfeeding or planning to do so, talk with your doctor before using this medication.

This drug comes with several precautions.

Before taking Vyvgart, discuss your health history with your doctor. Vyvgart may not be right for you if you have certain medical conditions or other factors affecting your health. Be sure to talk with your doctor if any of the following apply to you:

Note: For more information about the potential negative effects of Vyvgart, see the “Vyvgart side effects” section above.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.