SAFETY OF VYVGART
The most common side effects in efgartigimod alfa-fcab-treated patients were respiratory tract infection, headache, and urinary tract infection. Additional common side effects in patients treated with VYVGART Hytrulo for subcutaneous injection were injection site reactions.
VYVGART for IV infusion and VYVGART Hytrulo for subcutaneous injection may increase the risk of infection. Tell your doctor if you have any history of infections, and let them know right away if you have symptoms of an infection during treatment.
VYVGART for IV infusion and VYVGART Hytrulo for subcutaneous injection can cause allergic reactions such as rashes, swelling under the skin, and shortness of breath. VYVGART Hytrulo for subcutaneous injection can also cause hives. VYVGART for IV infusion and VYVGART Hytrulo for subcutaneous injection can also increase the risk of serious allergic reactions such as trouble breathing and decrease in blood pressure leading to fainting, as well as infusion or injection-related reactions including increase in blood pressure, chills, shivering, and chest, abdominal, and back pain. These reactions can occur during or after treatment and can cause doctors to pause or, in some cases, stop treatment. See Important Safety Information below.
Read more from the Voices of VYVGART
Videos and resources
Talk to your doctor to see if VYVGART is right for you
Use this guide to talk to your doctor about your current gMG symptoms, your treatment goals, and whether VYVGART Hytrulo for subcutaneous injection or VYVGART for IV infusion could be a fit for you.
VYVGART Videos
Learn about VYVGART and hear from gMG experts. You’ll get access to helpful information about a patient support program, symptom tracking, and much more.
Steve’s treatment journey: A candid conversation
Watch the video to hear how Steve—a real patient on VYVGART for IV infusion—discusses his symptoms and treatment plan with his doctor.
Do not take VYVGART if you are allergic to efgartigimod alfa or any of the ingredients in VYVGART. Do not take VYVGART HYTRULO if you are allergic to efgartigimod alfa, hyaluronidase, or any of the ingredients in VYVGART HYTRULO. VYVGART or VYVGART HYTRULO can cause serious allergic reactions and a decrease in blood pressure leading to fainting.
Before taking VYVGART or 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 or VYVGART HYTRULO will harm your unborn baby.
- Pregnancy Exposure Registry. There is a pregnancy exposure registry for women who use VYVGART or 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 or 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 or VYVGART HYTRULO can cause side effects which can be serious, including:
- Infection. VYVGART or VYVGART HYTRULO may increase the risk of infection. If you have an active infection, your healthcare provider should delay your treatment with VYVGART or 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:
- fever
- chills
- frequent and painful urination
- cough
- pain and blockage of nasal passages
- wheezing
- shortness of breath
- sore throat
- excess phlegm
- nasal discharge
Allergic reactions (hypersensitivity reactions). VYVGART or VYVGART HYTRULO can cause allergic reactions that can be severe. These reactions can happen during, shortly after, or weeks after your VYVGART infusion or 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 with VYVGART or VYVGART HYTRULO:
- rash
- swelling of the face, lips, throat, or tongue
- shortness of breath
- trouble breathing
- low blood pressure
- fainting
An additional symptom of an allergic reaction with VYVGART HYTRULO can include hives.
- Infusion or injection-related reactions. VYVGART can cause infusion-related reactions. VYVGART HYTRULO can cause infusion or injection-related reactions. These reactions can happen during or shortly after your VYVGART infusion or VYVGART HYTRULO injection. Tell your healthcare provider if you have any of the following symptoms of an infusion or injection-related reaction:
- high blood pressure
- chills
- shivering
- chest, stomach, or back pain
The most common side effects of VYVGART or VYVGART HYTRULO include respiratory tract infection, headache, and urinary tract infection. An additional common side effect with VYVGART HYTRULO includes injection site reactions.
These are not all the possible side effects of VYVGART or 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® (efgartigimod alfa-fcab) for intravenous (IV) infusion and what is VYVGART HYTRULO® (efgartigimod alfa and hyaluronidase-qvfc) for subcutaneous injection?
VYVGART and VYVGART HYTRULO are both prescription medicines used to treat adults with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive.
It is not known if VYVGART or VYVGART HYTRULO is safe and effective in children.
Please see full Prescribing and Patient Information for VYVGART HYTRULO for subcutaneous injection and full Prescribing Information for VYVGART for IV infusion.
Dosage forms and strengths:
VYVGART Hytrulo is available as a single-dose subcutaneous injection containing: 200 mg/mL of efgartigimod alfa and 2,000 U/mL of hyaluronidase per prefilled syringe, or 180 mg/mL of efgartigimod alfa and 2,000 U/mL of hyaluronidase per vial. VYVGART is available as a single-dose injection for intravenous use containing 400 mg/20 mL of efgartigimod alfa-fcab per vial.
IMPORTANT SAFETY INFORMATION
Do not take VYVGART if you are allergic to efgartigimod alfa or any of the ingredients in VYVGART. Do not take VYVGART HYTRULO if you are allergic to efgartigimod alfa, hyaluronidase, or any of the ingredients in VYVGART HYTRULO. VYVGART or VYVGART HYTRULO can cause serious allergic reactions and a decrease in blood pressure leading to fainting.
Before taking VYVGART or 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 or VYVGART HYTRULO will harm your unborn baby.
- Pregnancy Exposure Registry. There is a pregnancy exposure registry for women who use VYVGART or 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 or 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 or VYVGART HYTRULO can cause side effects which can be serious, including:
- Infection. VYVGART or VYVGART HYTRULO may increase the risk of infection. If you have an active infection, your healthcare provider should delay your treatment with VYVGART or 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:
- fever
- chills
- frequent and painful urination
- cough
- pain and blockage of nasal passages
- wheezing
- shortness of breath
- sore throat
- excess phlegm
- nasal discharge
Allergic reactions (hypersensitivity reactions). VYVGART or VYVGART HYTRULO can cause allergic reactions that can be severe. These reactions can happen during, shortly after, or weeks after your VYVGART infusion or 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 with VYVGART or VYVGART HYTRULO:
- rash
- swelling of the face, lips, throat, or tongue
- shortness of breath
- trouble breathing
- low blood pressure
- fainting
An additional symptom of an allergic reaction with VYVGART HYTRULO can include hives.
- Infusion or injection-related reactions. VYVGART can cause infusion-related reactions. VYVGART HYTRULO can cause infusion or injection-related reactions. These reactions can happen during or shortly after your VYVGART infusion or VYVGART HYTRULO injection. Tell your healthcare provider if you have any of the following symptoms of an infusion or injection-related reaction:
- high blood pressure
- chills
- shivering
- chest, stomach, or back pain
The most common side effects of VYVGART or VYVGART HYTRULO include respiratory tract infection, headache, and urinary tract infection. An additional common side effect with VYVGART HYTRULO includes injection site reactions.
These are not all the possible side effects of VYVGART or 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® (efgartigimod alfa-fcab) for intravenous (IV) infusion and what is VYVGART HYTRULO® (efgartigimod alfa and hyaluronidase-qvfc) for subcutaneous injection?
VYVGART and VYVGART HYTRULO are both prescription medicines used to treat adults with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive.
It is not known if VYVGART or VYVGART HYTRULO is safe and effective in children.
Please see full Prescribing and Patient Information for VYVGART HYTRULO for subcutaneous injection and full Prescribing Information for VYVGART for IV infusion.
Dosage forms and strengths:
VYVGART Hytrulo is available as a single-dose subcutaneous injection containing: 200 mg/mL of efgartigimod alfa and 2,000 U/mL of hyaluronidase per prefilled syringe, or 180 mg/mL of efgartigimod alfa and 2,000 U/mL of hyaluronidase per vial. VYVGART is available as a single-dose injection for intravenous use containing 400 mg/20 mL of efgartigimod alfa-fcab per vial.
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US-VYV-23-00229 V12 09/2025
