- All injection site reactions were mild to moderate and didn’t lead to treatment discontinuation
- The majority of injection site reactions occurred within 24 hours of injection and resolved on their own
- The majority of injection site reactions occurred during the first treatment cycle and decreased with each subsequent cycle
Side effects in the VYVGART for IV infusion study
The following side effects were reported in at least 5% of patients on VYVGART for IV infusion plus their current oral gMG treatment and more frequently than in patients on placebo plus their current oral gMG treatment.
- See as a graph
- See as a table
| SIDE EFFECT | VYVGART for IV infusion + current oral gMG treatment 84 patients | Placebo + current oral gMG treatment 83 patients |
|---|---|---|
| Respiratory tract infection | 33% | 29% |
| Headache | 32% | 29% |
| Urinary tract infection | 10% | 5% |
| Tingling sensation | 7% | 5% |
| Muscle pain | 6% | 1% |
Most infections in patients on VYVGART for IV infusion were mild to moderate. Additionally, more patients on VYVGART for IV infusion compared to placebo plus current oral gMG treatment had lower white blood cell counts that were mild to moderate in severity.
INFORMATION ABOUT ALLERGIC, INFUSION OR INJECTION-RELATED REACTIONS
VYVGART for IV infusion can cause allergic reactions such as rash, swelling of the face, lips, throat, or tongue, and shortness of breath. It can also increase the risk of serious allergic reactions such as trouble breathing, low blood pressure, and fainting, as well as infusion-related reactions including high blood pressure, chills, shivering, and chest, stomach, or back pain. These reactions can happen during, shortly after, or weeks after treatment and can cause doctors to pause or, in some cases, stop treatment.
Similar side effects in the VYVGART Hytrulo study
The overall safety of VYVGART Hytrulo for subcutaneous injection was consistent with the safety profile of VYVGART for IV infusion above, except patients on VYVGART Hytrulo for subcutaneous injection experienced more injection site reactions.
The safety of VYVGART Hytrulo was established through 2 studies
In the VYVGART for IV infusion study, the most common side effects of VYVGART for IV infusion-treated patients were respiratory tract infection, headache, and urinary tract infection. More patients had lower white blood cell counts that were mild to moderate in severity vs. placebo.
In the VYVGART Hytrulo study, the most common side effects of VYVGART Hytrulo-treated patients were injection site reactions 38% (21 of 55) and headache. Injection site reactions included injection site rash, redness of the skin, itching sensation, bruising, pain, and hives.
In the VYVGART Hytrulo study and its long-term safety study:
INFORMATION ABOUT ALLERGIC, INFUSION OR INJECTION-RELATED REACTIONS
VYVGART Hytrulo can cause allergic reactions such as rash, swelling of the face, lips, throat, or tongue, shortness of breath, and hives. It can also increase the risk of serious allergic reactions such as trouble breathing, low blood pressure, and fainting, as well as infusion or injection-related reactions including high blood pressure, chills, shivering, and chest, stomach, or back pain. These reactions can happen during, shortly after, or weeks after treatment and can cause doctors to pause or, in some cases, stop treatment.
Taking VYVGART during pregnancy?
Consider sharing your experience with argenx by participating in the Pregnancy Registry. It’s a way to provide information about your health and your baby’s health during your pregnancy. Learn more by calling 1-855-272-6524, visiting VYVGARTpregnancy.com, or talking to your healthcare provider.
Things to discuss with MY doctor before starting VYVGART Hytrulo or VYVGART
Getting started with VYVGART
How VYVGART works
See how VYVGART helps reduce harmful AChR antibodies, the main cause of gMG symptoms.
VYVGART dosing
Breaks between VYVGART treatment cycles are personalized to you. Find out how to work with your neurologist to make the most of your treatment plan.
Real Stories on VYVGART
This video series features real people who speak about the impact of living with anti-AChR antibody positive gMG—and their experiences with VYVGART.
AChR=acetylcholine receptor.
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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