The effectiveness of VYVGART Hytrulo was established through 2 studies.
IV=intravenous
VYVGART Hytrulo study design: The study compared antibody reduction in 110 adults (18 years or oldera) with gMG who remained on their current gMG treatment and were given either VYVGART Hytrulo for subcutaneous injection or VYVGART for IV infusion.
The criteria for participating in the study were the same as in the study that measured the safety and effectiveness of VYVGART for IV infusion.
aPatients in Japan were 20 years or older.
MG-ADL=Myasthenia Gravis Activities of Daily Living
VYVGART for IV infusion was evaluated in a global study of adults with anti-AChR antibody positive gMG.
The study examined the effectiveness and safety of VYVGART for IV infusion in 167 adults (18 years or oldera) with gMG. In addition to their current treatment, patients received either VYVGART for IV infusion or placebo.
Patients in this study needed to meet the following criteria:
- Adult (18 or oldera)
- Myasthenia Gravis Foundation of America (MGFA) clinical classification class II to IV
- MG-ADL score of 5 or more
- On a stable dose of their current gMG treatment throughout the study
Patients represented a range of adults with gMG:
- Median time since gMG diagnosis was 9 years
- Myasthenia Gravis Foundation of America (MGFA) class ranged from II to IV at the start of the study
The MG-ADL scale was used to measure gMG symptoms.
- The MG-ADL scale assesses the impact of gMG on daily functions by measuring 8 signs or symptoms that are commonly affected in gMG: the ability to speak, chew, swallow, breathe, brush teeth or comb hair, and get out of a chair, as well as the frequency of double vision and eyelid droop
- Each item is measured on a 4-point scale, where a score of 0 represents normal function and a score of 3 represents the loss of ability to perform that function. Total scores range from 0 to 24 points, with a higher score showing more severe gMG
- VYVGART for IV infusion was determined to be effective if an anti-AChR antibody positive patient’s MG-ADL score decreased by 2 or more points and stayed at that level for 4 weeks or more in a row, with the first improvement occurring no later than 1 week after the last infusion of treatment cycle 1
a Patients in Japan were 20 years or older.
MGFA=Myasthenia Gravis Foundation of America
The safety of VYVGART Hytrulo was established through 2 studies.
The overall safety of VYVGART Hytrulo for subcutaneous injection was consistent with the safety profile of VYVGART for IV infusion, except patients on VYVGART Hytrulo for subcutaneous injection experienced more injection site reactions.
In the VYVGART for IV infusion study, the most common side effects for VYVGART for IV infusion-treated patients were respiratory tract infection, headache, and urinary tract infection. Additionally, more patients on VYVGART for IV infusion vs. placebo had lower white blood cell counts that were mild to moderate in severity.
Learn more about the safety data in the VYVGART for IV infusion study.
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:
- 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
Hypersensitivity reactions including rash, swelling under the skin, shortness of breath, and hives were observed in some VYVGART Hytrulo-treated patients.
Getting started with VYVGART
How VYVGART works
Because of VYVGART, IgG antibodies are reduced, including the harmful AChR antibodies that cause gMG symptoms.
VYVGART dosing
Your neurologist will work with you to help determine when you need another treatment cycle, with the aim to help manage your symptoms.§
About subcutaneous injections
Learn how VYVGART Hytrulo is injected and get more information and resources on the process.
§If additional cycles are needed.
IgG=immunoglobulin G
What is the most important information I should know about VYVGART® (efgartigimod alfa-fcab) for intravenous (IV) infusion and VYVGART® HYTRULO (efgartigimod alfa and hyaluronidase-qvfc) for subcutaneous injection?
VYVGART and VYVGART HYTRULO may cause serious side effects, including:
- Infection. VYVGART and VYVGART HYTRULO may increase the risk of infection. The most common infections for efgartigimod alfa-fcab-treated patients were urinary tract and respiratory tract infections. More patients on efgartigimod alfa-fcab vs placebo had below normal levels for white blood cell counts, lymphocyte counts, and neutrophil counts. The majority of infections and observed lower white blood cell counts were mild to moderate in severity. Your healthcare provider should check you for infections before starting treatment, during treatment, and after treatment with VYVGART or VYVGART HYTRULO. Tell your healthcare provider if you have any history of infections. Tell your healthcare provider right away if you have signs or symptoms of an infection during treatment with VYVGART or VYVGART HYTRULO such as fever, chills, frequent and/or painful urination, cough, pain and blockage of nasal passages/sinus, wheezing, shortness of breath, fatigue, sore throat, excess phlegm, nasal discharge, back pain, and/or chest pain. If a serious infection occurs, your doctor will treat your infection and may even stop your VYVGART or VYVGART HYTRULO treatment until the infection has resolved.
- Undesirable immune reactions (hypersensitivity reactions). VYVGART and VYVGART HYTRULO can cause the immune system to have undesirable reactions such as rashes, swelling under the skin, and shortness of breath. Hives were also observed in patients treated with VYVGART HYTRULO. In clinical studies, the reactions were mild or moderate and occurred within 1 hour to 3 weeks of administration, and the reactions did not lead to treatment discontinuation. Your healthcare provider should monitor you during and after treatment and discontinue VYVGART or VYVGART HYTRULO if needed. Tell your healthcare provider immediately about any undesirable reactions to VYVGART or VYVGART HYTRULO.
Before taking VYVGART or VYVGART HYTRULO, tell your healthcare provider about all of your medical conditions, including if you:
- Have a history of infection or you think you have an infection.
- Have received or are scheduled to receive a vaccine (immunization). Discuss with your healthcare provider whether you need to receive age-appropriate immunizations before initiation of a new treatment cycle with VYVGART or VYVGART HYTRULO. The use of vaccines during treatment with VYVGART or VYVGART HYTRULO has not been studied, and the safety with live or live-attenuated vaccines is unknown. Administration of live or live-attenuated vaccines is not recommended during treatment with VYVGART or VYVGART HYTRULO.
- Are pregnant or plan to become pregnant and are breastfeeding or plan to breastfeed.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
What are the common side effects of VYVGART and VYVGART HYTRULO?
The most common side effects of efgartigimod-alfa-fcab-treated patients were respiratory tract infection, headache, and urinary tract infection. Additional common side effects with VYVGART HYTRULO are injection site reactions, including rash, redness of the skin, itching sensation, bruising, pain, and hives.
These are not all the possible side effects of VYVGART and VYVGART HYTRULO. Call your doctor for medical advice about side effects. You may report side effects to the US Food and Drug Administration at 1-800-FDA-1088.
What is VYVGART for IV infusion and what is VYVGART HYTRULO for subcutaneous injection?
VYVGART and VYVGART HYTRULO are both prescription medicines, each used to treat a condition called generalized myasthenia gravis, which causes muscles to tire and weaken easily throughout the body, in adults who are positive for antibodies directed toward a protein called acetylcholine receptor (anti-AChR antibody positive).
Please see the full Prescribing Information for VYVGART and the full Prescribing Information for VYVGART HYTRULO, and talk to your doctor.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about VYVGART® (efgartigimod alfa-fcab) for intravenous (IV) infusion and VYVGART® HYTRULO (efgartigimod alfa and hyaluronidase-qvfc) for subcutaneous injection?
VYVGART and VYVGART HYTRULO may cause serious side effects, including:
- Infection. VYVGART and VYVGART HYTRULO may increase the risk of infection. The most common infections for efgartigimod alfa-fcab-treated patients were urinary tract and respiratory tract infections. More patients on efgartigimod alfa-fcab vs placebo had below normal levels for white blood cell counts, lymphocyte counts, and neutrophil counts. The majority of infections and observed lower white blood cell counts were mild to moderate in severity. Your healthcare provider should check you for infections before starting treatment, during treatment, and after treatment with VYVGART or VYVGART HYTRULO. Tell your healthcare provider if you have any history of infections. Tell your healthcare provider right away if you have signs or symptoms of an infection during treatment with VYVGART or VYVGART HYTRULO such as fever, chills, frequent and/or painful urination, cough, pain and blockage of nasal passages/sinus, wheezing, shortness of breath, fatigue, sore throat, excess phlegm, nasal discharge, back pain, and/or chest pain. If a serious infection occurs, your doctor will treat your infection and may even stop your VYVGART or VYVGART HYTRULO treatment until the infection has resolved.
- Undesirable immune reactions (hypersensitivity reactions). VYVGART and VYVGART HYTRULO can cause the immune system to have undesirable reactions such as rashes, swelling under the skin, and shortness of breath. Hives were also observed in patients treated with VYVGART HYTRULO. In clinical studies, the reactions were mild or moderate and occurred within 1 hour to 3 weeks of administration, and the reactions did not lead to treatment discontinuation. Your healthcare provider should monitor you during and after treatment and discontinue VYVGART or VYVGART HYTRULO if needed. Tell your healthcare provider immediately about any undesirable reactions to VYVGART or VYVGART HYTRULO.
Before taking VYVGART or VYVGART HYTRULO, tell your healthcare provider about all of your medical conditions, including if you:
- Have a history of infection or you think you have an infection.
- Have received or are scheduled to receive a vaccine (immunization). Discuss with your healthcare provider whether you need to receive age-appropriate immunizations before initiation of a new treatment cycle with VYVGART or VYVGART HYTRULO. The use of vaccines during treatment with VYVGART or VYVGART HYTRULO has not been studied, and the safety with live or live-attenuated vaccines is unknown. Administration of live or live-attenuated vaccines is not recommended during treatment with VYVGART or VYVGART HYTRULO.
- Are pregnant or plan to become pregnant and are breastfeeding or plan to breastfeed.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
What are the common side effects of VYVGART and VYVGART HYTRULO?
The most common side effects of efgartigimod-alfa-fcab-treated patients were respiratory tract infection, headache, and urinary tract infection. Additional common side effects with VYVGART HYTRULO are injection site reactions, including rash, redness of the skin, itching sensation, bruising, pain, and hives.
These are not all the possible side effects of VYVGART and VYVGART HYTRULO. Call your doctor for medical advice about side effects. You may report side effects to the US Food and Drug Administration at 1-800-FDA-1088.
What is VYVGART for IV infusion and what is VYVGART HYTRULO for subcutaneous injection?
VYVGART and VYVGART HYTRULO are both prescription medicines, each used to treat a condition called generalized myasthenia gravis, which causes muscles to tire and weaken easily throughout the body, in adults who are positive for antibodies directed toward a protein called acetylcholine receptor (anti-AChR antibody positive).
Please see the full Prescribing Information for VYVGART and the full Prescribing Information for VYVGART HYTRULO, and talk to your doctor.
What is the most important information I should know about VYVGART® (efgartigimod alfa-fcab) for intravenous (IV) infusion and VYVGART® HYTRULO (efgartigimod alfa and hyaluronidase-qvfc) for subcutaneous injection?
VYVGART and VYVGART HYTRULO may cause serious side effects, including:
- Infection. VYVGART and VYVGART HYTRULO may increase the risk of infection. The most common infections for efgartigimod alfa-fcab-treated patients were urinary tract and respiratory tract infections. More patients on efgartigimod alfa-fcab vs placebo had below normal levels for white blood cell counts, lymphocyte counts, and neutrophil counts. The majority of infections and observed lower white blood cell counts were mild to moderate in severity. Your healthcare provider should check you for infections before starting treatment, during treatment, and after treatment with VYVGART or VYVGART HYTRULO. Tell your healthcare provider if you have any history of infections. Tell your healthcare provider right away if you have signs or symptoms of an infection during treatment with VYVGART or VYVGART HYTRULO such as fever, chills, frequent and/or painful urination, cough, pain and blockage of nasal passages/sinus, wheezing, shortness of breath, fatigue, sore throat, excess phlegm, nasal discharge, back pain, and/or chest pain. If a serious infection occurs, your doctor will treat your infection and may even stop your VYVGART or VYVGART HYTRULO treatment until the infection has resolved.
- Undesirable immune reactions (hypersensitivity reactions). VYVGART and VYVGART HYTRULO can cause the immune system to have undesirable reactions such as rashes, swelling under the skin, and shortness of breath. Hives were also observed in patients treated with VYVGART HYTRULO. In clinical studies, the reactions were mild or moderate and occurred within 1 hour to 3 weeks of administration, and the reactions did not lead to treatment discontinuation. Your healthcare provider should monitor you during and after treatment and discontinue VYVGART or VYVGART HYTRULO if needed. Tell your healthcare provider immediately about any undesirable reactions to VYVGART or VYVGART HYTRULO.
Before taking VYVGART or VYVGART HYTRULO, tell your healthcare provider about all of your medical conditions, including if you:
- Have a history of infection or you think you have an infection.
- Have received or are scheduled to receive a vaccine (immunization). Discuss with your healthcare provider whether you need to receive age-appropriate immunizations before initiation of a new treatment cycle with VYVGART or VYVGART HYTRULO. The use of vaccines during treatment with VYVGART or VYVGART HYTRULO has not been studied, and the safety with live or live-attenuated vaccines is unknown. Administration of live or live-attenuated vaccines is not recommended during treatment with VYVGART or VYVGART HYTRULO.
- Are pregnant or plan to become pregnant and are breastfeeding or plan to breastfeed.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
What are the common side effects of VYVGART and VYVGART HYTRULO?
The most common side effects of efgartigimod-alfa-fcab-treated patients were respiratory tract infection, headache, and urinary tract infection. Additional common side effects with VYVGART HYTRULO are injection site reactions, including rash, redness of the skin, itching sensation, bruising, pain, and hives.
These are not all the possible side effects of VYVGART and VYVGART HYTRULO. Call your doctor for medical advice about side effects. You may report side effects to the US Food and Drug Administration at 1-800-FDA-1088.
What is VYVGART for IV infusion and what is VYVGART HYTRULO for subcutaneous injection?
VYVGART and VYVGART HYTRULO are both prescription medicines, each used to treat a condition called generalized myasthenia gravis, which causes muscles to tire and weaken easily throughout the body, in adults who are positive for antibodies directed toward a protein called acetylcholine receptor (anti-AChR antibody positive).
Please see the full Prescribing Information for VYVGART and the full Prescribing Information for VYVGART HYTRULO, and talk to your doctor.
Questions? Call 1-833-VYVGART (1-833-898-4278)
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VYVGART Hytrulo is a trademark of argenx.
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US-VYV-23-00228 V1 08/2023
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