About gMG

gMG is a neuromuscular autoimmune disorder caused by pathogenic IgG autoantibodies1-3







gMG=generalized myasthenia gravis; IgG=immunoglobulin G.

What is gMG?

IgG autoantibodies are a key driver of gMG1-8

FcRn plays a critical role in enabling IgG-mediated damage at the NMJ by binding IgG antibodies, rescuing them from lysosomal degradation, and recycling them back into circulation. In doing so, FcRn maintains high levels of circulating IgG antibodies, including pathogenic AChR autoantibodies, which facilitates damage and dysfunction at the NMJ.

gMG Symptoms

gMG causes muscle weakness that can result in1,9

Impaired
mobility

Impaired
speech

Impaired
swallowing

Impaired
vision

Fatigue

 

AChR=acetylcholine receptor; FcRn=neonatal Fc receptor; gMG=generalized myasthenia gravis; IgG=immunoglobulin G; NMJ=neuromuscular junction.

Uncontrolled gMG can cause patients to struggle with activities of daily living9-15

Patients can suffer from severe physical and psychological burden

 

Anxiety Icon

Symptoms can make socializing difficult and increase feelings of anxiety and isolation.

The fluctuating nature of symptoms in gMG can have an impact on patients’ emotional, social, and economic well-being.

The MG-ADL scale16-18

The MG-ADL scale is a patient-reported, physician-assessed tool used to track disease progression. It assesses the impact of gMG on daily functions of 8 signs or symptoms that are typically affected in gMG. 

Each item is assessed on a 4-point scale where a score of 0 represents normal function and a score of 3 represents loss of ability to perform that function. A total score ranges from 0 to 24, with the higher scores indicating more impairment.

gMG=generalized myasthenia gravis; MG-ADL=Myasthenia Gravis Activities of Daily Living.

The use of patient-reported assessment may help patients become more active, informed participants in managing their disease and tracking its progression.

See how your patients score on the MG-ADL scale with an interactive tool

CONTRAINDICATIONS

VYVGART and VYVGART HYTRULO are contraindicated in patients with serious hypersensitivity to efgartigimod alfa products or to any of the excipients of VYVGART or VYVGART HYTRULO, respectively. VYVGART HYTRULO is also contraindicated in patients with serious hypersensitivity to hyaluronidase. Reactions have included anaphylaxis and hypotension leading to syncope.

WARNINGS AND PRECAUTIONS
Infection

VYVGART and VYVGART HYTRULO may increase the risk of infection. The most common infections observed in Study 1 were urinary tract infection (10% of efgartigimod alfa-fcab-treated patients vs 5% of placebo-treated patients) and respiratory tract infection (33% of efgartigimod alfa-fcab-treated patients vs 29% of placebo-treated patients). Patients on efgartigimod alfa-fcab vs placebo had below normal levels for white blood cell counts (12% vs 5%, respectively), lymphocyte counts (28% vs 19%, respectively), and neutrophil counts (13% vs 6%, respectively). The majority of infections and hematologic abnormalities were mild to moderate in severity. Delay the administration of VYVGART or VYVGART HYTRULO in patients with an active infection until the infection has resolved; monitor for clinical signs and symptoms of infections. If serious infection occurs, administer appropriate treatment and consider withholding treatment with VYVGART or VYVGART HYTRULO until the infection has resolved.

Immunization

Immunization with vaccines during treatment with VYVGART or VYVGART HYTRULO has not been studied; the safety with live or live-attenuated vaccines and the response to immunization with any vaccine are unknown. Because VYVGART and VYVGART HYTRULO cause a reduction in immunoglobulin G (IgG) levels, vaccination with live-attenuated or live vaccines is not recommended during treatment with VYVGART or VYVGART HYTRULO. Evaluate the need to administer age-appropriate vaccines according to immunization guidelines before initiation of a new treatment cycle with VYVGART or VYVGART HYTRULO.

Hypersensitivity Reactions

In clinical trials, hypersensitivity reactions, including rash, angioedema, and dyspnea were observed in patients treated with VYVGART or VYVGART HYTRULO. Urticaria was also observed in patients treated with VYVGART HYTRULO. Hypersensitivity reactions were mild or moderate, occurred within 1 hour to 3 weeks of administration, and did not lead to treatment discontinuation. Anaphylaxis and hypotension leading to syncope have been reported in postmarketing experience with intravenous efgartigimod alfa-fcab. Anaphylaxis and hypotension occurred during or within an hour of administration and led to infusion discontinuation and in some cases to permanent treatment discontinuation. Healthcare professionals should monitor patients during and for 1 hour after VYVGART administration, or for at least 30 minutes after VYVGART HYTRULO administration, for clinical signs and symptoms of hypersensitivity reactions. If a hypersensitivity reaction occurs, the healthcare professional should institute appropriate measures if needed or the patient should seek medical attention.

Infusion-Related Reactions

Infusion-related reactions have been reported with intravenous efgartigimod alfa-fcab in postmarketing experience. The most frequent symptoms and signs were hypertension, chills, shivering, and thoracic, abdominal, and back pain. Infusion-related reactions occurred during or within an hour of administration and led to infusion discontinuation. If a severe infusion-related reaction occurs during administration, discontinue VYVGART infusion and initiate appropriate therapy. If a severe infusion-related reaction occurs with VYVGART HYTRULO, initiate appropriate therapy. Consider the risks and benefits of readministering VYVGART or VYVGART HYTRULO following a severe infusion-related reaction. If a mild to moderate infusion-related reaction occurs, patients may be rechallenged with close clinical observation, slower infusion rates, and pre-medications.

ADVERSE REACTIONS

In Study 1, the most common (≥10%) adverse reactions in efgartigimod alfa-fcab-treated patients were respiratory tract infection, headache, and urinary tract infection. In Study 2, the most common (≥10%) adverse reactions in VYVGART HYTRULO-treated patients were injection site reactions and headache. Injection site reactions occurred in 38% of VYVGART HYTRULO-treated patients, including injection site rash, erythema, pruritus, bruising, pain, and urticaria. In Study 2 and its open-label extension, all injection site reactions were mild to moderate in severity and did not lead to treatment discontinuation. The majority occurred within 24 hours after administration and resolved spontaneously. Most injection site reactions occurred during the first treatment cycle, and the incidence decreased with each subsequent cycle.

USE IN SPECIFIC POPULATIONS
Pregnancy

As VYVGART and VYVGART HYTRULO are expected to reduce maternal IgG antibody levels, reduction in passive protection to the newborn is anticipated. Risks and benefits should be considered prior to administering live or live attenuated vaccines to infants exposed to VYVGART or VYVGART HYTRULO in utero.

Lactation

There is no information regarding the presence of efgartigimod alfa-fcab from administration of VYVGART, or efgartigimod alfa or hyaluronidase from administration of VYVGART HYTRULO, in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for VYVGART or VYVGART HYTRULO, and any potential adverse effects on the breastfed infant from VYVGART or VYVGART HYTRULO or from the underlying maternal condition.

INDICATION

VYVGART® (efgartigimod alfa-fcab) for intravenous infusion and VYVGART® HYTRULO (efgartigimod alfa and hyaluronidase-qvfc) for subcutaneous injection are each indicated for the treatment of generalized myasthenia gravis in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.

Please see the full Prescribing Information for VYVGART and the full Prescribing Information for VYVGART HYTRULO.

You may report side effects to the US Food and Drug Administration by visiting http://www.fda.gov/medwatch or calling 1-800-FDA-1088. You may also report side effects to argenx US, Inc, at 1-833-argx411 (1-833-274-9411).

CONTRAINDICATIONS

VYVGART and VYVGART HYTRULO are contraindicated in patients with serious hypersensitivity to efgartigimod alfa products or to any of the excipients of VYVGART or VYVGART HYTRULO, respectively. VYVGART HYTRULO is also contraindicated in patients with serious hypersensitivity to hyaluronidase. Reactions have included anaphylaxis and hypotension leading to syncope.

WARNINGS AND PRECAUTIONS
Infection

VYVGART and VYVGART HYTRULO may increase the risk of infection. The most common infections observed in Study 1 were urinary tract infection (10% of efgartigimod alfa-fcab-treated patients vs 5% of placebo-treated patients) and respiratory tract infection (33% of efgartigimod alfa-fcab-treated patients vs 29% of placebo-treated patients). Patients on efgartigimod alfa-fcab vs placebo had below normal levels for white blood cell counts (12% vs 5%, respectively), lymphocyte counts (28% vs 19%, respectively), and neutrophil counts (13% vs 6%, respectively). The majority of infections and hematologic abnormalities were mild to moderate in severity. Delay the administration of VYVGART or VYVGART HYTRULO in patients with an active infection until the infection has resolved; monitor for clinical signs and symptoms of infections. If serious infection occurs, administer appropriate treatment and consider withholding treatment with VYVGART or VYVGART HYTRULO until the infection has resolved.

Immunization

Immunization with vaccines during treatment with VYVGART or VYVGART HYTRULO has not been studied; the safety with live or live-attenuated vaccines and the response to immunization with any vaccine are unknown. Because VYVGART and VYVGART HYTRULO cause a reduction in immunoglobulin G (IgG) levels, vaccination with live-attenuated or live vaccines is not recommended during treatment with VYVGART or VYVGART HYTRULO. Evaluate the need to administer age-appropriate vaccines according to immunization guidelines before initiation of a new treatment cycle with VYVGART or VYVGART HYTRULO.

Hypersensitivity Reactions

In clinical trials, hypersensitivity reactions, including rash, angioedema, and dyspnea were observed in patients treated with VYVGART or VYVGART HYTRULO. Urticaria was also observed in patients treated with VYVGART HYTRULO. Hypersensitivity reactions were mild or moderate, occurred within 1 hour to 3 weeks of administration, and did not lead to treatment discontinuation. Anaphylaxis and hypotension leading to syncope have been reported in postmarketing experience with intravenous efgartigimod alfa-fcab. Anaphylaxis and hypotension occurred during or within an hour of administration and led to infusion discontinuation and in some cases to permanent treatment discontinuation. Healthcare professionals should monitor patients during and for 1 hour after VYVGART administration, or for at least 30 minutes after VYVGART HYTRULO administration, for clinical signs and symptoms of hypersensitivity reactions. If a hypersensitivity reaction occurs, the healthcare professional should institute appropriate measures if needed or the patient should seek medical attention.

Infusion-Related Reactions

Infusion-related reactions have been reported with intravenous efgartigimod alfa-fcab in postmarketing experience. The most frequent symptoms and signs were hypertension, chills, shivering, and thoracic, abdominal, and back pain. Infusion-related reactions occurred during or within an hour of administration and led to infusion discontinuation. If a severe infusion-related reaction occurs during administration, discontinue VYVGART infusion and initiate appropriate therapy. If a severe infusion-related reaction occurs with VYVGART HYTRULO, initiate appropriate therapy. Consider the risks and benefits of readministering VYVGART or VYVGART HYTRULO following a severe infusion-related reaction. If a mild to moderate infusion-related reaction occurs, patients may be rechallenged with close clinical observation, slower infusion rates, and pre-medications.

ADVERSE REACTIONS

In Study 1, the most common (≥10%) adverse reactions in efgartigimod alfa-fcab-treated patients were respiratory tract infection, headache, and urinary tract infection. In Study 2, the most common (≥10%) adverse reactions in VYVGART HYTRULO-treated patients were injection site reactions and headache. Injection site reactions occurred in 38% of VYVGART HYTRULO-treated patients, including injection site rash, erythema, pruritus, bruising, pain, and urticaria. In Study 2 and its open-label extension, all injection site reactions were mild to moderate in severity and did not lead to treatment discontinuation. The majority occurred within 24 hours after administration and resolved spontaneously. Most injection site reactions occurred during the first treatment cycle, and the incidence decreased with each subsequent cycle.

USE IN SPECIFIC POPULATIONS
Pregnancy

As VYVGART and VYVGART HYTRULO are expected to reduce maternal IgG antibody levels, reduction in passive protection to the newborn is anticipated. Risks and benefits should be considered prior to administering live or live attenuated vaccines to infants exposed to VYVGART or VYVGART HYTRULO in utero.

Lactation

There is no information regarding the presence of efgartigimod alfa-fcab from administration of VYVGART, or efgartigimod alfa or hyaluronidase from administration of VYVGART HYTRULO, in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for VYVGART or VYVGART HYTRULO, and any potential adverse effects on the breastfed infant from VYVGART or VYVGART HYTRULO or from the underlying maternal condition.

INDICATION

VYVGART® (efgartigimod alfa-fcab) for intravenous infusion and VYVGART® HYTRULO (efgartigimod alfa and hyaluronidase-qvfc) for subcutaneous injection are each indicated for the treatment of generalized myasthenia gravis in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.

Please see the full Prescribing Information for VYVGART and the full Prescribing Information for VYVGART HYTRULO.

You may report side effects to the US Food and Drug Administration by visiting http://www.fda.gov/medwatch or calling 1-800-FDA-1088. You may also report side effects to argenx US, Inc, at 1-833-argx411 (1-833-274-9411).

References: 1. Gilhus NE et al. Nat Rev Neurol. 2016;12(5):259-268. doi:10.1038/nrneurol.2016.44 2. Rødgaard A et al. Clin Exp Immunol. 1987;67(1):82-88. 3. Behin A, Le Panse R. J Neuromuscul Dis. 2018;5(3):265-277. doi:10.3233/JND-170294 4. Roopenian DC, Akilesh S. Nat Rev Immunol. 2007;7(9):715-725. doi:10.1038/nri2155 5. Zhu LN et al. Neural Regen Res. 2023;18(8):1637-1644 6. Ward ES, Ober RJ. Trends Pharmacol Sci. 2018;39(10):892-904. doi:10.1016/j.tips.2018.07.007 7. Ulrichts P et al. J Clin Invest. 2018;128(10):4372-4386. doi:10.1172/JCI97911 8. Mantegazza R et al. Neuropsychiatr Dis Treat. 2011;7:151-160. doi:10.2147/NDT.S8915 9. Twork S et al. Health Qual Life Outcomes. 2010;8:129. doi:10.1186/1477-7525-8-129  10. Boldingh MI et al. Health Qual Life Outcomes. 2015;13:115. doi:10.1186/s12955-015-0298-1 11. Eliasen A et al. J Neurol. 2018;265(6):1303-1309. doi:10.1007/s00415-018-8837-4 12. Chu HT et al. Front Psychiatry. 2019;10:481. doi:10.3389/fpsyt.2019.00481 13. Jackson K et al. Neurol Ther. 2023;12(1):107-128. doi:10.1007/s40120-022-00408-x 14. Howard JF Jr. Myasthenia Gravis: A Manual for the Health Care Provider. Myasthenia Gravis Foundation of America; 2009. 15. Suzuki Y et al. BMJ Open. 2011;1(2):e000313. doi:10.1136 bmjopen-2011-000313 16. Dewilde S et al. Muscle Nerve. 2023;68(1):65-72. doi:10.1002/mus.27837 17. Muppidi S et al. Muscle Nerve. 2022;65:630-639. doi:10.1002/mus.27476 18. Wolfe GI et al. Neurology. 1999;52(7):1487-1489. doi:10.1212/wnl.52.7.1487