Efgartigimod Alfa

Efgartigimod alfa-fcab is a human IgG1 antibody fragment that binds to the neonatal Fc receptor (FcRn), resulting in the reduction of circulating IgG.

• VYVGART is indicated for the treatment of adult patients with generalized myasthenia gravis (gMG). VYVGART is a neonatal Fc receptor blocker indicated for the treatment of adult patients with generalized myasthenia gravis (gMG).

• VYVGART is contraindicated in patients with serious hypersensitivity to efgartigimod alfa products or to any of the excipients of VYVGART . Reactions have included anaphylaxis and hypotension leading to syncope [see Warnings and Precautions (5.2) ] .contraindicated

Evaluate the need to administer age-appropriate vaccines according to immunization guidelines before initiation of a new treatment cycle with VYVGART. ( 2.1 ) The recommended dosage is 10 mg/kg administered as an intravenous infusion over one hour once weekly for 4 weeks. In patients weighing 120 kg or more, the recommended dose is 1,200 mg per infusion. ( 2.2 ) Administer subsequent treatment cycles based on clinical evaluation. ( 2.2 ) Dilute with 0.9% Sodium Chloride Injection prior to administration. ( 2.3 ) Administer as an intravenous infusion over one hour via a 0.2 micron in-line filter. ( 2.3 ) 2.1 Recommended Vaccination Evaluate the need to administer age-appropriate vaccines according to immunization guidelines before initiation of a new treatment cycle with VYVGART. Because VYVGART causes transient reduction in IgG levels, vaccination with live vaccines is not recommended during treatment with VYVGART [see Dosage and Administration (2.2) and Warnings and Precautions (5.1) ] . 2.2 Recommended Dose and Dose Schedules Dilute VYVGART prior to administration. Administer via intravenous infusion only [see Dosage and Administration (2.3) ] . The recommended dosage of VYVGART is 10 mg/kg administered as an intravenous infusion over one hour once weekly for 4 weeks. In patients weighing 120 kg or more, the recommended dose of VYVGART is 1,200 mg (3 vials) per infusion. Administer subsequent treatment cycles based on clinical evaluation. If a scheduled infusion is missed, VYVGART may be administered up to 3 days after the scheduled time point.

Infections: Delay administration of VYVGART to patients with an active infection. Monitor for signs and symptoms of infection in patients treated with VYVGART. If serious infection occurs, administer appropriate treatment and consider withholding VYVGART until the infection has resolved. ( 5.1 ) Hypersensitivity Reactions: Anaphylaxis, hypotension leading to syncope, angioedema, dyspnea, and rash have occurred. If a hypersensitivity reaction occurs, the healthcare professional should institute appropriate measures if needed or the patient should seek medical attention. ( 4 , 5.2 ) Infusion-Related Reactions: If a severe infusion-related reaction occurs, discontinue the infusion and initiate appropriate therapy; consider risks and benefits of readministering. If a mild to moderate infusion-related reaction occurs, consider rechallenging with close clinical observation, slower infusion rates, and pre-medications. ( 5.3 ) 5.1 Infections VYVGART may increase the risk of infection. The most common infections observed in Study 1 were urinary tract infection (10% of VYVGART-treated patients compared to 5% of placebo-treated patients) and respiratory tract infections (33% of VYVGART-treated patients compared to 29% of placebo-treated patients) [see Adverse Reactions (6.1) and Clinical Studies (14) ] . A higher frequency of patients who received VYVGART compared to placebo were observed to have below normal levels for white blood cell counts (12% versus 5%, respectively), lymphocyte counts (28% versus 19%, respectively), and neutrophil counts (13% versus 6%, respectively).

The following clinically significant adverse reactions are described elsewhere in the labeling: Infections [see Warnings and Precautions (5.1) ] Hypersensitivity Reactions [see Warnings and Precautions (5.2) ] Infusion-Related Reactions [see Warnings and Precautions (5.3) ] Most common adverse reactions (≥ 10%) in patients treated with gMG are respiratory tract infections, headache, and urinary tract infection. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact argenx at 1-833-argx411 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In clinical studies, the safety of VYVGART in adult patients with gMG has been evaluated in 364 patients who received at least one dose of VYVGART. In a placebo-controlled study (Study 1) in patients with gMG, 84 patients received VYVGART 10 mg/kg [see Clinical Studies (14) ]. Of these 84 patients, approximately 75% were female, 82% were White, 11% were Asian, and 8% were of Hispanic or Latino ethnicity. The mean age at study entry was 46 years (range 19 to 78). The minimum time to initiate a subsequent cycle, specified by study protocol, was 28 days from the last administration of the previous treatment cycle. On average, VYVGART-treated patients received 2 cycles in Study 1.

8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to VYVGART during pregnancy. Healthcare providers and patients may call 1-855-272-6524 or go to https://www.Vyvgartpregnancy.com to enroll in or to obtain information about the registry. Risk Summary There are no available data on the use of VYVGART during pregnancy. There is no evidence of adverse developmental outcomes following the administration of VYVGART at up to 100 mg/kg/day in rats and rabbits (see Data ). The background rate of major birth defects and miscarriage in the indicated population is unknown. In the U.S. general population, the estimated background rate of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Monoclonal antibodies are increasingly transported across the placenta as pregnancy progresses, with the largest amount transferred during the third trimester. Therefore, efgartigimod alfa-fcab may be transmitted from the mother to the developing fetus. As VYVGART is expected to reduce maternal IgG antibody levels, reduction in passive protection to the newborn is anticipated.

Metabolism

Efgartigimod alfa-fcab exhibits linear pharmacokinetics, and following single doses of efgartigimod alfa-fcab, exposures increase proportionally up to 50 mg/kg (5 times the recommended dosage). Distribution The volume of distribution is 15 to 20L.

• Dec 17, 2021BLABLA761195Argenx Bv
• Jun 20, 2023BLABLA761304Argenx Bv

1. 1Myasthenia Gravis81320%
2. 2Myasthenia Gravis Crisis45211%
3. 3Fatigue42310%
4. 4Dyspnoea3037.4%
5. 5Asthenia2766.8%
6. 6Fall2385.8%
7. 7Drug Ineffective2195.4%
8. 8Urinary Tract Infection2155.3%
9. 9Muscular Weakness2095.1%
10. 10Death1974.8%
11. 11Headache1974.8%
12. 12Dysphagia1824.5%
13. 13Covid-191784.4%
14. 14Symptom Recurrence1784.4%
15. 15Hospitalisation1754.3%

The 10 most recently updated of 35 ClinicalTrials.gov registrations naming Efgartigimod Alfa as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Pilot Study of Efgartigimod for Immune-mediated Thrombotic Thrombocytopenic Purpura (iTTP)
  Recruiting · Phase 2 · Interventional · 15 enrolled · University of Minnesota
  NCT06831058updated 2026-06-11
• Comparative Efficacy of Nipocalimab and Efgartigimod in Participants With Generalized Myasthenia Gravis
  Recruiting · Phase 3 · Interventional · 115 enrolled · Janssen Research & Development, LLC
  NCT07217587updated 2026-06-05
• A Study to Learn About How Well the Medicine Efgartigimod Works to Treat Autoimmune Encephalitis In Children 12 Years or Older and Adults
  Not yet recruiting · Phase 2 · Interventional · 170 enrolled · argenx
  NCT07583641updated 2026-05-13
• Targeting Collagen VII Antibodies in Bullous Diseases Using Efgartigimod IV (VYVGART)
  Not yet recruiting · Phase 1 · Phase 2 · Interventional · 18 enrolled · M. Peter Marinkovich
  NCT07011589updated 2026-05-05
• A Long-term Study to Assess the Safety and Efficacy of Efgartigimod in Adult Patients With Primary Immune Thrombocytopenia (ITP).
  Completed · Phase 3 · Interventional · 101 enrolled · argenx
  NCT04225156updated 2026-03-16
• Evaluating Efgartigimod in Patients With Guillain-Barré Syndrome
  Withdrawn · Phase 2 · Interventional · 0 enrolled · Chafic Karam
  NCT05701189updated 2026-03-12
• Open-Label Extension Study to Evaluate the Safety of Efgartigimod in Adult Patients With Primary Sjögren's Syndrome
  Completed · Phase 2 · Interventional · 24 enrolled · argenx
  NCT06203457updated 2026-02-20
• A Non-interventional, Post-authorisation Safety Study of Patients Treated With Efgartigimod Alfa
  Recruiting · Observational · 680 enrolled · argenx
  NCT06298565updated 2026-02-17
• A Worldwide Pregnancy Safety Study to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to Efgartigimod During Pregnancy and/or Breastfeeding.
  Recruiting · Observational · 279 enrolled · argenx
  NCT06299748updated 2026-02-17
• A Study of Efgartigimod in Patients With IgG4-Related Disease
  Recruiting · Phase 2 · Interventional · 5 enrolled · Stanford University
  NCT07025330updated 2026-02-10

Frequently asked questions

How does Efgartigimod Alfa work?

Efgartigimod alfa-fcab is a human IgG1 antibody fragment that binds to the neonatal Fc receptor (FcRn), resulting in the reduction of circulating IgG.

What is Efgartigimod Alfa used for?

According to FDA labeling, Efgartigimod Alfa carries indications including: VYVGART is indicated for the treatment of adult patients with generalized myasthenia gravis (gMG). VYVGART is a neonatal Fc receptor blocker indicated for the treatment of adult patients with generalized myasthenia gravis (gMG).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Efgartigimod Alfa?

Efgartigimod Alfa is classified as Neonatal fragment crystallizable receptor (FcRn) inhibitors, Selective immunosuppressants, Neonatal Fc Receptor Blocker, Antibody-Receptor Interactions, Neonatal Fc Receptor Blockers.

What are the brand names for Efgartigimod Alfa?

Efgartigimod Alfa is marketed under brand names including Vyvgart, Vyvgart Hytrulo.

What are the contraindications for Efgartigimod Alfa?

Efgartigimod Alfa labeling lists contraindications including: VYVGART is contraindicated in patients with serious hypersensitivity to efgartigimod alfa products or to any of the excipients of VYVGART . Reactions have included anaphylaxis and hypotension leading to syncope [see Warnings and Precautions (5.2) ] .. Always consult the full prescribing information and a clinician.