Section 07 · Monograph

Efgartigimod alfa-hyaluronidase

Reviewed Nov 2026FDA label

Vyvgart HytruloFcRn blocker · SC

Forms: SC vial: 1008mg/11,200 units per 5.6mL | Prefilled syringe: 1000mg/10,000 units
Dose: gMG: once weekly x4 weeks per cycle | CIDP: once weekly
MOA: Blocks neonatal Fc receptor, ↓circulating IgG

Indications

Generalized myasthenia gravis in adults who are anti-AChR antibody positiveFDA-labeled
Chronic inflammatory demyelinating polyneuropathy (CIDP) in adultsFDA-labeled

Neonatal Fc receptor (FcRn) antagonist (human IgG1 Fc fragment) co-formulated with hyaluronidase; reduces circulating IgG including pathogenic autoantibodies

gMG: 1008mg/11,200 units (vial) subcutaneously over 30-90 seconds once weekly for 4 weeks per cycle; subsequent cycles by clinical evaluation (safety of cycles less than 50 days apart not established)
CIDP: 1008mg/11,200 units subcutaneously once weekly
Prefilled syringe (1000mg/10,000 units) can be self-administered after training; vial is administered by a healthcare professional; do not dilute
Missed injection may be given up to 3 days after the scheduled time, then resume the original schedule
Observe for hypersensitivity for at least 30 minutes after injection

Serious hypersensitivity to efgartigimod alfa products, hyaluronidase or any excipient (anaphylaxis and hypotension leading to syncope have occurred)

Avoid live or live-attenuated vaccines; complete age-appropriate vaccinations before starting
Other FcRn-binding drugs may reduce effectiveness