Efgartigimod
VYVGART
What it isFcRn blocker accelerating IgG clearance; generalized myasthenia gravis.
Why this oneThe first FcRn blocker approved for myasthenia gravis, it is given in repeat cycles timed to clinical response.
What limits itLowering protective IgG raises infection risk; avoid live vaccines and postpone treatment during active infection.
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Generalized myasthenia gravis (gMG) | Adults | 10 mg/kg IV over 1 hour once weekly for 4 weeks (one cycle); ≥120 kg: 1,200 mg per infusion | 10 mg/kg IV weekly x4 per cycle | 1,200 mg per infusion (≥120 kg) |
Renal No adjustment for mild renal impairment; insufficient data for moderate/severe (eGFR <60)
Hepatic Undefined
Administer subsequent treatment cycles based on clinical evaluation; a missed infusion may be given up to 3 days late, then resume the original schedule
Instructions
- Evaluate need for age-appropriate vaccines before each new cycle; live vaccines not recommended during treatment
- Dilute in 0.9% NaCl to 125 mL total; infuse IV over 1 hour via 0.2 micron in-line filter
- Monitor during and for 1 hour after administration for hypersensitivity reactions
- Delay administration in patients with active infection until resolved
Contraindications
- Serious hypersensitivity to efgartigimod alfa products or excipients (reactions have included anaphylaxis and hypotension leading to syncope)
Cautions
- Infections — increased risk (UTI, respiratory tract infection); delay in active infection
- Hypersensitivity reactions (anaphylaxis, hypotension, angioedema, dyspnea, rash)
- Infusion-related reactions
Adverse reactions
- Respiratory tract infection
- Headache
- Urinary tract infection
- Paraesthesia
- Myalgia
Pregnancy No available human data; may reduce maternal IgG and passive protection to newborn; no adverse effects in animal studies
Lactation No information on presence in human milk; maternal IgG present in human milk
NO BOXED WARNINGS
Principal riskLowers all IgG, including protective antibody
Classes and tags
Clinical profile
Mechanism of action: Efgartigimod ballicule
