Efgartigimod

VYVGART

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Pronunciation: ef-gar-TIG-i-mod (VIV-gart)

Efgartigimod ballicule: receptor binding, kinetics and half-life diagram — Mechanism of action: Efgartigimod ballicule

What it isFcRn blocker accelerating IgG clearance; generalized myasthenia gravis.

Why this oneFirst 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.

Principal riskLowers all IgG, including protective antibody

Classes and tags

Clinical profile

Therapeutic safety burden1 / 4

Overdose danger1 / 4

Weight-gain liability0 / 4

Sedation liability0 / 4

QT / Torsades0 / 4

Direct muscarinic antagonism0 / 4

Embryofetal risk2 / 4

Legacy pregnancy categoryN/A (post-2015 labeling)

Defining liabilityIgG reduction increases infection risk

FDA label

Read the full label on DailyMed ↗

NO BOXED WARNINGS

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

Available strengths

inj 20 mg/mL

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

Cost

Efgartigimod (VYVGART)

Strength		#/mo	generic $/unit	CostPlus
20 mg/mL	inj	per unit		not offered

NADAC is a voluntary CMS survey of what retail community pharmacies pay for the drugs they stock. Efgartigimod is administered under clinical supervision and dispensed outside retail pharmacies, so it rarely appears on surveyed invoices.

Available combined with: efgartigimod / alfa

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Self-check

When should efgartigimod treatment be postponed?
Active infection.
Which immunoglobulin does efgartigimod clear faster?
IgG.