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Prescription medicine

Efgartigimod alfa and hyaluronidase Brand names: Vyvgart

Efgartigimod alfa and hyaluronidase (Vyvgart) is a prescription medicine. No generic is listed in FDA's NDC Directory.

  • No generic listed

Check it at the source: the efgartigimod alfa and hyaluronidase FDA label on DailyMed (effective July 15, 2026); every efgartigimod alfa and hyaluronidase label on DailyMed.

Highlights of the record

FDA label of July 15, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Used for

From the label: indications and usage

VYVGART HYTRULO is indicated for the treatment of adult patients with: generalized myasthenia gravis (gMG) chronic inflammatory demyelinating polyneuropathy (CIDP) VYVGART HYTRULO is a combination of efgartigimod alfa, a neonatal Fc receptor blocker, and hyaluronidase, an endoglycosidase, indicated for the treatment of adult patients with: generalized myasthenia gravis (gMG) ( 1 ) chronic inflammatory demyelinating p

Forms and strengths

  • 180 mg/ml
  • 200 mg/ml

Injection (solution).

On the market

Generic approvals
No generic approved
Labelers listed (NDC)
1 of which 0 under generic applications, 1 under brand applications, repackagers included

Supply and safety

Pharmacy cost (NADAC)
Not in the survey
Shortage (FDA)
No current entry
Recalls by its makers (FDA)
No recall recorded
FAERS reports
427 through July 30, 2026

What is efgartigimod alfa and hyaluronidase used for?

From the label: indications and usage

VYVGART HYTRULO is indicated for the treatment of adult patients with: generalized myasthenia gravis (gMG) chronic inflammatory demyelinating polyneuropathy (CIDP) VYVGART HYTRULO is a combination of efgartigimod alfa, a neonatal Fc receptor blocker, and hyaluronidase, an endoglycosidase, indicated for the treatment of adult patients with: generalized myasthenia gravis (gMG) ( 1 ) chronic inflammatory demyelinating polyneuropathy (CIDP)

FDA pharmacologic class: Endoglycosidase and Neonatal Fc Receptor Blocker.

Source: FDA drug label (VYVGART Hytrulo), argenx US, effective July 15, 2026 (SPL set 7104d9e5-9910-47f5-9a93-741ac50f43b6), via openFDA; the full label on DailyMed

Is there a generic for efgartigimod alfa and hyaluronidase (Vyvgart)?

No generic efgartigimod alfa and hyaluronidase is approved (Drugs@FDA, October 8, 2026).

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What do FAERS reports show for efgartigimod alfa and hyaluronidase?

The FDA Adverse Event Reporting System holds 427 reports that list efgartigimod alfa and hyaluronidase among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 19 are coded as a death and 153 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

The most reported reactions

  • Myasthenia Gravis (a use or a product term, not a reaction)64
  • Fatigue57
  • Asthenia (a use or a product term, not a reaction)38
  • Drug Ineffective (a use or a product term, not a reaction)35
  • Fall32
  • Muscular Weakness32
  • Injection Site Erythema (named in the label)23
  • Injection Site Pain23

Side effects: the label's list and every FAERS reaction

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What next?

Other endoglycosidases
the pharmacologic class, with prices and generics
Efgartigimod alfa and hyaluronidase side effects
the label's list beside FAERS reports
Check an interaction
what two or more labels say about each other