Molecule
Efgartigimod alfa is a neonatal Fc receptor blocker indicated for the treatment of adult patients with generalized myasthenia gravis (gMG). It is available as injection for intravenous use. MedsAcross supplies Efgartigimod alfa for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
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).
Source: US FDA prescribing information
Efgartigimod alfa-fcab is a human IgG1 antibody fragment that binds to the neonatal Fc receptor (FcRn), resulting in the reduction of circulating IgG.
Source: US FDA prescribing information
Evaluate the need to administer age-appropriate vaccines according to immunization guidelines before initiation of a new treatment cycle with VYVGART. 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. Administer subsequent treatment cycles based on clinical evaluation. Dilute with 0.9% Sodium Chloride Injection prior to administration. Administer as an intravenous infusion over one hour via a 0.2 micron in-line filter.
Source: US FDA prescribing information
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.
Source: US FDA prescribing information
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. 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. Infusion-Related Reactions: If a severe infusion-related reaction occurs, discontinue the infusion and initiate appropriate therapy, consider risks and benefits of readministering.
Source: US FDA prescribing information
The following clinically significant adverse reactions are described elsewhere in the labeling: Infections Hypersensitivity Reactions Infusion-Related Reactions Most common adverse reactions (≥ 10%) in patients treated with gMG are respiratory tract infections, headache, and urinary tract infection.
Source: US FDA prescribing information
Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. When concomitant long-term use of such medications is essential for patient care, consider discontinuing VYVGART and using alternative therapies.
Source: US FDA prescribing information
Store VYVGART vials refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light until time of use. Do not freeze. Do not shake. Refer to Dosage and Administration for information on stability and storage of the diluted solutions of VYVGART.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Efgartigimod alfa, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Vyvgart 400 mg/20 mL injectionIntravenous Cold chain | argenx | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Conditions linked to Efgartigimod alfa in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 1 presentations of Efgartigimod alfa and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Efgartigimod alfa, including Vyvgart.
Yes. The US FDA first approved Efgartigimod alfa on 17 December 2021, according to Drugs@FDA.
Yes. Efgartigimod alfa has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
At least one listed presentation of Efgartigimod alfa must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Efgartigimod alfa is classified under ATC code L04AA58 (Efgartigimod alfa).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.