Vyvgart Generic Name & Formulations
Legal Class
Rx
General Description
Efgartigimod alfa-fcab 20mg/mL; soln for IV infusion after dilution; preservative-free.
Pharmacological Class
Neonatal Fc receptor blocker.
How Supplied
Single-dose vial (20mL)—1
Manufacturer
Generic Availability
NO
Vyvgart Indications
Indications
Generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) antibody positive.
Vyvgart Dosage and Administration
Adult
Give by IV infusion over 60mins. 10mg/kg once weekly for 4 weeks. In patients weighing ≥120kg: 1200mg (3 vials) per infusion. Administer subsequent cycles based on clinical evaluation. Safety of initiating subsequent cycles sooner than 50 days from the start of the previous treatment cycle: not established.
Children
Not established.
Vyvgart Contraindications
Not Applicable
Vyvgart Boxed Warnings
Not Applicable
Vyvgart Warnings/Precautions
Warnings/Precautions
Increased risk of infection; monitor. Delay treatment in those with an active infection until resolved. If serious infection occurs, treat appropriately and consider withholding Vyvgart until resolved. Evaluate for age-appropriate vaccinations according to guidelines prior to initiation of a new treatment cycle. Monitor for hypersensitivity reactions during and for 1hr thereafter; discontinue if occurs. Moderate or severe renal impairment. Pregnancy. Nursing mothers.
Vyvgart Pharmacokinetics
See Literature
Vyvgart Interactions
Interactions
Concomitant live or live-attenuated vaccines: not recommended. May antagonize immunoglobulin products, monoclonal antibodies, or antibody derivatives containing the human Fc domain of the IgG subclass; closely monitor for reduced effects; if concomitant long-term use is necessary, consider discontinuing Vyvgart and use alternatives.
Vyvgart Adverse Reactions
Adverse Reactions
Respiratory tract infection, headache, urinary tract infection, paresthesia, myalgia.
Vyvgart Clinical Trials
See Literature
Vyvgart Note
Not Applicable
Vyvgart Patient Counseling
See Literature