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Vyvgart Hytrulo Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Single-dose vial (5.6mL)—1
Manufacturer
Generic Availability
NO
Mechanism of Action
Efgartigimod alfa-fcab is a human IgG1 antibody fragment that binds to the neonatal Fc receptor (FcRn), resulting in the reduction of circulating IgG. Hyaluronidase is an endoglycosidase that increases permeability of the subcutaneous tissue by depolymerizing hyaluronan.
Vyvgart Hytrulo Indications
Indications
Generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) antibody positive.
Vyvgart Hytrulo Dosage and Administration
Adult
Give by SC inj into the abdomen (at least 2–3 inches away from the navel); rotate inj sites. 1008mg/11,200 Units over 30–90secs once weekly for 4 weeks. 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 Hytrulo Contraindications
Not Applicable
Vyvgart Hytrulo Boxed Warnings
Not Applicable
Vyvgart Hytrulo 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 Hytrulo until resolved. Evaluate for age-appropriate vaccinations according to guidelines prior to initiation of a new treatment cycle. Monitor for signs of hypersensitivity reactions for at least 30mins after administration. Infusion-related reactions. Moderate or severe renal impairment. Pregnancy. Nursing mothers.
Vyvgart Hytrulo Pharmacokinetics
Distribution
Volume of distribution: 15–20 L.
Elimination
Half-life: 80–120 hours (3–5 days).
Vyvgart Hytrulo 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 Hytrulo and use alternatives.
Vyvgart Hytrulo Adverse Reactions
Adverse Reactions
Respiratory tract infection, headache, urinary tract infection, paresthesia, myalgia, inj site reactions.
Vyvgart Hytrulo Clinical Trials
See Literature
Vyvgart Hytrulo Note
Not Applicable
Vyvgart Hytrulo Patient Counseling
See Literature
