Additional Information

Description

VYVGART HYTRULO SDV is a subcutaneous formulation of efgartigimod alfa and hyaluronidase-qvfc, developed for the treatment of generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) antibody positive. This innovative therapy modulates the neonatal Fc receptor (FcRn), reducing pathogenic IgG autoantibodies responsible for the symptoms of gMG.

The formulation combines efgartigimod alfa, a human IgG1-derived Fc fragment, with recombinant human hyaluronidase PH20. Hyaluronidase facilitates the dispersion and absorption of the biologic agent in the subcutaneous tissue, enabling an alternative to intravenous administration. This combination enhances patient convenience and allows for consistent systemic exposure with less frequent dosing.

VYVGART HYTRULO is administered via subcutaneous injection and is intended for use under the guidance of a healthcare professional. The dosing schedule typically consists of weekly administrations for four weeks per treatment cycle. The product is supplied through specialty distribution as a drop ship to maintain cold chain integrity and ensure proper handling.