Myasthenia gravis is an autoimmune disease of the neuromuscular junction caused by antibodies that attack components of the postsynaptic membrane, impair neuromuscular transmission, and therefore causes weakness and fatigue of the skeletal and bulbar muscle. A new approach to treating generalized MG involves predictable lowering levels of pathogenic autoantibodies. In gMG, the neonatal Fc receptor (FcRn) is a major factor regulating the serum levels of IgG antibodies. While FcRn-mediated half-life extension is beneficial for IgG antibody responses against pathogens, it also prolongs the serum half-life of IgG autoantibodies and thus promotes tissue damage in autoimmune diseases such as MG. A mutated antibody to the FcRn can block that IgG-associated damage and potentially improve outcomes and treatment tolerance in generalized MG. The US FDA has now approved FcRn blockers for both intravenous and subcutaneous infusion.
A cost-effective and comfortable setting for patients to receive infusions by either route is the infusion center. An infusion center is an outpatient clinic that is certified to administer infusion therapy. These medical facilities have advanced equipment and competent staff who specialize in infusions. Infusion therapy has traditionally been administered only in hospitals. Due to an emphasis on cost-containment in health care and developments in the clinical administration of the treatment, outpatient infusion centers are now more common. Certified infusion centers are licensed by a state board and meet strict standards and regulations set by the board and the government. At present, there are over 3,600 infusion centers throughout the United States, according to the National Infusion Center Association.
Clinicians who deliver care in infusion centers include infusion nurses, nurse practitioners and physician associates (formerly physician assistants), and pharmacists. Given that medications delivered by IV or SQ infusion for the treatment of gMG have only been recently approved, many infusion center HCPs have a lack of familiarity with the disease and its pathophysiology, the mechanism of action of FcRn blockers, and the practical aspects of administration and monitoring of patients receiving these medications. This interprofessional program addresses this knowledge gap and aims to improve patient care and HCP-patient communication in the infusion center-based management of gMG.
Infusion Center HCPs, inclusive of nurses, PA/NPs, pharmacists, and physicians who manage gMG with FcRn blockers
Understand the basic pathophysiology of gMG and the mechanism of action of FnRn blockers
Understand the specifics of administration by (as approved by FDA) intravenous and subcutaneous infusion including medication preparation, dose calculation and duration of infusion, adverse events that might occur during infusion and their management, and clinical issues of interest that should be reported to the prescribing physician
Recognize and inform practice and patient communication by an appreciation of the burden of illness and social/emotional support needs of patients with gMG receiving FnRn blockers
Myasthenia Gravis 101: Pathophysiology, Signs and Symptoms, Burden of Illness
The Mechanism of Action and Role of FcRn Blockers in Treating gMG
Recognizing Potential Adverse Events During the Administration of FcRn Blockers
Infusion of FcRn Blockers: The How’s, The How-Not’s, and What to Watch For
Optimal Function of the Infusion Center Team in the Care of Patients with gMG
Expert Panel Discussion
It is the policy of AcademicCME that all faculty, instructors, and planners disclose relevant financial relationships with ineligible companies. Planners have no relevant financial relationships with ineligible companies to disclose related to this activity. Faculty have disclosed the following relevant financial relationships. All relevant financial relationships have been mitigated.
Faculty | Relationship Identified With: |
James F. Howard Jr., MD | Consultant/Advisor: Alexion Pharmaceuticals; Amgen; argenx; Avilar Therapeutics; Biohaven Ltd.; F. Hoffman LaRoche; Merck EMD Serono; NMD Pharma; Novartis Pharmaceuticals; Regeneron Pharma; Sanofi; Seismic Therapeutics; Toleranzia AB; UCB Bioscience Research/Grant Support: Ad Scientiam; Alexion Pharmaceuticals; argenx; Cartesian Therapeutics; NMD Pharma; UCB Bioscience |
Lauren Pica, APRN | Nothing to disclose |
Kipp Tiger, PharmD, CSP | Nothing to disclose |
Timothy Hayes, MD, PhD; Charles V. Pollack Jr., MD; Kim Cheramie, MSN, RN-BC; Patrick Hayes and Nicole McMenamin hereby state that they do not have any relevant financial relationships to products or devices with any commercial interests related to the content of this activity.
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