EFGARTIGIMOD ALFA-FCAB INJ,SOLN

Clinical Criteria Summary

Concomitant therapy with other monoclonal antibody or neonatal Fc receptor antagonist (e.g., rozanolixizumab)
Thymectomy within 3 months
Intravenous immunoglobulin (IVIG) or plasma exchange within 1 month
Untreated hepatitis B, hepatitis C, or HIV with low CD4 count
Serum IgG level less than 600 mg/dL
Active, untreated infection

Care provided by a VA/VA Community Care neurologist
Anti-acetylcholine receptor (AChR) antibody positive
Myasthenia Gravis Foundation of America (MGFA) clinical classification II to IV
Myasthenia Gravis-specific Activities of Daily Living scale (MG-ADL) total score ≥ 5

One of the following must be met:
Inadequate symptom control, contraindication, or intolerance to high dose steroid burst, plasma exchange or IVIG and patient requires rapid onset or bridge therapy
Inadequate symptom control to maximally tolerated pyridostigmine and at least two immunosuppressive agents separately trialed for at least 6 months each (e.g., azathioprine, cyclosporine, mycophenolate, etc.)
History of intolerance or contraindication preventing trial of immunosuppressive agents (e.g., azathioprine, cyclosporine, mycophenolate, etc.)

Treatment of generalized myasthenia gravis in adults who are antiacetylcholine receptor (AchR) antibody positive
May be effective for other myasthenia gravis subtypes

10 mg/kg IV once weekly for 4 weeks per cycle
Maximum dose of 1.2 grams IV (1200 mg for patients weighing 120 kg or more)
Subsequent treatment cycles may be administered based on clinical evaluation
Treatment cycles must not be initiated sooner than 50 days from the start of the previous cycle

Infections: Delay administration in patients with an active infection; monitor for signs and symptoms; withhold until resolved if a serious infection occurs
Hypersensitivity Reactions: Discontinue infusion and institute appropriate therapy if angioedema, dyspnea, or rash occurs
Common adverse reactions (≥10% incidence): Headache, upper respiratory tract infection, urinary tract infection
Serious adverse events reported include thrombocytosis, rectal adenocarcinoma, myasthenia gravis worsening, depression, myocardial ischemia, atrial fibrillation, spinal ligament ossification, spinal compression fracture, and myasthenia gravis crisis

Weak recommendation for patients remaining symptomatic on pyridostigmine, steroids, or nonsteroidal immunosuppressive therapy (NSISTs)
Considered steroid-sparing with potential for additional benefit when added to other NSIST agents
Provides rapid onset of effect (observed as early as 2 weeks in clinical trials)
Demonstrated additional benefit in patients already receiving other immunotherapies