ROZANOLIXIZUMAB-NOLI INJ,SOLN
Clinical Criteria Summary
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Exclusion Criteria
- Concomitant therapy with other monoclonal antibody or neonatal Fc receptor antagonist (e.g., efgartigimod)
- Thymectomy within 3 months
- Intravenous immunoglobulin (IVIG) or plasma exchange within 1 month
- Untreated hepatitis B, hepatitis C, or HIV with low CD4 count
- Active, untreated infection
Core Inclusion Criteria
- Care provided by a VA/VA Community Care neurologist
- Acetylcholine receptor (AChR) antibody positive generalized myasthenia gravis or muscle-specific tyrosine kinase (MuSK) antibody positive myasthenia gravis
- Myasthenia Gravis Foundation of America (MGFA) clinical classification II to IV
- Myasthenia Gravis-specific Activities of Daily Living scale (MG-ADL) total score ≥ 5
Additional Inclusion Criteria (Therapy-Specific)
- Bridge therapy: Inadequate symptom control, contraindication, or intolerance to high dose steroid burst, plasma exchange or IVIG
- AChR+ chronic 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)
- MuSK+ chronic therapy: Inadequate symptom control to rituximab trialed for at least 6 months
- AChR+ or MuSK+ chronic therapy: History of intolerance or contraindication preventing trial of above immunosuppressive agents
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Indication & Patient Population
- Generalized myasthenia gravis (gMG) who are positive for acetylcholine receptor antibody (AChR+) or muscle-specific tyrosine kinase antibody (MuSK+)
- Not supported for other antibody types of MG including LRP4+ and seronegative disease
Dosing & Administration
- Single dose vial for injection 280mg/2mL administered via subcutaneous (SC) infusion
- Administered weekly for 6 weeks per treatment cycle
- Repeat cycles as needed no more than 63 days from start of previous cycle
Safety & Monitoring Requirements
- Monitor patients for 15 minutes after administration for possible development of hypersensitivity reactions (including angioedema and rash)
- Avoid in active infection, which may mean delaying or holding treatment until infection resolves
- Live or live-attenuated vaccines are not recommended during treatment
Contraindications & Treatment Restrictions
- Should not be used with other IgG-affecting agents for chronic management including intravenous immunoglobulin (IVIg) or efgartigimod
Therapeutic Positioning
- Short-term bridge therapy to initiation or switch of chronic immunosuppressant therapy in patients with gMG who are AChR+ or MuSK+
- Steroid-sparing chronic treatment option when other traditional oral immunosuppressants (azathioprine, mycophenolate) and/or steroids are ineffective