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ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS › IMMUNOSUPPRESSANTS › IMMUNOSUPPRESSANTS › Neonatal fragment crystallizable receptor (FcRn) inhibitors
rozanolixizumab
L04AL02
Forms & Strengths
- Subcutaneous injection: 170 mg/mL in a single-dose vial
Adult Dosing
- Generalized Myasthenia Gravis (gMG): 7 mg/kg subcutaneously once weekly for 6 weeks
- Repeat courses based on clinical evaluation
Pediatric Dosing
- Safety and effectiveness in pediatric patients have not been established
Indications
- Treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody-positive
Mechanism of Action
- Humanized IgG4 monoclonal antibody that binds to neonatal Fc receptor (FcRn), blocking FcRn-IgG interaction and reducing circulating IgG concentrations (including pathogenic autoantibodies)
Contraindications
- Serious hypersensitivity to rozanolixizumab or any of its excipients
Adverse Reactions
- Headache
- Infections (including viral upper respiratory tract infections)
- Diarrhea
- Pyrexia
- Hypogammaglobulinemia
- Aseptic meningitis
Drug Interactions
- Live or live-attenuated vaccines (avoid concurrent administration)
- Other agents that significantly lower IgG levels or affect the immune system (additive immunosuppressive risk)
Curated Content: Needs Vetting Before Put to Clinical Use