NIPOCALIMAB-AAHU INJ,SOLN

Clinical Criteria Summary

Generalized myasthenia gravis (gMG) in adult and pediatric patients 12 years of age and older
Must be anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive
Not supported for antibody-negative patients
LRP4+ gMG is not included in the FDA-approved indication due to insufficient patient numbers in clinical trials

Initial dose: Single 30 mg/kg IV infusion administered over at least 30 minutes
Maintenance dose: 15 mg/kg IV infusion administered over at least 15 minutes every 2 weeks, starting 2 weeks after the initial dose
Must be diluted with 0.9% sodium chloride
Must use a 0.2 micron in-line or add-on filter

Infections: Increased risk; delay administration in patients with an active infection
Hypersensitivity reactions (anaphylaxis, angioedema, rash, urticaria, eczema): Discontinue infusion if a reaction occurs
Infusion-related reactions (headache, rash, nausea, chills): Discontinue for severe reactions; mild to moderate reactions may be considered for rechallenge with close observation, slower infusion rate, and premedication
Monitor patients for 30 minutes after each infusion for infusion-related or hypersensitivity reactions
Live or live-attenuated vaccines are not recommended during treatment

Should not be combined with other IgG-affecting agents for chronic management (e.g., IVIg, rozanolixizumab, efgartigimod)
May reduce the effectiveness of immunoglobulin products and monoclonal antibodies (regardless of indication)

May be considered a steroid-sparing treatment option in AChR+ or MuSK+ gMG patients when traditional oral immunosuppressants (azathioprine, mycophenolate, steroids) are ineffective
Offers fast-onset steroid-sparing control of gMG symptoms as a neonatal Fc receptor antagonist with pre-defined scheduled dosing

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