Section 07 · Monograph
Nipocalimab
Reviewed Nov 2026FDA label
ImaavyFcRn blocker
- Forms
- IV: 300mg/1.62mL and 1200mg/6.5mL vials
- Dose
- 30mg/kg IV once, then 15mg/kg every 2 weeks (gMG, age 12+)
- MOA
- Blocks neonatal Fc receptor, ↓circulating IgG
Indications
- Generalized myasthenia gravis in adults and pediatric patients 12 years and older who are anti-acetylcholine receptor (AChR) or anti-MuSK antibody positiveFDA-labeled
Mechanism of Action
- Neonatal Fc receptor (FcRn) blocker that reduces circulating IgG, including pathogenic autoantibodies
Full Dosing
Adult / usual
- Initial dose 30mg/kg IV infused over at least 30 minutes, then 15mg/kg IV every 2 weeks starting 2 weeks later (infused over at least 15 minutes)
- Dilute in 0.9% sodium chloride; use a 0.2-micron in-line filter
- Complete age-appropriate vaccinations before starting; live vaccines are not recommended during treatment
Contraindications
- History of serious hypersensitivity reaction (including anaphylaxis, angioedema) to nipocalimab or its excipients
Drug Interactions
- May reduce the effect of medications that bind FcRn — monitor when used with other FcRn blockers or IgG-based therapies
Adverse Effects
- Respiratory tract infections
- Peripheral edema
- Muscle spasms
- Infusion-related reactions (headache, fatigue, rash, nausea, chills)
- Hypersensitivity reactions including anaphylaxis
- Reduced IgG levels and infection risk
Monitoring Parameters
- Signs of infection
- Infusion reactions
- Blood pressure and edema
Pregnancy & Lactation
- IgG crosses the placenta; animal data showed placental effects associated with fetal loss — weigh risk and benefit