Nipocalimab

Nipocalimab – Description

• Nipocalimab is a neonatal Fc receptor (FcRn) blocker indicated for the treatment of anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive generalized myasthenia gravis.
• The blockade of FcRn reduces IgG antibody concentrations, including the abnormal anti-AChR antibodies and anti-MuSK antibodies that are present in individuals with generalized myasthenia gravis (gMG). In a clinical trial, nipocalimab showed statistically significant changes in the
• Myasthenia Gravis Activities of Daily Living Scale and Quantitative Myasthenia Gravis total score, indicating greater functional and muscle strength improvements in individuals treated with nipocalimab. Infection, infusion-related reactions, and hypersensitivity reactions were the most commonly reported side effects.
• Monitor individuals for 30 minutes after the infusion for infusion-related adverse effects. Treatment may also increase the risk for infection. Nipocalimab was FDA-approved in April 2025.⁷²¹⁶⁵

Indications & Dosage

•  myasthenia gravis

Prior to nipocalimab initiation

• Evaluate the need to administer age-appropriate vaccines according to immunization guidelines before initiation of nipocalimab. Vaccination with live-attenuated or live vaccines is not recommended during treatment with nipocalimab. The safety of immunization with live or live-attenuated vaccines and the response to immunization with any vaccine are unknown.⁷²¹⁶⁵

For the treatment of generalized myasthenia gravis in individuals who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuKS) antibody positive

NOTE: Nipocalimab is designated as an orphan drug by the FDA for this indication.

Intravenous dosage

Adults:

30 mg/kg IV infusion over 30 minutes as a single dose. Starting 2 weeks after the initial dose, begin maintenance dose of 15 mg/kg IV every 2 weeks, infused over at least 15 minutes.⁷²¹⁶⁵

Children and Adolescents 12 to 17 years:

30 mg/kg IV infusion over 30 minutes as a single dose. Starting 2 weeks after the initial dose, begin maintenance dose of 15 mg/kg IV every 2 weeks, infused over at least 15 minutes.⁷²¹⁶⁵

Maximum Dosage Limits:

•Adults

30 mg/kg IV initial dose; 15 mg/kg IV every 2 weeks maintenance dose.

•Geriatric

30 mg/kg IV initial dose; 15 mg/kg IV every 2 weeks maintenance dose.

•Adolescents

30 mg/kg IV initial dose; 15 mg/kg IV every 2 weeks maintenance dose.

•Children

12 years: 30 mg/kg IV initial dose; 15 mg/kg IV every 2 weeks maintenance dose.

1 to 11 years: Safety and efficacy have not been established.

•Infants

Safety and efficacy have not been established.

•Neonates

Safety and efficacy have not been established.

Patients with Hepatic Impairment Dosing

No dosage adjustments are needed.⁷²¹⁶⁵

Patients with Renal Impairment Dosing

No dosage adjustments are needed.⁷²¹⁶⁵

Precautions

•  breast-feeding
•  infection
•  neonates and infants exposed to this medication in utero
•  pregnancy

Pregnancy

• There are limited data on the use of nipocalimab in pregnant individuals regarding the risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
• In studies with pregnant monkeys, no direct adverse reactions on fetal development were observed at nipocalimab doses higher than the recommended human maintenance dose; however, adverse effects on the placenta were associated with placental ischemia, fetal loss, and decreased IgG concentrations in the offspring. IgG concentrations returned to normal by 6 months after birth, and no adverse reactions on immune function were noted.
• There is a pregnancy safety study for nipocalimab.
• If nipocalimab is administered during pregnancy, or if an individual becomes pregnant while receiving nipocalimab, report the exposure to the manufacturer at 1-800-526-7736 or www.imaavy.com.⁷²¹⁶⁵

Lactation

• Use nipocalimab with caution during breast-feeding.
• Nipocalimab is excreted in human colostrum and breast milk, based on limited data from a study of pregnant women (n = 13) receiving nipocalimab during pregnancy, where colostrum and breast milk were assessed in the first 8 days after birth.
• There is insufficient data on the effect of nipocalimab in the breastfed infant or the effect on milk production.
• The development and health benefits of breast-feeding should be considered along with the clinical need for nipocalimab, any adverse effects on the breastfed infant from nipocalimab or from the underlying maternal condition.⁷²¹⁶⁵

Interactions

•  Bacillus Calmette-Guerin Vaccine, BCG
•  Chikungunya Vaccine, Live
•  Cholera Vaccine
•  Dengue Tetravalent Vaccine, Live
•  Ebola Zaire Vaccine, Live
•  Eculizumab
•  Hyaluronidase, Recombinant; Immune Globulin
•  Immune Globulin IV, IVIG, IGIV
•  Intranasal Influenza Vaccine
•  Live Vaccines
•  Measles Virus; Mumps Virus; Rubella Virus; Varicella Virus Vaccine, Live
•  Measles/Mumps/Rubella Vaccines, MMR
•  Ravulizumab
•  Rotavirus Vaccine
•  SARS-CoV-2 (COVID-19) vaccines
•  SARS-CoV-2 Virus (COVID-19) mRNA Vaccine
•  SARS-CoV-2 Virus (COVID-19) Recombinant Spike Protein Nanoparticle Vaccine
•  Smallpox and Monkeypox Vaccine, Live, Nonreplicating
•  Smallpox and Mpox (Vaccinia) Vaccine, Live
•  Typhoid Vaccine
•  Varicella-Zoster Virus Vaccine, Live
•  Yellow Fever Vaccine, Live

Adverse Reactions

•  abdominal pain
•  anaphylactoid reactions
•  anemia
•  angioedema
•  antibody formation
•  back pain
•  candidiasis
•  cough
•  diarrhea
•  dizziness
•  fever
•  hypercholesterolemia
•  hypertension
•  infection
•  infusion-related reactions
•  insomnia
•  muscle cramps
•  nausea
•  peripheral edema
•  rash
•  urticaria

Monitoring Parameters

•  laboratory monitoring not necessary

Classifications

• Musculo-Skeletal System
  • Other Agents For Disorders of The Musculo-skeletal System
    • Myasthenia Gravis Agents

References

45742.Soliris (eculizumab) package insert. Boston, MA: Alexion Pharmaceuticals, Inc.; 2025 Feb.

60092.Rubin LG, Levin MJ, Ljungman P, et al. 2013 IDSA clinical practice guideline for vaccination of the immunocompromised host. Clin Infect Dis. 2014; 58: e44-100.

60871.Vaxchora (Cholera Vaccine, live, oral) package insert. Redwood City, CA: Emergent Travel Health Inc.; 2024 Jan.

63845.Ultomiris (ravulizumab-cwvs) injection package insert. Boston, MA; Alexion Pharmaceuticals, Inc. 2024 Sept.

64100.Dengvaxia (dengue tetravalent vaccine, live) package insert. Swiftwater, PA: Sanofi Pasteur Inc.; 2023 August.

65107.Kroger A, Bahta L, Hunter P. General Best Practice Guidelines for Immunization. Best Practices Guidance of the Advisory Committee on Immunization Practices (ACIP). Accessed April 25, 2024. Available at https://www.cdc.gov/vaccines/hcp/imz-best-practices/?CDC_AAref_Val=https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/index.html.

66080.Food and Drug Administration (FDA). Fact Sheet for Healthcare Providers Administering Vaccine: Emergency Use Authorization (EUA) of Pfizer-BioNTech COVID-19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19) for 12 years and older. Purple cap and purple border. Retrieved November 22, 2022.

67194.Vyvgart (efgartigimod alfa-facb) package insert. Boston, MA: Argenx US, Inc.; 2024 Aug.

69130.Rystiggo (rozanolixizumab-noli) injection package insert. Smyrna, GA: UCB, Inc.; 2024 Jun.

72165.Imaavy (nipocalimab-aahu) injection package insert. Horsham, PA: Janssen Biotech, Inc.; 2025 Apr.

72168.Seth NP, Xu R, DuPrie M, et al. Nipocalimab, an immunoselective FcRn blocker that lowers IgG and has unique molecular properties. MAbs 2025;17(1):2461191.