Nipocalimab

Nipocalimab-aahu is a human IgG1 monoclonal antibody that binds to neonatal Fc receptor (FcRn), resulting in the reduction of circulating IgG levels.

• IMAAVY is indicated for the treatment of generalized myasthenia gravis (gMG) in adult and pediatric patients 12 years of age and older who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive. IMAAVY is a neonatal Fc receptor blocker indicated for the treatment of generalized myasthenia gravis (gMG) in adult and pediatric patients 12 years of age and older who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.

• IMAAVY is contraindicated in patients with a history of serious hypersensitivity reaction to nipocalimab or any of the excipients in IMAAVY. Reactions have included anaphylaxis and angioedema [see Warnings and Precautions (5.2) ] .contraindicated

See Full Prescribing Information for instructions on dosage, preparation, and administration. ( 2.1 , 2.2 , 2.3 ) Evaluate the need to administer age-appropriate vaccines according to immunization guidelines before initiation of IMAAVY. ( 2.1 ) Administer via intravenous infusion only. ( 2.2 ) The recommended initial dosage is 30 mg/kg once via intravenous infusion over at least 30 minutes. Two weeks after the initial dosage, administer a maintenance dosage of 15 mg/kg via intravenous infusion over at least 15 minutes, and continue every two weeks thereafter. ( 2.2 ) Must be diluted with 0.9% sodium chloride injection prior to administration. ( 2.3 ) Administer as an intravenous infusion via a 0.2 micron in-line or add-on filter. ( 2.3 ) 2.1 Recommended Vaccination Evaluate the need to administer age-appropriate vaccines according to immunization guidelines before initiation of IMAAVY. Because IMAAVY causes transient reduction in IgG levels, vaccination with live vaccines is not recommended during treatment with IMAAVY [see Warnings and Precautions (5.1) ]. 2.2 Recommended Dosage Dilute IMAAVY prior to administration. Administer via intravenous infusion only [see Dosage and Administration (2.3) ] . The recommended initial dosage of IMAAVY is 30 mg/kg administered once via intravenous infusion over at least 30 minutes. Two weeks after the initial dosage administer a maintenance dosage of 15 mg/kg via intravenous infusion over at least 15 minutes. Continue the maintenance dosage every two weeks thereafter.

Infections: Delay administration of IMAAVY to patients with an active infection. Monitor for signs and symptoms of infection in patients treated with IMAAVY. If serious infection occurs, administer appropriate treatment and consider withholding IMAAVY until the infection has resolved. ( 5.1 ) Hypersensitivity Reactions: Angioedema, anaphylaxis, rash, urticaria, and eczema have occurred in patients treated with IMAAVY. If a hypersensitivity reaction occurs, discontinue the infusion and institute appropriate therapy. ( 5.2 ) Infusion-Related Reactions: If a severe infusion-related reaction occurs, discontinue the infusion and initiate appropriate therapy; consider the risks and benefits of readministering. If a mild to moderate infusion-related reaction occurs, may rechallenge with close clinical observation, slower infusion rates, and pre-medication. ( 5.3 ) 5.1 Infections IMAAVY may increase the risk of infection [see Adverse Reactions (6.1) ] . In Study 1 [see Clinical Studies (14) ] , 42 (43%) out of 98 patients treated with IMAAVY reported 71 events of infection. Across Study 1 (double blind period) and its extension study (open label-period), out of 186 patients treated with IMAAVY, 132 (71%) patients reported 360 events of infection. Serious infections were reported in 7% of patients treated with IMAAVY. Delay IMAAVY administration in patients with an active infection until the infection is resolved. During treatment with IMAAVY, monitor for clinical signs and symptoms of infection.

The following clinically significant adverse reactions are described elsewhere in the labeling Infections [see Warnings and Precautions (5.1) ] Hypersensitivity Reactions [see Warnings and Precautions (5.2) ] Infusion-related Reactions [see Warnings and Precautions (5.3) ] The most common adverse reactions (≥10%) in patients with gMG treated with IMAAVY were respiratory tract infections, peripheral edema, and muscle spasms. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Janssen Biotech, Inc. at 1-800-526-7736 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adults In Study 1 and its extension study the safety of IMAAVY was evaluated in 186 patients with gMG who received at least one dose of IMAAVY. Of those patients, 168 patients were exposed to IMAAVY every 2 weeks for at least 6 months, and 140 patients were exposed for at least 12 months. In Study 1, 98 adult patients with gMG received IMAAVY 15 mg/kg every two weeks (after 30 mg/kg initial dose) [see Clinical Studies (14) ]. Of these 98 patients, approximately 67% were female, 67% were White, 29% were Asian, and 10% were of Hispanic or Latino ethnicity. The mean age at study entry was 53 years (range 20 to 81).

8.1 Pregnancy Risk Summary There are limited data on the use of IMAAVY in pregnant women to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. There was no evidence of direct adverse effects on fetal development following administration of nipocalimab-aahu to pregnant monkeys; however, adverse effects on the placenta were associated with fetal loss at both doses tested (see Data ) . The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background rate of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. There is a pregnancy safety study for IMAAVY. If IMAAVY is administered during pregnancy, or if a patient becomes pregnant while receiving IMAAVY, healthcare providers should report IMAAVY exposure by contacting Janssen at 1-800-526-7736 or www.IMAAVY.com Clinical Considerations Fetal/Neonatal Adverse Reactions Monoclonal antibodies are increasingly transported across the placenta as pregnancy progresses, with the largest amount transferred during the third trimester.

Metabolism

Nipocalimab exhibits nonlinear pharmacokinetics. Following a single intravenous infusion of IMAAVY at doses ranging from 0.3 to 60 mg/kg (4 times the recommended maintenance dosage) in healthy participants, C max of nipocalimab-aahu increased in a dose-proportional manner while AUC increased in a greater than dose-proportional manner.

• Apr 29, 2025BLABLA761430Janssen Biotech

1. 1Drug Ineffective159.6%
2. 2Headache138.3%
3. 3Oedema Peripheral127.7%
4. 4Off Label Use117.1%
5. 5Fatigue106.4%
6. 6Influenza106.4%
7. 7Cough85.1%
8. 8Myasthenia Gravis85.1%
9. 9Asthenia74.5%
10. 10Product Dose Omission Issue74.5%
11. 11Dizziness63.8%
12. 12Dyspnoea63.8%
13. 13Infection63.8%
14. 14Rash53.2%
15. 15Therapeutic Response Decreased53.2%

The 10 most recently updated of 21 ClinicalTrials.gov registrations naming Nipocalimab as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Study of Nipocalimab or Intravenous Immunoglobulin (IVIG) in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)
  Recruiting · Phase 3 · Interventional · 50 enrolled · Janssen Research & Development, LLC
  NCT06533098updated 2026-06-05
• Nipocalimab in Moderate to Severe Sjogren's Disease
  Active not recruiting · Phase 3 · Interventional · 655 enrolled · Janssen Research & Development, LLC
  NCT06741969updated 2026-06-05
• Efficacy and Safety of M281 in Adults With Warm Autoimmune Hemolytic Anemia
  Active not recruiting · Phase 2 · Phase 3 · Interventional · 118 enrolled · Janssen Research & Development, LLC
  NCT04119050updated 2026-06-05
• A Study of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)
  Recruiting · Phase 3 · Interventional · 39 enrolled · Janssen Research & Development, LLC
  NCT06449651updated 2026-06-05
• A Study of Nipocalimab in Participants With Active Idiopathic Inflammatory Myopathies
  Active not recruiting · Phase 2 · Interventional · 36 enrolled · Janssen Research & Development, LLC
  NCT05379634updated 2026-06-05
• Comparative Efficacy of Nipocalimab and Efgartigimod in Participants With Generalized Myasthenia Gravis
  Recruiting · Phase 3 · Interventional · 115 enrolled · Janssen Research & Development, LLC
  NCT07217587updated 2026-06-05
• Efficacy and Safety Study of Nipocalimab for Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
  Recruiting · Phase 2 · Phase 3 · Interventional · 201 enrolled · Janssen Research & Development, LLC
  NCT05327114updated 2026-06-05
• A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus
  Recruiting · Phase 3 · Interventional · 600 enrolled · Janssen Research & Development, LLC
  NCT07438496updated 2026-06-05
• A Study of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN)
  Recruiting · Phase 3 · Interventional · 120 enrolled · Janssen Research & Development, LLC
  NCT05912517updated 2026-06-05
• A Study of Nipocalimab in Children Aged 2 to Less Than 18 Years With Generalized Myasthenia Gravis
  Recruiting · Phase 2 · Phase 3 · Interventional · 12 enrolled · Janssen Research & Development, LLC
  NCT05265273updated 2026-03-13

Frequently asked questions

How does Nipocalimab work?

Nipocalimab-aahu is a human IgG1 monoclonal antibody that binds to neonatal Fc receptor (FcRn), resulting in the reduction of circulating IgG levels.

What is Nipocalimab used for?

According to FDA labeling, Nipocalimab carries indications including: IMAAVY is indicated for the treatment of generalized myasthenia gravis (gMG) in adult and pediatric patients 12 years of age and older who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive. IMAAVY is a neonatal Fc receptor blocker indicated for the treatment of generalized myasthenia gravis (gMG) in adult and pediatric patients 12 years of age and older who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Nipocalimab?

Nipocalimab is classified as Neonatal fragment crystallizable receptor (FcRn) inhibitors, Antibody-Receptor Interactions, Neonatal Fc Receptor Blockers.

What are the brand names for Nipocalimab?

Nipocalimab is marketed under brand names including Imaavy.

What are the contraindications for Nipocalimab?

Nipocalimab labeling lists contraindications including: IMAAVY is contraindicated in patients with a history of serious hypersensitivity reaction to nipocalimab or any of the excipients in IMAAVY. Reactions have included anaphylaxis and angioedema [see Warnings and Precautions (5.2) ] .. Always consult the full prescribing information and a clinician.