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IMAAVY® (nipocalimab-aahu) demonstrates durable hemoglobin response and rapid onset of effect in pivotal Phase 2/3 study in warm autoimmune hemolytic anemia (wAIHA), an autoantibody-driven disease with no FDA-approved therapies

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  • Patients in the IMAAVY 30 mg/kg treatment groupa achieved statistically significant durable hemoglobin responseb, with mean hemoglobin improvement of at least 1 g/dL as early as Week 1c

  • More patients treated with IMAAVY experienced improvement in fatigued and corticosteroid dose reductionse

  • IMAAVY is designed to target pathogenic immunoglobulin G (IgG) autoantibodies in warm autoimmune hemolytic anemia while preserving immune function

  • Pivotal results will be presented at EHA 2026

STOCKHOLM, June 11, 2026 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today is presenting the first comprehensive results from the Phase 2/3 ENERGY study showing that IMAAVY® (nipocalimab-aahu) produced a statistically significant durable hemoglobin (Hgb) responseb with rapid onset of effect in patients with warm autoimmune hemolytic anemia (wAIHA)e in the 30 mg/kg treatment group,a compared with those who received placebo. The randomized, placebo-controlled trial demonstrated approximately three times as many patients achieved durable Hgb levels versus placebo by 24 weeks. Overall, patients treated with this dose of IMAAVY showed a mean Hgb improvement of at least 1g/dL as early as Week 1.1,c

To be presented at the European Hematology Association (EHA) 2026 Congress, these results mark an important step forward for people living with wAIHA, a rare, life-threatening condition for which patients currently have no U.S. Food and Drug Administration (FDA)-approved treatment options.

"These data from the Phase 2/3 ENERGY study showed the rapid onset of effect and durable improvement in anemia which occurs by targeting the autoantibody-mediated destruction of red blood cells in people living with warm autoimmune hemolytic anemia," said Bruno Fattizzo, M.D., Assistant Professor at the Department of Oncology and Hematology-Oncology, University of Milan, Italy.g "Achieving hemoglobin improvements this quickly and at this scale is important in clinical practice, as it could help improve the debilitating fatigue that people living with warm autoimmune hemolytic anemia experience."

Key findings from the Phase 2/3 ENERGY study
The ENERGY study compared IMAAVY to placebo in achieving the primary endpoint of durable Hgb improvement, which was defined as achieving the following stringent criteria1:

  • An increase from baseline in Hgb ≥2 g/dL

  • Hgb concentration ≥10 g/dL

  • For at least three visits (≥28 days, where criteria was met, starting by Week 16)

  • Without the need for rescue therapy or changes to background medications for wAIHA

In the 30 mg/kg treatment group, a mean increase of 1 g/dL in Hgb was observed at Week 1, compared to no change in the placebo group.c In wAIHA, treatment also aims to maintain Hgb ≥10 g/dL and achieve a ≥2 g/dL increase from baseline and nearly two-thirds of patients achieved both of these targets by Week 24.

IMAAVY was also associated with improvements in fatigued and reduction in steroid usef, two key secondary endpoints. Changes in patient-reported fatigue were observed as early as Week 2 and sustained throughout the 24-week treatment period.d

In the study, IMAAVY demonstrated a safety profile consistent with the established safety profile of IMAAVY in the approved indication of generalized myasthenia gravis. The most common adverse reactions (≥10%) in patients with wAIHA treated with IMAAVY were peripheral edema, diarrhea and fever.

By targeting the pathogenic IgG autoantibodies that lead to red blood cell destruction in wAIHA, IMAAVY is designed to utilize a differentiated, immunoselective approach, preserving underlying key humoral immune functions in a condition where many patients currently can only rely on unapproved therapies, including corticosteroids and broad immunosuppressants.2

"In the first large, placebo-controlled trial of its kind, IMAAVY delivered durable improvements in hemoglobin levels and showed no new safety signals, in a disease with no FDA-approved therapies," said Leonard L. Dragone, M.D., Ph.D., Disease Area Leader, Autoantibody and Rheumatology, Johnson & Johnson. "This immunoselective approach targets the underlying autoantibodies driving disease while preserving key immune functions, which is important for people living with this disease who frequently suffer with comorbid conditions."

These data support the supplemental Biologics License Application (sBLA) for IMAAVY which has since been granted U.S. FDA Priority Review.

Editor's Notes:

a. The dose submitted to the FDA for approval (30 mg/kg IV every four weeks). 
b. Durable hemoglobin response, the primary endpoint of the Phase 2/3 ENERGY trial, is defined as hemoglobin concentration ≥10 g/dL and an increase from baseline in hemoglobin ≥2 g/dL for at least 28 days (where criteria was met starting by Week 16 of the double-blind period), without the need of rescue therapy. This endpoint was prespecified within the equal-weight hierarchical testing procedure; the resulting one-sided p-value was considered statistically significant in accordance with the predefined multiplicity control strategy.
c. These data were not a part of the hierarchical testing procedure.
d. Based on mean change from baseline of Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) score at Week 24, a key secondary endpoint, with mean change of 3.51 points over placebo for 30 mg/kg IV treatment group (dose filed with the FDA). This endpoint was prespecified within the hierarchical testing procedure; the resulting one-sided p-value was considered nominal in accordance with the predefined multiplicity control strategy.
e. IMAAVY is not approved for the treatment of warm autoimmune hemolytic anemia.
f. Participants who achieved durable Hgb response were required to initiate corticosteroid (CS) dose tapering. Doses were reduced by 10% of the baseline CS dose every two weeks, provided Hgb levels did not decline by ≥1 g/dL. At Week 24, the mean percent reduction in CS dose was numerically higher in the nipocalimab 30 mg/kg treatment group (15% reduction from baseline dose) compared with placebo (4% reduction from baseline dose). This endpoint was prespecified within the hierarchical testing procedure.
g. Dr. Bruno Fattizzo is a paid consultant for Johnson & Johnson. He has not been compensated for any media work.

ABOUT THE ENERGY TRIAL
ENERGY (NCT04119050) is a multicenter, randomized, double-blind, placebo-controlled Phase 2/3 study evaluating the efficacy and safety of nipocalimab compared with placebo followed by an open-label extension period, in adults living with warm autoimmune hemolytic anemia (wAIHA). 115 adults were randomized approximately 1:1:1 to receive nipocalimab at two different dose schedules or placebo. Following completion of 24 weeks of double-blind treatment, patients could enter an open-label extension period to receive nipocalimab for 144 weeks with a follow-up period of 6 weeks after last assessment.3

ABOUT WARM AUTOIMMUNE HEMOLYTIC ANEMIA (wAIHA)
Warm autoimmune hemolytic anemia (wAIHA) is a rare, life-threatening condition where autoantibodies attach to and destroy red blood cells (RBCs), resulting in anemia.4 Approximately 1-3 new people per 100,000 are affected by wAIHA per year, and about 1 in 8,000 individuals are living with the condition.4,5 This condition affects both women and men, and can affect people at any age with incidence increasing over the age of 50.5,6 Additionally, people with wAIHA are at increased risk of other serious complications such as venous thrombotic events, acute renal failure, and infection.7

There are no Food and Drug Administration (FDA)-approved drugs indicated for wAIHA, and treatment typically consists of unapproved corticosteroids, broad immunosuppressants, and B-cell directed therapies.4 With an unmet need for treatment in wAIHA, novel therapies like nipocalimab are being developed to potentially address this need.7

ABOUT IMAAVY (nipocalimab-aahu)
IMAAVY® is an immunoselective treatment designed to target, bind with high affinity, and block the neonatal Fc receptor (FcRn), reducing circulating immunoglobulin G (IgG) antibodies that drive disease while also preserving key immune functions. IMAAVY is currently approved for the treatment of generalized myasthenia gravis (gMG) in adults and pediatric patients 12 years of age and older who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.8

Nipocalimab is being investigated across three key segments in the autoantibody space including Rheumatologic diseases, Rare Autoantibody diseases and Maternal Fetal diseases mediated by maternal alloantibodies, in which blockade of IgG binding to FcRn in the placenta is believed to limit transplacental transfer of maternal alloantibodies to the fetus. 3,9,10,11,12,13,14,15,16,17

The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have granted several key designations to nipocalimab including:

  • EU EMA Orphan medicinal product designation for hemolytic disease of the fetus and newborn (HDFN) in October 2019 and fetal and neonatal alloimmune thrombocytopenia (FNAIT) in April 2025

  • U.S. FDA Fast Track designation in HDFN and warm autoimmune hemolytic anemia (wAIHA) in July 2019, gMG in December 2021, FNAIT in March 2024, Sjögren's disease (SjD) in March 2025, and systemic lupus erythematosus (SLE) in January 2026

  • U.S. FDA Orphan drug status for wAIHA in December 2019, HDFN in June 2020, generalized myasthenia gravis (gMG) in February 2021, chronic inflammatory demyelinating polyneuropathy (CIDP) in October 2021 and FNAIT in December 2023

  • U.S. FDA Breakthrough Therapy designation for HDFN in February 2024 and for SjD in November 2024

  • U.S. FDA granted Priority Review in gMG in Q4 2024 and wAIHA in Q2 2026

The legal manufacturer for IMAAVY is Janssen Biotech, Inc.

WHAT IS IMAAVY (nipocalimab-aahu)?
IMAAVY is a prescription medicine used to treat adults and children 12 years of age and older with a disease called generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.

It is not known if IMAAVY is safe and effective in children under 12 years of age.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about IMAAVY?

IMAAVY is a prescription medicine that may cause serious side effects, including:

  • Infections are a common side effect of IMAAVY that can be serious. Receiving IMAAVY may increase your risk of infection. Tell your healthcare provider right away if you have any of the following infection symptoms:

  • fever

  • chills

  • shivering

  • cough

  • sore throat

  • fever blisters

  • burning when you urinate

  • Allergic (hypersensitivity) reactions may happen during or up to a few weeks after your IMAAVY infusion. Get emergency medical help right away if you get any of these symptoms during or after your IMAAVY infusion:

  • a swollen face, lips, mouth, tongue, or throat

  • difficulty swallowing or breathing

  • itchy rash (hives)

  • chest pain or tightness

  • Infusion-related reactions are possible. Tell your healthcare provider right away if you get any of these symptoms during or a few days after your IMAAVY infusion:

  • headache

  • rash

  • nausea

  • fatigue

  • dizziness

  • chills

  • flu-like symptoms

  • redness of skin

Do not receive IMAAVY if you have a severe allergic reaction to nipocalimab-aahu or any of the ingredients in IMAAVY. Reactions have included angioedema and anaphylaxis.

Before using IMAAVY, tell your healthcare provider about all of your medical conditions, including if you:

  • ever had an allergic reaction to IMAAVY.

  • have or had any recent infections or symptoms of infection.

  • have recently received or are scheduled to receive an immunization (vaccine). People who take IMAAVY should not receive live vaccines.

  • are pregnant, plan to become pregnant, or are breastfeeding. It is not known whether IMAAVY will harm your baby.

Pregnancy Safety Study. There is a pregnancy safety study for IMAAVY if IMAAVY is given during pregnancy or you become pregnant while receiving IMAAVY. Your healthcare provider should report IMAAVY exposure by contacting Janssen at 1-800-526-7736 or www.IMAAVY.com.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the possible side effects of IMAAVY?
IMAAVY may cause serious side effects. See "What is the most important information I should know about IMAAVY?"

The most common side effects of IMAAVY include: respiratory tract infection, peripheral edema (swelling in your hands, ankles, or feet), and muscle spasms.

These are not all the possible side effects of IMAAVY. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see the full Prescribing Information and Medication Guide for IMAAVY and discuss any questions you have with your doctor.

Dosage Form and Strengths: IMAAVY is supplied as a 300 mg/1.62 mL and a 1,200 mg/6.5 mL (185 mg/mL) single-dose vial per carton for intravenous injection.

ABOUT JOHNSON & JOHNSON
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity.

Learn more at https://www.jnj.com/ or at www.innovativemedicine.jnj.com.

Follow us at @JNJInnovMed.

Janssen Biotech, Inc. is a Johnson & Johnson company.

Cautions Concerning Forward-Looking Statements

This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of IMAAVY. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com, www.investor.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.

REFERENCES

1 Fattizzo B, Murakhovskaya I, Ueda.Y, Schlichting D, Sweet K, Zelasky M, Craig J, Liva S, Leu J, Ling L, Pease S, Anakor A, Shu C, Nipocalimab for warm autoimmune hemolytic anemia: results from the Phase 2/3 randomized, double-blind ENERGY study, Presented at EHA 2026 Congress, Available at https://library.ehaweb.org/eha/2026/eha-2026/4206854/bruno.fattizzo.nipocalimab.for.warm.autoimmune.hemolytic.anemia.results.from.html?f=listing%3D0%2Abrowseby%3D8%2Asortby%3D1%2Asearch%3DS300
2 Seth N, et al. Nipocalimab, an immunoselective FcRn blocker that lowers IgG and has unique molecular properties. mAbs. 2025 Feb; 17(1). https://doi.org/10.1080/19420862.2025.2461191
3 ClinicalTrials.gov Identifier: NCT04119050. Available at: https://clinicaltrials.gov/study/NCT04119050. Last accessed: June 2026.
4 National Organization for Rare Disorders, Warm autoimmune Hemolytic Anemia. Available at: https://rarediseases.org/rare-diseases/warm-autoimmune-hemolytic-anemia/. Last accessed: June 2026.
5 Tranekær S, Hansen DL, Frederiksen H. Epidemiology of Secondary Warm Autoimmune Haemolytic Anaemia-A Systematic Review and Meta-Analysis. J Clin Med. 2021 Mar 17;10(6):1244. doi: 10.3390/jcm10061244. PMID: 33802848; PMCID: PMC8002719.
6 Cherif, H, Cai, Q, Crivera, C, Leon, A, Rahman, I, Leval, A, Noel, W and Kjellander, C. (2024), Overall Survival and Treatment Patterns Among Patients With Warm Autoimmune Hemolytic Anemia in Sweden: A Nationwide Population-based Study. Eur J Haematol. https://doi.org/10.1111/ejh.14311.
7 Fattizzo B, Barcellini W. New Therapies for the Treatment of Warm Autoimmune Hemolytic Anemia. Transfusion Medical Reviews, Vol. 36, Issue 4. October 2022 https://doi.org/10.1016/j.tmrv.2022.08.001.
8 IMAAVY® U.S. Prescribing Information.
9 ClinicalTrials.gov Identifier: NCT04951622. Available at: https://clinicaltrials.gov/ct2/show/NCT04951622. Last accessed: June 2026.
10 ClinicalTrials.gov. NCT03842189. Available at: https://clinicaltrials.gov/ct2/show/NCT03842189. Last accessed: June 2026.
11 ClinicalTrials.gov Identifier: NCT05327114. Available at: https://www.clinicaltrials.gov/study/NCT05327114. Last accessed: June 2026.
12 ClinicalTrials.gov Identifier: NCT05379634. Available at: https://clinicaltrials.gov/study/NCT05379634. Last accessed: June 2026.
13 ClinicalTrials.gov Identifier: NCT05912517. Available at: https://www.clinicaltrials.gov/study/NCT05912517. Last accessed: June 2026.
14 ClinicalTrials.gov Identifier: NCT04968912. Available at: https://clinicaltrials.gov/study/NCT04968912. Last accessed: June 2026.
15 ClinicalTrials.gov Identifier: NCT04882878. Available at: https://clinicaltrials.gov/study/NCT04882878. Last accessed: June 2026.
16 ClinicalTrials.gov Identifier: NCT06449651. Available at: https://clinicaltrials.gov/study/NCT06449651. Last accessed: June 2026.
17 ClinicalTrials.gov Identifier: NCT06533098 Available at: https://clinicaltrials.gov/study/NCT06533098. Last accessed: June 2026.

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Attached document

Contents
  1. HIGHLIGHTS OF PRESCRIBING INFORMATION · page 1
  2. Initial U.S. Approval: 2025 · page 1
  3. --DOSAGE AND ADMINISTRATION- · page 1
  4. DOSAGE FORMS AND STRENGTHS- · page 1
  5. CONTRAINDICATIONS · page 1
  6. WARNINGS AND PRECAUTIONS · page 1
  7. -DRUG INTERACTIONS- · page 1
  8. FULL PRESCRIBING INFORMATION: CONTENTS* · page 1
  9. 1 INDICATIONS AND USAGE · page 1
  10. 2 DOSAGE AND ADMINISTRATION · page 1
  11. 3 DOSAGE FORMS AND STRENGTHS · page 1
  12. 4 CONTRAINDICATIONS · page 1
  13. 5 WARNINGS AND PRECAUTIONS · page 1
  14. 6 ADVERSE REACTIONS · page 1
  15. 7 DRUG INTERACTIONS · page 1
  16. 8 USE IN SPECIFIC POPULATIONS · page 1
  17. 11 DESCRIPTION · page 1
  18. 12 CLINICAL PHARMACOLOGY · page 1
  19. 13 NONCLINICAL TOXICOLOGY · page 1
  20. 14 CLINICAL STUDIES · page 1
  21. FULL PRESCRIBING INFORMATION · page 2
  22. 1 INDICATIONS AND USAGE · page 2
  23. 1.1 Generalized Myasthenia Gravis (gMG) · page 2
  24. 1.2 Warm Autoimmune Hemolytic Anemia (wAIHA) · page 2
  25. 2 DOSAGE AND ADMINISTRATION · page 2
  26. 2.1 Recommended Vaccination · page 2
  27. 2.2 Recommended Dosage for gMG · page 2
  28. 2.3 Recommended Dosage for wAIHA · page 2
  29. Table 2: wAIHA Recommended Dose Regimen · page 2
  30. 2.4 Missed Doses · page 2
  31. 2.5 Preparation and Administration Instructions · page 2
  32. Preparation · page 2
  33. Administration · page 2
  34. 3 DOSAGE FORMS AND STRENGTHS · page 2
  35. 4 CONTRAINDICATIONS · page 2
  36. 5 WARNINGS AND PRECAUTIONS · page 2
  37. 5.1 Infections · page 2
  38. Latent Viral Infections · page 2
  39. Immunization · page 2
  40. 5.2 Hypersensitivity Reactions · page 2
  41. 5.3 Infusion-Related Reactions · page 3
  42. 6 ADVERSE REACTIONS · page 3
  43. 6.1 Clinical Trials Experience · page 3
  44. Adults with gMG · page 3
  45. Infections · page 3
  46. Hypersensitivity Reactions · page 3
  47. Infusion-Related Reactions · page 3
  48. Laboratory Findings · page 3
  49. Lipids · page 3
  50. Pediatric Patients 12 Years of Age and Older with gMG · page 3
  51. Adults with wAIHA · page 3
  52. Infections · page 3
  53. Hypersensitivity Reactions · page 4
  54. Infusion-Related Reactions · page 4
  55. Laboratory Findings · page 4
  56. Lipids · page 4
  57. 7 DRUG INTERACTIONS · page 4
  58. 7.1 Effect of IMAAVY on Other Drugs · page 4
  59. 8 USE IN SPECIFIC POPULATIONS · page 4
  60. 8.1 Pregnancy · page 4
  61. Risk Summary · page 4
  62. Clinical Considerations · page 4
  63. Fetal/Neonatal Adverse Reactions · page 4
  64. Data · page 4
  65. Animal Data · page 4
  66. 8.2 Lactation · page 4
  67. Risk Summary · page 4
  68. 8.4 Pediatric Use · page 4
  69. gMG · page 4
  70. wAIHA · page 4
  71. 8.5 Geriatric Use · page 4
  72. 11 DESCRIPTION · page 4
  73. 12 CLINICAL PHARMACOLOGY · page 4
  74. 12.1 Mechanism of Action · page 4
  75. 12.2 Pharmacodynamics · page 4
  76. wAIHA · page 4
  77. 12.3 Pharmacokinetics · page 5
  78. Distribution · page 5
  79. Metabolism · page 5
  80. Elimination · page 5
  81. Specific Populations · page 5
  82. Age, Sex, and Race · page 5
  83. Pediatric Patients · page 5
  84. gMG · page 5
  85. wAIHA · page 5
  86. Patients with Renal Impairment · page 5
  87. Patients with Hepatic Impairment · page 5
  88. Drug Interactions with Other Drugs or Biological Products · page 5
  89. IgG-Based Monoclonal Antibodies · page 5
  90. Cytochrome P450 Enzymes · page 5
  91. 12.6 Immunogenicity · page 5
  92. gMG · page 5
  93. wAIHA · page 5
  94. 13 NONCLINICAL TOXICOLOGY · page 5
  95. 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility · page 5
  96. Carcinogenesis · page 5
  97. Mutagenesis · page 5
  98. Impairment of Fertility · page 5
  99. 14 CLINICAL STUDIES · page 5
  100. 14.1 Adults with gMG · page 5
  101. 14.2 Adults with wAIHA · page 6
  102. * IMAAVY dose; SE=Standard Error · page 7
  103. 16 HOW SUPPLIED/STORAGE AND HANDLING · page 7
  104. How Supplied · page 7
  105. Storage and Handling · page 7
  106. Unopened Vials · page 7
  107. Diluted Solution · page 7
  108. 17 PATIENT COUNSELING INFORMATION · page 7
  109. Infections · page 7
  110. Administration of Vaccines · page 7
  111. Hypersensitivity Reactions · page 7
  112. Infusion-Related Reactions · page 7
  113. Pregnancy · page 7
  114. Manufactured by: · page 7
  115. PATIENT INFORMATION IMAAVY $ ^{\circ} $ (im-AH-vee) （nipocalimab-aahu） injection, for intravenous use · page 8
  116. What is IMAAVY? · page 8
  117. Do not receive IMAAVY if you · page 8
  118. How will I receive IMAAVY? · page 8
  119. What are the possible side effects of IMAAVY? · page 9
  120. IMAAVY can cause serious side effects, including: · page 9
  121. The most common side effects in people with gMG treated with IMAAVY include: · page 9
  122. General information about the safe and effective use of IMAAVY. · page 9
  123. What are the ingredients in IMAAVY? · page 9
  124. Active ingredient:nipocalimab-aahu · page 9

Page 1

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use IMAAVY safely and effectively. See full prescribing information for IMAAVY.

IMAAVY $ ^{\circ} $ (nipocalimab-aahu) injection, for intravenous use Initial U.S. Approval: 2025

Initial U.S. Approval: 2025

RECENT MAJOR CHANGES

Indications and Usage (1.2)

Dosage and Administration (2.2, 2.3, 2.4, 2.5)

Warnings and Precautions (5.1, 5.2, 5.3)

INDICATIONS AND USAGE

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. (1.1)

- warm autoimmune hemolytic anemia (wAIHA) in adult and pediatric patients 12 years of age and older currently or previously treated with corticosteroids. (1.2)

DOSAGE AND ADMINISTRATION

--DOSAGE AND ADMINISTRATION-

- See Full Prescribing Information for instructions on dosage, preparation, and administration. (2.1, 2.2, 2.3, 2.4, 2.5)

- 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, 2.3)

- gMG: 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)

- wAIHA: The recommended initial dosage is 30 mg/kg once via intravenous infusion over at least 30 minutes. Four weeks after the initial dosage, administer a subsequent dosage of 30 mg/kg via intravenous infusion over at least 15 minutes, and continue every four weeks thereafter. (2.3)

- Must be diluted with 0.9% Sodium Chloride Injection prior to administration. (2.5)

- Administer as an intravenous infusion via a 0.2 micron in-line or add-on filter. (2.5)

DOSAGE FORMS AND STRENGTHS-

DOSAGE FORMS AND STRENGTHS-----------

IMAAVY $ ^{\textcircled{2}} $ (nipocalimab-aahu) injection

- Injection: 300 mg/1.62 mL (185 mg/mL) in a single-dose vial (3)

- Injection: 1,200 mg/6.5 mL (185 mg/mL) in a single-dose vial (3)

CONTRAINDICATIONS

IMAAVY is contraindicated in patients with a history of serious hypersensitivity reaction to nipocalimab-aahu or to any of the excipients in IMAAVY. (4)

WARNINGS AND PRECAUTIONS

WARNINGS AND PRECAUTIONS.....

- 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)

ADVERSE REACTIONS

- The most common adverse reactions ( $ \geq10% $ ) in patients with gMG treated with IMAAVY were respiratory tract infections, peripheral edema, and muscle spasms. (6.1)

- The most common adverse reactions ( $ \geq10% $ ) in patients with wAIHA treated with IMAAVY were peripheral edema, diarrhea and pyrexia. (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.

DRUG INTERACTIONS-

-DRUG INTERACTIONS-

Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. When concomitant long-term use of such medications is essential for patient care, consider discontinuing IMAAVY and using alternative therapies. (7.1)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 08/2026

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE

1.1 Generalized Myasthenia Gravis (gMG)

1.2 Warm Autoimmune Hemolytic Anemia (wAIHA)

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Vaccination

2.2 Recommended Dosage for gMG

2.3 Recommended Dosage for wAIHA

2.4 Missed Doses

2.5 Preparation and Administration Instructions

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Infections

5.2 Hypersensitivity Reactions

5.3 Infusion-Related Reactions

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

7 DRUG INTERACTIONS

7.1 Effect of IMAAVY on Other Drugs

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Lactation

8.4 Pediatric Use

8.5 Geriatric Use

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

12.6 Immunogenicity

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

14 CLINICAL STUDIES

14 CLINICAL STUDIES 14.1 Adults with gMG 14.2 Adults with wAIH

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

*Sections or subsections omitted from the full prescribing information are not listed.

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IMAAVY $ ^{\textcircled{R}} $ (nipocalimab-aahu) injection

FULL PRESCRIBING INFORMATION

1 INDICATIONS AND USAGE

1.1 Generalized Myasthenia Gravis (gMG)

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.

1.2 Warm Autoimmune Hemolytic Anemia (wAIHA)

IMAAVY is indicated for the treatment of warm autoimmune hemolytic anemia (wAIHA) in adult and pediatric patients 12 years of age and older currently or previously treated with corticosteroids.

2 DOSAGE AND ADMINISTRATION

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 for gMG

Dilute IMAAVY prior to administration. Administer via intravenous infusion only [see Dosage and Administration (2.5)].

Initial dosageMaintenance dosage
30 mg/kg administered once via intravenous infusion over at least 30 minutes.Two weeks after the initial dose administer a maintenance dose of 15 mg/kg via intravenous infusion over at least 15 minutes. Continue the maintenance dose every two weeks thereafter.

2.3 Recommended Dosage for wAIHA

Dilute IMAAVY prior to administration. Administer via intravenous infusion only [see Dosage and Administration (2.5)].

IMAAVY $ ^{\circ} $ (nipocalimab-aahu) injection

Table 2: wAIHA Recommended Dose Regimen

Initial dosageSubsequent dosage
30 mg/kg administered once via intravenous infusion over at least 30 minutes.Four weeks after the initial dose administer a subsequent dose of 30 mg/kg via intravenous infusion over at least 15 minutes. Continue the subsequent dose every four weeks thereafter.

2.4 Missed Doses

If a scheduled infusion is missed, administer the dose of IMAAVY as soon as possible. Resume dosing, maintaining the treatment interval.

2.5 Preparation and Administration Instructions

Prior to administration, dilute IMAAVY single-dose vials with only 0.9% Sodium Chloride Injection using the instructions below. For patients who weigh 40 kg or more, the total volume to be administered is 250 mL; for patients who are 12 years older and weigh less than 40 kg,the total volume to be administered is 100 mL (see Preparation).

Preparation

Prepare the solution for infusion using aseptic technique as follows:

- Calculate the dosage (mg), total drug volume (mL) of IMAAVY solution required, and the number of IMAAVY vials needed, based on the patient's current weight [see Dosage and Administration (2.2, 2.3)]. Each single-dose vial of IMAAVY is at a concentration of 185 mg/mL.

Show more of the filing

- Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Check that the solution in each vial is colorless to slightly brownish, clear to slightly opalescent, and free of visible particles. Do not use if visible particles are present or if the solution is discolored (other than colorless to slightly brownish).

- Gently withdraw the calculated volume of IMAAVY from the vial(s). Discard any unused portion of the vials.

- Dilute total volume withdrawn of IMAAVY by adding to an infusion container containing 0.9% Sodium Chloride Injection to a final volume of:

- 250 mL for patients who weigh 40 kg or more, or

o 100 mL for patients who weigh less than 40 kg.

Only use infusion containers made of polyolefin, polypropylene, or polyvinylchloride.

- Gently invert the infusion container at least 10 times to mix the solution. Do not shake.

- Verify that a uniform solution has been achieved by visual inspection. Do not use if particulate matter or discoloration is present.

Storage Conditions of the Diluted Solution

- Administer the diluted IMAAVY solution immediately after preparation.

- If the diluted IMAAVY solution is not used immediately:

Protect from light.

- Store refrigerated at 2 $^{\circ} \mathrm{C}$ to 8 $^{\circ} \mathrm{C}$ (36 $^{\circ} \mathrm{F}$ to 46 $^{\circ} \mathrm{F}$) for no more than 24 hours.

Do not freeze.

- After preparation or removal from the refrigerator, use or discard the IMAAVY diluted solution within 12 hours, including infusion time. During these 12 hours, store under ambient light at $ 15^{\circ} \mathrm{C} $ to $ 30^{\circ} \mathrm{C} $ ( $ 59^{\circ} \mathrm{F} $ to $ 86^{\circ} \mathrm{F} $ ).

Administration

- If the diluted solution is refrigerated prior to administration, allow to warm to room temperature. Do not use external heat sources to warm IMAAVY.

- Administer the diluted solution by intravenous infusion only using an infusion set with an in-line or add-on, sterile, non-pyrogenic, low protein-binding filter made of polyethersulfone or polysulfone (pore size 0.2 micrometer or less). Administration sets must be made of either polybutadiene, polyethylene, polyurethane, polypropylene, or polyvinylchloride.

- Do not infuse IMAAVY concomitantly in the same intravenous line with other agents.

- Administer IMAAVY infusion intravenously over at least 30 minutes for the initial dose and at least 15 minutes for subsequent doses [see Dosage and Administration (2.2, 2.3)].

- If an adverse reaction occurs during administration of IMAAVY, the infusion may be slowed or stopped at the discretion of the healthcare professional.

- Monitor the patient for 30 minutes after each infusion for signs or symptoms of an infusion-related or hypersensitivity reaction [see Warnings and Precautions (5.2, 5.3)].

3 DOSAGE FORMS AND STRENGTHS

Injection: colorless to slightly brownish, clear to slightly opalescent solution available as:

- 300 mg/1.62 mL (185 mg/mL) in a single-dose vial

- 1,200 mg/6.5 mL (185 mg/mL) in a single-dose vial

4 CONTRAINDICATIONS

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

5 WARNINGS AND PRECAUTIONS

5.1 Infections

IMAAVY may increase the risk of infection [see Adverse Reactions (6.1)]. In gMG Study 1 [see Clinical Studies (14.1)], 42 (43%) out of 98 patients treated with IMAAVY reported 71 events of infection. Across gMG 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 and serious infections were reported in 7% of patients treated with IMAAVY. In the wAIHA Study (double-blind period), 35 (45%) out of 78 patients treated with IMAAVY reported 52 events of infection [see Clinical Studies (14.2)]. Across the wAIHA Study (double-blind period) and its extension study (open label-period), out of 113 patients treated with IMAAVY, 80 (71%) patients reported 184 events of infection and serious infections were reported in 12% 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. If serious infection occurs, administer appropriate treatment and consider withholding IMAAVY until the infection has resolved.

Latent Viral Infections

Patients treated with IMAAVY may be at an increased risk of activation of latent viral infections, such as herpes zoster [see Adverse Reactions (6.1)]. In the extension period of gMG Study 1, there were 2 patients with serious adverse reactions related to Epstein-Barr virus (EBV) infection, and 1 of these patients had fatal complications. Patients who screened positive for hepatitis were excluded from gMG Study 1. Follow standard vaccination guidelines [see Dosage and Administration (2.1)].

Immunization

The safety of immunization with live vaccines and the immune response to vaccination during treatment with IMAAVY are unknown. Because IMAAVY causes a reduction in IgG levels, vaccination with live vaccines is not recommended during treatment with IMAAVY.

Evaluate the need to administer age-appropriate vaccines according to immunization guidelines before initiation of treatment with IMAAVY.

5.2 Hypersensitivity Reactions

In clinical trials, hypersensitivity reactions, including angioedema, anaphylaxis, rash, urticaria, and eczema were observed in patients treated with IMAAVY. In gMG Study 1 and the wAIHA Study, hypersensitivity reactions were mild or moderate. In gMG Study 1, all hypersensitivity reactions occurred within one hour to 2 weeks of administration. In the wAIHA Study, $76%$ of hypersensitivity reactions occurred within 2 weeks of administration [see Adverse Reactions (6.1)]. In gMG Study 1, one patient experienced a hypersensitivity reaction (urticaria) that led to treatment discontinuation.

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Management of hypersensitivity reactions depends on the type and severity of the reaction. Monitor the patient during treatment with IMAAVY and for 30 minutes after the administration is complete for clinical signs and symptoms of hypersensitivity reactions [see Dosage and Administration (2.5)]. If a hypersensitivity reaction occurs during administration, discontinue IMAAVY infusion and institute appropriate supportive measures if needed. IMAAVY is contraindicated in patients with a history of serious hypersensitivity to nipocalimab-aahu or any of the excipients of IMAAVY [see Contraindications (4)].

5.3 Infusion-Related Reactions

In clinical trials, infusion-related reactions, including headache, influenza-like illness, rash, nausea, fatigue, dizziness, chills, and erythema were observed in patients treated with IMAAVY. In gMG Study 1 and the wAIHA Study, infusionrelated reactions were mild to moderate in severity. In gMG Study 1, all infusion-related reactions occurred within one hour to 2 days of administration. In the wAIHA Study, $ 89% $ of infusion-related reactions occurred within 2 days of administration [see Adverse Reactions (6.1)].

Monitor patients during treatment with IMAAVY and for 30 minutes after each infusion [see Dosage and Administration (2.5)]. If a severe infusion-related reaction occurs, discontinue IMAAVY infusion and initiate appropriate therapy. Consider the risks and benefits of readministering IMAAVY following a severe infusionrelated reaction. If a mild to moderate infusion-related reaction occurs, patients may be rechallenged with close clinical observation, slower infusion rates, and pre-medication.

6 ADVERSE REACTIONS

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)]

6.1 Clinical Trials Experience

Adults with gMG

In gMG 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 gMG Study 1, 98 adult patients with gMG received IMAAVY $15\mathrm{mg/kg}$ every two weeks (after $30\mathrm{mg/kg}$ initial dose) [see Clinical Studies (14.1)]. 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).

Adverse reactions reported in gMG Study 1 in at least $5%$ of patients treated with IMAAVY and more frequently than placebo, are summarized in Table 3. The most common adverse reactions (reported in at least $10%$ of patients treated with IMAAVY) were respiratory tract infection, peripheral edema, and muscle spasms.

Table 3: Adverse Reactions ( $ \geq5% $ ) of Patients Treated with IMAAVY and More Frequently than in Placebo in gMG Study 1

Includes the following reported in patients treated with IMAAVY:

a COVID-19 (and other related terms), pneumonia, bronchitis, pneumonia bacteria b other related terms

c glossitis, oral candidiasis, pericoronitis, pulpitis dental, tooth abscess, tooth infection d angioedema, dermatitis atopic, eczema, gingival swelling, rash (and other related terms), urticaria

Infections

In gMG Study 1 and its extension study, infections that occurred in patients treated with IMAAVY (n=186) included upper respiratory tract infection (46%), respiratory tract infection (28%; including pneumonia, bronchitis, COVID-19), urinary tract infection (15%), herpes (8%; including herpes simplex, herpes zoster, herpes zoster oticus), influenza (8%) oral infection (8%; including candidiasis and dental infections), and skin infection (7%; including cellulitis). Two (1%) cases of infections (cellulitis and urinary tract infection) led to discontinuation of IMAAVY [see Warnings and Precautions (5.1)].

Hypersensitivity Reactions

In gMG Study 1 and its extension study, out of 186 patients treated with IMAAVY, 30 (16%) patients experienced hypersensitivity reactions, which occurred within one hour to two weeks of administration. One patient experienced hypersensitivity reaction (urticaria) that required discontinuation of IMAAVY [see Warnings and Precautions (5.2)].

Infusion-Related Reactions

In gMG Study 1 and its extension study, out of 186 patients treated with IMAAVY,20 (11%) patients experienced infusion-related reactions, which occurred within one hour to 2 days of administration. No patients experienced infusion-related reaction that required discontinuation of IMAAVY [see Warnings and Precautions (5.3)].

Laboratory Findings

Lipids

In gMG Study 1 (N=98), patients treated with IMAAVY had elevations from normal to high of fasting total cholesterol $ \left( {\geq} {240}\mathrm{{mg}}/\mathrm{dL}}\right) $ and LDL cholesterol $ \left( {\geq} {160}\mathrm{{mg}}/\mathrm{dL}}\right) $ （24% and 11% of patients, respectively). In gMG Study 1, these changes from baseline peaked at Week 4, then decreased and plateaued by Week 24 to mean increases of 14 mg/dL and 7 mg/dL, respectively. Five percent of patients treated with IMAAVY had decreases from normal to low of fasting HDL cholesterol $ (< 40\mathrm{{mg}}/\mathrm{dL})。 $

Pediatric Patients 12 Years of Age and Older with gMG

In a 24-week, single arm study (gMG Study 2), evaluating the safety of IMAAVY in 7 pediatric patients age 12 to 16 years with gMG who were AChR positive, adverse reactions were consistent with those observed in adult patients with gMG [see Use in Specific Populations (8.4)].

Adults with wAIHA

The safety of IMAAVY in patients with wAIHA was evaluated in 113 adult patients with wAIHA who received at least one dose of IMAAVY. Of these patients, 84 patients received IMAAVY for at least 6 months, and 49 patients received IMAAVY for at least 12 months. The median duration of treatment was 44 weeks.

In the double-blind phase of the wAIHA Study, 78 patients received IMAAVY across the dose regimens evaluated in the study [see Clinical Studies (14.2)].

Adverse reactions that occurred in the wAIHA Study in at least 5% of patients treated with IMAAVY are summarized in Table 4. The most common adverse reactions (reported in at least 10% of patients treated with IMAAVY) were peripheral edema, diarrhea, and pyrexia.

Table 4: Adverse Reactions ( $ \geq5% $ ) of Patients Treated with IMAAVY and More Frequently than in Placebo in the wAIHA Study

Adverse ReactionIMAAVY N=78 %Placebo N=39 %
Peripheral edemaa122.6
Diarrhea128
Pyrexia102.6
Dizziness98
Infection Urinary tract infectionb95
Headache65

a Includes Edema peripheral, Edema and Generalized edema.

b Includes Urinary tract infection, Pyelonephritis and Urinary tract infection bacterial.

Additional Clinically Relevant Adverse Reactions occurring in $ \leq5% $ of patients

- Pneumonia (5% with IMAAVY; 5% with placebo)

- Nausea (3.8% with IMAAVY; 2.6% with placebo)

- Insomnia (1.3% with IMAAVY; 0% with placebo)

Infections

In the wAIHA Study and its extension study, infections that occurred in patients treated with IMAAVY (n=113) included upper respiratory tract infection (34%) respiratory tract infection (33%), urinary tract infection (12%), gastroenteritis (5%). Three (2.7%) cases of infections (pneumonia, salmonella sepsis and spontaneous bacterial peritonitis) led to discontinuation of IMAAVY [see Warnings and Precautions (5.1)].

Page 4

Hypersensitivity Reactions

In the wAIHA Study and its extension study, out of 113 patients treated with IMAAVY, 9 (8%) patients experienced hypersensitivity reactions [see Warnings and Precautions (5.2)].

Infusion-Related Reactions

In the wAIHA Study and its extension study, out of 113 patients treated with IMAAVY, 12 (11%) patients experienced infusion-related reactions. One patient in the wAIHA Study discontinued IMAAVY due to an infusion-related reaction (back pain) [see Warnings and Precautions (5.3)].

Laboratory Findings

Lipids

In the double-blind phase of the wAIHA Study (N=78), 2.3% of patients treated with IMAAVY had elevations from normal to high of fasting total cholesterol ( $ \geq 240 $ mg/dL) and LDL cholesterol remained $ < 160 $ mg/dL for all patients at Week 24. These changes from baseline peaked between Week 4 and Week 12, then decreased and plateaued by Week 24 to mean increases in fasting total cholesterol of 6 mg/dL and fasting LDL of 4.2 mg/dL. Of the patients treated with IMAAVY, 12% had fasting HDL cholesterol of $ < 40 $ mg/dL.

7 DRUG INTERACTIONS

7.1 Effect of IMAAVY on Other Drugs

Concomitant use of IMAAVY with medications that bind to the human neonatal Fc receptor (FcRn) (e.g., immunoglobulin products, monoclonal antibodies, or antibody derivates containing the human Fc domain of the IgG subclass) may lower systemic exposures and reduce effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. When concomitant long-term use of such medications is essential for patient care, consider discontinuing IMAAVY, and using alternative therapies [see Clinical Pharmacology (12.3)]

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

There are limited data on the use of IMAAVY in pregnant women to inform a drugassociated 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. Because IMAAVY reduces maternal serum IgG concentration and impedes placental IgG transfer to the fetus, passive immunity in the infant may be reduced for 6 months or more; therefore:

- Monitor for the development of serious infection.

- Effectiveness of vaccines may be reduced.

- Consider the risks and benefits prior to administering live vaccines to infants exposed to IMAAVY in utero.

Data

Animal Data

Intravenous administration of nipocalimab-aahu (0,100,or 300 mg/kg) to pregnant monkeys weekly from the end of organogenesis (gestation day 45) through parturition resulted in placental ischemia, associated with fetal loss and decreased levels of immunoglobulin (IgG) in the offspring at both doses tested. IgG levels in offspring returned to normal levels and no adverse effects on immune function were evident by 6 months after birth. Mean systemic exposures achieved at the doses tested were 5- and 24-times the population PK model simulated mean steady state exposure at the recommended human maintenance dose for gMG (15 mg/kg) and 5.5- and 28-times the population PK model simulated mean steady state exposure at the recommended human maintenance dose for wAIHA (30 mg/kg) on an AUC basis.

8.2 Lactation

Risk Summary

Nipocalimab-aahu is excreted in human colostrum and breastmilk based on limited data from an investigational study of 13 pregnant women administered nipocalimab-aahu during pregnancy where colostrum and breastmilk was assessed in the first 8 days after birth. There are insufficient data on the effect of IMAAVY in the breastfed infant. There are no data on the effect of nipocalimab-aahu on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for IMAAVY, and any potential adverse effects on the breastfed infant from IMAAVY, or from the underlying maternal condition.

8.4 Pediatric Use

gMG

The safety and effectiveness of IMAAVY for the treatment of gMG have been established in pediatric patients 12 years of age and older. Use of IMAAVY in pediatric patients for this indication is supported by evidence from an adequate and well-controlled trial in adults with additional pharmacokinetic and safety data in pediatric patients who are 12 years of age and older [see Adverse Reactions (6.1), Clinical Pharmacology (12.3), and Clinical Studies (14.1)].

Safety and effectiveness of IMAAVY for the treatment of gMG in pediatric patients below the age of 12 years have not been established.

wAIHA

The safety and effectiveness of IMAAVY for the treatment of wAIHA have been established in pediatric patients 12 years of age and older currently or previously treated with corticosteroids. Use of IMAAVY in pediatric patients for the treatment of wAIHA is supported by evidence from an adequate and well-controlled trial in adults with additional pharmacokinetic data in pediatric patients who are 12 years of age and older [see Adverse Reactions (6.1), Clinical Pharmacology (12.3), and Clinical Studies (14.2)].

Safety and effectiveness of IMAAVY for the treatment of wAIHA in pediatric patients below the age of 12 years have not been established.

8.5 Geriatric Use

There were 86 patients 65 years of age and older in the clinical studies for gMG (n=37) and wAIHA (n=49) [see Clinical Studies (14)]. Of the total number of IMAAVY-treated patients in gMG, 12 were 65 to 74 years of age and 6 were 75 to 84 years of age. Of the total number of IMAAVY-treated patients in wAIHA, 19 were 65 to 74 years of age and 12 were 75 to 84 years of age.

Clinical studies of IMAAVY did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger adult patients.

11 DESCRIPTION

Nipocalimab-aahu, a neonatal Fc receptor blocker, is a recombinant human immunoglobulin G1 lambda (IgG1 $ \lambda $ ) monoclonal antibody, expressed in a genetically engineered Chinese hamster ovary cell line. Nipocalimab-aahu has an aglycosylated Fc region, therefore it lacks effector functions. Nipocalimab-aahu has an approximate molecular weight of 142 kilodaltons (kDa).

IMAAVY $ ^{\textcircled{8}} $ (nipocalimab-aahu) injection is a sterile, preservative-free, colorless to slightly brownish, clear to slightly opalescent solution, supplied in a single-dose vial for intravenous infusion after dilution.

Each single-dose vial contains either 300 mg/1.62 mL or 1,200 mg/6.5 mL of nipocalimab-aahu at a concentration of 185 mg/mL. In addition, each mL of solution contains arginine hydrochloride (25.35 mg), histidine (0.77 mg), L-histidine monohydrochloride monohydrate (1.07 mg), methionine (1.0 mg), polysorbate 80 (0.60 mg), sucrose (64.3 mg), and water for injection, USP, at a pH of 6.0.

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

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

12.2 Pharmacodynamics

gMG

Showing pages 1–3 of 9.

Attached document

Contents
  1. PATIENT INFORMATION IMAAVY® (im-AH-vee) (nipocalimab-aahu) injection, for intravenous use · page 1
  2. IMAAVY ® (im-AH-vee) · page 1
  3. What is IMAAVY? · page 1
  4. Do not receive IMAAVY if you · page 1
  5. Before receiving IMAAVY, tell your healthcare provider about all of your medical conditions, including if you: · page 1
  6. How will I receive IMAAVY? · page 1
  7. What are the possible side effects of IMAAVY? · page 2
  8. IMAAVY can cause serious side effects, including: · page 2
  9. The most common side effects in people with gMG treated with IMAAVY include: · page 2
  10. The most common side effects in people with wAIHA treated with IMAAVY include: · page 2
  11. General information about the safe and effective use of IMAAVY. · page 2
  12. What are the ingredients in IMAAVY? · page 2
  13. Active ingredient: nipocalimab-aahu · page 2

Page 1

PATIENT INFORMATION IMAAVY® (im-AH-vee) (nipocalimab-aahu) injection, for intravenous use

IMAAVY ® (im-AH-vee)

What is IMAAVY?

IMAAVY is a prescription medicine used to treat adults and children 12 years of age and older with:

• generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.

• warm Autoimmune Hemolytic Anemia (wAIHA) currently or previously treated with corticosteroids.

It is not known if IMAAVY is safe and effective in children under 12 years of age.

Do not receive IMAAVY if you

have a history of a severe allergic reactions to nipocalimab-aahu or any of the ingredients in IMAAVY. See the end of this Patient Information leaflet for a complete list of ingredients in IMAAVY.

Before receiving IMAAVY, tell your healthcare provider about all of your medical conditions, including if you:

• have had an allergic reaction to IMAAVY. Ask your healthcare provider if you are not sure.

• have or had any recent infections or have any symptoms of infection.

• have or had shingles (herpes zoster) or mono (mononucleosis caused by Epstein-Barr virus).

• have recently received or are scheduled to receive an immunization (vaccine). You should not receive live vaccines during treatment with IMAAVY.

• are pregnant or plan to become pregnant. It is not known if IMAAVY will harm your unborn baby.

Pregnancy Safety Study. There is a pregnancy safety study for IMAAVY. If IMAAVY is given during pregnancy or you become ° pregnant while receiving IMAAVY, your healthcare provider should report IMAAVY exposure by contacting Janssen at 1-800-526-7736 or www.IMAAVY.com.

• are breastfeeding or plan to breastfeed. IMAAVY can pass into your breast milk. It is not known if IMAAVY will harm your baby. Talk to your healthcare provider about the best way to feed your baby during treatment with IMAAVY.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. IMAAVY may affect the way that some medicines work.

How will I receive IMAAVY?

• Your healthcare provider will give you IMAAVY through a needle placed into your vein (intravenous [IV] infusion).

• For gMG, you will receive a starting dose of IMAAVY infusion lasting at least 30 minutes. Two weeks later you will receive your next dose of IMAAVY infusion lasting at least 15 minutes. You will receive your following doses every 2 weeks.

• For wAIHA, you will receive a starting dose of IMAAVY infusion lasting at least 30 minutes. Four weeks later you will receive your next dose of IMAAVY infusion lasting at least 15 minutes. You will receive your following doses every 4 weeks.

• Your healthcare provider should monitor you for reactions to IMAAVY during the infusion and for 30 minutes after each infusion. If you have a reaction during your IMAAVY infusion, your healthcare provider may infuse IMAAVY more slowly, or give you medicine before your infusion, or stop your infusion if your reaction is severe.

• If you miss a scheduled IMAAVY infusion, you should receive your next dose as soon as possible.

What should I avoid while receiving IMAAVY?

• You should not receive live vaccines during treatment with IMAAVY.

Page 2

IMAAVY® (nipocalimab-aahu) injection

What are the possible side effects of IMAAVY?

IMAAVY can cause serious side effects, including:

• Infections. IMAAVY may increase your risk of infections, including serious infections. If you have an infection, your healthcare provider will treat your infection or delay your infusion until your infection is gone. Tell your healthcare provider right away if you get any of the following symptoms of infection:

fever °

°

sore throat

chills °

°

fever blisters

shivering °

°

burning when you urinate

cough °

°

trouble breathing

• Allergic (hypersensitivity) reactions. Allergic reactions can happen during or up to a few weeks after your IMAAVY infusion. Tell your healthcare provider and get emergency medical help right away if you get any of these symptoms during or after your IMAAVY infusion:

° swelling of your face, lips, mouth, tongue, or throat

° trouble swallowing or breathing

itchy rash °

chest pain or tightness °

° hives

• Infusion-related reactions. Tell your healthcare provider right away if you get any of the following symptoms during or within a few days after your infusion of IMAAVY:

° headache

dizziness °

° rash

chills °

° nausea

° fatigue

flu-like symptoms °

redness of skin °

The most common side effects in people with gMG treated with IMAAVY include:

• infection in parts of your body that you use for breathing (respiratory tract infection)

• swelling in your hands, ankles, or feet (peripheral edema)

• muscle spasms

The most common side effects in people with wAIHA treated with IMAAVY include:

• swelling in your hands, ankles, or feet (peripheral edema)

• diarrhea

• fever (pyrexia)

These are not all of the possible side effects of IMAAVY.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of IMAAVY.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet.

You can ask your pharmacist or healthcare provider for information about IMAAVY that is written for health professionals.

What are the ingredients in IMAAVY?

Active ingredient: nipocalimab-aahu

Inactive ingredients: arginine hydrochloride, histidine, L-histidine monohydrochloride monohydrate, methionine, polysorbate 80, sucrose, and water for injection.

Manufactured by: Janssen Biotech, Inc., Horsham, PA 19044, USA

U.S. License Number 1864

For patent information: www.janssenpatents.com

© Johnson & Johnson and its affiliates 2026

For more information, call 1-800-526-7736 or go to www.IMAAVY.com

This Patient Information has been approved by the U.S. Food and Drug Administration

cp-509743v5

Revised: 08/2026

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