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IMAAVY nipocalimab-aahu 185 mg/mL Injection, Solution, Concentrate, 1 vial — NDC 57894-0800-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

IMAAVY nipocalimab-aahu 185 mg/mL Injection, Solution, Concentrate, 1 vial — NDC 57894-800-01 (Billing 57894-0800-01)

by Janssen Biotech, Inc. · 1 VIAL, SINGLE-DOSE in 1 BOX / 1.62 mL in 1 VIAL, SINGLE-DOSE

This is a package of 1 vial of IMAAVY nipocalimab-aahu 185 mg/mL Injection, Solution, Concentrate from Janssen Biotech, Inc., marketed since Apr 2025 and currently FDA-listed. It is this product's only package size.

NDC 57894-0800-01
🏷️ FDA NDC (as labeled) 57894-800-01 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Sep 10, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 57894-800-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
57894 labeler · 800 product · 01 package
Package marketed since
Apr 29, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 5789480001 9
FDA record last changed
Sep 10, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 57894-800-01
Product NDC 57894-800
11-digit billing NDC 57894080001
NCPDP billing unit ML — per mL (volume)
RxCUI 2712699, 2712706, 2712708, 2712709
UNII 87M90CV8NC
Application # BLA761430
SPL Set ID 8886274c-f2b2-48af-85c1-2f90bfe304b8
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-04-29
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION, CONCENTRATE
Substance NIPOCALIMAB
Biologic (Purple Book) 351(a)

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 087668
GCN 57657
HICL code 050526
Ingredient (HICL) Nipocalimab-Aahu
HIC1 code Z
Therapeutic class — broad (HIC1) Body As A Whole
HIC2 code Z2
Therapeutic class — intermediate (HIC2) Antihistamines, Antiserotonins, Immunosuppressants
HIC3 code Z29
Therapeutic class — specific (HIC3) Neonatal Fc Receptor (Fcrn) Inhibitors
AHFS code 90:08.04.00
AHFS class Neonatal Fc Receptor Blockers
FDB label name IMAAVY 300 MG/1.62 ML VIAL
FDB brand name Imaavy
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 087668
  • GCN: 57657
  • HICL (First Databank): 050526
  • AHFS class code: 90:08.04.00
  • RxCUI (RxNorm): 2712699
Why two NDCs? The FDA registers this code as 57894-800-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 57894-0800-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Neonatal fragment crystallizable receptor (FcRn) inhibitors class.

Drug family (ATC) Neonatal fragment crystallizable receptor (FcRn) inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name IMAAVY 300 MG/1.62 ML VIAL Ingredient Nipocalimab-Aahu
📖 What it is MedlinePlus · NLM

Nipocalimab-aahu injection is used to treat certain types of myasthenia gravis (MG; a disorder of the nervous system that causes muscle weakness). Nipocalimab-aahu is in a group of medications called monoclonal antibodies. It works by reducing a certain natural substance in the body that causes symptoms of myasthenia gravis.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It treats generalized myasthenia gravis in people 12 and older who test positive for certain antibodies. It also treats warm autoimmune hemolytic anemia in people 12 and older who...
  • It is given only as an IV infusion after being diluted, by a healthcare professional. You will be watched for 30 minutes afterward for allergic or infusion reactions. If you miss a...
  • Common ones include respiratory infections, swelling in the legs or arms, and muscle spasms in gMG. In wAIHA, diarrhea and fever were common. Some people have headache, chills, nau...
  • Call if you have signs of infection, like fever, or a new rash, hives or eczema. Get emergency help for swelling of the face or throat or trouble breathing, since these can be sign...
📖 Read our full Nipocalimab-Aahu guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J9256 $32.568 / J9256 unit —
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Billing & reimbursement

FDA NDC (as labeled)57894-800-01
11-digit billing NDC57894-0800-01
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ9256
DescriptorINJECTION, NIPOCALIMAB-AAHU, 3 MG
Billing units / pkg61.73 units
How the units are derivedThis package is 1.62 ML; the HCPCS unit is 3 MG, so one package = 61.73 billing units.
Medicare Part B spend (2026 (Q1))$9,420,555 · 487 claims · $19,344.06 per claim (all NDCs under J9256)
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
57894-0800-01 You're viewing this Main listing 1 VIAL, SINGLE-DOSE in 1 BOX / 1.62 mL in 1 VIAL, SINGLE-DOSE 2025-04-29 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Imaavy 185 mg/mLthis 57894-0800-01 Janssen 1 vial — — FDA listed —
Imaavy 185 mg/mL 57894-0801-01 Janssen 1 vial — — FDA listed —
About this product: this is a biologic. Biologics don't have small-molecule generics — competition comes from FDA-licensed biosimilars (shown above), not generics.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & biosimilar status

🏛️
2025
First FDA approval
Apr 2025
📍
2026
Currently FDA-listed
1 year listed
🛡️
2037
Latest patent/protection listed
not a guaranteed launch date
🧬Biologic — competition comes from biosimilars

Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Apr 2037. This may affect when biosimilars become widely available, but it is not a guaranteed launch date.
📅 FDA approved Apr 29, 2025 ⏳ ~10.6 yr to latest listed protection

Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.

FDA Purple Book — biosimilars & interchangeables ⓘ
Reference product
Imaavynipocalimab-aahu
🔒 No FDA-licensed biosimilars or interchangeable biosimilars are listed yet for this biologic. It currently has no biosimilar competition in the FDA Purple Book.
Source: FDA Purple Book (purplebooksearch.fda.gov), matched on the reference product’s active ingredient.
Patents & exclusivity — FDA Purple Book
Exclusivity RefProduct
2025 2027 2029 2031 2033 2035 2037
Today
LOE
Biologic patent Exclusivity
🏛️Reference-product exclusivity
A flat 12 years of FDA market protection from first licensure. No biosimilar can be licensed before it ends — regardless of patents.
🧪Listed biologic patents
Patents the reference maker lists covering the molecule, formulation, or manufacturing. A biosimilar generally can’t launch until these resolve.
🔁Interchangeability
An interchangeable biosimilar may be substituted at the pharmacy (state laws vary). The first one can earn its own exclusivity period.
🛈 What do these terms mean?
Biologic patent
A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
Reference-product exclusivity
A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
Interchangeable exclusivity
The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
Earliest biosimilar (LOE)
The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.

Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.

FDA exclusivity
CodeWhat it grantsExpires
RefProductReference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this dateApr 29, 2037
Common questions
Is there a biosimilar for IMAAVY 300 MG/1.62 ML VIAL?
No FDA-licensed biosimilar is currently listed for this biologic in the FDA Purple Book.
Why do different websites show different biosimilar dates?
Biosimilar availability isn’t based on one single date. Some sources use the reference-product exclusivity, some use the last listed patent, and patent litigation, settlements, and licenses can all change the real-world launch date. This page shows the underlying Purple Book dates so you can see why estimates differ.
Can a biosimilar launch before the last patent expires?
Sometimes. A biosimilar maker may settle with the reference manufacturer or receive a license to launch earlier. In other cases, the last listed protection delays competition.
What does “current Purple Book estimate” mean?
It means we’re using the latest patent and exclusivity dates currently listed in the FDA Purple Book. It is not a guaranteed launch date.
What does “FDA listed” mean?
It means the product appears in the FDA’s official directory. That’s a good sign a product exists for the U.S. market, but on its own it does not confirm a pharmacy can get it today. Where we have recent retail pricing data, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Purple Book for a patent or exclusivity on the reference biologic. It can affect when a biosimilar becomes widely available — but it is not a guaranteed launch date. Settlements and licenses can move the real date earlier or later.
Built from the FDA Purple Book Patent List (patents the reference-product sponsor has publicly listed under the BPCIA) plus reference-product exclusivity. Biosimilars cannot launch until these clear; patent litigation and settlements can shift the real date. Biologics have no small-molecule generics — competition comes from FDA-licensed biosimilars, not the Orange Book.
Where does this data come from?
Patents and exclusivity from the FDA Purple Book (biologics), refreshed from public FDA data. Biosimilar launch timing is an estimate, not a guarantee.

What it looks like

Color Brown / brown
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

🧪 Avoiding an ingredient? See Nipocalimab-Aahu inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII F7LTH1E20Y
    Arginine hydrochloride is an amino acid salt used as a buffer and pH adjuster in medicines. It helps maintain the correct acidity level to keep the drug stable and effective.
  • UNII 4QD397987E
    An amino acid used as a buffer and stabilizer in medications. It helps maintain the pH balance and protects the active drug from breaking down during storage and use.
  • UNII X573657P6P
    Histidine monohydrochloride monohydrate is an amino acid salt used as a buffer in medicines. It helps maintain the proper acidity level of liquid formulations to keep the drug stable and effective.
  • UNII AE28F7PNPL
    Methionine is an amino acid used as a nutrient supplement and pH buffer in medicines. It helps stabilize the formulation and supports the product's overall composition.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

7 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerJanssen Biotech, Inc.
FDA applicationBLA761430 (BLA)
Labeler code57894
First marketedApr 2025
Product typeHuman Prescription Drug
Portfolio36 products on file

More NDCs from Janssen Biotech, Inc. labeler code 57894

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 145 words ▾

1 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 )

1.1Generalized 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.

1.2Warm 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.

⏱️ Dosage and Administration ~3 min read ▾

2 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 )

2.1Recommended 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) ].

2.2Recommended Dosage for gMG Dilute IMAAVY prior to administration. Administer via intravenous infusion only [see Dosage and Administration (2.5) ] . Table 1: gMG Recommended Dose Regimen Initial dosage Maintenance 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.

2.3Recommended Dosage for wAIHA Dilute IMAAVY prior to administration. Administer via intravenous infusion only [see Dosage and Administration (2.5) ] . Table 2: wAIHA Recommended Dose Regimen Initial dosage Subsequent 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.

2.4Missed Doses If a scheduled infusion is missed, administer the dose of IMAAVY as soon as possible. Resume dosing, maintaining the treatment interval.

2.5Preparation 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 or 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. 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 100… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 61 words ▾

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 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 61 words ▾

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) ] . 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 Cautions ~3 min read ▾

5 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 )

5.1Infections 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.

5.2Hypersensitivity 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. 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 admini… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

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) ] The most common adverse reactions (≥10%) in patients with gMG treated with IMAAVY were respiratory tract infections, peripheral edema, and muscle spasms. ( 6.1 ) The most common adverse reactions (≥10%) 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.

6.1Clinical 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 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 mg/kg every two weeks (after 30 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 (≥ 5%) of Patients Treated with IMAAVY and More Frequently than in Placebo in gMG Study 1 Adverse Reaction IMAAVY N=98 % Placebo N=98 % Includes the following reported in patients treated with IMAAVY: Infection Respiratory tract infection COVID-19 (and other related terms), pneumonia, bronchitis, pneumonia bacteria 18 13 Urinary tract infection other related terms 6 3 Herpes zoster and Herpes simplex 6 2 Oral infection glossitis, oral candidiasis, pericoronitis, pulpitis dental, tooth abscess, tooth infection 5 3 Peripheral edema 12 2 Muscle spasm 12 3 Hypersensitivity reaction angioedema, dermatitis atopic, eczema, gingival swelling, rash (and other related terms), urticaria 8 7 Abdominal pain 8 3 Back pain 8 5 Pyrexia 7 1 Diarrhea 7 3 Cough 7 3 Anemia 6 4 Dizziness 5 1 Nausea 5 2 Hypertension 5 2 Insomnia 5 2 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 occur… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 129 words ▾

7 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 )

7.1Effect 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) ] .

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy 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. 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.

8.2Lactation 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.

8.4Pediatric 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 corticos… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy 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. 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.

🧒 Pediatric Use 210 words ▾

8.4Pediatric 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 .

🧓 Geriatric Use 106 words ▾

8.5Geriatric 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.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism 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.

12.2Pharmacodynamics gMG In gMG Study 1 [see Clinical Studies (14.1) ], the pharmacological effect of nipocalimab-aahu was assessed by measuring the decrease in serum IgG levels and anti-AChR and anti-MuSK autoantibody levels. In patients positive for AChR and MuSK autoantibodies who were treated with IMAAVY, there was a reduction in AChR and MuSK autoantibodies relative to baseline. Decreases in total IgG levels followed a similar pattern.

A similar reduction in AChR autoantibodies was observed in adolescent patients with gMG compared to adults. wAIHA In the wAIHA Study [see Clinical Studies (14.2) ] , the pharmacological effect of nipocalimab-aahu was assessed by measuring the decrease in serum IgG levels and pathogenic anti-RBC IgG autoantibody levels. In patients treated with IMAAVY, there was a reduction in total IgG and anti-RBC IgG autoantibody relative to baseline.

12.3Pharmacokinetics Nipocalimab-aahu 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 for gMG) in healthy participants, C max of nipocalimab-aahu increased in a dose-proportional manner while AUC increased in a greater than dose-proportional manner. Distribution Mean volume of distribution of nipocalimab-aahu is

2.67L. Metabolism Nipocalimab-aahu is expected to be degraded by proteolytic enzymes into small peptides and amino acids. Elimination Nipocalimab-aahu exhibits concentration-dependent pharmacokinetics.

After a single intravenous administration of 15 mg/kg nipocalimab-aahu, the mean clearance is 0.0627 L/h and half-life is 29.3 hours. Specific Populations Age, Sex, and Race The pharmacokinetics of nipocalimab-aahu were not affected by age, sex, or race based on a population pharmacokinetics analysis. Pediatric Patients gMG Following the recommended intravenous doses of IMAAVY in pediatric patients 12 to 16 years of age with gMG (N=7), the observed steady-state serum nipocalimab-aahu concentrations were within the range of those observed for adult patients with gMG [see Use in Specific Populations (8.4) ] . wAIHA Steady-state serum concentrations are predicted to be similar between adults and pediatric patients 12 to <18 years of age with wAIHA [see Use in Specific Populations (8.4) ] .

Patients with Renal Impairment No dedicated pharmacokinetic study has been conducted in patients with renal impairment. Renal impairment is not expected to affect the pharmacokinetics of nipocalimab-aahu. Based on a population pharmacokinetic analysis, which included participants with mild to severe renal impairment (estimated glomerular filtration rate [eGFR] 22-204 mL/min/1.73 m 2 ), renal function had no clinically significant effect on nipocalimab-aahu clearance.

No dose adjustment is required in patients with renal impairment. Patients with Hepatic Impairment No dedicated pharmacokinetic study has been performed in patients with hepatic impairment. Nipocalimab-aahu is not metabolized by cytochrome P450 enzymes, and hepatic impairment is not expected to affect the pharmacokinetics of nipocalimab-aahu.

Based on a population pharmacokinetic analysis, which included participants with mild to moderate hepatic impairment, there was no clinically significant effect on nipocalimab-aahu clearance. No dose adjustment is required in patients with hepatic impairment. Drug Interactions with Other Drugs or Biological Products IgG-Based Monoclonal Antibodies Nipocalimab-aahu decreases concentrations of compounds that bind to the human FcRn, including IgG based monoclonal antibodies.

Cytochrome P450 Enzymes Nipocalimab-aahu is not metabolized by cytochrome P450 enzymes; therefore, interactions with concomitant medications that are substrates, inducers, or inhibit… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 26 words ▾

12.1Mechanism 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.

📦 How Supplied / Storage and Handling 108 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied IMAAVY ® (nipocalimab-aahu) injection is a sterile, preservative-free, colorless to slightly brownish, clear to slightly opalescent solution for intravenous use after dilution. IMAAVY is supplied in cartons containing a single-dose vial per carton as: 300 mg/1.62 mL (185 mg/mL) NDC 57894-800-01 1,200 mg/6.5 mL (185 mg/mL) NDC 57894-801-01 Storage and Handling Unopened Vials Store vials refrigerated at 2 ºC to 8 ºC (36 ºF to 46 ºF) in the original carton to protect from light until the time of use.

Do not freeze. Do not shake. Diluted Solution For storage of the diluted IMAAVY solution, see Dosage and Administration (2.5) .

📦 Storage and Handling 53 words ▾

Storage and Handling Unopened Vials Store vials refrigerated at 2 ºC to 8 ºC (36 ºF to 46 ºF) in the original carton to protect from light until the time of use. Do not freeze. Do not shake. Diluted Solution For storage of the diluted IMAAVY solution, see Dosage and Administration (2.5) .

📋 Description 135 words ▾

11 DESCRIPTION Nipocalimab-aahu, a neonatal Fc receptor blocker, is a recombinant human immunoglobulin G1 lambda (IgG1λ) 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 ® (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.

💬 Information for Patients 216 words ▾

17 PATIENT COUNSELING INFORMATION Advise the patient and/or caregiver to read the FDA-approved patient labeling (Patient Information). Infections Instruct patients to communicate any history of infections to the healthcare provider and to contact their healthcare provider if they develop any symptoms of an infection [see Warnings and Precautions (5.1) ] . Administration of Vaccines Advise patients to complete all age-appropriate vaccines according to immunization guidelines prior to initiation of treatment with IMAAVY.

Administration of live vaccines is not recommended during treatment with IMAAVY. Instruct patients to inform the healthcare provider that they are being treated with IMAAVY prior to a potential vaccination [see Warnings and Precautions (5.1) ] . Hypersensitivity Reactions Inform patients that hypersensitivity reactions, including anaphylaxis, angioedema, rash, urticaria, and eczema have occurred in patients treated with IMAAVY.

Inform patients about the signs and symptoms of hypersensitivity reactions. Advise patients to contact their healthcare provider immediately if these occur [see Warnings and Precautions (5.2) ] . Infusion-Related Reactions Advise patients that administration of IMAAVY may result in infusion-related reactions [see Warnings and Precautions (5.3) ] .

Pregnancy Advise patients that there is a pregnancy safety study that monitors pregnancy outcomes in women exposed to IMAAVY during pregnancy, and they can be enrolled by calling 1-800-526-7736 or www.IMAAVY.com [see Use in Specific Populations (8.1) ].

🧬 Pharmacokinetics ~2 min read ▾

12.3Pharmacokinetics Nipocalimab-aahu 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 for gMG) in healthy participants, C max of nipocalimab-aahu increased in a dose-proportional manner while AUC increased in a greater than dose-proportional manner. Distribution Mean volume of distribution of nipocalimab-aahu is

2.67L. Metabolism Nipocalimab-aahu is expected to be degraded by proteolytic enzymes into small peptides and amino acids. Elimination Nipocalimab-aahu exhibits concentration-dependent pharmacokinetics.

After a single intravenous administration of 15 mg/kg nipocalimab-aahu, the mean clearance is 0.0627 L/h and half-life is 29.3 hours. Specific Populations Age, Sex, and Race The pharmacokinetics of nipocalimab-aahu were not affected by age, sex, or race based on a population pharmacokinetics analysis. Pediatric Patients gMG Following the recommended intravenous doses of IMAAVY in pediatric patients 12 to 16 years of age with gMG (N=7), the observed steady-state serum nipocalimab-aahu concentrations were within the range of those observed for adult patients with gMG [see Use in Specific Populations (8.4) ] . wAIHA Steady-state serum concentrations are predicted to be similar between adults and pediatric patients 12 to <18 years of age with wAIHA [see Use in Specific Populations (8.4) ] .

Patients with Renal Impairment No dedicated pharmacokinetic study has been conducted in patients with renal impairment. Renal impairment is not expected to affect the pharmacokinetics of nipocalimab-aahu. Based on a population pharmacokinetic analysis, which included participants with mild to severe renal impairment (estimated glomerular filtration rate [eGFR] 22-204 mL/min/1.73 m 2 ), renal function had no clinically significant effect on nipocalimab-aahu clearance.

No dose adjustment is required in patients with renal impairment. Patients with Hepatic Impairment No dedicated pharmacokinetic study has been performed in patients with hepatic impairment. Nipocalimab-aahu is not metabolized by cytochrome P450 enzymes, and hepatic impairment is not expected to affect the pharmacokinetics of nipocalimab-aahu.

Based on a population pharmacokinetic analysis, which included participants with mild to moderate hepatic impairment, there was no clinically significant effect on nipocalimab-aahu clearance. No dose adjustment is required in patients with hepatic impairment. Drug Interactions with Other Drugs or Biological Products IgG-Based Monoclonal Antibodies Nipocalimab-aahu decreases concentrations of compounds that bind to the human FcRn, including IgG based monoclonal antibodies.

Cytochrome P450 Enzymes Nipocalimab-aahu is not metabolized by cytochrome P450 enzymes; therefore, interactions with concomitant medications that are substrates, inducers, or inhibitors of cytochrome P450 enzymes are unlikely.

🧬 Pharmacodynamics 134 words ▾

12.2Pharmacodynamics gMG In gMG Study 1 [see Clinical Studies (14.1) ], the pharmacological effect of nipocalimab-aahu was assessed by measuring the decrease in serum IgG levels and anti-AChR and anti-MuSK autoantibody levels. In patients positive for AChR and MuSK autoantibodies who were treated with IMAAVY, there was a reduction in AChR and MuSK autoantibodies relative to baseline. Decreases in total IgG levels followed a similar pattern.

A similar reduction in AChR autoantibodies was observed in adolescent patients with gMG compared to adults. wAIHA In the wAIHA Study [see Clinical Studies (14.2) ] , the pharmacological effect of nipocalimab-aahu was assessed by measuring the decrease in serum IgG levels and pathogenic anti-RBC IgG autoantibody levels. In patients treated with IMAAVY, there was a reduction in total IgG and anti-RBC IgG autoantibody relative to baseline.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Adults with gMG The efficacy of IMAAVY for the treatment of gMG in adults who are anti-AChR or anti-MuSK antibody positive was established in a 24-week, multicenter, randomized, double-blind, placebo-controlled study (gMG Study 1; NCT04951622). Patients were treated with IMAAVY with the recommended dosage regimen [see Dosage and Administration (2.1) ] . gMG Study 1 enrolled patients with gMG who met the following criteria: Myasthenia Gravis Foundation of America (MGFA) Clinical Classification Class II to IV Myasthenia Gravis-Activities of Daily Living (MG-ADL) total score of at least 6 On stable dose of standard of care MG therapy prior to baseline that included acetylcholinesterase (AChE) inhibitors, steroids or non-steroidal immunosuppressive therapies (NSISTs), either in combination or alone.

In gMG Study 1, a total of 196 patients were randomized 1:1 to receive IMAAVY (n=98) or placebo (n=98). Baseline characteristics were similar between treatment groups. For the primary efficacy analysis population (n=153), patients had a median age of 52 years at screening (range 20 to 81 years) and a median time since diagnosis of 6 years.

Sixty percent of patients were female; 63% were White; 32% were Asian; 1% were Black or African-American; and <1% were American Indian or Alaskan Native. At baseline, median MG-ADL total score was 9, and median Quantitative Myasthenia Gravis (QMG) total score was 15. Eighty-eight percent (n=134) of patients were positive for AChR antibodies and 10% (n=16) were positive for MuSK antibodies.

At baseline, in each group, 85% of patients received AChE inhibitors, 66% of patients received steroids, and 54% of patients received NSISTs at stable doses. The efficacy of IMAAVY was measured using the MG-ADL scale, which assesses the impact of gMG on daily functions of 8 signs and symptoms that are typically affected in gMG. Each item is assessed on a 4-point scale, where a score of 0 represents normal function and a score of 3 represents loss of ability to perform that function.

A total score ranges from 0 to 24, with the higher scores indicating more impairment. The primary efficacy endpoint was the comparison of the mean change from baseline to Weeks 22, 23, and 24 between treatment groups in the MG-ADL total score. A statistically significant difference favoring IMAAVY was observed in MG-ADL total score change from baseline (p=0.002; see Table 5 and Figure 1 ).

The efficacy of IMAAVY was also measured using the QMG total score, which is a 13-item categorial grading system that assesses muscle weakness. Each item is assessed on a 4 -point scale, where a score of 0 represents no weakness, and a score of 3 represents severe weakness. A total possible score ranges from 0 to 39, where higher scores indicate more severe impairment.

The secondary endpoint was the comparison of the mean change from baseline to Weeks 22 and 24 between treatment groups in the QMG total score. A statistically significant difference favoring IMAAVY was observed in the QMG total score change from baseline (p<0.001; see Table 5 ). The results are presented shown in Table 5.

Table 5: Least Squares Mean Change from Baseline to Week 24 in MG-ADL and QMG Total Scores in gMG Study 1 Efficacy Endpoints IMAAVY N = 77 LS Mean (SE) Placebo N = 76 LS Mean (SE) IMAAVY Change Relative to Placebo LS Mean Difference (95% CI) p-value Key: CI=confidence interval; MG-ADL = Myasthenia Gravis – Activities of Daily Living; QMG = Quantitative Myasthenia Gravis; LS mean = Least squares mean; SE = standard error Primary Endpoint MG-ADL Total Score Mean change from baseline over weeks 22, 23, and 24 -4.7 (0.33) -3.3 (0.34) -1.5 (-2.4, -0.5) 0.002 Secondary Endpoint QMG Total Score Mean change from baseline over weeks 22 and 24 -4.9 (0.5) -2.1 (0.5) -2.8 (-4.2, -1.4) <0.001 Figure 1 shows the mean change from baseline to Week 24 in MG-ADL total score in gMG Study 1, and Figure 2 shows the mean change from baseline to Week 24 in QMG total… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 125 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Studies to assess the carcinogenic potential of nipocalimab-aahu have not been conducted. Mutagenesis Studies to assess the genotoxic potential of nipocalimab-aahu have not been conducted. As an antibody, nipocalimab-aahu is not expected to interact directly with DNA.

Impairment of Fertility Once or twice weekly intravenous administration of nipocalimab-aahu (0, 20, 50, 100, or 300 mg/kg) to male and female monkeys for 26 weeks resulted in no adverse effects on reproductive organs upon histopathological examination. Mean systemic exposures achieved at the highest dose tested are 42-times or 49-times the population PK model simulated mean steady state exposures at the recommended human maintenance dose for gMG (15 mg/kg) or wAIHA (30 mg/kg), respectively, on an AUC basis.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 122 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Studies to assess the carcinogenic potential of nipocalimab-aahu have not been conducted. Mutagenesis Studies to assess the genotoxic potential of nipocalimab-aahu have not been conducted. As an antibody, nipocalimab-aahu is not expected to interact directly with DNA.

Impairment of Fertility Once or twice weekly intravenous administration of nipocalimab-aahu (0, 20, 50, 100, or 300 mg/kg) to male and female monkeys for 26 weeks resulted in no adverse effects on reproductive organs upon histopathological examination. Mean systemic exposures achieved at the highest dose tested are 42-times or 49-times the population PK model simulated mean steady state exposures at the recommended human maintenance dose for gMG (15 mg/kg) or wAIHA (30 mg/kg), respectively, on an AUC basis.

📄 Patient Package Insert ~3 min read ▾

This Patient Information has been approved by the U.S. Food and Drug Administration Revised: 08/2026 PATIENT INFORMATION IMAAVY ® (im-AH-vee) (nipocalimab-aahu) injection, for intravenous use 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. 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 chills shivering cough sore throat fever blisters burning when you urinate 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 med… [Excerpted — this section continues on DailyMed.]

📄 Recent Major Changes 31 words ▾

Indications and Usage ( 1.2 ) 08/2026 Dosage and Administration ( 2.2 , 2.3 , 2.4 , 2.5 ) 08/2026 Warnings and Precautions ( 5.1 , 5.2 , 5.3 ) 08/2026

📄 Package Label / Principal Display Panel 84 words ▾

PRINCIPAL DISPLAY PANEL - 300 mg / 1.62 mL Vial Box NDC 57894-800-01 imaavy™ (nipocalimab-aahu) Injection 300 mg / 1.62 mL (185 mg / mL) For Intravenous Infusion After Dilution Rx only One single-dose vial. Discard unused portion. Johnson & Johnson 300mg

PRINCIPAL DISPLAY PANEL - 1,200 mg / 6.5 mL Vial Box NDC 57894-801-01 imaavy™ (nipocalimab-aahu) Injection 1,200 mg / 6.5 mL (185 mg / mL) For Intravenous Infusion After Dilution Rx only One single-dose vial. Discard unused portion. Johnson & Johnson 1200mg

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Imaavy — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Imaavy. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$14.44M
Claims incl. refills
491
Beneficiaries
165
Spend / beneficiary
$87,512.72
Spend / claim
$29,408.55
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk ✓ Available
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Janssen Biotech, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Janssen Biotech, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J9256 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 57894-0651-02 · Janssen 57894-0801-01 · Janssen →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.