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UPLIZNA Inebilizumab 10 mg/mL Injection — NDC 75987-0150-03 package photo

UPLIZNA Inebilizumab 10 mg/mL Injection

by Horizon Therapeutics USA, Inc. · 3 VIAL, SINGLE-DOSE in 1 CARTON (75987-150-03) / 10 mL in 1 VIAL, SINGLE-DOSE (75987-150-01)
NDC 75987-0150-03
🏷️ FDA NDC (as labeled) 75987-150-03 billing pads the product segment with a zero
Rx only Brand On market Non-controlled
🗂️ Data synced Jul 24, 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

🆔 Identity & classification

FDA NDC (as labeled) 75987-150-03
Product NDC 75987-150
11-digit billing NDC 75987015003
NCPDP billing unit ML — per mL (volume)
RxCUI 2373955, 2373960, 2373966, 2373967
UNII 74T7185BMM
UPC 0375987150032
Application # BLA761142
SPL Set ID 834db232-afb0-4dcf-93e0-009ce8245c20
Established class (EPC) CD19-directed Cytolytic Antibody
Mechanism of action CD19-directed Antibody Interactions
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-06-11
Route INTRAVENOUS
Dosage form INJECTION
Substance INEBILIZUMAB
GPI-14 99405040202020
GPI class Uplizna
GCN Seq No 081189
GCN 48233
HICL code 046617
Ingredient (HICL) Inebilizumab-Cdon
HIC1 code Z
Therapeutic class — broad (HIC1) Body As A Whole
HIC2 code Z2
Therapeutic class — intermediate (HIC2) Antihistamines, Antiserotonins, Immunosuppressants
HIC3 code Z27
Therapeutic class — specific (HIC3) Anti-Cd19 (B Lymphocyte) Monoclonal Antibody
AHFS code 90:12.04.00
AHFS class Monoclonal Antibodies (90:12)
FDB label name UPLIZNA 100 MG/10 ML VIAL
FDB brand name Uplizna
Legend status F — Federal legend — prescription drug or device
Biologic (Purple Book) 351(a)
Why two NDCs? The FDA registers this code as 75987-150-03 — 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 → 75987-0150-03. 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 CD19-directed Cytolytic Antibody class.

Pharmacologic class CD19-directed Cytolytic Antibody
Drug family (ATC) Monoclonal antibodies
How it works CD19-directed Antibody Interactions
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.

🏭 Manufacturer & labeler

LabelerHorizon Therapeutics USA, Inc.
FDA applicationBLA761142 (BLA)
Labeler code75987
First marketedJun 2020
Product typeHuman Prescription Drug
Portfolio12 products on file
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.

🩺 Clinical

Label name UPLIZNA 100 MG/10 ML VIAL Ingredient Inebilizumab-Cdon

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.

🧪 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.

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

  • 1.4 mg / 1 mL 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.
  • 2.3 mg / 1 mL 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.
  • 0.1 mg / 1 mL 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.
  • 4.1 mg / 1 mL UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • 40.1 mg / 1 mL UNII 7YIN7J07X4
    A natural sugar derived from plants and microorganisms. It acts as a filler to give the medication bulk and stability, and helps preserve the active ingredient during storage and manufacturing.
  • 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.

6 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.

💲 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 eachPer 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 · J1823 $510.652 / J1823 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)75987-150-03
11-digit billing NDC75987-0150-03
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ1823
DescriptorInjection, inebilizumab-cdon, 1 mg
Billing units / pkg300 units
Crosswalk sourceCMS ASP NDC-HCPCS Crosswalk
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Uplizna 10 mg/mLthis 75987-0150-03 Horizon 3 vials — — 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

🏛️
2020
First FDA approval
Jun 2020
📍
2026
Currently FDA-listed
6 years listed
🛡️
2032
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 Jun 2032. This may affect when biosimilars become widely available, but it is not a guaranteed launch date.
📅 FDA approved Jun 11, 2020 ⏳ ~5.7 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
Upliznainebilizumab-cdon
🔒 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
2020 2022 2024 2026 2028 2030 2032
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 dateJun 11, 2032
Common questions
Is there a biosimilar for UPLIZNA 100 MG/10 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.

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

Medicare Part D (outpatient prescription) spending for Uplizna — 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 Uplizna. 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
$9.4M
Claims incl. refills
56
Beneficiaries
52
Spend / beneficiary
$180,851.18
Spend / claim
$167,933.24
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
75987-0150-03 You're viewing this 3 VIAL, SINGLE-DOSE in 1 CARTON (75987-150-03) / 10 mL in 1 VIAL, SINGLE-DOSE (75987-150-01) 2020-06-11 Active

🧭 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 FDA registers it as 75987-150-03, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 75987-0150-03, written without dashes as 75987015003. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 75987-0150-03, the first segment (75987) is the labeler code FDA assigned to Horizon Therapeutics USA, Inc.; the middle segment (0150) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Horizon Therapeutics USA, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Horizon Therapeutics USA, 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 J1823 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.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. 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 💬 Medication Guide
🎯 Indications and Usage 143 words ▾

1 INDICATIONS AND USAGE UPLIZNA is a CD19-directed cytolytic antibody indicated for the treatment of: Neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. ( 1.1 ) Immunoglobulin G4-related disease (IgG4-RD) in adult patients. ( 1.2 ) Generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle specific tyrosine kinase (MuSK) antibody positive.

( 1.2 )

1.1Neuromyelitis Optica Spectrum Disorder (NMOSD) UPLIZNA is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.

1.2Immunoglobulin G4-Related Disease (IgG4-RD) UPLIZNA is indicated for the treatment of Immunoglobulin G4-related disease (IgG4-RD) in adult patients.

1.3Generalized Myasthenia Gravis (gMG) UPLIZNA is indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle specific tyrosine kinase (MuSK) antibody positive.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Hepatitis B virus, quantitative serum immunoglobulins, and tuberculosis screening is required before the first dose. ( 2.1 ) Prior to every infusion: Determine if there is an active infection ( 2.2 , 5.2 ) Premedicate with a corticosteroid, an antihistamine, and an antipyretic ( 2.2 , 5.1 ) UPLIZNA must be diluted in 250 mL of 0.9% Sodium Chloride Injection, USP prior to administration. ( 2.3 , 2.4 ) UPLIZNA is administered as an intravenous infusion titrated to completion, approximately 90 minutes.

The recommended dose is: Initial dose: 300 mg intravenous infusion followed two weeks later by a second 300 mg intravenous infusion. Subsequent doses (starting 6 months from the first infusion): single 300 mg intravenous infusion every 6 months. ( 2.3 ) Monitor patients closely during the infusion and for at least one hour after completion of the infusion.

( 2.3 )

2.1Assessments Prior to First Dose of UPLIZNA Hepatitis B Virus Screening Prior to initiating UPLIZNA, perform Hepatitis B virus (HBV) screening. UPLIZNA is contraindicated in patients with active HBV confirmed by positive results for surface antigen [HBsAg] and anti-HBV tests. For patients who are negative for HBsAg and positive for HB core antibody [HBcAb+] or are carriers of HBV [HBsAg+], consult liver disease experts before starting and during treatment with UPLIZNA [see Contraindications (4) and Warnings and Precautions (5.2) ].

Serum Immunoglobulins Prior to initiating UPLIZNA, perform testing for quantitative serum immunoglobulins. For patients with low serum immunoglobulins, consult immunology experts before initiating treatment with UPLIZNA [see Warnings and Precautions (5.3) ]. Tuberculosis Screening Prior to initiating UPLIZNA, evaluate for active tuberculosis and test for latent infection.

For patients with active tuberculosis or positive tuberculosis screening without a history of appropriate treatment, consult infectious disease experts before initiating treatment with UPLIZNA [see Contraindications (4) and Warnings and Precautions (5.2) ] . Vaccinations Because vaccination with live-attenuated or live vaccines is not recommended during treatment and after discontinuation until B-cell repletion, administer all immunizations according to immunization guidelines at least 4 weeks prior to initiation of UPLIZNA for live or live-attenuated vaccines [see Warnings and Precautions (5.2) and Clinical Pharmacology (12.2) ].

2.2Assessment and Premedication Before Every Infusion Infection Assessment Prior to every infusion of UPLIZNA, determine whether there is an active infection. In case of active infection, delay infusion of UPLIZNA until the infection resolves [see Warnings and Precautions (5.2) ]. Premedication Table 1 shows premedication to administer prior to each infusion of UPLIZNA to reduce the frequency and severity of infusion reactions [see Warnings and Precautions (5.1) ].

Table 1. Premedication Prior to Each UPLIZNA Infusion Type of Premedication Route of Administration Examples (or Equivalent) Administration Time Prior to UPLIZNA Infusion corticosteroid intravenous methylprednisolone 80 mg to 125 mg 30 minutes antihistamine oral diphenhydramine 25 mg to 50 mg 30 to 60 minutes antipyretic oral acetaminophen 500 mg to 650 mg 30 to 60 minutes

2.3Recommended Dosage and Administration NMOSD, IgG4-RD, and gMG UPLIZNA is administered as an intravenous infusion (see Table 2 ). The recommended dosage is: Initial dose: 300 mg intravenous infusion followed 2 weeks later by a second 300 mg intravenous infusion. Subsequent doses (starting 6 months from the first infusion): single 300 mg intravenous infusion every 6 months.

Administration UPLIZNA must be diluted prior to administration [see Dosage and Administration (2.4) ]. Prior to the start of the intravenous infusion, the prepared infusion solution should be at room temperature. Administer UPLIZNA under the close supervision of an experienced healthcare professional with access to ap…

💊 Dosage Forms and Strengths 38 words ▾

3 DOSAGE FORMS AND STRENGTHS Injection: 100 mg/10 mL (10 mg/mL) clear to slightly opalescent, colorless to slightly yellow solution in a single-dose vial. Injection: 100 mg/10 mL (10 mg/mL) solution in a single-dose vial ( 3 )

⛔ Contraindications 69 words ▾

4 CONTRAINDICATIONS UPLIZNA is contraindicated in patients with: A history of a life-threatening infusion reaction to UPLIZNA [see Warnings and Precautions (5.1) ] Active hepatitis B infection [see Warnings and Precautions (5.2) ] Active or untreated latent tuberculosis [see Warnings and Precautions (5.2) ] Previous life-threatening reaction to infusion of UPLIZNA ( 4 ) Active hepatitis B infection ( 4 ) Active or untreated latent tuberculosis ( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Infusion reactions: Administer premedications prior to infusion. ( 2.2 ) Management recommendations for infusion reactions depend on the type and severity of the reaction. Permanently discontinue UPLIZNA if a life-threatening or disabling infusion reaction occurs.

( 5.1 ) Infections: Serious, including life-threatening and fatal infections, have occurred in patients treated with B-cell depleting therapies, including UPLIZNA. Delay UPLIZNA administration in patients with an active infection until the infection is resolved. Vaccination with live-attenuated or live vaccines is not recommended during treatment and after discontinuation, until B-cell repletion.

( 5.2 ) Immunoglobulin levels: Monitor the level of immunoglobulins at the beginning, during, and after discontinuation of treatment with UPLIZNA until B-cell repletion. Consider discontinuing UPLIZNA if a patient develops a serious opportunistic infection or recurrent infections if immunoglobulin levels indicate immune compromise. ( 5.3 ) Fetal Risk: May cause fetal harm based on animal data.

Advise females of reproductive potential of the potential risk to a fetus and to use an effective method of contraception during treatment and for 6 months after stopping UPLIZNA. ( 5.4 , 8.1 )

5.1Infusion Reactions UPLIZNA can cause infusion reactions, including anaphylaxis. Symptoms of infusion reactions can include headache, nausea, somnolence, dyspnea, fever, myalgia, rash, or palpitations. Infusion reactions were observed in 9.3%, 7.4%, and 10.1% of patients treated with UPLIZNA during the randomized controlled periods of Study 1 in patients with NMOSD, Study 2 in patients with IgG4-RD, and Study 3 in patients with gMG, respectively.

Infusion reactions were most common with the first infusion but were also observed during subsequent infusions. Reducing the Risk of Infusion Reactions and Managing Infusion Reactions Administer pre-medication with a corticosteroid, an antihistamine, and an antipyretic [see Dosage and Administration (2.2) ]. Management recommendations for infusion reactions depend on the type and severity of the reaction .

For life-threatening infusion reactions, immediately and permanently stop UPLIZNA and administer appropriate supportive treatment. For less severe infusion reactions, management may involve temporarily stopping the infusion, reducing the infusion rate, and/or administering symptomatic treatment.

5.2Infections Serious, including life-threatening or fatal, bacterial, fungal, and new or reactivated viral infections have been observed during and following completion of treatment with B-cell depleting therapies, including UPLIZNA. The most common infections reported by UPLIZNA-treated patients in the randomized and open-label clinical trial periods for NMOSD included urinary tract infection (20%), nasopharyngitis (13%), upper respiratory tract infection (8%), and influenza (7%). In the IgG4-RD randomized controlled and open-label periods, the most common infections reported by UPLIZNA-treated patients were upper respiratory tract infection (11%), nasopharyngitis (10%), urinary tract infection (9%), and influenza (6%).

In the gMG randomized controlled period, the most common infections reported by UPLIZNA-treated patients were urinary tract infection (7%) and nasopharyngitis (7%). Delay UPLIZNA administration in patients with an active infection until the infection is resolved. Possible Increased Risk of Immunosuppressant Effects with Other Immunosuppressants If combining UPLIZNA with another immunosuppressive therapy, consider the potential for increased immunosuppressive effects.

Hepatitis B Virus (HBV) Reactivation HBV reactivation has been observed with the use of B-cell depleting therapies, including UPLIZNA. Fulminant hepatitis, hepatic failure, and death caused by HBV reactivation have occurred in patients treated with B-cell depleting therapies. HBV reactivation was observed in a patient treated with UPLIZNA during the…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Infusion Reactions [see Warnings and Precautions (5.1) ] Infections [see Warnings and Precautions (5.2) ] Reduction in Immunoglobulins [see Warnings and Precautions (5.3) ] The most common adverse reactions (at least 10% of patients treated with UPLIZNA and greater than placebo) were NMOSD: urinary tract infection and arthralgia. ( 6.1 ) IgG4-RD: urinary tract infections and lymphopenia. ( 6.1 ) gMG: headache and infusion-related reactions.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Amgen Inc. at 1-800-77-AMGEN (1-800-772-6436) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trial 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. Adverse Reactions NMOSD The safety of UPLIZNA was evaluated in Study 1, in which 161 patients were exposed to UPLIZNA at the recommended dosage regimen during the randomized, controlled treatment period; during which 52 patients received placebo [see Dosage and Administration (2.1) and Clinical Studies (14) ] .

Subsequently, 198 patients were exposed to UPLIZNA during an open-label treatment period. Two-hundred and eight patients in the randomized and open-label treatment periods had a total of 324 person-years of exposure to UPLIZNA, including 165 patients with exposure for at least 6 months and 128 with exposure for one year or more. Table 3 lists adverse reactions that occurred in at least 5% of patients treated with UPLIZNA and at a greater incidence than in patients who received placebo in Study 1.

The most common adverse reactions (incidence of at least 10% in patients treated with UPLIZNA and at a greater incidence than placebo) were urinary tract infection and arthralgia. Table 3. Adverse Reactions in Patients with NMOSD with an Incidence of at Least 5% with UPLIZNA and a Greater Incidence than Placebo in Study 1 Adverse Reactions UPLIZNA N = 161 % Placebo N = 52 % Urinary tract infection 11 10 Arthralgia 10 4 Headache 8 8 Back pain 7 4 Across both the randomized and open-label treatment in Study 1, the most common adverse reactions (greater than 10%) were urinary tract infection (20%), nasopharyngitis (13%), infusion reaction (12%), arthralgia (11%), and headache (10%).

IgG4-RD The safety of UPLIZNA was evaluated in Study 2, in which 68 patients were exposed to UPLIZNA at the recommended dosage regimen during the randomized, controlled treatment period; during which 67 patients received placebo [see Dosage and Administration (2.1) and Clinical Studies (14) ] . Table 4 lists adverse reactions that occurred in at least 5% of patients treated with UPLIZNA and at a greater incidence than in patients who received placebo in Study 2. The most common adverse reactions (incidence of at least 10% in patients treated with UPLIZNA and at a greater incidence than placebo) were urinary tract infection and lymphopenia.

Table 4. Adverse Reactions in Patients with IgG4-RD with an Incidence of at Least 5% with UPLIZNA and a Greater Incidence than Placebo in Study 2 Adverse Reactions UPLIZNA N = 68 % Placebo N = 67 % Lymphopenia 19 Lymphopenia includes both lymphopenia and lymphocyte count decreased. 9 Urinary tract infection 12 6 Pyrexia 9 5 Neutropenia 6 5 Myalgia 6 0 Additional adverse reactions during the randomized controlled period in Study 2 were infusion related reactions, influenza, and pneumonia. gMG The safety of UPLIZNA was evaluated in Study 3, in which 119 patients were exposed to UPLIZNA at the recommended dosage regimen and 119 patients received placebo during the randomized, placebo-controlled treatment period.

The randomized controlled treatment period was 52 weeks for patients who were anti-AChR antibody positive (n=95 each group…

🔄 Drug Interactions 38 words ▾

7 DRUG INTERACTIONS

7.1Immunosuppressive or Immune-Modulating Therapies Concomitant usage of UPLIZNA with immunosuppressant drugs, including systemic corticosteroids, may increase the risk of infection. Consider the risk of additive immune system effects when co-administering immunosuppressive therapies with UPLIZNA.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to UPLIZNA during pregnancy or shortly before conception. Healthcare providers are encouraged to advise their patients to register by contacting the UPLIZNA Pregnancy Registry by calling the coordinating center at 1 (303) 724-4644 or www.upliznapregnancyregistry.com. Risk Summary UPLIZNA is a humanized IgG1 monoclonal antibody and immunoglobulins are known to cross the placental barrier.

There are no adequate data on the developmental risk associated with the use of UPLIZNA in pregnant women. However, transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other B-cell depleting antibodies during pregnancy. B-cell levels in infants following maternal exposure to UPLIZNA have not been studied in clinical trials.

The potential duration of B-cell depletion in such infants, and the impact of B-cell depletion on vaccine safety and effectiveness, is unknown [see Warnings and Precautions (5.2) ]. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data Intravenous administration of inebilizumab-cdon (0, 3, or 30 mg/kg/week) to human CD19 transgenic (huCD19 Tg) male and female mice prior to and during mating and continuing in females through gestation day 15 resulted in no adverse effects on embryofetal development; however, there was a marked reduction in B-cells in fetal blood and liver at both doses tested.

These results demonstrate that inebilizumab-cdon crosses the placenta and depletes B-cells in the fetus. Intravenous administration of inebilizumab-cdon (0, 3, or 30 mg/kg) to huCD19 Tg mice every three days throughout organogenesis and lactation resulted in depletion of B-cells and persistent reductions in immune function (even following repletion of B-cells and lasting into adulthood) in offspring at both doses tested. At the end of the lactation period, plasma inebilizumab-cdon levels in offspring were only slightly lower than those in maternal plasma.

A no-effect level for immunotoxicity in the offspring was not identified.

8.2Lactation Risk Summary There are no data on the presence of inebilizumab-cdon in human milk, the effects on a breastfed infant, or the effects on milk production. Human IgG is excreted in human milk, and the potential for absorption of UPLIZNA to lead to B-cell depletion in the breastfed infant is unknown. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for UPLIZNA and any potential adverse effects on the breastfed infant from UPLIZNA or from the underlying maternal condition.

8.3Females of Reproductive Potential Contraception Women of childbearing potential should use contraception while receiving UPLIZNA and for 6 months after the last infusion of UPLIZNA [see Clinical Pharmacology (12.3) ] .

8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.

8.5Geriatric Use NMOSD Clinical studies of UPLIZNA did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients (aged 18 to 64 years of age). IgG4-RD Twenty-nine percent (32 out of 112) of patients 65 years of age or older, were treated with UPLIZNA. There were no overall age-related differences in safety or efficacy observed compared to younger patients (aged 18 to 64 years of age). gMG Clinical studies of UPLIZNA did not include sufficient numbers of patients aged 65 and older to determine whether they respond differently from younger patients (aged 18 to 64 years of age).

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to UPLIZNA during pregnancy or shortly before conception. Healthcare providers are encouraged to advise their patients to register by contacting the UPLIZNA Pregnancy Registry by calling the coordinating center at 1 (303) 724-4644 or www.upliznapregnancyregistry.com. Risk Summary UPLIZNA is a humanized IgG1 monoclonal antibody and immunoglobulins are known to cross the placental barrier.

There are no adequate data on the developmental risk associated with the use of UPLIZNA in pregnant women. However, transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other B-cell depleting antibodies during pregnancy. B-cell levels in infants following maternal exposure to UPLIZNA have not been studied in clinical trials.

The potential duration of B-cell depletion in such infants, and the impact of B-cell depletion on vaccine safety and effectiveness, is unknown [see Warnings and Precautions (5.2) ]. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data Intravenous administration of inebilizumab-cdon (0, 3, or 30 mg/kg/week) to human CD19 transgenic (huCD19 Tg) male and female mice prior to and during mating and continuing in females through gestation day 15 resulted in no adverse effects on embryofetal development; however, there was a marked reduction in B-cells in fetal blood and liver at both doses tested.

These results demonstrate that inebilizumab-cdon crosses the placenta and depletes B-cells in the fetus. Intravenous administration of inebilizumab-cdon (0, 3, or 30 mg/kg) to huCD19 Tg mice every three days throughout organogenesis and lactation resulted in depletion of B-cells and persistent reductions in immune function (even following repletion of B-cells and lasting into adulthood) in offspring at both doses tested. At the end of the lactation period, plasma inebilizumab-cdon levels in offspring were only slightly lower than those in maternal plasma.

A no-effect level for immunotoxicity in the offspring was not identified.

🧒 Pediatric Use 13 words ▾

8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.

🧓 Geriatric Use 108 words ▾

8.5Geriatric Use NMOSD Clinical studies of UPLIZNA did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients (aged 18 to 64 years of age). IgG4-RD Twenty-nine percent (32 out of 112) of patients 65 years of age or older, were treated with UPLIZNA. There were no overall age-related differences in safety or efficacy observed compared to younger patients (aged 18 to 64 years of age). gMG Clinical studies of UPLIZNA did not include sufficient numbers of patients aged 65 and older to determine whether they respond differently from younger patients (aged 18 to 64 years of age).

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The mechanism by which inebilizumab-cdon exerts its therapeutic effects in NMOSD, IgG4-RD, and gMG is presumed to involve binding to CD19, a cell surface antigen presents on pre-B and mature B lymphocytes. Following cell surface binding to B lymphocytes, inebilizumab-cdon results in antibody-dependent cellular cytolysis.

12.2Pharmacodynamics Pharmacodynamics of UPLIZNA were assessed with an assay for CD20+ B-cells, since UPLIZNA can interfere with the CD19+ B-cell assay. Treatment with UPLIZNA reduces CD20+ B-cell counts in blood by 8 days after infusion. In Study 1 [see Clinical Studies (14.1) ] , CD20+ B-cell counts were reduced below the lower limit of normal by 4 weeks in 100% of patients treated with UPLIZNA and remained below the lower limit of normal in 94% of patients for 28 weeks after initiation of treatment.

In Study 2 [see Clinical Studies (14.2) ], CD20+ B-cell counts were reduced below the lower limit of normal by week 2 in 100% of patients treated with UPLIZNA and remained below the lower limit of normal in 85% of patients for up to 52 weeks after initiation of treatment. In Study 3 [see Clinical Studies (14.3) ] , CD20+ B-cell counts were reduced below the lower limit of normal by week 4 in ≥ 99% of patients in the overall population (anti-AChR antibody positive and anti-MuSK antibody positive patients) treated with UPLIZNA.

B-cell counts remained below the lower limit of normal in ≥ 96% of patients treated with UPLIZNA in the anti-AChR antibody positive population for 52 weeks after initiation of treatment, and in > 96% of patients treated with UPLIZNA in the anti-MuSK antibody positive population for 26 weeks after initiation of treatment.

12.3Pharmacokinetics The pharmacokinetics of inebilizumab-cdon in patients with NMOSD, IgG4-RD, and gMG was similar, and was biphasic with a mean terminal half-life of 18 days. In patients with NMOSD, the mean maximum concentration was 108 µg/mL (following the second 300 mg dose on day 15), and the cumulative AUC of the 26-week treatment period in which NMOSD patients received two intravenous administrations 2 week apart was 2980 µg∙d/mL. In patients with IgG4-RD, the mean maximum concentration was 127 µg/mL (following the second 300 mg dose on day 15), and the cumulative AUC of the 52-week treatment period in which IgG4-RD patients received two intravenous administrations 2 weeks apart, followed by a third dose at week 26 was 4290 µg×d/mL.

In patients with gMG, the mean maximum concentration was 139 µg/mL (following the second 300 mg dose on day 15) for the overall population. The cumulative AUC of the 52-week treatment period in which anti-AChR antibody positive patients (n = 84) received two intravenous administrations 2 weeks apart, followed by a third dose at week 26 was 4240 µg×d/mL. The cumulative AUC of the 26-week treatment period in which anti-MuSK antibody positive patients (n = 17) received two intravenous administrations 2 weeks apart was 3740 µg×d/mL.

Distribution Based on population pharmacokinetic analysis, the estimated typical central and peripheral volume of distribution of inebilizumab-cdon was

2.95 L and

2.57L, respectively. Metabolism Inebilizumab-cdon is a humanized IgG1 monoclonal antibody that is degraded by proteolytic enzymes widely distributed in the body. Elimination The results of population pharmacokinetic analysis indicated that the estimated inebilizumab-cdon systemic clearance of the first-order elimination pathway was

0.19L/day. At low exposure levels, inebilizumab-cdon was likely subject to the receptor (CD19)-mediated clearance, which decreased with time presumably because of the depletion of B-cells by UPLIZNA treatment. Specific Populations Gender, Race, Geriatric Use A population pharmacokinetic analysis indicated that there was no significant effect of gender, race, and age on inebilizumab-cdon clearance.

Renal/Hepatic Impairment No formal clinical studies have been conducted to i…

🧬 Mechanism of Action 49 words ▾

12.1Mechanism of Action The mechanism by which inebilizumab-cdon exerts its therapeutic effects in NMOSD, IgG4-RD, and gMG is presumed to involve binding to CD19, a cell surface antigen presents on pre-B and mature B lymphocytes. Following cell surface binding to B lymphocytes, inebilizumab-cdon results in antibody-dependent cellular cytolysis.

📦 How Supplied / Storage and Handling 67 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied UPLIZNA (inebilizumab-cdon) injection is a clear to slightly opalescent, colorless to slightly yellow solution supplied as: One carton containing three 100 mg/10 mL single-dose vials – NDC 75987-150-03

16.2Storage and Handling Store in a refrigerator at 2°C to 8°C (36°F to 46°F) in original carton to protect from light. Do not freeze. Do not shake. Store vials upright.

📦 Storage and Handling 31 words ▾

16.2Storage and Handling Store in a refrigerator at 2°C to 8°C (36°F to 46°F) in original carton to protect from light. Do not freeze. Do not shake. Store vials upright.

📋 Description 104 words ▾

11 DESCRIPTION Inebilizumab-cdon is a CD19-directed humanized afucosylated IgG1 monoclonal antibody produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture. The molecular weight is approximately 149 kDa. UPLIZNA (inebilizumab-cdon) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution, free from visible particles, for intravenous use.

Each single-dose vial contains 100 mg of inebilizumab in 10 mL of solution. Each mL contains 10 mg of inebilizumab-cdon, L-histidine (1.4 mg), L-histidine hydrochloride monohydrate (2.3 mg), polysorbate 80 (0.1 mg), sodium chloride (4.1 mg), α,α-trehalose dihydrate (40.1 mg), and Water for Injection, USP and a pH of 6.

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient and/or caregiver to read the FDA-approved patient labeling (Medication Guide). Infusion Reactions Inform patients about the signs and symptoms of infusion reactions, including anaphylaxis, and advise them to contact their healthcare provider immediately if they observe signs or symptoms of infusion reactions [see Warnings and Precautions (5.1) ] . Infections Advise patients to contact their healthcare provider for any signs of infection during treatment or after the last dose .

Signs include fever, chills, constant cough, or dysuria [see Warnings and Precautions (5.2) ] . Advise patients that UPLIZNA may cause reactivation of hepatitis B infection and that monitoring will be required if they are at risk [see Warnings and Precautions (5.2) ] . Advise patients that PML has happened with drugs that are similar to UPLIZNA and may happen with UPLIZNA.

Inform the patient that PML is characterized by a progression of deficits and usually leads to death or severe disability over weeks or months. Instruct the patient of the importance of contacting their healthcare provider if they develop any symptoms suggestive of PML. Inform the patient that typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes [see Warnings and Precautions (5.2) ].

Vaccinations Advise patients to complete any required vaccinations at least 4 weeks prior to initiation of UPLIZNA. Administration of live-attenuated or live vaccines is not recommended during UPLIZNA treatment and until B-cell recovery [see Warnings and Precautions (5.2) ] . Pregnancy Instruct patients that if they are pregnant or plan to become pregnant while taking UPLIZNA, they should inform their healthcare provider [see Use in Specific Populations (8.1) ].

Advise females of reproductive potential that they should use effective contraception during treatment and for 6 months after UPLIZNA therapy [see Use in Specific Populations (8.3) ]. Advise patients to register with the UPLIZNA pregnancy exposure registry [see Use in Specific Populations (8.3) ].

💬 Medication Guide ~3 min read ▾

This Medication Guide has been approved by the U.S. Food and Drug Administration Revised: 12/2025 Medication Guide UPLIZNA ® (up-liz'-nah) (inebilizumab-cdon) injection, for intravenous use What is the most important information I should know about UPLIZNA? UPLIZNA may cause serious side effects, including: Infusion reactions.

UPLIZNA can cause infusion reactions, including anaphylaxis, that can be serious or may cause you to be hospitalized. You will be monitored during your infusion and for at least 1 hour after each infusion of UPLIZNA for signs and symptoms of an infusion reaction. Tell your healthcare provider right away if you get any of these symptoms: headache nausea sleepiness shortness of breath fever muscle aches rash palpitations If you develop an infusion reaction, your healthcare provider may need to stop or slow down the rate of your infusion and treat your symptoms.

Infections. Infections can happen during treatment with UPLIZNA. Tell your healthcare provider right away if you have an infection or get any of these symptoms: painful and frequent urination nasal congestion, runny nose, sore throat, fever, chills, cough, body aches UPLIZNA taken before or after other medicines that weaken the immune system may increase your risk of getting infections.

Hepatitis B virus (HBV) reactivation. Before starting treatment with UPLIZNA, your healthcare provider will do blood tests to check for hepatitis B viral infection. If you have ever had hepatitis B virus infection, the hepatitis B virus may become active again during or after treatment with UPLIZNA.

Hepatitis B virus becoming active again (called reactivation) may cause serious liver problems, including liver failure or death. Your healthcare provider will monitor you if you are at risk for hepatitis B virus reactivation during treatment and after you stop receiving UPLIZNA. Progressive Multifocal Leukoencephalopathy (PML).

PML may happen with UPLIZNA. PML is a rare brain infection that leads to death or severe disability. Symptoms of PML may get worse over days to weeks.

Call your healthcare provider right away if you get any of these symptoms: weakness on one side of the body loss of coordination in your arms and legs changes in your vision changes in thinking or memory confusion changes in your personality Tuberculosis (TB). TB is caused by an infection in the lungs. Before starting treatment with UPLIZNA, your healthcare provider will check to see if you are at risk for getting TB or have ever had TB.

Vaccinations. Certain vaccines, called "live" or "live attenuated" vaccines, are not recommended in people receiving UPLIZNA. Talk to your healthcare provider before receiving any vaccinations.

If you have a baby and you were receiving UPLIZNA during pregnancy, it is important to tell your baby's healthcare provider about your UPLIZNA use so they can decide when your baby should receive any vaccine. See " What are the possible side effects of UPLIZNA? " for more information about side effects. What is UPLIZNA?

UPLIZNA is a prescription medicine used to treat adults with: Neuromyelitis optic spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive. Immunoglobulin G4-related disease (IgG4-RD). Generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) or anti-muscle specific tyrosine kinase (MuSK) antibody positive.

It is not known if UPLIZNA is safe or effective in children. Who should not receive UPLIZNA? You should not receive UPLIZNA if you have: had a life-threatening infusion reaction to UPLIZNA. an active hepatitis B virus infection. active or untreated inactive (latent) tuberculosis.

Before receiving UPLIZNA, tell your healthcare provider about all of your medical conditions, including if you: have or think you have an infection. have ever taken, currently take, or plan to take medicines that affect your immune system, or other treatments for NMOSD, IgG4-RD, or gMG. These medicines may increase your risk of getting an inf…

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