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ZILBRYSQ zilucoplan 40 mg/mL Injection, Solution — NDC 50474-0992-80 package photo

ZILBRYSQ zilucoplan 40 mg/mL Injection, Solution

by UCB, Inc. · 4 CARTON in 1 BOX (50474-992-80) / 7 SYRINGE, GLASS in 1 CARTON / .81 mL in 1 SYRINGE, GLASS
NDC 50474-0992-80
🏷️ FDA NDC (as labeled) 50474-992-80 billing pads the product segment with a zero
Rx only Brand On market Non-controlled 🛡 REMS
🗂️ 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) 50474-992-80
Product NDC 50474-992
11-digit billing NDC 50474099280
NCPDP billing unit ML — per mL (volume)
RxCUI 2672496, 2672502, 2672504, 2672505, 2672506, 2672507
UNII YG391PK0CC
Application # NDA216834
SPL Set ID 9f1d53d6-e495-4a3a-8bb9-680a15d25034
Established class (EPC) Complement Inhibitor
Mechanism of action Complement Inhibitors
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-01-03
Route SUBCUTANEOUS
Dosage form INJECTION, SOLUTION
Substance ZILUCOPLAN
GPI-14 8580509520E540
GCN Seq No 085407
GCN 54878
HICL code 049273
Ingredient (HICL) Zilucoplan Sodium
HIC1 code M
Therapeutic class — broad (HIC1) Blood
HIC2 code M0
Therapeutic class — intermediate (HIC2) Blood And Blood Replacement Preparations
HIC3 code M0L
Therapeutic class — specific (HIC3) Complement Inhibitors
AHFS code 90:08.08.00
AHFS class Complement Inhibitors (90:08)
FDB label name ZILBRYSQ 32.4 MG/0.81 ML SYRNG
FDB brand name Zilbrysq
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 50474-992-80 — 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 → 50474-0992-80. 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 Complement Inhibitor class.

Pharmacologic class Complement Inhibitor
Drug family (ATC) Complement inhibitors
How it works Complement 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.

🏭 Manufacturer & labeler

LabelerUCB, Inc.
Application holderUCB INC
FDA applicationNDA216834 (NDA)
Labeler code50474
First marketedJan 2024
Product typeHuman Prescription Drug
Portfolio45 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 ZILBRYSQ 32.4 MG/0.81 ML SYRNG Ingredient Zilucoplan Sodium
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.

  • 3.58 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.
  • 3.33 mg / 1 mL UNII 22ADO53M6F
    A mineral salt derived from phosphoric acid, used as a buffer to maintain the pH balance of the medication and help stabilize the active ingredients.
  • 2.35 mg / 1 mL UNII 593YOG76RN
    A salt made from sodium and phosphate that helps regulate acidity and maintain proper pH balance in the medicine. It also acts as a buffer to keep the product stable.
  • 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.

4 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 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 · Q2 2026 $1,927.28 $43,710.82 / 22.68 ml
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Zilbrysq 40 mg/mLthis 50474-0992-80 UCB, 7 syringes — — FDA listed —
Zilbrysq 40 mg/mL 50474-0990-80 UCB, 7 syringes — — FDA listed —
Zilbrysq 40 mg/mL 50474-0991-80 UCB, 7 syringes — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
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 & generic status

🏛️
2023
First FDA approval
Oct 2023
📍
2026
Currently FDA-listed
3 years listed
🛡️
2035
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Jun 2035. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Oct 17, 2023 RLD RS ⏳ ~8.7 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 11752190 — method of use (U-3735)
US 11752190 — method of use (U-3735)
US 11752190 — method of use (U-3735)
US 11014965 — drug substance (U-3735)
US 11014965 — drug substance (U-3735)
US 11014965 — drug substance (U-3735)
US 10435438 — drug substance (U-3735)
US 10435438 — drug substance (U-3735)
US 10435438 — drug substance (U-3735)
US 10208089 — drug substance (U-3735)
US 10208089 — drug substance (U-3735)
US 10208089 — drug substance (U-3735)
US 10106579 — drug substance (U-3735)
US 10106579 — drug substance (U-3735)
US 10106579 — drug substance (U-3735)
US 10835574 — drug product
US 10835574 — drug product
US 11965040 — drug product
US 11535650 — drug product
US 10835574 — drug product
US 11535650 — drug product
US 10562934 — drug substance
US 10562934 — drug substance
US 10562934 — drug substance
US 11535650 — drug product
US 11965040 — drug product
US 11965040 — drug product
Exclusivity NCE
Exclusivity ODE-446
Exclusivity NCE
Exclusivity ODE-446
Exclusivity NCE
Exclusivity ODE-446
2023 2025 2027 2029 2031 2033 2035
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (27)
PatentTypeUse codeExpires
US 11752190 ↗ Method of use U-3735 Jun 12, 2035
US 11752190 ↗ Method of use U-3735 Jun 12, 2035
US 11752190 ↗ Method of use U-3735 Jun 12, 2035
US 11014965 ↗ Drug substance U-3735 Jun 12, 2035
US 11014965 ↗ Drug substance U-3735 Jun 12, 2035
US 11014965 ↗ Drug substance U-3735 Jun 12, 2035
US 10435438 ↗ Drug substance U-3735 Jun 12, 2035
US 10435438 ↗ Drug substance U-3735 Jun 12, 2035
US 10435438 ↗ Drug substance U-3735 Jun 12, 2035
US 10208089 ↗ Drug substance U-3735 Jun 12, 2035
US 10208089 ↗ Drug substance U-3735 Jun 12, 2035
US 10208089 ↗ Drug substance U-3735 Jun 12, 2035
US 10106579 ↗ Drug substance U-3735 Jun 12, 2035
US 10106579 ↗ Drug substance U-3735 Jun 12, 2035
US 10106579 ↗ Drug substance U-3735 Jun 12, 2035
US 10835574 ↗ Drug product — Jun 12, 2035
US 10835574 ↗ Drug product — Jun 12, 2035
US 11965040 ↗ Drug product — Jun 12, 2035
US 11535650 ↗ Drug product — Jun 12, 2035
US 10835574 ↗ Drug product — Jun 12, 2035
US 11535650 ↗ Drug product — Jun 12, 2035
US 10562934 ↗ Drug substance — Jun 12, 2035
US 10562934 ↗ Drug substance — Jun 12, 2035
US 10562934 ↗ Drug substance — Jun 12, 2035
US 11535650 ↗ Drug product — Jun 12, 2035
US 11965040 ↗ Drug product — Jun 12, 2035
US 11965040 ↗ Drug product — Jun 12, 2035
FDA exclusivity
CodeWhat it grantsExpires
NCENew Chemical Entity (5-year)Oct 17, 2028
ODE-446Orphan Drug Exclusivity (7-year)Oct 17, 2030
NCENew Chemical Entity (5-year)Oct 17, 2028
ODE-446Orphan Drug Exclusivity (7-year)Oct 17, 2030
NCENew Chemical Entity (5-year)Oct 17, 2028
ODE-446Orphan Drug Exclusivity (7-year)Oct 17, 2030
Common questions
Is there a generic version of ZILBRYSQ 32.4 MG/0.81 ML SYRNG?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for ZILBRYSQ 32.4 MG/0.81 ML SYRNG. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Jun 2035 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, 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 Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

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

Medicare Part D (outpatient prescription) spending for Zilbrysq — 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 Zilbrysq. 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
$43.9M
Claims incl. refills
1K
Beneficiaries
371
Spend / beneficiary
$118,332.05
Spend / claim
$43,124.94
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.
🛡
This drug has a REMS — ZILBRYSQ REMS. A Risk Evaluation & Mitigation Strategy is an FDA-required safety program. It is available only through a restricted program (certified prescribers/pharmacies, enrollment, or required monitoring). See the boxed warning & full label below, and REMS@FDA ↗.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for ZILBRYSQ (this brand).

Top reported reactions

Myasthenia Gravis296
Injection Site Pain95
Fatigue75
Diarrhoea63
Hospitalisation62
Myasthenia Gravis Crisis42
Weight Decreased40

Age at onset

Adult21
Elderly22

Reporter sex

817 reports
Male · 45%
Female · 55%

Serious outcomes

Hospitalization329
Life-threatening44
Disabling19
Reports over time (by year) — tap or hover for the count & year
2023 2024 2025 2026 2 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
50474-0992-80 You're viewing this 4 CARTON in 1 BOX (50474-992-80) / 7 SYRINGE, GLASS in 1 CARTON / .81 mL in 1 SYRINGE, GLASS 2024-01-03 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 — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
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 50474-992-80, 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: 50474-0992-80, written without dashes as 50474099280. 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 50474-0992-80, the first segment (50474) is the labeler code FDA assigned to UCB, Inc.; the middle segment (0992) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (80) 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 UCB, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
UCB, 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.
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.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 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
🚨 Boxed Warning ~2 min read ▾

WARNING: SERIOUS MENINGOCOCCAL INFECTIONS ZILBRYSQ, a complement inhibitor, increases the risk of serious infections caused by Neisseria meningitidis [see Warnings and Precautions (5.1) ] . Life-threatening and fatal meningococcal infections have occurred in patients treated with complement inhibitors. These infections may become rapidly life-threatening or fatal if not recognized and treated early.

Complete or update vaccination for meningococcal bacteria (for serogroups A, C, W, Y, and B) at least 2 weeks prior to the first dose of ZILBRYSQ, unless the risks of delaying therapy outweigh the risk of developing a serious infection. Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for vaccination against meningococcal bacteria in patients receiving a complement inhibitor. See Warnings and Precautions (5.1) for additional guidance on the management of the risk of serious infections caused by meningococcal bacteria.

Patients receiving ZILBRYSQ are at increased risk for invasive disease caused by Neisseria meningitidis , even if they develop antibodies following vaccination. Monitor patients for early signs and symptoms of serious meningococcal infections and evaluate immediately if infection is suspected. Because of the risk of serious meningococcal infections, ZILBRYSQ is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called ZILBRYSQ REMS [see Warnings and Precautions (5.2) ] .

WARNING: SERIOUS MENINGOCOCCAL INFECTIONS See full prescribing information for complete boxed warning. ZILBRYSQ increases the risk of serious and life-threatening infections caused by Neisseria meningitidis . ( 5.1 ) Complete or update meningococcal vaccination at least 2 weeks prior to the first dose of ZILBRYSQ, unless the risks of delaying ZILBRYSQ outweigh the risks of developing a serious infection.

Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for meningococcal vaccination in patients receiving a complement inhibitor. ( 5.1 ) Patients receiving ZILBRYSQ are at increased risk for invasive disease caused by N. meningitidis , even if they develop antibodies following vaccination. Monitor patients for early signs and symptoms of meningococcal infections and evaluate immediately if infection is suspected.

( 5.1 ) ZILBRYSQ is available only through a restricted program called ZILBRYSQ REMS. ( 5.2 )

🎯 Indications and Usage 52 words ▾

1 INDICATIONS AND USAGE ZILBRYSQ is indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive. ZILBRYSQ is a complement inhibitor indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive. ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Obtain baseline amylase and lipase. ( 2.2 ) For subcutaneous injection only. ( 2.3 ) Recommended dosage ( 2.3 ): Body Weight Once Daily Dosage Plunger Rod Color of Prefilled Syringe Less than 56 kg 16.6 mg RUBINE RED 56 kg to less than 77 kg 23 mg ORANGE 77 kg and above 32.4 mg DARK BLUE See Full Prescribing Information for instructions on dosage, preparation, and administration. ( 2.4 , 2.5 )

2.1Recommended Vaccination and Prophylaxis for Meningococcal Infection Vaccinate patients against meningococcal infection (serogroups A, C, W, Y, and B) according to current ACIP recommendations at least 2 weeks prior to initiation of ZILBRYSQ [see Warnings and Precautions (5.1) ] . If urgent ZILBRYSQ therapy is indicated in a patient who is not up to date with meningococcal vaccines according to ACIP recommendations, provide the patient with antibacterial drug prophylaxis and administer these vaccines as soon as possible [see Warnings and Precautions (5.1) ] .

Healthcare providers who prescribe ZILBRYSQ must enroll in the ZILBRYSQ REMS [see Warnings and Precautions (5.2) ] .

2.2Recommended Testing Before Initiating ZILBRYSQ Before initiating ZILBRYSQ, obtain baseline lipase and amylase levels [see Warnings and Precautions (5.4) ] .

2.3Recommended Dosage The recommended dosage of ZILBRYSQ is given once daily as a subcutaneous injection and is dependent on actual body weight (see Table 1 ). Table 1: Total Daily Dosage by Body Weight Range Body Weight Once Daily Dosage Plunger Rod Color of Prefilled Syringe Less than 56 kg 16.6 mg RUBINE RED 56 kg to less than 77 kg 23 mg ORANGE 77 kg and above 32.4 mg DARK BLUE

2.4Preparation Instructions ZILBRYSQ prefilled syringes can be stored in a refrigerator in the original carton. ZILBRYSQ can also be stored at room temperature in the original carton for up to 3 months or until the expiration date, whichever occurs first. If stored in the refrigerator: Before injecting, take 1 ZILBRYSQ prefilled syringe out of the refrigerator and place it on a clean, flat surface.

Allow ZILBRYSQ to reach room temperature out of direct sunlight (30 to 45 minutes). Do not heat or place in microwave. Immediately return the carton with the other prefilled syringes to the refrigerator.

If stored at room temperature: Remove 1 ZILBRYSQ prefilled syringe from the carton. Do not return ZILBRYSQ to the refrigerator after it has been stored at room temperature. Visually inspect ZILBRYSQ for particulate matter and discoloration prior to administration.

ZILBRYSQ is a clear to slightly opalescent, colorless solution. Do not use if the solution contains visible particles, is cloudy, or if foreign particulate matter is present. ZILBRYSQ does not contain preservatives; unused portions of drug remaining in the syringe should be discarded.

Each prefilled syringe is single-dose only.

2.5Administration Instructions ZILBRYSQ is intended for use under the guidance and supervision of a healthcare professional. Patients may self-inject ZILBRYSQ after training in subcutaneous injection technique. Provide proper training to patients and/or caregivers on the subcutaneous injection technique of ZILBRYSQ according to the "Instructions for Use" [see Instructions for Use ] .

Administer ZILBRYSQ subcutaneously into areas of the abdomen, thighs, or back of the upper arms that are not tender, bruised, red, or hard. Avoid injecting into areas with scars or stretch marks. Rotate injection sites for each administration.

Administration of ZILBRYSQ in the upper, outer arm should be performed by a caregiver. When using ZILBRYSQ prefilled syringes, inject the full contents of the single-dose prefilled syringe. Discard ZILBRYSQ prefilled syringe after use.

Do not reuse. Instruct the patient that the daily dose should be administered at approximately the same time each day. If a dose is missed, administer the dose as soon as possible.

Thereafter, resume dosing at the regular scheduled time. Do not administer more than 1 dose…

💊 Dosage Forms and Strengths 49 words ▾

3 DOSAGE FORMS AND STRENGTHS Injection: 16.6 mg/0.416 mL, 23 mg/0.574 mL, or 32.4 mg/0.81 mL of zilucoplan as a clear to slightly opalescent, colorless solution in single-dose prefilled syringes. Injection: 16.6 mg/0.416 mL, 23 mg/0.574 mL, or 32.4 mg/0.81 mL zilucoplan in single-dose prefilled syringes. ( 3 )

⛔ Contraindications 38 words ▾

4 CONTRAINDICATIONS ZILBRYSQ is contraindicated for initiation in patients with unresolved serious Neisseria meningitidis infection [see Warnings and Precautions (5.1) ] . ZILBRYSQ is contraindicated for initiation in patients with unresolved serious Neisseria meningitidis infection. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Other Infections: Use caution when administering ZILBRYSQ to patients with any other systemic infection. ( 5.3 ) Pancreatitis and pancreatic cysts have been reported in patients treated with ZILBRYSQ. Discontinue ZILBRYSQ in patients with suspected pancreatitis and initiate appropriate management until pancreatitis is ruled out or has resolved. ( 5.4 )

5.1Serious Meningococcal Infections ZILBRYSQ, a complement inhibitor, increases a patient's susceptibility to serious, life-threatening, or fatal infections caused by meningococcal bacteria (septicemia and/or meningitis) in any serogroup, including non-groupable strains. Life-threatening and fatal meningococcal infections have occurred in both vaccinated and unvaccinated patients treated with complement inhibitors. The initiation of ZILBRYSQ treatment is contraindicated in patients with unresolved serious Neisseria meningitidis infection.

Complete or update meningococcal vaccination (for serogroups A, C, W, Y and B) at least 2 weeks prior to administration of the first dose of ZILBRYSQ, according to current ACIP recommendations for patients receiving a complement inhibitor. Revaccinate patients in accordance with ACIP recommendations considering the duration of ZILBRYSQ therapy. Note that ACIP recommends an administration schedule in patients receiving complement inhibitors that differs from the administration schedule in the vaccine prescribing information.

If urgent ZILBRYSQ therapy is indicated in a patient who is not up to date with meningococcal vaccines according to ACIP recommendations, provide the patient with antibacterial drug prophylaxis and administer meningococcal vaccines as soon as possible. Various durations and regimens of antibacterial drug prophylaxis have been considered, but the optimal durations and drug regimens for prophylaxis and their efficacy have not been studied in unvaccinated or vaccinated patients receiving complement inhibitors, including ZILBRYSQ.

The benefits and risks of treatment with ZILBRYSQ, as well as the benefits and risks of antibacterial drug prophylaxis in unvaccinated or vaccinated patients, must be considered against the known risks for serious infections caused by Neisseria meningitidis . Vaccination does not eliminate the risk of meningococcal infections, despite development of antibodies following vaccination. Closely monitor patients for early signs and symptoms of meningococcal infection and evaluate patients immediately if infection is suspected.

Inform patients of these signs and symptoms and instruct patients to seek immediate medical care if these signs and symptoms occur. Promptly treat known infections. Meningococcal infection may become rapidly life-threatening or fatal if not recognized and treated early.

Consider interruption of ZILBRYSQ in patients who are undergoing treatment for serious meningococcal infection, depending on the risks of interrupting treatment in the disease being treated [ see Contraindications (4) ] . ZILBRYSQ is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) [see Warnings and Precautions (5.2) ] .

5.2ZILBRYSQ REMS ZILBRYSQ is available only through a restricted program under a REMS called ZILBRYSQ REMS, because of the risk of serious meningococcal infections [see Warnings and Precautions (5.1) ] . Notable requirements of the ZILBRYSQ REMS include the following: Prescribers must enroll in the REMS. Prescribers must counsel patients about the risk of serious meningococcal infection.

Prescribers must provide the patients with the REMS educational materials. Prescribers must assess patient vaccination status for meningococcal vaccines (against serogroups A, C, W, Y, and B) and vaccinate if needed according to current ACIP recommendations two weeks prior to the first dose of ZILBRYSQ. Prescribers must provide a prescription for antibacterial drug prophylaxis if treatment must be started urgently and the patient is not up t…

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Serious Meningococcal Infections [see Warnings and Precautions (5.1) ] Other Infections [see Warnings and Precautions (5.3) ] Pancreatitis and Other Pancreatic Conditions [see Warnings and Precautions (5.4) ] The most common adverse reactions (≥10%) in patients with gMG were injection site reactions, upper respiratory tract infection, and diarrhea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact UCB, Inc. at 844-599-2273 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. A total of 212 patients were treated with ZILBRYSQ 0.3 mg/kg in clinical studies in gMG. Of these, 137 patients were exposed for at least 6 months, and 87 were exposed for at least 1 year.

In a placebo-controlled study (Study 1) in patients with gMG, 86 patients received ZILBRYSQ 0.3 mg/kg [see Clinical Studies (14) ] . Of these 86 patients, approximately 61% were female, 77% were White, 8% were Asian, and 8% were of Hispanic or Latino ethnicity. The mean age at study entry was 52.6 years (range 21 to 75 years).

Table 2 summarizes the adverse reactions reported in at least 5% of patients treated with ZILBRYSQ and more frequently than placebo. The most common adverse reactions (reported in at least 10% of patients treated with ZILBRYSQ) were injection site reactions, upper respiratory tract infections, and diarrhea. Table 2: Adverse Reactions in at least 5% of Patients Treated with ZILBRYSQ and More Frequently than in Patients who Received Placebo in Study 1 Adverse Reaction ZILBRYSQ 0.3 mg/kg (n=86) % Placebo (n=88) % Injection site reactions 29 16 Upper respiratory tract infections 14 7 Diarrhea 11 2 Urinary tract infection 8 5 Nausea or vomiting 8 7 Lipase increased 7 0 Amylase increased 5 1 Pancreatic Events In addition to increases in amylase and lipase observed in Study 1, pancreatic events, including pancreatitis and pancreatic cysts have been observed in patients taking ZILBRYSQ [see Warnings and Precautions (5.4) ] .

Adverse Laboratory Changes in Clinical Trials Additional laboratory abnormalities included transient elevations of blood eosinophils, which were of uncertain clinical significance.

6.2Postmarketing Experience Adverse Reactions from Observational Studies Morphea In the open-label extension studies, which included 213 patients, morphea was observed in 10 (5%) patients; most cases had a time to onset longer than one year after start of treatment and were mild to moderate in severity. One patient discontinued ZILBRYSQ because of morphea.

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, may cause fetal harm. ( 8.1 )

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ZILBRYSQ during pregnancy. Patients or healthcare providers may contact UCBCares at 1-844-599-CARE (2273) or email [email protected], so that information about the exposure of ZILBRYSQ during pregnancy and/or breastfeeding can be collected. Risk Summary There are no available data on ZILBRYSQ use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.

Administration of zilucoplan to pregnant monkeys resulted in increases in embryofetal death at maternal exposures similar to those in humans at therapeutic doses (see Animal Data ) . All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The background rate of major birth defects and miscarriage in the indicated population is unknown.

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 Subcutaneous administration of zilucoplan (0, 1, 2, or 4 mg/kg/day) to pregnant monkeys throughout gestation resulted in an increase in embryofetal death at all doses, in the absence of maternal toxicity. A no effect dose for adverse developmental effects in monkeys was not identified.

The lowest dose tested was associated with maternal exposures (AUC) similar to that in humans at the maximum recommended human dose of 32.4 mg/day. Data from an ex vivo human placental transfer model demonstrated transfer of zilucoplan into the fetal compartment at a rate of 0.5% at a steady state plasma concentration of 10 µg/mL zilucoplan, which corresponds to a therapeutic dose of 0.3 mg/kg. The clinical significance of these data in human pregnancies is unknown.

8.2Lactation Risk Summary There are no data on the presence of zilucoplan in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for ZILBRYSQ and any potential adverse effects on the breastfed infant from ZILBRYSQ or from the underlying maternal condition.

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

8.5Geriatric Use Clinical studies of ZILBRYSQ did not include sufficient numbers of patients aged 65 and older to determine whether they respond differently from younger adult patients.

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ZILBRYSQ during pregnancy. Patients or healthcare providers may contact UCBCares at 1-844-599-CARE (2273) or email [email protected], so that information about the exposure of ZILBRYSQ during pregnancy and/or breastfeeding can be collected. Risk Summary There are no available data on ZILBRYSQ use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.

Administration of zilucoplan to pregnant monkeys resulted in increases in embryofetal death at maternal exposures similar to those in humans at therapeutic doses (see Animal Data ) . All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The background rate of major birth defects and miscarriage in the indicated population is unknown.

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 Subcutaneous administration of zilucoplan (0, 1, 2, or 4 mg/kg/day) to pregnant monkeys throughout gestation resulted in an increase in embryofetal death at all doses, in the absence of maternal toxicity. A no effect dose for adverse developmental effects in monkeys was not identified.

The lowest dose tested was associated with maternal exposures (AUC) similar to that in humans at the maximum recommended human dose of 32.4 mg/day. Data from an ex vivo human placental transfer model demonstrated transfer of zilucoplan into the fetal compartment at a rate of 0.5% at a steady state plasma concentration of 10 µg/mL zilucoplan, which corresponds to a therapeutic dose of 0.3 mg/kg. The clinical significance of these data in human pregnancies is unknown.

🧒 Pediatric Use 13 words ▾

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

🧓 Geriatric Use 28 words ▾

8.5Geriatric Use Clinical studies of ZILBRYSQ did not include sufficient numbers of patients aged 65 and older to determine whether they respond differently from younger adult patients.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Zilucoplan binds to the complement protein C5 and inhibits its cleavage to C5a and C5b, preventing the generation of the terminal complement complex, C5b-9. The precise mechanism by which zilucoplan exerts its therapeutic effect in generalized myasthenia gravis is unknown but is presumed to involve reduction of C5b-9 deposition at the neuromuscular junction.

12.2Pharmacodynamics In a placebo-controlled Phase 2 study, patients received zilucoplan 0.3 mg/kg or 0.1 mg/kg for 12 weeks. There was a dose dependent inhibition of complement. Complement inhibition as represented by inhibition of sheep red blood cell (sRBC) lysis was 89.1% within 3 hours after the first administration and 94.9% after the 12-week treatment period in patients receiving ZILBRYSQ 0.3 mg/kg.

In Study 1 [see Clinical Studies (14) ], complement inhibition of 97.5% was observed by the end of the first week and sustained throughout the 12-week treatment period for gMG patients treated with the recommended dosage regimen of ZILBRYSQ. Cardiac Electrophysiology At a dose two times the maximum approved recommended dose, ZILBRYSQ does not cause clinically significant QTc interval prolongation.

12.3Pharmacokinetics The population pharmacokinetics (PK) analysis showed that zilucoplan PK was not time dependent. Following single daily subcutaneous administration of ZILBRYSQ (0.05 mg/kg, 0.1 mg/kg, 0.2 mg/kg, and 0.4 mg/kg) in healthy subjects, increase in peak plasma concentration was approximately dose proportional and increase in area under the curve was less than dose proportional. Absorption Following single and multiple daily subcutaneous administration of ZILBRYSQ 0.3 mg/kg in healthy subjects, zilucoplan reached peak plasma concentration generally between 3 to 6 hours post-dose.

Following daily subcutaneous dosing of ZILBRYSQ 0.3 mg/kg for 14 days in healthy subjects, both the peak plasma concentration and exposure (AUC tau ) increased by approximately 3-fold. In Study 1 [see Clinical Studies (14) ] , after daily repeated subcutaneous administration of ZILBRYSQ 0.3 mg/kg, plasma concentrations of zilucoplan were consistent, with steady state trough concentrations being reached by four weeks of treatment with ZILBRYSQ through twelve weeks. Distribution The mean volume of distribution at steady state was

3.51L in the population pharmacokinetics analysis for adult patients with gMG. Zilucoplan and its 2 major metabolites are highly bound to plasma proteins (>99%). Elimination The mean plasma terminal half-life of zilucoplan was approximately 172 hours (7 to 8 days).

Metabolism As a peptide, ZILBRYSQ is expected to be degraded into small peptides and amino acids via catabolic pathways. In plasma, two major metabolites, RA103488 and RA102758, were detected. The metabolite RA103488, formed mainly because of cytochrome CYP450 4F2, has pharmacological activity similar to zilucoplan but is present at a much lower concentration compared to zilucoplan.

The metabolite RA102758, formed by protease mediated degradation, is pharmacologically inactive. The AUCs of both metabolites were approximately 10% of the parent AUC. The contribution of RA103488 to pharmacological activity is therefore expected to be low.

Excretion Excretion of zilucoplan and its metabolite in urine and feces was negligible (<1% of the dose). Specific Populations Age, Sex, and Race A population pharmacokinetics analysis assessing the effects of age, sex, and race did not suggest any clinically significant impact of these covariates on zilucoplan exposures. Patients with Renal Impairment A dedicated clinical study compared the pharmacokinetics of a single subcutaneous dose of ZILBRYSQ 0.3 mg/kg in subjects with severe renal impairment (as defined by a creatinine clearance <30 mL/min estimated by Cockcroft-Gault formula) to that of matched healthy subjects with normal renal function.

A decrease in zilucoplan exposure (AUC 0-inf ) of 13% was observed. This ch…

🧬 Mechanism of Action 57 words ▾

12.1Mechanism of Action Zilucoplan binds to the complement protein C5 and inhibits its cleavage to C5a and C5b, preventing the generation of the terminal complement complex, C5b-9. The precise mechanism by which zilucoplan exerts its therapeutic effect in generalized myasthenia gravis is unknown but is presumed to involve reduction of C5b-9 deposition at the neuromuscular junction.

📦 How Supplied / Storage and Handling ~2 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied ZILBRYSQ (zilucoplan) injection prefilled syringe contains a sterile, preservative-free, clear to slightly opalescent, colorless solution. Each single-dose prefilled syringe consists of a 1 mL glass syringe with a 29-gauge ½ inch needle, a needle safety guard, and a needle cover. The ZILBRYSQ prefilled syringe components are not made with natural rubber latex.

ZILBRYSQ is available as follows: NDC Carton Pack Size Strength Plunger Color 50474-990-80 28 single-dose prefilled syringes (4 cartons each containing 7 syringes for a total of 28 syringes) 16.6 mg/0.416 mL RUBINE RED 50474-991-80 28 single-dose prefilled syringes (4 cartons each containing 7 syringes for a total of 28 syringes) 23 mg/0.574 mL ORANGE 50474-992-80 28 single-dose prefilled syringes (4 cartons each containing 7 syringes for a total of 28 syringes) 32.4 mg/0.81 mL DARK BLUE

16.2Storage and Handling Pharmacy Prior to Dispensing Store ZILBRYSQ prefilled syringes refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton until dispensing. Do not freeze. Storage for Patients or Caregivers After Dispensing Storage conditions after dispensing by pharmacist are summarized in Table 4: Table 4: After Dispensing Storage Conditions Temperature Refrigeration 2°C to 8°C (36°F to 46°F) Room Temperature Up to 30°C (86°F) Time Period Until expiration date on the carton Up to 3 months after removing from refrigerator or until expiration date on the carton, whichever occurs first Do not freeze.

Store ZILBRYSQ prefilled syringes in the original carton to protect them from light until time of use. ZILBRYSQ prefilled syringes may be stored at room temperature in the original carton for a single period of up to 3 months. When storing ZILBRYSQ prefilled syringes at room temperature, write the date removed from the refrigerator in the space provided on the carton and discard if not used within 3 months or if the expiration date has passed, whichever occurs first.

Do not return ZILBRYSQ to the refrigerator after it has been stored at room temperature. ZILBRYSQ does not contain a preservative; discard any unused portion.

📦 Storage and Handling 200 words ▾

16.2Storage and Handling Pharmacy Prior to Dispensing Store ZILBRYSQ prefilled syringes refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton until dispensing. Do not freeze. Storage for Patients or Caregivers After Dispensing Storage conditions after dispensing by pharmacist are summarized in Table 4: Table 4: After Dispensing Storage Conditions Temperature Refrigeration 2°C to 8°C (36°F to 46°F) Room Temperature Up to 30°C (86°F) Time Period Until expiration date on the carton Up to 3 months after removing from refrigerator or until expiration date on the carton, whichever occurs first Do not freeze.

Store ZILBRYSQ prefilled syringes in the original carton to protect them from light until time of use. ZILBRYSQ prefilled syringes may be stored at room temperature in the original carton for a single period of up to 3 months. When storing ZILBRYSQ prefilled syringes at room temperature, write the date removed from the refrigerator in the space provided on the carton and discard if not used within 3 months or if the expiration date has passed, whichever occurs first.

Do not return ZILBRYSQ to the refrigerator after it has been stored at room temperature. ZILBRYSQ does not contain a preservative; discard any unused portion.

📋 Description 205 words ▾

11 DESCRIPTION Zilucoplan, a complement inhibitor, is a 15 amino-acid, synthetic macrocyclic peptide. The molecular formula of zilucoplan is C 172 H 278 N 24 O 55 in free acid form and its molecular weight is 3562.23 Daltons (free acid form). The chemical name for zilucoplan sodium is: acetyl‐[L-lysyl 1 -L-valyl 2 -L-glutamyl 3 -L-arginyl 4 -L phenylalanyl 5 -L aspartyl 6 ]- N -methyl L-aspartyl 7 -L tert-leucyl 8 -L tyrosyl 9 -L-7-azatryptophyl 10 -L glutamyl 11 -L-tyrosyl 12 -L prolyl 13 -L cyclohexylglycyl 14 -[L-lysyl 15 , N ε -palmitoyl-γ-L-glutamyl-(1-amino-3,6,9,12,15,18,21,24,27,30,33,36,39,42,45,48,51,54,57,60,63,66,69,72-tetracosaoxapentaheptacontan-75-oyl)], cyclic (Lactam 1-6), tetra sodium.

The primary structure for zilucoplan sodium is shown below: ZILBRYSQ injection is a sterile, clear to slightly opalescent, colorless, preservative-free, buffered solution of zilucoplan (as zilucoplan sodium) for subcutaneous injection, in single-dose prefilled syringes. The solution pH is between 6.5 and 7.5. ZILBRYSQ is supplied in three dose strengths containing 16.6 mg /0.416 mL, 23 mg /0.574 mL, and 32.4 mg/0.81 mL of zilucoplan free acid equivalent to 17 mg, 23.6 mg, and 33.2 mg of zilucoplan sodium, respectively.

Additionally, each mL of the solution contains dibasic sodium phosphate, anhydrous (4.11 mg); monobasic sodium phosphate, monohydrate (2.9 mg); sodium chloride (4.42 mg); and water for injection. Chemical Structure

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patients and/or caregivers to read FDA-approved patient labeling (Medication Guide and Instructions for Use) . Serious Meningococcal Infection Advise patients of the risk of serious meningococcal infection [see Warnings and Precautions (5.1) ] . Inform patients of the need to complete or update meningococcal vaccinations at least 2 weeks prior to receiving the first dose of ZILBRYSQ or receive antibacterial drug prophylaxis if ZILBRYSQ treatment must be initiated immediately and they have not been previously vaccinated.

Inform patients of the requirement to be revaccinated according to current ACIP recommendations for meningococcal infection while on ZILBRYSQ therapy. Inform patients that vaccination may not prevent serious meningococcal infection and to seek immediate medical attention if the following signs or symptoms occur: fever fever and a rash fever with high heart rate headache with nausea or vomiting headache and a fever headache with a stiff neck or stiff back confusion muscle aches with flu-like symptoms eyes sensitive to light Inform patients that they will be given a Patient Safety Card for ZILBRYSQ that they should carry with them at all times and for 2 months following treatment with ZILBRYSQ.

This card describes symptoms which, if experienced, should prompt the patient to immediately seek medical evaluation. ZILBRYSQ REMS ZILBRYSQ is available only through a restricted program called ZILBRYSQ REMS [see Warnings and Precautions (5.2) ]. Inform the patient of the following notable requirements: Patients must receive counseling about the risk of serious meningococcal infections.

Patients must receive written educational materials about this risk. Patients must be instructed to carry the Patient Safety Card with them at all times during and for 2 months following treatment with ZILBRYSQ. Patients must be instructed to complete or update meningococcal vaccines for serogroups A, C, W, Y, and B per ACIP recommendations as directed by the prescriber prior to treatment with ZILBRYSQ.

Patients must receive antibiotics as directed by the prescriber if they are not up to date with meningococcal vaccines and have to start ZILBRYSQ right away. Other Infections Counsel patients of the increased risk of infections, particularly those due to encapsulated bacteria, especially Neisseria species. Advise patients of the need for vaccination against meningococcal infections according to current medical guidelines [see Warnings and Precautions (5.3) ] .

Counsel patients about gonorrhea prevention and advise regular testing for patients at risk. Advise patients to report any new signs and symptoms of infection. Pancreatitis and Other Pancreatic Conditions Inform patients that pancreatitis and pancreatic cysts have been reported in patients taking ZILBRYSQ.

Inform patients that persistent abdominal pain, sometimes severe or radiating to the back, which may or may not be accompanied by vomiting, is the hallmark symptom of acute pancreatitis. Instruct patients to contact their healthcare provider if these symptoms occur to determine if they should discontinue ZILBRYSQ [see Warnings and Precautions (5.4) ] . Pregnancy Registry Advise patients that there is registry that monitors outcomes in patients with Myasthenia Gravis, including women exposed to ZILBRYSQ during pregnancy and/or breastfeeding [see Use in Specific Populations (8.1) ].

Administration Provide training to patients and caregivers on proper subcutaneous injection technique. Instruct patients to inject the full dose of ZILBRYSQ [see Medication Guide and Instructions for Use ] . Instruct patients or caregivers in the technique of needle and syringe disposal [see Instructions for Use ].

Remind patients if they forget to take their dose of ZILBRYSQ to inject their dose as soon as they remember. They should then take their next dose at the appropriate scheduled time. They should not take more than 1 dose per day.

💬 Medication Guide ~3 min read ▾

This Medication Guide has been approved by the U.S. Food and Drug Administration. Issued: 1/2026 MEDICATION GUIDE ZILBRYSQ ® (ZIL-brisk) (zilucoplan) injection, for subcutaneous use What is the most important information I should know about ZILBRYSQ?

ZILBRYSQ is a medicine that affects part of your immune system. ZILBRYSQ may lower the ability of your immune system to fight infections. ZILBRYSQ increases your chance of getting serious meningococcal infections caused by Neisseria meningitidis bacteria.

Meningococcal infections may quickly become life-threatening or cause death if not recognized and treated early. You must complete or update your meningococcal vaccine(s) at least 2 weeks before your first dose of ZILBRYSQ. If you have not completed your meningococcal vaccines and ZILBRYSQ must be started right away, you should receive the required vaccine(s) as soon as possible.

If you have not been vaccinated and ZILBRYSQ must be started right away, you should also receive antibiotics to take for as long as your healthcare provider tells you. If you had a meningococcal vaccine in the past, you might need additional vaccines before starting ZILBRYSQ. Your healthcare provider will decide if you need additional meningococcal vaccines.

Meningococcal vaccines do not prevent all meningococcal infections. Call your healthcare provider or get emergency medical care right away if you get any of these signs and symptoms of a meningococcal infection: fever fever with high heart rate headache and fever confusion muscle aches with flu-like symptoms fever and a rash headache with nausea or vomiting headache with a stiff neck or stiff back eyes sensitive to light Your healthcare provider will give you a Patient Safety Card about the risk of serious meningococcal infection.

Carry it with you at all times during treatment and for 2 months after your last ZILBRYSQ dose. Your risk of meningococcal infection may continue for several weeks after your last dose of ZILBRYSQ. It is important to show this card to any healthcare provider who treats you.

This will help them diagnose and treat you quickly. ZILBRYSQ is only available through a program called the ZILBRYSQ Risk Evaluation and Mitigation Strategy (REMS). Before you can receive ZILBRYSQ, your healthcare provider must: enroll in the ZILBRYSQ REMS program. counsel you about the risk of meningococcal infections. give you the Patient Guide, including information about the signs and symptoms of meningococcal infection. give you a Patient Safety Card about your risk of meningococcal infection, as discussed above. make sure that you are vaccinated against serious infections caused by meningococcal bacteria and that you receive antibiotics if you need to start ZILBRYSQ right away and you are not up to date on your vaccines.

ZILBRYSQ may also increase the risk of other types of serious infections caused by encapsulated bacteria, including Streptococcus pneumoniae, Haemophilus influenzae , and Neisseria gonorrhoeae . Certain people may be at risk of serious infections with gonorrhea. Talk to your healthcare provider about whether you are at risk for gonorrhea infection, about gonorrhea prevention, and about regular testing.

Call your healthcare provider right away if you have new signs or symptoms of infection. What is ZILBRYSQ? ZILBRYSQ is a prescription medicine used to treat adults with a disease called generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive.

It is not known if ZILBRYSQ is safe and effective in children. Who should not use ZILBRYSQ? Do not use ZILBRYSQ if you have a serious meningococcal infection when you are starting ZILBRYSQ treatment.

Before you use ZILBRYSQ, tell your healthcare provider about all of your medical conditions, including if you: have an infection or fever. are pregnant or plan to become pregnant. It is not known if ZILBRYSQ will harm your unborn baby. There is a pregnancy registry for women who use ZILBRYSQ during pregnancy.…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 50474-0991-80 · UCB, 50484-0010-30 · SMITH →
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.