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BKEMV eculizumab-aeeb 300 mg/30mL Injection, Solution, Concentrate — NDC 55513-0180-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

BKEMV eculizumab-aeeb 300 mg/30mL Injection, Solution, Concentrate — NDC 55513-180-01 (Billing 55513-0180-01)

by Amgen Inc · 1 VIAL in 1 CARTON / 30 mL in 1 VIAL

This is a package of BKEMV eculizumab-aeeb 300 mg/30mL Injection, Solution, Concentrate from Amgen Inc, marketed since Mar 2025 and currently FDA-listed. It is this product's only package size.

NDC 55513-0180-01
🏷️ FDA NDC (as labeled) 55513-180-01 billing pads the product segment with a zero
Rx only Brand On market Non-controlled 🛡 REMS ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 55513-180-01
Product NDC 55513-180
11-digit billing NDC 55513018001
NCPDP billing unit ML — per mL (volume)
RxCUI 2706351, 2706358
UNII A3ULP0F556
Application # BLA761333
SPL Set ID 002f9748-b0e8-4b6e-a38b-56930a839491
Established class (EPC) Complement Inhibitor
Mechanism of action Complement Inhibitors
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-03-01
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION, CONCENTRATE
Substance ECULIZUMAB
Biologic (Purple Book) 351(k) Interchangeable · interchangeable biosimilar
Reference product eculizumab

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

GPI-14 85805050012020
GCN Seq No 086149
GCN 47665
HICL code 049642
Ingredient (HICL) Eculizumab-Aeeb
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 90:20.00.00
AHFS class Complement Inhibitor Agents (90:20)
FDB label name BKEMV 300 MG/30 ML VIAL
FDB brand name Bkemv
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 086149
  • GCN: 47665
  • GPI-14 (Medi-Span): 85805050012020
  • HICL (First Databank): 049642
  • AHFS class code: 90:20.00.00
  • RxCUI (RxNorm): 2706351
Why two NDCs? The FDA registers this code as 55513-180-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 55513-0180-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the 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.

Clinical

Label name BKEMV 300 MG/30 ML VIAL Ingredient Eculizumab-Aeeb
📖 What it is MedlinePlus · NLM

Eculizumab injection is used to treat paroxysmal nocturnal hemoglobinuria (PNH: a type of anemia in which too many red blood cells are broken down in the body, so there are not enough healthy cells to bring oxygen to all parts of the body), atypical hemolytic uremic syndrome (aHUS; an inherited condition in which small blood clots form in the body and may cause damage to the blood vessels, blood cells, kidneys, and other parts of the body), a certain type of myasthenia gravis (MG; a disorder of the nervous system that causes muscle weakness), and a certain type of neuromyelitis optica spectru...

Read the full MedlinePlus article ↗

Supplement & herbal interactions

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

Pricing

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

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · Q5152 $41.156 / Q5152 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)55513-180-01
11-digit billing NDC55513-0180-01
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeQ5152
Descriptor2 MG
Billing units / pkg150 units
How the units are derivedThis package is 30; the HCPCS unit is 2 MG, so one package = 150 billing units.
Medicare Part B spend (2026 (Q1))$2,097,206 · 84 claims · $24,966.74 per claim (all NDCs under Q5152)
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
55513-0180-01 You're viewing this Main listing 1 VIAL in 1 CARTON / 30 mL in 1 VIAL 2025-03-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Bkemv 300 mg/30mLthis 55513-0180-01 Amgen 1 vial — — FDA listed —
About this product: this is a biologic. Biologics don't have small-molecule generics — competition comes from FDA-licensed biosimilars (shown above), not generics.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & biosimilar status

🏛️
2024
First FDA approval
May 2024
📍
2026
Currently FDA-listed
2 years listed
🔓
2026
Biosimilars listed
2 FDA-licensed
🧬FDA-licensed biosimilars listed

1 biosimilar and 1 interchangeable are FDA-licensed for this reference biologic — see the list below. (Biologics have no small-molecule generics.)

🛡️ Latest patent/protection date listed: Biosimilars are already FDA-licensed for this product — the last listed patent runs to May 2036.
📅 FDA approved May 28, 2024

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
Soliriseculizumab
Interchangeable 1
Bkemveculizumab-aeeb
Biosimilars 1
Epysqlieculizumab-aagh
Source: FDA Purple Book (purplebooksearch.fda.gov), matched on the reference product’s active ingredient.
Patents & exclusivity — FDA Purple Book
Exclusivity RefProduct
2024 2026 2028 2030 2032 2034 2036
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 dateMay 28, 2036
Common questions
Is there a biosimilar for BKEMV 300 MG/30 ML VIAL?
Yes — at least one FDA-licensed biosimilar is listed for this biologic. See the Purple Book family above for the available products.
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.

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.

  • UNII Q40Q9N063P
    Acetic acid is a weak organic acid commonly used in medicines as a buffer and pH adjuster. It helps maintain the proper acidity level to ensure the drug remains stable and effective in its formulation.
  • UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in 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.

Manufacturer & labeler

LabelerAmgen Inc
FDA applicationBLA761333 (BLA)
Labeler code55513
First marketedMar 2025
Product typeHuman Prescription Drug
Portfolio18 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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 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 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🚨 Boxed Warning ~2 min read ▾

WARNING: SERIOUS MENINGOCOCCAL INFECTIONS Eculizumab products, complement inhibitors, increase 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 BKEMV, unless the risks of delaying therapy with BKEMV outweigh the risk of developing a serious infection. Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for vaccinations 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 eculizumab products 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, BKEMV is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called BKEMV REMS [see Warnings and Precautions (5.2) ] .

WARNING: SERIOUS MENINGOCOCCAL INFECTIONS See full prescribing information for complete boxed warning Eculizumab products increase the risk of serious and life-threatening infections caused by Neisseria meningitidis . Complete or update meningococcal vaccination at least 2 weeks prior to the first dose of BKEMV, unless the risks of delaying BKEMV outweigh the risk 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 eculizumab products 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 ) BKEMV is available only through a restricted program called BKEMV REMS.

( 5.2 )

🎯 Indications and Usage ~1 min read ▾

1 INDICATIONS AND USAGE BKEMV is a complement inhibitor indicated for: The treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis. ( 1.1 ) The treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy. ( 1.2 ) Limitation of Use BKEMV is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS).

The treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive. ( 1.3 ) The treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. ( 1.4 )

1.1Paroxysmal Nocturnal Hemoglobinuria (PNH) BKEMV is indicated for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis.

1.2Atypical Hemolytic Uremic Syndrome (aHUS) BKEMV is indicated for the treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy. Limitation of Use BKEMV is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS).

1.3Generalized Myasthenia Gravis (gMG) BKEMV is indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.

1.4Neuromyelitis Optica Spectrum Disorder (NMOSD) BKEMV is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION For intravenous infusion only; recommended dosage for: PNH: ( 2.2 ) aHUS, gMG, and NMOSD in adults: ( 2.3 ) aHUS in pediatric patients: ( 2.4 )

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 BKEMV [see Warnings and Precautions (5.1) ] . If urgent BKEMV 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.

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

2.2Recommended Dosage for Adults – PNH The recommended dosage of BKEMV for the treatment of PNH in patients 18 years of age and older is administered as an intravenous infusion [see Dosage and Administration (2.7) ] as follows: 600 mg weekly for the first 4 weeks, followed by 900 mg for the fifth dose 1 week later, then 900 mg every 2 weeks thereafter. Administer BKEMV at the recommended dosage regimen time points, or within two days of these time points [see Warnings and Precautions (5.4)] .

2.3Recommended Dosage for Adults – aHUS, gMG, and NMOSD The recommended dosage of BKEMV for the treatment of aHUS, gMG, or NMOSD in patients 18 years of age and older is administered as an intravenous infusion [see Dosage and Administration (2.7) ] as follows: 900 mg weekly for the first 4 weeks, followed by 1,200 mg for the fifth dose 1 week later, then 1,200 mg every 2 weeks thereafter.

2.4Recommended Dosage for Pediatric Patients – aHUS The recommended dosage of BKEMV for the treatment of aHUS in pediatric patients less than 18 years of age is administered as an intravenous infusion based upon body weight, according to the following schedule (Table 1): Table 1: Dosing Recommendations in Pediatric Patients Less Than 18 Years of Age with aHUS Patient Body Weight Induction Maintenance 40 kg and over 900 mg weekly for the first 4 weeks 1,200 mg at week 5; then 1,200 mg every 2 weeks 30 kg to less than 40 kg 600 mg weekly for the first 2 weeks 900 mg at week 3; then 900 mg every 2 weeks 20 kg to less than 30 kg 600 mg weekly for the first 2 weeks 600 mg at week 3; then 600 mg every 2 weeks 10 kg to less than 20 kg 600 mg single dose at Week 1 300 mg at week 2; then 300 mg every 2 weeks 5 kg to less than 10 kg 300 mg single dose at Week 1 300 mg at week 2; then 300 mg every 3 weeks Administer BKEMV at the recommended dosage regimen time points, or within two days of these time points.

2.5Dose Adjustment in Case of Plasmapheresis, Plasma Exchange, Fresh Frozen Plasma Infusion or IVIg For adult and pediatric patients with aHUS, and adult patients with gMG or NMOSD, supplemental dosing of BKEMV is required in the setting of concomitant plasmapheresis or plasma exchange, or fresh frozen plasma infusion (PE/PI) (Table 2). Table 2: Supplemental Dose of BKEMV after Plasmapheresis/PE/PI Type of Plasma Intervention Most Recent BKEMV Dose Supplemental BKEMV Dose with Each Plasma Intervention Timing of Supplemental BKEMV Dose Plasmapheresis or plasma exchange 300 mg 300 mg per each plasmapheresis or plasma exchange session Within 60 minutes after each plasmapheresis or plasma exchange 600 mg or greater 600 mg per each plasmapheresis or plasma exchange session Fresh frozen plasma infusion 300 mg or greater 300 mg per infusion of fresh frozen plasma 60 minutes prior to each infusion of fresh frozen plasma For patients with gMG, a supplemental dose of BKEMV is required in the setting of concomitant use of intravenous immunoglobulin (IVIg) treatment as described in Table 3.

Table 3: Supplemental Dose of BKEMV with concomitant IVIg IVIg Frequency Most Recent BKEMV Dose Supplemental BKEMV Dose per IVIg Cycle Timing of Supplemental BKEMV Dose Acute rescue therapy N… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 39 words ▾

3 DOSAGE FORMS AND STRENGTHS Injection: 300 mg/30 mL (10 mg/mL) as a clear to opalescent and colorless to slightly yellow solution in a single-dose vial. Injection: 300 mg/30 mL (10 mg/mL) in a single-dose vial. ( 3 )

⛔ Contraindications 38 words ▾

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

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Use caution when administering BKEMV to patients with any other systemic infection. ( 5.3 ) Infusion-Related Reactions: Monitor patients during infusion, interrupt for reactions, and institute appropriate supportive measures. ( 5.6 )

5.1Serious Meningococcal Infections Eculizumab products, complement inhibitors, increase 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 BKEMV 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 BKEMV, according to current ACIP recommendations for patients receiving a complement inhibitor. Revaccinate patients in accordance with ACIP recommendations considering the duration of therapy with BKEMV. 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 BKEMV 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 eculizumab products.

The benefits and risks of treatment with BKEMV, 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 serious 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 BKEMV in patients who are undergoing treatment for serious meningococcal infection, depending on the risks of interrupting treatment in the disease being treated. BKEMV is available only through a restricted program under a REMS [see Warnings and Precautions (5.2) ] .

5.2BKEMV REMS BKEMV is available only through a restricted program under a REMS called BKEMV REMS, because of the risk of serious meningococcal infections [see Warnings and Precautions (5.1) ] . Notable requirements of the BKEMV 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 2 weeks prior to the first dose of BKEMV. Prescribers must provide a prescription for antibacterial drug prophylaxis if treatment must be started urgently and the patient is not up to date with meningococcal vaccines according to current ACIP recommendations at least two weeks prior to the first dose of BKEMV.

Healthcare settings and pharmacies that dispense BKEMV must be certifi… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious 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) ] Monitoring Disease Manifestations after BKEMV Discontinuation [see Warnings and Precautions (5.4) ] Thrombosis Prevention and Management [see Warnings and Precautions (5.5) ] Infusion-Related Reactions [see Warnings and Precautions (5.6) ] The most frequently reported adverse reactions in the PNH randomized trial (≥ 10% overall and greater than placebo) are: headache, nasopharyngitis, back pain, and nausea.

( 6.1 ) The most frequently reported adverse reactions in aHUS single arm prospective trials (≥ 20%) are: headache, diarrhea, hypertension, upper respiratory infection, abdominal pain, vomiting, nasopharyngitis, anemia, cough, peripheral edema, nausea, urinary tract infections, pyrexia. ( 6.1 ) The most frequently reported adverse reaction in the gMG placebo-controlled clinical trial (≥ 10%) in adult patients is musculoskeletal pain. ( 6.1 ) The most frequently reported adverse reactions in the NMOSD placebo-controlled trial (≥ 10%) are: upper respiratory infection, nasopharyngitis, diarrhea, back pain, dizziness, influenza, arthralgia, pharyngitis, and contusion.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Amgen Medical Information 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. Meningococcal infections are the most important adverse reactions experienced by patients receiving eculizumab. In PNH clinical studies, two patients experienced meningococcal sepsis.

Both patients had previously received a meningococcal vaccine. In clinical studies among patients without PNH, meningococcal meningitis occurred in one unvaccinated patient. Meningococcal sepsis occurred in one previously vaccinated patient enrolled in the retrospective aHUS study during the post-study follow-up period [see Warnings and Precautions (5.1) ] .

PNH The data described below reflect exposure to eculizumab in 196 adult patients with PNH, age 18-85, of whom 55% were female. All had signs or symptoms of intravascular hemolysis. Eculizumab was studied in a placebo-controlled clinical study (PNH Study 1, in which 43 patients received eculizumab and 44, placebo); a single arm clinical study (PNH Study 2); and a long-term extension study (E05-001).

One hundred and eighty two patients were exposed for greater than one year. All patients received the recommended eculizumab dose regimen. Table 5 summarizes the adverse reactions that occurred at a numerically higher rate in the eculizumab group than the placebo group and at a rate of 5% or more among patients treated with eculizumab.

Table 5: Adverse Reactions Reported in 5% or More of Eculizumab Treated Patients with PNH and Greater than Placebo in the Controlled Clinical Study Reaction Eculizumab (N = 43) N (%) Placebo (N = 44) N (%) Headache 19 (44) 12 (27) Nasopharyngitis 10 (23) 8 (18) Back pain 8 (19) 4 (9) Nausea 7 (16) 5 (11) Fatigue 5 (12) 1 (2) Cough 5 (12) 4 (9) Herpes simplex infections 3 (7) 0 Sinusitis 3 (7) 0 Respiratory tract infection 3 (7) 1 (2) Constipation 3 (7) 2 (5) Myalgia 3 (7) 1 (2) Pain in extremity 3 (7) 1 (2) Influenza-like illness 2 (5) 1 (2) In the placebo-controlled clinical study, serious adverse reactions occurred among 4 (9%) patients receiving eculizumab and 9 (21%) patients receiving placebo.

The serious reactions included infections and progression of PNH. No deaths occurred in the study and no patients receiving eculizumab experienced a thrombotic event; one thrombotic event occurred in a patient… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 91 words ▾

7 DRUG INTERACTIONS

7.1Plasmapheresis, Plasma Exchange, Fresh Frozen Plasma Infusion or IVIg Concomitant use of eculizumab products with plasma exchange (PE), plasmapheresis (PP), fresh frozen plasma infusion (PE/PI), or in patients with gMG on concomitant IVIg treatment can reduce serum eculizumab product concentrations and requires a supplemental dose of BKEMV [see Dosage and Administration (2.5) ] .

7.2Neonatal Fc Receptor Blockers Concomitant use of eculizumab products with neonatal Fc receptor (FcRn) blockers may lower systemic exposures and reduce effectiveness of eculizumab products. Closely monitor for reduced effectiveness of BKEMV.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Limited data on outcomes of pregnancies that have occurred following eculizumab use in pregnant women have not identified a concern for specific adverse developmental outcomes ( see Data ). There are risks to the mother and fetus associated with untreated paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS) in pregnancy ( see Clinical Considerations ). Animal studies using a mouse analogue of the eculizumab molecule (murine anti-C5 antibody) showed increased rates of developmental abnormalities and an increased rate of dead and moribund offspring at doses 2-8 times the human dose ( see Data ) .

The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defect and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Clinical Considerations Disease-associated maternal and/or fetal/neonatal risk PNH in pregnancy is associated with adverse maternal outcomes, including worsening cytopenias, thrombotic events, infections, bleeding, miscarriages and increased maternal mortality, and adverse fetal outcomes, including fetal death and premature delivery. aHUS in pregnancy is associated with adverse maternal outcomes, including pre-eclampsia and preterm delivery, and adverse fetal/neonatal outcomes, including intrauterine growth restriction (IUGR), fetal death and low birth weight.

Data Human Data A pooled analysis of prospectively (50.3%) and retrospectively (49.7%) collected data in more than 300 pregnant women with live births following exposure to eculizumab have not suggested safety concerns. However, these data cannot definitively exclude any drug-associated risk during pregnancy, because of the limited sample size. Animal Data Animal reproduction studies were conducted in mice using doses of a murine anti-C5 antibody that approximated 2-4 times (low dose) and 4-8 times (high dose) the recommended human eculizumab dose, based on a body weight comparison.

When animal exposure to the antibody occurred in the time period from before mating until early gestation, no decrease in fertility or reproductive performance was observed. When maternal exposure to the antibody occurred during organogenesis, two cases of retinal dysplasia and one case of umbilical hernia were observed among 230 offspring born to mothers exposed to the higher antibody dose; however, the exposure did not increase fetal loss or neonatal death. When maternal exposure to the antibody occurred in the time period from implantation through weaning, a higher number of male offspring became moribund or died (1/25 controls, 2/25 low dose group, 5/25 high dose group).

Surviving offspring had normal development and reproductive function.

8.2Lactation Risk Summary Although limited published data does not report detectable levels of eculizumab in human milk, maternal IgG is known to be present in human milk. Available information is insufficient to inform the effect of eculizumab products on the breastfed infant. There are no data on the effects of eculizumab products on milk production.

The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for BKEMV and any potential adverse effects on the breastfed child from BKEMV or from the underlying maternal condition.

8.4Pediatric Use PNH and NMOSD Safety and effectiveness of BKEMV for the treatment of PNH or NMOSD in pediatric patients have not been established. aHUS The safety and effectiveness of BKEMV for the treatment of aHUS have been established in pediatric patients. Use of BKEMV in pediatric patients for this indication is supported by evidence from four adequate and well-controlled clinical studies assessing the safety and effective… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Limited data on outcomes of pregnancies that have occurred following eculizumab use in pregnant women have not identified a concern for specific adverse developmental outcomes ( see Data ). There are risks to the mother and fetus associated with untreated paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS) in pregnancy ( see Clinical Considerations ). Animal studies using a mouse analogue of the eculizumab molecule (murine anti-C5 antibody) showed increased rates of developmental abnormalities and an increased rate of dead and moribund offspring at doses 2-8 times the human dose ( see Data ) .

The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defect and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Clinical Considerations Disease-associated maternal and/or fetal/neonatal risk PNH in pregnancy is associated with adverse maternal outcomes, including worsening cytopenias, thrombotic events, infections, bleeding, miscarriages and increased maternal mortality, and adverse fetal outcomes, including fetal death and premature delivery. aHUS in pregnancy is associated with adverse maternal outcomes, including pre-eclampsia and preterm delivery, and adverse fetal/neonatal outcomes, including intrauterine growth restriction (IUGR), fetal death and low birth weight.

Data Human Data A pooled analysis of prospectively (50.3%) and retrospectively (49.7%) collected data in more than 300 pregnant women with live births following exposure to eculizumab have not suggested safety concerns. However, these data cannot definitively exclude any drug-associated risk during pregnancy, because of the limited sample size. Animal Data Animal reproduction studies were conducted in mice using doses of a murine anti-C5 antibody that approximated 2-4 times (low dose) and 4-8 times (high dose) the recommended human eculizumab dose, based on a body weight comparison.

When animal exposure to the antibody occurred in the time period from before mating until early gestation, no decrease in fertility or reproductive performance was observed. When maternal exposure to the antibody occurred during organogenesis, two cases of retinal dysplasia and one case of umbilical hernia were observed among 230 offspring born to mothers exposed to the higher antibody dose; however, the exposure did not increase fetal loss or neonatal death. When maternal exposure to the antibody occurred in the time period from implantation through weaning, a higher number of male offspring became moribund or died (1/25 controls, 2/25 low dose group, 5/25 high dose group).

Surviving offspring had normal development and reproductive function.

🧒 Pediatric Use 153 words ▾

8.4Pediatric Use PNH and NMOSD Safety and effectiveness of BKEMV for the treatment of PNH or NMOSD in pediatric patients have not been established. aHUS The safety and effectiveness of BKEMV for the treatment of aHUS have been established in pediatric patients. Use of BKEMV in pediatric patients for this indication is supported by evidence from four adequate and well-controlled clinical studies assessing the safety and effectiveness of eculizumab for the treatment of aHUS. The studies included a total of 47 pediatric patients (ages 2 months to 17 years).

The safety and effectiveness of eculizumab for the treatment of aHUS appear similar in pediatric and adult patients [see Adverse Reactions (6.1) , and Clinical Studies (14.2) ] . Vaccinations Administer vaccinations for the prevention of infection due to Neisseria meningitidis , Streptococcus pneumoniae and Haemophilus influenzae type b (Hib) according to ACIP guidelines [see Warnings and Precautions (5.1 , 5.3) ] .

🧓 Geriatric Use 66 words ▾

8.5Geriatric Use Fifty-one patients 65 years of age or older (15 with PNH, 4 with aHUS, 26 with gMG, and 6 with NMOSD) were treated with eculizumab in clinical trials in the approved indications. Although there were no apparent age-related differences observed in these studies, the number of patients aged 65 and over is not sufficient to determine whether they respond differently from younger patients.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Eculizumab-aeeb, the active ingredient in BKEMV, is a monoclonal antibody that specifically binds to the complement protein C5 with high affinity, thereby inhibiting its cleavage to C5a and C5b and preventing the generation of the terminal complement complex C5b-9. Eculizumab products inhibit terminal complement-mediated intravascular hemolysis in PNH patients and complement-mediated thrombotic microangiopathy (TMA) in patients with aHUS. The precise mechanism by which eculizumab products exert their therapeutic effect in gMG patients is unknown, but is presumed to involve reduction of terminal complement complex C5b-9 deposition at the neuromuscular junction.

The precise mechanism by which eculizumab products exert their therapeutic effect in NMOSD is unknown, but is presumed to involve inhibition of aquaporin-4-antibody induced terminal complement C5b-9 deposition.

12.2Pharmacodynamics In the placebo-controlled clinical study (PNH Study 1), eculizumab when administered as recommended reduced serum LDH levels from 2200 ± 1034 U/L (mean ± SD) at baseline to 700 ± 388 U/L by week one and maintained the effect through the end of the study at week 26 (327 ± 433 U/L) in patients with PNH. In the single arm clinical study (PNH Study 2), the effect was maintained through week 52 [see Clinical Studies (14) ] . In patients with PNH, aHUS, gMG, and NMOSD, free C5 concentrations of < 0.5 mcg/mL was correlated with complete blockade of terminal complement activity.

12.3Pharmacokinetics Following intravenous maintenance doses of 900 mg once every 2 weeks in patients with PNH, the week 26 observed mean ± SD serum eculizumab maximum concentration (C max ) was 194 ± 76 mcg/mL and the trough concentration (C trough ) was 97 ± 60 mcg/mL. Following intravenous maintenance doses of 1200 mg once every 2 weeks in patients with aHUS, the week 26 observed mean ± SD C trough was 242 ± 101 mcg/mL. Following intravenous maintenance doses of 1200 mg once every 2 weeks in adult patients with gMG, the week 26 observed mean ± SD C max was 783 ± 288 mcg/mL and the C trough was 341 ± 172 mcg/mL.

Following intravenous maintenance doses of 1200 mg once every 2 weeks in patients with NMOSD, at week 24, the observed mean ± SD C max was 877 ± 331 and the C trough was 429 ± 188 mcg/mL. Steady state was achieved 4 weeks after starting eculizumab treatment, with accumulation ratio of approximately 2-fold in all studied indications. Population pharmacokinetic analyses showed that eculizumab pharmacokinetics were dose-linear and time-independent over the 600 mg to 1200 mg dose range, with inter-individual variability of 21% to 38%.

Distribution The eculizumab volume of distribution for a typical 70 kg patient was 5 L to 8 L. Elimination The half-life of eculizumab ranged between 141 hours and 882 hours. Plasma exchange or infusion increased the clearance of eculizumab by approximately 6.01-fold and reduced the half-life to 90.2 hours.

Supplemental dosing is recommended when BKEMV is administered to patients receiving plasma exchange or infusion [see Dosage and Administration (2.5) ] . Specific Populations Age, Sex, and Race: The pharmacokinetics of eculizumab were not affected by age (2 months to 85 years), sex, or race. Renal Impairment: Renal function did not affect the pharmacokinetics of eculizumab in PNH (creatinine clearance of 8 mL/min to 396 mL/min calculated using Cockcroft-Gault formula), aHUS (estimated glomerular filtration rate [eGFR] of 5 mL/min/1.73 m 2 to 105 mL/min/1.73 m 2 using the Modification of Diet in Renal Disease [MDRD] formula), or gMG patients (eGFR of 44 mL/min/1.73 m 2 to 168 mL/min/1.73 m 2 using MDRD formula).

12.6Immunogenicity The observed incidence of anti-drug antibodies is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of anti-drug antibodies in the studies described below with the inc… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 122 words ▾

12.1Mechanism of Action Eculizumab-aeeb, the active ingredient in BKEMV, is a monoclonal antibody that specifically binds to the complement protein C5 with high affinity, thereby inhibiting its cleavage to C5a and C5b and preventing the generation of the terminal complement complex C5b-9. Eculizumab products inhibit terminal complement-mediated intravascular hemolysis in PNH patients and complement-mediated thrombotic microangiopathy (TMA) in patients with aHUS. The precise mechanism by which eculizumab products exert their therapeutic effect in gMG patients is unknown, but is presumed to involve reduction of terminal complement complex C5b-9 deposition at the neuromuscular junction.

The precise mechanism by which eculizumab products exert their therapeutic effect in NMOSD is unknown, but is presumed to involve inhibition of aquaporin-4-antibody induced terminal complement C5b-9 deposition.

📦 How Supplied / Storage and Handling 119 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING BKEMV (eculizumab-aeeb) injection is a sterile, preservative-free, clear to opalescent, colorless to slightly yellow solution supplied as one 300 mg/30 mL (10 mg/mL) single-dose vial per carton (NDC 55513-180-01). Store BKEMV vials refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light until time of use. BKEMV vials may be stored in the original carton at controlled room temperature [not more than 25°C (77°F)] for only a single period up to 7 days.

Do not use beyond the expiration date stamped on the carton. Refer to Dosage and Administration (2) for information on the stability and storage of diluted solutions of BKEMV. DO NOT FREEZE.

DO NOT SHAKE.

📦 Storage and Handling 85 words ▾

Store BKEMV vials refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light until time of use. BKEMV vials may be stored in the original carton at controlled room temperature [not more than 25°C (77°F)] for only a single period up to 7 days. Do not use beyond the expiration date stamped on the carton.

Refer to Dosage and Administration (2) for information on the stability and storage of diluted solutions of BKEMV. DO NOT FREEZE. DO NOT SHAKE.

📋 Description 157 words ▾

11 DESCRIPTION Eculizumab-aeeb, a complement inhibitor, is a recombinant humanized monoclonal IgG2/4κ antibody produced by Chinese Hamster Ovary (CHO) cell culture and purified by standard bioprocess technology. Eculizumab-aeeb contains human constant regions from human IgG2 sequences and human IgG4 sequences and murine complementarity-determining regions grafted onto the human framework light- and heavy-chain variable regions. Eculizumab-aeeb is composed of two 448 amino acid heavy chains and two 214 amino acid light chains and has a molecular weight of approximately 148 kDa.

BKEMV (eculizumab-aeeb) injection is a sterile, clear to opalescent, colorless to slightly yellow, preservative-free 10 mg/mL solution for intravenous infusion and is supplied in 30 mL single-dose vials. The product is formulated at pH 5.2 and each 30 mL vial contains 300 mg of eculizumab-aeeb, sorbitol (E420) (1500 mg), acetic acid (18 mg), polysorbate 80 (3 mg) (vegetable origin), edetate disodium (EDTA) (0.6 mg), sodium hydroxide may be added to adjust pH, and Water for Injection, USP.

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patients and/or caregivers to read the FDA-approved patient labeling (Medication Guide). Serious Meningococcal Infections Advise patients of the risk of serious meningococcal infection. Inform patients of the need to complete or update their meningococcal vaccinations at least 2 weeks prior to receiving the first dose of BKEMV or receive antibacterial drug prophylaxis if BKEMV 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 BKEMV therapy [see Warnings and Precautions (5.1) ] . Inform patients that vaccination may not prevent serious meningococcal infection and to seek immediate medical attention if the following signs or symptoms occur [see Warnings and Precautions (5.1) ] : 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 BKEMV that they should carry with them at all times during and for 3 months following treatment with BKEMV.

This card describes symptoms which, if experienced, should prompt the patient to immediately seek medical evaluation. BKEMV REMS BKEMV is available only through a restricted program called BKEMV 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 3 months following treatment with BKEMV. 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 BKEMV.

Patients must receive antibiotics as directed by the prescriber if they are not up to date with meningococcal vaccines and have to start BKEMV right away. Other Infections Counsel patients about gonorrhea prevention and advise regular testing for patients at-risk. Inform patients that there may be an increased risk of other types of infections, particularly those due to encapsulated bacteria.

Aspergillus infections have occurred in immunocompromised and neutropenic patients. Inform parents or caregivers of children receiving BKEMV for the treatment of aHUS that their child should be vaccinated against Streptococcus pneumoniae and Haemophilus influenzae type b (Hib) according to current medical guidelines. Infusion-Related Reactions Advise patients that administration of BKEMV may result in infusion-related reactions.

Discontinuation Inform patients with PNH that they may develop serious hemolysis due to PNH when BKEMV is discontinued and that they will be monitored by their healthcare professional for at least 8 weeks following BKEMV discontinuation. Inform patients with aHUS that there is a potential for TMA complications due to aHUS when BKEMV is discontinued and that they will be monitored by their healthcare professional for at least 12 weeks following BKEMV discontinuation. Inform patients who discontinue BKEMV to keep the Patient Safety Card with them for three months after the last BKEMV dose, because the increased risk of meningococcal infection persists for several weeks following discontinuation of BKEMV.

💬 Medication Guide ~3 min read ▾

This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised 06/2026 MEDICATION GUIDE BKEMV ® (bee-KEM-vee) (eculizumab-aeeb) injection, for intravenous use What is the most important information I should know about BKEMV?

BKEMV is a medicine that affects your immune system. BKEMV may lower the ability of your immune system to fight infections. BKEMV 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 BKEMV. If you have not completed your meningococcal vaccines and BKEMV must be started right away, you should receive the required vaccine(s) as soon as possible.

If you have not been vaccinated and BKEMV 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 BKEMV. 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 serious 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 3 months after your last dose of BKEMV. Your risk of meningococcal infection may continue for several weeks after your last dose of BKEMV. It is important to show this card to any healthcare provider who treats you.

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

BKEMV may also increase the risk of other types of serious infections caused by encapsulated bacteria, including Streptococcus pneumoniae , Haemophilus influenzae , and Neisseria gonorrhoeae . If your child is treated with BKEMV, your child should receive vaccines against Streptococcus pneumoniae and Haemophilus influenzae type b (Hib). 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 regular testing. Certain fungal infections (aspergillus) may also happen if you take BKEMV and have a weak immune system or a low white blood cell count. For more information about side effects, see " What are the possible side effects of BKEMV? " What is BKEMV?

BKEMV is a prescription medicine used to treat: people with paroxysmal nocturnal hemoglobinuria (PNH). people with atypical hemolytic uremic syndrome (aHUS). BKEMV is not for use in treating people with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS). adults with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive. adults with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics ~2 min read ▾

12.3Pharmacokinetics Following intravenous maintenance doses of 900 mg once every 2 weeks in patients with PNH, the week 26 observed mean ± SD serum eculizumab maximum concentration (C max ) was 194 ± 76 mcg/mL and the trough concentration (C trough ) was 97 ± 60 mcg/mL. Following intravenous maintenance doses of 1200 mg once every 2 weeks in patients with aHUS, the week 26 observed mean ± SD C trough was 242 ± 101 mcg/mL. Following intravenous maintenance doses of 1200 mg once every 2 weeks in adult patients with gMG, the week 26 observed mean ± SD C max was 783 ± 288 mcg/mL and the C trough was 341 ± 172 mcg/mL.

Following intravenous maintenance doses of 1200 mg once every 2 weeks in patients with NMOSD, at week 24, the observed mean ± SD C max was 877 ± 331 and the C trough was 429 ± 188 mcg/mL. Steady state was achieved 4 weeks after starting eculizumab treatment, with accumulation ratio of approximately 2-fold in all studied indications. Population pharmacokinetic analyses showed that eculizumab pharmacokinetics were dose-linear and time-independent over the 600 mg to 1200 mg dose range, with inter-individual variability of 21% to 38%.

Distribution The eculizumab volume of distribution for a typical 70 kg patient was 5 L to 8 L. Elimination The half-life of eculizumab ranged between 141 hours and 882 hours. Plasma exchange or infusion increased the clearance of eculizumab by approximately 6.01-fold and reduced the half-life to 90.2 hours.

Supplemental dosing is recommended when BKEMV is administered to patients receiving plasma exchange or infusion [see Dosage and Administration (2.5) ] . Specific Populations Age, Sex, and Race: The pharmacokinetics of eculizumab were not affected by age (2 months to 85 years), sex, or race. Renal Impairment: Renal function did not affect the pharmacokinetics of eculizumab in PNH (creatinine clearance of 8 mL/min to 396 mL/min calculated using Cockcroft-Gault formula), aHUS (estimated glomerular filtration rate [eGFR] of 5 mL/min/1.73 m 2 to 105 mL/min/1.73 m 2 using the Modification of Diet in Renal Disease [MDRD] formula), or gMG patients (eGFR of 44 mL/min/1.73 m 2 to 168 mL/min/1.73 m 2 using MDRD formula).

🧬 Pharmacodynamics 104 words ▾

12.2Pharmacodynamics In the placebo-controlled clinical study (PNH Study 1), eculizumab when administered as recommended reduced serum LDH levels from 2200 ± 1034 U/L (mean ± SD) at baseline to 700 ± 388 U/L by week one and maintained the effect through the end of the study at week 26 (327 ± 433 U/L) in patients with PNH. In the single arm clinical study (PNH Study 2), the effect was maintained through week 52 [see Clinical Studies (14) ] . In patients with PNH, aHUS, gMG, and NMOSD, free C5 concentrations of < 0.5 mcg/mL was correlated with complete blockade of terminal complement activity.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Paroxysmal Nocturnal Hemoglobinuria (PNH) The safety and efficacy of eculizumab in PNH patients with hemolysis were assessed in a randomized, double-blind, placebo-controlled 26-week study (PNH Study 1, NCT00122330); PNH patients were also treated with eculizumab in a single arm 52-week study (PNH Study 2, NCT00122304) and in a long-term extension study (E05-001, NCT00122317). Patients received meningococcal vaccination prior to receipt of eculizumab. In all studies, the dose of eculizumab was 600 mg study drug every 7 ± 2 days for 4 weeks, followed by 900 mg 7 ± 2 days later, then 900 mg every 14 ± 2 days for the study duration.

Eculizumab was administered as an intravenous infusion over 25 - 45 minutes. PNH Study 1: PNH patients with at least four transfusions in the prior 12 months, flow cytometric confirmation of at least 10% PNH cells and platelet counts of at least 100,000/microliter were randomized to either eculizumab (n = 43) or placebo (n = 44). Prior to randomization, all patients underwent an initial observation period to confirm the need for RBC transfusion and to identify the hemoglobin concentration (the "set-point") which would define each patient's hemoglobin stabilization and transfusion outcomes.

The hemoglobin set-point was less than or equal to 9 g/dL in patients with symptoms and was less than or equal to 7 g/dL in patients without symptoms. Endpoints related to hemolysis included the numbers of patients achieving hemoglobin stabilization, the number of RBC units transfused, fatigue, and health-related quality of life. To achieve a designation of hemoglobin stabilization, a patient had to maintain a hemoglobin concentration above the hemoglobin set-point and avoid any RBC transfusion for the entire 26-week period.

Hemolysis was monitored mainly by the measurement of serum LDH levels, and the proportion of PNH RBCs was monitored by flow cytometry. Patients receiving anticoagulants and systemic corticosteroids at baseline continued these medications. Major baseline characteristics were balanced (see Table 11 ).

Table 11: PNH Study 1 Patient Baseline Characteristics Study 1 Parameter Placebo (N = 44) Eculizumab (N = 43) Mean age (SD) 38 (13) 42 (16) Gender - female (%) 29 (66) 23 (54) History of aplastic anemia or myelodysplastic syndrome (%) 12 (27) 8 (19) Patients with history of thrombosis (events) 8 (11) 9 (16) Concomitant anticoagulants (%) 20 (46) 24 (56) Concomitant steroids/immunosuppressant treatments (%) 16 (36) 14 (33) Packed RBC units transfused per patient in previous 12 months (median (Q1, Q3)) 17 (14, 25) 18 (12, 24) Mean Hgb level (g/dL) at setpoint (SD) 8 (1) 8 (1) Pre-treatment LDH levels (median, U/L) 2,234 2,032 Free hemoglobin at baseline (median, mg/dL) 46 41 Patients treated with eculizumab had significantly reduced (p<0.001) hemolysis resulting in improvements in anemia as indicated by increased hemoglobin stabilization and reduced need for RBC transfusions compared to placebo treated patients (see Table 12 ).

These effects were seen among patients within each of the three pre-study RBC transfusion strata (4 - 14 units; 15 - 25 units; >25 units). After 3 weeks of eculizumab treatment, patients reported less fatigue and improved health-related quality of life. Because of the study sample size and duration, the effects of eculizumab products on thrombotic events could not be determined.

Table 12: PNH Study 1 Results Placebo (N = 44) eculizumab (N = 43) Percentage of patients with stabilized hemoglobin levels 0 49 Packed RBC units transfused per patient (median) 10 0 (range) (2 - 21) (0 - 16) Transfusion avoidance (%) 0 51 LDH levels at end of study (median, U/L) 2,167 239 Free hemoglobin at end of study (median, mg/dL) 62 5 PNH Study 2 and Extension Study : PNH patients with at least one transfusion in the prior 24 months and at least 30,000 platelets/microliter received eculizumab over a 52-week period.

Concomitant medications included anti-thrombotic agents in… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 74 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal carcinogenicity studies of eculizumab products have not been conducted. Genotoxicity studies have not been conducted with eculizumab products. Effects of eculizumab products upon fertility have not been studied in animals.

Intravenous injections of male and female mice with a murine anti-C5 antibody at up to 4-8 times the equivalent of the clinical dose of eculizumab had no adverse effects on mating or fertility.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 71 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal carcinogenicity studies of eculizumab products have not been conducted. Genotoxicity studies have not been conducted with eculizumab products. Effects of eculizumab products upon fertility have not been studied in animals.

Intravenous injections of male and female mice with a murine anti-C5 antibody at up to 4-8 times the equivalent of the clinical dose of eculizumab had no adverse effects on mating or fertility.

📄 Recent Major Changes 28 words ▾

Indications and Usage ( 1.4 ) 06/2026 Dosage and Administration, ( 2.3 ) 06/2026 Dosage and Administration, ( 2.4 ) 11/2025 Dosage and Administration, ( 2.5 ) 06/2026

📄 Package Label / Principal Display Panel 64 words ▾

PRINCIPAL DISPLAY PANEL - 30 mL Vial Carton 300 mg/30 mL BKEMV™ (eculizumab-aeeb) Injection NDC 55513-180-01 300 mg/30 mL (10 mg/mL) For Intravenous Infusion Only ATTENTION: Enclosed Medication Guide is required for each patient. Sterile Solution - No Preservative Must be diluted prior to use. Contains 1 Single-Dose Vial Discard unused portion. AMGEN ® Rx Only PRINCIPAL DISPLAY PANEL - 30 mL Vial Carton

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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This drug has a REMS — BKEMV 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 Eculizumab-aeeb — the ingredient across all brands.

Top reported reactions

Arthropathy1
Death1
Gallbladder Operation1
Gastrointestinal Haemorrhage1
Muscle Discomfort1
Premature Baby1
Rash1

Age at onset

Neonate1
Adult2
Elderly1

Reporter sex

7 reports

Serious outcomes

Hospitalization2
Death1
Reports over time (by year) — tap or hover for the count & year
2025 2026 1 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.

About this NDC listing & data coverage

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

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Amgen Inc. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Amgen 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 Q5152 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.
← 55513-0168-80 · Amgen, 55513-0190-01 · Amgen, →
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.