NDC 55513-0283-10 — EPOGEN epoetin alfa 10000 [iU]/mL Solution

🆔 Identity & classification

FDA NDC (as labeled) 55513-283-10

Product NDC 55513-283

11-digit billing NDC 55513028310

NCPDP billing unit ML — per mL (volume)

RxCUI 205912, 205917, 205921, 205923, 212218, 239998, 239999, 240000,

UNII 64FS3BFH5W

Application # BLA103234

SPL Set ID 1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5

Established class (EPC) Erythropoiesis-stimulating Agent

Physiologic effect Increased Erythroid Cell Production

Chemical class Erythropoietin

DEA schedule Non-controlled

Marketing category BLA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 1994-12-05

Route INTRAVENOUS, SUBCUTANEOUS

Dosage form SOLUTION

Substance EPOETIN

GPI-14 82401020002040

GCN Seq No 058592

GCN 24059

HICL code 004553

Ingredient (HICL) Epoetin Alfa

HIC1 code N

Therapeutic class — broad (HIC1) Bone Marrow

HIC2 code N1

Therapeutic class — intermediate (HIC2) Affecting Blood, Non-Iron Hematinics And Others

HIC3 code N1B

Therapeutic class — specific (HIC3) Erythropoiesis-Stimulating Agents

AHFS code 20:16.00.00

AHFS class Hematopoietic Agents

FDB label name EPOGEN 20,000 UNIT/2 ML VIAL

FDB brand name Epogen

Legend status F — Federal legend — prescription drug or device

Biologic (Purple Book) 351(a)

Why two NDCs? The FDA registers this code as 55513-283-10 — 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 → 55513-0283-10. 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 Erythropoiesis-stimulating Agent class.

Pharmacologic class Erythropoiesis-stimulating Agent

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

LabelerAmgen, Inc

FDA applicationBLA103234 (BLA)

Labeler code55513

First marketedDec 1994

Product typeHuman Prescription Drug

Portfolio81 products on file

🔎 All NDCs from Amgen, Inc

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 EPOGEN 20,000 UNIT/2 ML VIAL Ingredient Epoetin Alfa

📖 What it is MedlinePlus · NLM

Epoetin alfa injection products are used to treat anemia (a lower than normal number of red blood cells) in people with chronic kidney failure (condition in which the kidneys slowly and permanently stop working over a period of time). Epoetin alfa injection products are also used to treat anemia caused by chemotherapy in people with certain types of cancer or caused by zidovudine (AZT, Retrovir, in Trizivir, in Combivir), a medication used to treat human immunodeficiency virus (HIV). Epoetin alfa injection products are also used before and after certain types of surgery to decrease the chance...

Read the full MedlinePlus article ↗

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

Some supplements/herbs that may interact with Epoetin Alfa — tap one for details:

BiofeedbackModerate DendrobiumModerate GinkgoModerate MelatoninModerate RauwolscineModerate ThujaModerate

🌿 Every supplement checked against Epoetin Alfa (6 interactions) — ranked by severity →

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.

2.5 mg / 1 mL UNII ZIF514RVZR
A protein derived from human blood plasma. In medicines, it acts as a stabilizer and binder, helping maintain drug potency and form, and may improve how the medication disperses or dissolves in the body.
0.01 mL / 1 mL UNII LKG8494WBH
Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
0.11 mg / 1 mL UNII 2968PHW8QP
A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
8.2 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.
1.3 mg / 1 mL UNII 1Q73Q2JULR
Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.

5 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 system	Per mL	Per package
Retail pharmacies payNADAC · weekly	Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo	$145.14	$2,902.70 / 20 ml
Medicare drug plans payPart D · Q2 2026	$159.57	$3,191.40 / 20 ml
Medicare Part B allowsASP · J0885	$6.876 / J0885 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)55513-283-10

11-digit billing NDC55513-0283-10

Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)

HCPCS J-codeJ0885

DescriptorINJECTION, EPOETIN ALFA, (FOR NON-ESRD USE), 1000 UNITS

Billing units / pkg10 units

Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)

Where does this data come from?

The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Epogen 10000 [iU]/mL 55513-0144-10	Amgen,	10 vials	$161.800	—	Availability likely	—
Epogen 10000 [iU]/mLthis 55513-0283-10	Amgen,	10 vials	—	—	FDA listed	—
Procrit 10000 [iU]/mL 59676-0312-04	Janssen	4 vials	—	—	FDA listed	—

About this product: this is a biologic. Biologics don't have small-molecule generics — competition comes from FDA-licensed biosimilars (shown above), not generics.

Where does this data come from?

Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & biosimilar status

🏛️

1989

First FDA approval

Jun 1989

📍

2026

Currently FDA-listed

37 years listed

🔓

2026

Biosimilars listed

1 FDA-licensed

🧬FDA-licensed biosimilars listed

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

FDA Purple Book — biosimilars & interchangeables ⓘ

Reference product

Epogen/Procritepoetin alfa Procritepoetin alfa

Biosimilars 1

Retacritepoetin alfa-epbx

Source: FDA Purple Book (purplebooksearch.fda.gov), matched on the reference product’s active ingredient.

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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 55513-0283-10, not the drug overall. Other pack sizes report separately.

💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.

📅 Q1 2025 – Q4 2025 · 4 quarters of data

ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.

Prescriptions last 4 qtrs

139.6K

Units reimbursed last 4 qtrs

105.1K

Gross reimbursed last 4 qtrs

$15.25M

Avg / prescription

$109.20

Avg / unit

$145.14

Latest quarter Q4 2025

35.1KRx

Fee-for-service vs managed care ⓘ

55% FFS 45% MCO

Fee-for-service · 76,841 Rx Managed care · 62,783 Rx

State Medicaid map

Units reimbursed · per 100k residents

0.0209

gray = no data reported ⓘ

Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.

Tap or hover a state

…for its Medicaid breakdown

🏆 Top states by units · per 100k residents

1 Vermont 209 /100k

2 New York 197 /100k

3 North Carolina 131 /100k

4 California 95.0 /100k

5 Maryland 44.7 /100k

6 Illinois 28.6 /100k

7 Ohio 25.5 /100k

8 Arkansas 15.2 /100k

National units — by quarter

💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.

10 vials this page55513-0283-10 142,853 Rx · $18,010,076

10 vials55513-0283-20 No Medicaid data

Drug total (last 4 qtrs): 142,853 Rx · 94,466 units · $18,010,076 gross reimbursed

Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for Epogen — 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 Epogen. 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

$1.41M

Claims incl. refills

2.8K

Beneficiaries

1.3K

Spend / beneficiary

$1,064.45

Spend / claim

$500.37

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.

🔬 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 EPOGEN (this brand).

Top reported reactions

Product Storage Error1,124

Anaemia768

Dyspnoea631

Haemoglobin Decreased605

Nausea598

Pain560

Diarrhoea549

Age at onset

Neonate20

Infant27

Child44

Adolescent37

Adult761

Elderly703

Reporter sex

Male · 50%

Female · 48%

Unknown · 1%

Serious outcomes

Hospitalization4,579

Disabling367

Reports over time (by year) — tap or hover for the count & year

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 NDC	Description	Marketing start	Status
55513-0283-10 You're viewing this	10 VIAL in 1 PACKAGE (55513-283-10) / 2 mL in 1 VIAL (55513-283-01)	1994-12-05	Active
55513-0283-20	10 VIAL in 1 PACKAGE (55513-283-20) / 2 mL in 1 VIAL (55513-283-01)	2025-04-14	Active

In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 55513-0283-10?

NDC 55513-0283-10 is listed by the FDA — 10 vial in 1 package / 2 ml in 1 vial.

What NDC number is used to bill for this package of EPOGEN epoetin alfa 10000 [iU]/mL Solution?

Bill NDC 55513-0283-10 — the 11-digit billing format is 55513028310. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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	— Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk	✓ Available
Medicaid utilization (CMS SDUD)	✓ Available

“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 55513-283-10, 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: 55513-0283-10, written without dashes as 55513028310. 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 55513-0283-10, the first segment (55513) is the labeler code FDA assigned to Amgen, Inc; the middle segment (0283) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (10) 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 Amgen, Inc. Listing status can change — the directory data on this page refreshes weekly.

Does this product come in other package sizes?

Yes — the FDA directory lists 1 other package presentation of this same product, including 10 vials (55513-0283-20). Each has its own NDC and its own page — see the package list near the top of this page.

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 J0885 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.

This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.

Where does this data come from?

Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.

🚨 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 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide

🚨 Boxed Warning ~2 min read ▾

WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE Chronic Kidney Disease: In controlled trials, patients with chronic kidney disease (CKD) experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target a hemoglobin level of greater than 11 g/dL [see Warnings and Precautions ( 5.1 )] . No trial has identified a hemoglobin target level, E SA dose, or dosing strategy that does not increase these risks [see Dosage and Administration ( 2.2 )] .

Use the lowest Epogen dose sufficient to reduce the need for red blood cell (RBC) transfusions [see Warnings and Precautions ( 5.1 )] . Cancer: ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in clinical studies of patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers [see Warnings and Precautions ( 5.2 )] . To decrease these risks, as well as the risk of serious cardiovascular and thromboembolic reactions, use the lowest dose needed to avoid RBC transfusions [see Dosage and Administration ( 2.4 )] .

Use ESAs only for anemia from myelosuppressive chemotherapy [see Indications and Usage ( 1.3 )] . ESAs are not indicated for patients receiving myelosuppressive chemotherapy when the anticipated outcome is cure [see Indications and Usage ( 1.5 )] . Discontinue following the completion of a chemotherapy course [see Dosage and Administration ( 2.4 )] .

Perisurgery: Due to increased risk of Deep Venous Thrombosis (DVT), DVT prophylaxis is recommended [see Dosage and Administration ( 2.5 ), Warnings and Precautions ( 5.1 )] . WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE See full prescribing information for complete boxed warning. Chronic Kidney Disease: In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target a hemoglobin level of greater than 11 g/dL ( 5.1 ).

No trial has identified a hemoglobin target level, E SA dose, or dosing strategy that does not increase these risks ( 2.2 ) . Use the lowest Epogen dose sufficient to reduce the need for red blood cell (RBC) transfusions ( 5.1 ). Cancer : ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in clinical studies of patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers ( 5.2 ).

Use the lowest dose to avoid RBC transfusions ( 2.4 ). Use ESAs only for anemia from myelosuppressive chemotherapy ( 1.3 ) . ESAs are not indicated for patients receiving myelosuppressive chemotherapy when the anticipated outcome is cure ( 1.5 ).

Discontinue following the completion of a chemotherapy course ( 2.4 ). Perisurgery : Due to increased risk of deep venous thrombosis ( DVT ) , DVT prophylaxis is recommended ( 5.1 ).

🎯 Indications and Usage ~2 min read ▾

1 INDICATIONS AND USAGE Epogen is an erythropoiesis-stimulating agent (ESA) indicated for: Treatment of anemia due to: - Chronic Kidney Disease (CKD) in patients on dialysis and not on dialysis ( 1.1 ). - Zidovudine in patients with Human Immunodeficiency Virus (HIV) infection ( 1.2 ). - The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy ( 1.3 ). Reduction of allogeneic red blood cell (RBC) transfusions in patients undergoing elective, noncardiac, nonvascular surgery ( 1.4 ).

Limitations of Use Epogen has not been shown to improve quality of life, fatigue, or patient well-being ( 1.5 ). Epogen is not indicated for use: In patients with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy ( 1.5 ). In patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure ( 1.5 ).

In patients with cancer receiving myelosuppressive chemotherapy in whom the anemia can be managed by transfusion ( 1.5 ). In patients scheduled for surgery who are willing to donate autologous blood ( 1.5 ). In patients undergoing cardiac or vascular surgery ( 1.5 ).

As a substitute for RBC transfusions in patients who require immediate correction of anemia ( 1.5 ).

1.1Anemia Due to Chronic Kidney Disease Epogen is indicated for the treatment of anemia due to chronic kidney disease (CKD), including patients on dialysis and not on dialysis to decrease the need for red blood cell (RBC) transfusion.

1.2Anemia Due to Zidovudine in Patients with HIV Infection Epogen is indicated for the treatment of anemia due to zidovudine administered at ≤ 4200 mg/week in patients with HIV infection with endogenous serum erythropoietin levels of ≤ 500 mUnits/mL.

1.3Anemia Due to Chemotherapy in Patients with Cancer Epogen is indicated for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy.

1.4Reduction of Allogeneic Red Blood Cell Transfusions in Patients Undergoing Elective, Noncardiac, Nonvascular Surgery Epogen is indicated to reduce the need for allogeneic RBC transfusions among patients with perioperative hemoglobin > 10 to ≤ 13 g/dL who are at high risk for perioperative blood loss from elective, noncardiac, nonvascular surgery. Epogen is not indicated for patients who are willing to donate autologous blood pre-operatively.

1.5Limitations of Use Epogen has not been shown to improve quality of life, fatigue, or patient well-being. Epogen is not indicated for use: In patients with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy. In patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure.

In patients with cancer receiving myelosuppressive chemotherapy in whom the anemia can be managed by transfusion. In patients scheduled for surgery who are willing to donate autologous blood. In patients undergoing cardiac or vascular surgery.

As a substitute for RBC transfusions in patients who require immediate correction of anemia.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Evaluate iron status before and during treatment and maintain iron repletion. Correct or exclude other causes of anemia before initiating treatment ( 2.1 ). In pregnant women, lactating women, neonates, infants: Use only single-dose vials ( 2.1 ).

Patients with CKD: Initial dose: 50 to 100 Units/kg 3 times weekly (adults) and 50 Units/kg 3 times weekly (pediatric patients). Individualize maintenance dose. Intravenous route recommended for patients on hemodialysis ( 2.2 ).

Patients on Zidovudine due to HIV infection: 100 Units/kg 3 times weekly ( 2.3 ). Patients with Cancer on Chemotherapy: 40,000 Units weekly or 150 Units/kg 3 times weekly (adults); 600 Units/kg intravenously weekly (pediatric patients ≥ 5 years) ( 2.4 ). Surgery Patients: 300 Units/kg per day daily for 15 days or 600 Units/kg weekly ( 2.5 ).

2.1Important Dosing Information Evaluation of Iron Stores and Nutritional Factors Evaluate the iron status in all patients before and during treatment. Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. The majority of patients with CKD will require supplemental iron during the course of ESA therapy.

Monitoring of Response to Therapy Correct or exclude other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.) before initiating Epogen. Following initiation of therapy and after each dose adjustment, monitor hemoglobin weekly until the hemoglobin level is stable and sufficient to minimize the need for RBC transfusion. Selection of Formulation In pregnant women, lactating women, neonates, and infants use only single-dose vials (the benzyl alcohol-free formulation) [see Contraindication s ( 4 ) and Use in Specific Populations ( 8.1 , 8.2 , and 8.4 )] .

2.2Patients with Chronic Kidney Disease In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered ESAs to target a hemoglobin level of greater than 11 g/dL. No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks. Individualize dosing and use the lowest dose of Epogen sufficient to reduce the need for RBC transfusions [see Warnings and Precautions ( 5.1 )] .

Physicians and patients should weigh the possible benefits of decreasing transfusions against the increased risks of death and other serious cardiovascular adverse reactions [see Boxed Warning and Clinical Studies ( 14 ) ] . For all patients with CKD: When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable, then monitor at least monthly. When adjusting therapy consider hemoglobin rate of rise, rate of decline, ESA responsiveness and hemoglobin variability.

A single hemoglobin excursion may not require a dosing change. Do not increase the dose more frequently than once every 4 weeks. Decreases in dose can occur more frequently.

Avoid frequent dose adjustments. If the hemoglobin rises rapidly (e.g., more than 1 g/dL in any 2-week period), reduce the dose of Epogen by 25% or more as needed to reduce rapid responses. For patients who do not respond adequately, if the hemoglobin has not increased by more than 1 g/dL after 4 weeks of therapy, increase the dose by 25%.

For patients who do not respond adequately over a 12-week escalation period, increasing the Epogen dose further is unlikely to improve response and may increase risks. Use the lowest dose that will maintain a hemoglobin level sufficient to reduce the need for RBC transfusions. Evaluate other causes of anemia.

Discontinue Epogen if responsiveness does not improve. For adult patients with CKD on dialysis: Initiate Epogen treatment when the hemoglobin level is less than 10 g/dL. If the hemoglobin level approaches or exceeds 11 g/dL, reduce or interrupt the dose of Epogen.

The recommended starting dose for adult patients is 50 to 10…

💊 Dosage Forms and Strengths 81 words ▾

3 DOSAGE FORMS AND STRENGTHS Injection: 2,000 Units/mL, 3,000 Units/mL, 4,000 Units/mL, and 10,000 Units/mL of Epogen as a clear and colorless liquid in single-dose vials. 20,000 Units/2 mL (10,000 Units/mL) and 20,000 Units/mL of Epogen as a clear and colorless liquid in multiple-dose vials (contains benzyl alcohol). Injection 2,000 Units/mL, 3,000 Units/mL, 4,000 Units/mL, and 10,000 Units/mL in single-dose vials ( 3 ) 20,000 Units/2 mL (10,000 Units/mL) and 20,000 Units/mL in multiple-dose vials containing benzyl alcohol ( 3 )

⛔ Contraindications 140 words ▾

4 CONTRAINDICATIONS Epogen is contraindicated in patients with: Uncontrolled hypertension [see Warnings and Precautions ( 5.3 )] Pure red cell aplasia (PRCA) that begins after treatment with Epogen or other erythropoietin protein drugs [see Warnings and Precautions ( 5.6 )] Serious allergic reactions to Epogen [see Warnings and Precautions ( 5.7 )] Epogen from multiple-dose vials contains benzyl alcohol and is contraindicated in: Neonates, infants, pregnant women, and lactating women [see Warnings and Precautions ( 5.9 ), Use in Specific Populations ( 8.1 , 8.2 , 8.4 )] .

Uncontrolled hypertension ( 4 ) Pure red cell aplasia (PRCA) that begins after treatment with Epogen or other erythropoietin protein drugs ( 4 ) Serious allergic reactions to Epogen ( 4 ) Use of the multiple-dose vials containing benzyl alcohol in neonates, infants, pregnant women, and lactating women ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism: Using ESAs to target a hemoglobin level of greater than 11 g/dL increases the risk of serious adverse cardiovascular reactions and has not been shown to provide additional benefit ( 5.1 and 14.1 ). Use caution in patients with coexistent cardiovascular disease and stroke ( 5.1 ). Increased Mortality and/or Increased Risk of Tumor Progression or Recurrence in Patients with Cancer ( 5.2 ).

Hypertension: Control hypertension prior to initiating and during treatment with Epogen ( 5.3 ). Seizures: Epogen increases the risk for seizures in patients with CKD ( 5.4 ). Increase monitoring of these patients for changes in seizure frequency or premonitory symptoms ( 5.4 ).

PRCA: If severe anemia and low reticulocyte count develop during Epogen treatment, withhold Epogen and evaluate for PRCA ( 5.6 ). Serious Allergic Reactions: Discontinue Epogen and manage reactions ( 5.7 ). Severe Cutaneous Reactions: Discontinue Epogen ( 5.8 ).

5.1Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism In controlled clinical trials of patients with CKD comparing higher hemoglobin targets (13 – 14 g/dL) to lower targets (9 - 11.3 g/dL), Epogen and other ESAs increased the risk of death, myocardial infarction, stroke, congestive heart failure, thrombosis of hemodialysis vascular access, and other thromboembolic events in the higher target groups. Using ESAs to target a hemoglobin level of greater than 11 g/dL increases the risk of serious adverse cardiovascular reactions and has not been shown to provide additional benefit [see Clinical Studies ( 14.1 )] .

Use caution in patients with coexistent cardiovascular disease and stroke [see Dosage and Administration ( 2.2 )] . Patients with CKD and an insufficient hemoglobin response to ESA therapy may be at even greater risk for cardiovascular reactions and mortality than other patients. A rate of hemoglobin rise of greater than 1 g/dL over 2 weeks may contribute to these risks.

In controlled clinical trials of patients with cancer, Epogen and other ESAs increased the risks for death and serious adverse cardiovascular reactions. These adverse reactions included myocardial infarction and stroke. In controlled clinical trials, ESAs increased the risk of death in patients undergoing coronary artery bypass graft surgery (CABG) and the risk of deep venous thrombosis (DVT) in patients undergoing orthopedic procedures.

The design and overall results of the 3 large trials comparing higher and lower hemoglobin targets are shown in Table 1. Table 1. Randomized Controlled Trials Showing Adverse Cardiovascular Outcomes in Patients with CKD Normal Hematocrit Study (NHS) (N = 1265 ) CHOIR (N = 1432) TREAT (N = 4038) Time Period of Trial 1993 to 1996 2003 to 2006 2004 to 2009 Population CKD patients on hemodialysis with coexisting CHF or CAD, hematocrit 30 ± 3% on epoetin alfa CKD patients not on dialysis with hemoglobin < 11 g/dL not previously administered epoetin alfa CKD patients not on dialysis with type II diabetes, hemoglobin ≤ 11 g/dL Hemoglobin Target; Higher vs.

Lower (g/dL) 14.0 vs. 10.0 13.5 vs. 11.3 13.0 vs. ≥

9.0Median (Q1, Q3) Achieved Hemoglobin level (g/dL) 12.6 (11.6, 13.3) vs. 10.3 (10.0, 10.7) 13.0 (12.2, 13.4) vs. 11.4 (11.1, 11.6) 12.5 (12.0, 12.8) vs.

10.6(9.9, 11.3) Primary Endpoint All-cause mortality or non-fatal MI All-cause mortality, MI, hospitalization for CHF, or stroke All-cause mortality, MI, myocardial ischemia, heart failure, and stroke Hazard Ratio or Relative Risk (95% CI) 1.28 (1.06 - 1.56) 1.34 (1.03 - 1.74) 1.05 (0.94 - 1.17) Adverse Outcome for Higher Target Group All-cause mortality All-cause mortality Stroke Hazard Ratio or Relative Risk (95% CI) 1.27 (1.04 - 1.54) 1.48 (0.97 - 2.27) 1.92 (1.38 - 2.68) Patients with Chronic Kidney Disease Normal Hematocrit Study (NHS): A prospective, randomized, open-label study of 1265 patients with chronic kidney disease on dialy…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the label: Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism [see Warnings and Precautions ( 5.1 )] Increased Mortality and/or Increased Risk of Tumor Progression or Recurrence in Patients with Cancer [see Warnings and Precautions ( 5.2 )] Hypertension [see Warnings and Precautions ( 5.3 )] Seizures [see Warnings and Precautions ( 5.4 )] PRCA [see Warnings and Precautions ( 5.6 )] Serious Allergic Reactions [see Warnings and Precautions ( 5.7 )] Severe Cutaneous Reactions [see Warnings and Precautions ( 5.8 )] Patients with CKD: Adverse reactions in ≥ 5% of Epogen-treated patients in clinical studies were hypertension, arthralgia, muscle spasm, pyrexia, dizziness, medical device malfunction, vascular occlusion, and upper respiratory tract infection ( 6.1 ).

Patients on Zidovudine due to HIV infection: Adverse reactions in ≥ 5% of Epogen-treated patients in clinical studies were pyrexia, cough, rash, and injection site irritation ( 6.1 ). Patients with Cancer on Chemotherapy: Adverse reactions in ≥ 5% of Epogen-treated patients in clinical studies were nausea, vomiting, myalgia, arthralgia, stomatitis, cough, weight decrease, leukopenia, bone pain, rash, hyperglycemia, insomnia, headache, depression, dysphagia, hypokalemia, and thrombosis ( 6.1 ). Surgery Patients: Adverse reactions in ≥ 5% of Epogen-treated patients in clinical studies were nausea, vomiting, pruritus, headache, injection site pain, chills, deep vein thrombosis, cough, and hypertension ( 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 other drugs and may not reflect the rates observed in practice. Patients with Chronic Kidney Disease Adult Patients Three double-blind, placebo-controlled studies, including 244 patients with CKD on dialysis, were used to identify the adverse reactions to Epogen. In these studies, the mean age of patients was 48 years (range: 20 to 80 years).

One hundred and thirty-three (55%) patients were men. The racial distribution was as follows: 177 (73%) patients were white, 48 (20%) patients were black, 4 (2%) patients were Asian, 12 (5%) patients were other, and racial information was missing for 3 (1%) patients. Two double-blind, placebo-controlled studies, including 210 patients with CKD not on dialysis, were used to identify the adverse reactions to Epogen.

In these studies, the mean age of patients was 57 years (range: 24 to 79 years). One hundred and twenty-one (58%) patients were men. The racial distribution was as follows: 164 (78%) patients were white, 38 (18%) patients were black, 3 (1%) patients were Asian, 3 (1%) patients were other, and racial information was missing for 2 (1%) patients.

The adverse reactions with a reported incidence of ≥ 5% in Epogen-treated patients and that occurred at a ≥ 1% higher frequency than in placebo-treated patients are shown in the table below: Table 3. Adverse Reactions in Patients with CKD on Dialysis Adverse Reaction Epogen -treated Patients (n = 148 ) Placebo- t reated Patients (n = 96 ) Hypertension 27.7% 12.5% Arthralgia 16.2% 3.1% Muscle spasm 7.4% 6.3% Pyrexia 10.1% 8.3% Dizziness 9.5% 8.3% Medical Device Malfunction (artificial kidney clotting during dialysis) 8.1% 4.2% Vascular Occlusion (vascular access thrombosis) 8.1% 2.1% Upper respiratory tract infection 6.8% 5.2% An additional serious adverse reaction that occurred in less than 5% of epoetin alfa-treated dialysis patients and greater than placebo was thrombosis (2.7% Epogen and 1% placebo) [see Warnings and Precautions ( 5.1 )] .

The adverse reactions with a…

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Epogen from multiple-dose vials contains benzyl alcohol and is contraindicated in pregnant women [see Contraindications ( 4 )] . When therapy with Epogen is needed during pregnancy, use a benzyl alcohol-free formulation (i.e., single-dose vial). Do not mix Epogen with bacteriostatic saline when administering to pregnant women because it contains benzyl alcohol ( see Clinical Considerations ) [see Dosage and Administration ( 2.1 ) ] .

The limited available data on Epogen use in pregnant women are insufficient to determine a drug-associated risk of adverse developmental outcomes. In animal reproductive and developmental toxicity studies, adverse fetal effects including embryo-fetal death, skeletal anomalies, and growth defects occurred when pregnant rats received epoetin alfa at doses approximating the clinical recommended starting doses ( see Dat a) . Consider the benefits and risks of Epogen single-dose vials for the mother and possible risks to the fetus when prescribing Epogen to a pregnant woman.

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

Clinical Considerations Fetal / Neonatal Adverse Reactions The multiple-dose vials of Epogen contain benzyl alcohol. The preservative benzyl alcohol has been associated with serious adverse reactions and death when administered intravenously to neonates and infants [ see Warnings and Precautions ( 5.9 ), Use in Specific Populations ( 8.4 ) ] . There is a potential for similar risks to fetuses exposed to benzyl alcohol in utero .

Data Human Data There are reports of pregnant women with anemia alone or anemia associated with severe renal disease and other hematologic disorders who received Epogen. Polyhydramnios and intrauterine growth restriction were reported in women with chronic renal disease, which is associated with an increased risk for these adverse pregnancy outcomes. Due to the limited number of exposed pregnancies and multiple confounding factors (such as underlying maternal conditions, other maternal medications, and gestational timing of exposure), these published case reports and studies do not reliably estimate the frequency, presence or absence of adverse outcomes.

Animal Data When rats received Epogen at doses greater than or equal to 100 Units/kg/day during mating and through early pregnancy (dosing stopped prior to organogenesis), there were slight increases in the incidences of pre- and post-implantation loss, and a decrease in live fetuses in the presence of maternal toxicity (red limbs/pinna, focal splenic capsular toxicity, increased organ weights). This animal dose level of 100 Units/kg/day may approximate the clinical recommended starting dose, depending on the treatment indication.

When pregnant rats and rabbits received intravenous doses of up to 500 mg/kg/day of Epogen only during organogenesis (gestational days 7 to 17 in rats and gestational days 6 to 18 in rabbits), no teratogenic effects were observed in the offspring. The offspring (F1 generation) of the treated rats were observed postnatally; rats from the F1 generation reached maturity and were mated; no Epogen-related effects were apparent for their offspring (F2 generation fetuses). When pregnant rats received Epogen at doses of 500 Units/kg/day late in pregnancy (after the period of organogenesis from day 17 of gestation through day 21 of lactation), pups exhibited decreased number of caudal vertebrae, decreased body weight gain, and delayed appearance of abdominal hair, eyelid opening, and ossification in the presence of maternal toxicity (red limbs/pinna, increased organ weights).

This animal dose level of 500 U/kg/day is a…

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Risk Summary Epogen from multiple-dose vials contains benzyl alcohol and is contraindicated in pregnant women [see Contraindications ( 4 )] . When therapy with Epogen is needed during pregnancy, use a benzyl alcohol-free formulation (i.e., single-dose vial). Do not mix Epogen with bacteriostatic saline when administering to pregnant women because it contains benzyl alcohol ( see Clinical Considerations ) [see Dosage and Administration ( 2.1 ) ] .

The limited available data on Epogen use in pregnant women are insufficient to determine a drug-associated risk of adverse developmental outcomes. In animal reproductive and developmental toxicity studies, adverse fetal effects including embryo-fetal death, skeletal anomalies, and growth defects occurred when pregnant rats received epoetin alfa at doses approximating the clinical recommended starting doses ( see Dat a) . Consider the benefits and risks of Epogen single-dose vials for the mother and possible risks to the fetus when prescribing Epogen to a pregnant woman.

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

Clinical Considerations Fetal / Neonatal Adverse Reactions The multiple-dose vials of Epogen contain benzyl alcohol. The preservative benzyl alcohol has been associated with serious adverse reactions and death when administered intravenously to neonates and infants [ see Warnings and Precautions ( 5.9 ), Use in Specific Populations ( 8.4 ) ] . There is a potential for similar risks to fetuses exposed to benzyl alcohol in utero .

Data Human Data There are reports of pregnant women with anemia alone or anemia associated with severe renal disease and other hematologic disorders who received Epogen. Polyhydramnios and intrauterine growth restriction were reported in women with chronic renal disease, which is associated with an increased risk for these adverse pregnancy outcomes. Due to the limited number of exposed pregnancies and multiple confounding factors (such as underlying maternal conditions, other maternal medications, and gestational timing of exposure), these published case reports and studies do not reliably estimate the frequency, presence or absence of adverse outcomes.

Animal Data When rats received Epogen at doses greater than or equal to 100 Units/kg/day during mating and through early pregnancy (dosing stopped prior to organogenesis), there were slight increases in the incidences of pre- and post-implantation loss, and a decrease in live fetuses in the presence of maternal toxicity (red limbs/pinna, focal splenic capsular toxicity, increased organ weights). This animal dose level of 100 Units/kg/day may approximate the clinical recommended starting dose, depending on the treatment indication.

When pregnant rats and rabbits received intravenous doses of up to 500 mg/kg/day of Epogen only during organogenesis (gestational days 7 to 17 in rats and gestational days 6 to 18 in rabbits), no teratogenic effects were observed in the offspring. The offspring (F1 generation) of the treated rats were observed postnatally; rats from the F1 generation reached maturity and were mated; no Epogen-related effects were apparent for their offspring (F2 generation fetuses). When pregnant rats received Epogen at doses of 500 Units/kg/day late in pregnancy (after the period of organogenesis from day 17 of gestation through day 21 of lactation), pups exhibited decreased number of caudal vertebrae, decreased body weight gain, and delayed appearance of abdominal hair, eyelid opening, and ossification in the presence of maternal toxicity (red limbs/pinna, increased organ weights).

This animal dose level of 500 U/kg/day is approximately five times the cl…

🧒 Pediatric Use ~3 min read ▾

8.4Pediatric Use The multiple-dose vials are formulated with benzyl alcohol and are contraindicated for use in neonates and infants [see Contraindications ( 4 ) , Warnings and Precautions ( 5.9 ) ] . When therapy with Epogen is needed in neonates and infants, use the single-dose vial, which is a benzyl alcohol-free formulation. Do not mix the single-dose vials with bacteriostatic saline when administering Epogen to neonates or infants because it contains benzyl alcohol [se e Dosage and Administration ( 2.6 ) ] .

Serious adverse reactions including fatal reactions and the “gasping syndrome” occurred in premature neonates and infants in the neonatal intensive care unit who received drugs containing benzyl alcohol as a preservative. In these cases, benzyl alcohol dosages of 99 to 234 mg/kg/day produced high levels of benzyl alcohol and its metabolites in the blood and urine (blood levels of benzyl alcohol were 0.61 to 1.378 mmol/L). Additional adverse reactions included gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse.

Preterm, low birth weight infants may be more likely to develop these reactions because they may be less able to metabolize benzyl alcohol. The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known [see Warnings and Precautions ( 5.9 )] . Pediatric Patients with CKD Epogen is indicated in pediatric patients, ages 1 month to 16 years of age, for the treatment of anemia associated with CKD requiring dialysis.

Safety and effectiveness in pediatric patients less than 1 month old have not been established [see Clinical Studies ( 14.1 )] . Use of Epogen in pediatric patients with CKD not requiring dialysis is supported by efficacy in pediatric patients requiring dialysis. The mechanism of action of Epogen is the same for these two populations.

Published literature also has reported the use of Epogen in pediatric patients with CKD not requiring dialysis. Dose-dependent increases in hemoglobin and hematocrit were observed with reductions in transfusion requirements. The safety data from the pediatric studies and postmarketing reports are similar to those obtained from the studies of Epogen in adult patients with CKD [see Warnings and Precautions ( 5 ) and Adverse Reactions ( 6.1 )] .

Postmarketing reports do not indicate a difference in safety profiles in pediatric patients with CKD requiring dialysis and not requiring dialysis. Pediatric Patients with Cancer on Chemotherapy Epogen is indicated in patients 5 to 18 years old for the treatment of anemia due to concomitant myelosuppressive chemotherapy. Safety and effectiveness in pediatric patients less than 5 years of age have not been established [see Clinical Studies ( 14.3 )] .

The safety data from these studies are similar to those obtained from the studies of Epogen in adult patients with cancer [see Warnings and Precautions ( 5.1 , 5.2 ) and Adverse Reactions ( 6.1 )] . Pediatric Patients with HIV I nfection Receiving Zidovudine Published literature has reported the use of Epogen in 20 zidovudine-treated, anemic, pediatric patients with HIV infection, ages 8 months to 17 years, treated with 50 to 400 Units/kg subcutaneously or intravenously 2 to 3 times per week. Increases in hemoglobin levels and in reticulocyte counts and decreases in or elimination of RBC transfusions were observed.

Pharmacokinetics in N eonates Limited pharmacokinetic data from a study of 7 preterm, very low birth weight neonates and 10 healthy adults given intravenous erythropoietin suggested that distribution volume was approximately 1.5 to 2 times higher in the preterm neonates than in the healthy adults, and clearance was approximately 3 times higher in the preterm neonates than in the healthy adults.

🧓 Geriatric Use ~1 min read ▾

8.5Geriatric Use Of the 4553 patients who received Epogen in the 6 studies for treatment of anemia due to CKD not receiving dialysis, 2726 (60%) were age 65 years and over, while 1418 (31%) were 75 years and over. Of the 757 patients who received Epogen in the 3 studies of CKD patients on dialysis, 361 (47%) were age 65 years and over, while 100 (13%) were 75 years and over. No differences in safety or effectiveness were observed between geriatric and younger patients.

Dose selection and adjustment for an elderly patient should be individualized to achieve and maintain the target hemoglobin [see Dosage and Administration ( 2 )] . Among 778 patients enrolled in the 3 clinical studies of Epogen for the treatment of anemia due to concomitant chemotherapy, 419 received Epogen and 359 received placebo. Of the 419 who received Epogen, 247 (59%) were age 65 years and over, while 78 (19%) were 75 years and over.

No overall differences in safety or effectiveness were observed between geriatric and younger patients. The dose requirements for Epogen in geriatric and younger patients within the 3 studies were similar. Among 1731 patients enrolled in the 6 clinical studies of Epogen for reduction of allogeneic RBC transfusions in patients undergoing elective surgery, 1085 received Epogen and 646 received placebo or standard of care treatment.

Of the 1085 patients who received Epogen, 582 (54%) were age 65 years and over, while 245 (23%) were 75 years and over. No overall differences in safety or effectiveness were observed between geriatric and younger patients. The dose requirements for Epogen in geriatric and younger patients within the 4 studies using the 3 times weekly schedule and 2 studies using the weekly schedule were similar.

Insufficient numbers of patients age 65 years or older were enrolled in clinical studies of Epogen for the treatment of patients treated with zidovudine for HIV infection to determine whether they respond differently from younger patients.

🆘 Overdosage 55 words ▾

10 OVERDOSAGE Epogen overdosage can cause hemoglobin levels above the desired level, which should be managed with discontinuation or reduction of Epogen dosage and/or with phlebotomy, as clinically indicated [see Clinical Pharmacology ( 12.2 )] . Cases of severe hypertension have been observed following overdose with ESAs [see Warnings and Precautions ( 5.3 )] .

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Epogen stimulates erythropoiesis by the same mechanism as endogenous erythropoietin.

12.2Pharmacodynamics Epogen increases the reticulocyte count within 10 days of initiation, followed by increases in the RBC count, hemoglobin, and hematocrit, usually within 2 to 6 weeks. The rate of hemoglobin increase varies among patients and is dependent upon the dose of Epogen administered. For correction of anemia in hemodialysis patients, a greater biologic response is not observed at doses exceeding 300 Units/kg 3 times weekly.

12.3Pharmacokinetics In adult and pediatric patients with CKD, the elimination half-life (t 1/2 ) of plasma erythropoietin after intravenous administration of Epogen ranged from 4 to 13 hours. After subcutaneous administration, C max was achieved within 5 to 24 hours. The t 1/2 in adult patients with serum creatinine greater than 3 mg/dL was similar between those not on dialysis and those maintained on dialysis.

The pharmacokinetic data indicate no apparent difference in Epogen t 1/2 among adult patients above or below 65 years of age. A pharmacokinetic study comparing 150 Units/kg subcutaneous 3 times weekly to 40,000 Units subcutaneous weekly dosing regimen was conducted for 4 weeks in healthy subjects (n = 12) and for 6 weeks in anemic cancer patients (n = 32) receiving cyclic chemotherapy. There was no accumulation of serum erythropoietin after the 2 dosing regimens during the study period.

The 40,000 Units weekly regimen had a higher C max (3- to 7-fold), longer T max (2- to 3-fold), higher AUC 0-168 h (2- to 3-fold) of erythropoietin and lower clearance (CL) (50%) than the 150 Units/kg 3 times weekly regimen. In anemic cancer patients, the average t 1/2 was similar (40 hours with range of 16 to 67 hours) after both dosing regimens. After the 150 Units/kg 3 times weekly dosing, the values of T max and CL were similar (13.3 ± 12.4 vs.

14.2± 6.7 hours, and 20.2 ± 15.9 vs. 23.6 ± 9.5 mL/hr/kg) between week 1 when patients were receiving chemotherapy (n = 14) and week 3 when patients were not receiving chemotherapy (n = 4). Differences were observed after the 40,000 Units weekly dosing with longer T max (38 ± 18 hours) and lower CL (9.2 ± 4.7 mL/hr/kg) during week 1 when patients were receiving chemotherapy (n = 18) compared with those (22 ± 4.5 hours, 13.9 ± 7.6 mL/hr/kg, respectively) during week 3 when patients were not receiving chemotherapy (n = 7).

The pharmacokinetic profile of Epogen in pediatric patients appeared similar to that of adults. The pharmacokinetics of Epogen has not been studied in patients with HIV infection.

🧬 Mechanism of Action 14 words ▾

12.1Mechanism of Action Epogen stimulates erythropoiesis by the same mechanism as endogenous erythropoietin.

📦 How Supplied / Storage and Handling 156 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Epogen (epoetin alfa) injection is a sterile, clear, and colorless solution available as: Preservative- f ree , s ingle- d ose v ial s (in citrate-buffered formulation) : 2,000 Units/mL (NDC 55513-126-10, NDC 55513-126-20), 3,000 Units/mL (NDC 55513-267-10, NDC 55513-267-20), 4,000 Units/mL (NDC 55513-148-10, NDC 55513-148-20), or 10,000 Units/mL (NDC 55513-144-10, NDC 55513-144-20) supplied in dispensing packs containing ten 1 mL single-dose vials. Preserved, m ulti ple - dose v ial: 20,000 Units/2 mL (10,000 Units/mL) (NDC 55513-283-10, NDC 55513-283-20) supplied in dispensing packs containing ten 2 mL multiple-dose vials.

Preserved , m ulti ple- dose v ial: 20,000 Units/mL (NDC 55513-478-10, NDC 55513-478-20) supplied in dispensing packs containing ten 1 mL multiple-dose vials. Store at 36°F to 46°F (2°C to 8°C). Do not freeze.

Do not shake. Do not use Epogen that has been shaken or frozen. Store Epogen vials in the original carton until use to protect from light.

📋 Description 210 words ▾

11 DESCRIPTION Epoetin alfa is a 165-amino acid erythropoiesis-stimulating glycoprotein manufactured by recombinant DNA technology. It has a molecular weight of approximately 30,400 daltons and is produced by mammalian cells into which the human erythropoietin gene has been introduced. The product contains the identical amino acid sequence of isolated natural erythropoietin.

Epogen (epoetin alfa) injection for intravenous or subcutaneous administration is formulated as a sterile, clear, colorless liquid in vials in multiple formulations. Single-dose vials, formulated with an isotonic sodium chloride/sodium citrate-buffered solution, are supplied in multiple strengths. Each single-dose 1 mL vial contains 2,000, 3,000, 4,000, or 10,000 Units of epoetin alfa, Albumin (Human) (2.5 mg), citric acid (0.06 mg), sodium chloride (5.9 mg), and sodium citrate (5.8 mg) in Water for Injection, USP (pH 6.9 ± 0.3).

Multiple-dose, 2 mL vials contain 10,000 Units epoetin alfa, albumin (human) (2.5 mg), benzyl alcohol (1%), sodium chloride (8.2 mg), citric acid (0.11 mg), and sodium citrate (1.3 mg) per 1 mL Water for Injection, USP (pH 6.1 ± 0.3). Multiple-dose 1 mL vials contain 20,000 Units epoetin alfa, albumin (human) (2.5 mg), benzyl alcohol (1%), sodium chloride (8.2 mg), citric acid (0.11 mg), and sodium citrate (1.3 mg), per 1 mL in Water for Injection, USP (pH 6.1 ± 0.3).

💬 Information for Patients 185 words ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Medication Guide and Instructions for Use ). Inform patients: Of the increased risks of mortality, serious cardiovascular reactions, thromboembolic reactions, stroke, and tumor progression [ see Warnings and Precautions ( 5.1 , 5.2 )] . To undergo regular blood pressure monitoring, adhere to prescribed anti-hypertensive regimen and follow recommended dietary restrictions.

To contact their healthcare provider for new-onset neurologic symptoms or change in seizure frequency. Of the need to have regular laboratory tests for hemoglobin. Risks are associated with benzyl alcohol in neonates, infants, pregnant women, and lactating women [see Use in Specific Populations ( 8.1 , 8.2 , 8.4 )] .

Instruct patients who self-administer Epogen of the: Importance of following the Instructions for Use. Dangers of reusing needles, syringes, or unused portions of single-dose vials. Proper disposal of used syringes, needles, and unused vials, and of the full container.

EPOGEN ® (epoetin alfa) Manufactured by: Amgen Inc. One Amgen Center Drive Thousand Oaks, CA 91320-1799 U.S.A. U.S.

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE EPOGEN ® (Ee-po-jen) (epoetin alfa) Read this Medication Guide: before you start Epogen. if you are told by your healthcare provider that there is new information about Epogen. if you are told by your healthcare provider that you may inject Epogen at home, read this Medication Guide each time you receive a new supply of medicine. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or your treatment. Talk with your healthcare provider regularly about the use of Epogen and ask if there is new information about Epogen.

What is the most important information I should know about Epogen? Epogen may cause serious side effects that can lead to death, including: For people with cancer: Your tumor may grow faster and you may die sooner if you choose to take Epogen. Your healthcare provider will talk with you about these risks.

For all people who take Epogen, including people with cancer or chronic kidney disease: Serious heart problems, such as heart attack or heart failure, and stroke. You may die sooner if you are treated with Epogen to increase red blood cells (RBCs) to near the same level found in healthy people. Blood clots.

Blood clots may happen at any time while taking Epogen. If you are receiving Epogen for any reason and you are going to have surgery, talk to your healthcare provider about whether or not you need to take a blood thinner to lessen the chance of blood clots during or following surgery. Blood clots can form in blood vessels (veins), especially in your leg (deep venous thrombosis or DVT).

Pieces of a blood clot may travel to the lungs and block the blood circulation in the lungs (pulmonary embolus). Call your healthcare provider or get medical help right away if you have any of these symptoms: • Chest pain • Trouble breathing or shortness of breath • Pain in your legs, with or without swelling • A cool or pale arm or leg • Sudden confusion, trouble speaking, or trouble understanding others’ speech • Sudden numbness or weakness in your face, arm, or leg, especially on one side of your body • Sudden trouble seeing • Sudden trouble walking, dizziness, loss of balance or coordination • Loss of consciousness (fainting) • Hemodialysis vascular access stops working See “What are the possible side effects of Epogen?” below for more information.

If you decide to take Epogen, your healthcare provider should prescribe the smallest dose of Epogen that is necessary to reduce your chance of needing RBC transfusions. What is Epogen? Epogen is a prescription medicine used to treat anemia.

People with anemia have a lower-than-normal number of RBCs. Epogen works like the human protein called erythropoietin to help your body make more RBCs. Epogen is used to reduce or avoid the need for RBC transfusions.

Epogen may be used to treat anemia if it is caused by: Chronic kidney disease (you may or may not be on dialysis). Chemotherapy that will be used for at least two months after starting Epogen. A medicine called zidovudine (AZT) used to treat HIV infection.

Epogen may also be used to reduce the chance you will need RBC transfusions if you are scheduled for certain surgeries where a lot of blood loss is expected. If your hemoglobin level stays too high or if your hemoglobin goes up too quickly, this may lead to serious health problems which may result in death. These serious health problems may happen if you take Epogen, even if you do not have an increase in your hemoglobin level.

Epogen has not been proven to improve quality of life, fatigue, or well-being. Epogen should not be used for treatment of anemia: If you have cancer and you will not be receiving chemotherapy that may cause anemia. If you have a cancer that has a high chance of being cured.

Talk with your healthcare provider about the kind of cancer you have. If your anemia caused by chemotherapy treatment can be managed by RBC transfusion. In place of emergency treatment for anemia (RBC transfus…

Glossary — plain-language definitions of medical terms used in this label:

contraindicated: Should not be used in that situation, because the risk is considered too high.

contraindication: A situation in which a medicine should not be used because the risk is considered too high.

accumulation: A buildup of a medicine in the body when new doses are taken before earlier ones are fully removed.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

anemia: A low level of red blood cells or the oxygen-carrying protein inside them, which can cause tiredness, weakness, and paleness.

arthralgia: Joint pain.

AUC: A measure of total drug exposure over time, showing how much medicine the blood is exposed to overall.

bacteriostatic: Describes a medicine that stops bacteria from multiplying so the body's own defenses can clear them.

Boxed Warning: The strongest safety warning the FDA can require, set inside a bold black border because the risk it describes can be very serious.

bradycardia: A slower-than-normal heart rate, usually under 60 beats per minute.

clearance: How quickly the body removes a medicine from the blood, usually through the liver and kidneys.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

deep vein thrombosis: A blood clot that forms in a deep vein, usually in the leg, causing swelling and pain.

depression: A lasting low mood with loss of interest that affects everyday life.

Distribution: How a medicine spreads from the blood into the body's tissues and organs after it is absorbed.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

double-blind: A study in which neither the patients nor their doctors know who is getting the real medicine and who is getting the dummy.

DVT: A blood clot that forms in a deep vein, usually in the leg, causing swelling and pain.

dysphagia: Trouble or discomfort swallowing food, liquids, or pills.

efficacy: How well a treatment works under the controlled conditions of a clinical study.

Elimination: The overall removal of a medicine from the body by breaking it down and passing it out.

endpoint: A specific outcome, such as a symptom or lab value, that a study measures to judge whether a treatment works.

estimated background risk: The normal chance that any pregnancy will have a birth defect or problem, even without taking any medicine.

Full Prescribing Information: The complete, detailed label for a prescription medicine that follows the summary highlights.

Half-life: The time it takes for the amount of medicine in the blood to drop by half.

hazard ratio: A number comparing how quickly an event happens in one group versus another; above 1 means more often, below 1 means less often.

heart failure: A condition in which the heart cannot pump blood as well as it should, causing tiredness, breathlessness, and swelling.

hematocrit: A blood test showing what share of your blood is made up of red blood cells.

hemodialysis: A treatment that uses a machine to filter waste and extra fluid from the blood when the kidneys cannot.

hemoglobin: The iron-containing protein inside red blood cells that carries oxygen throughout the body.

hemorrhage: Bleeding, especially heavy or uncontrolled bleeding, either inside the body or from an outside wound.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hyperglycemia: High blood sugar, meaning there is more glucose (sugar) in the blood than normal.

hypertension: Blood pressure that stays higher than normal, commonly called high blood pressure.

hypokalemia: A lower-than-normal level of potassium, an important mineral, in the blood.

hypotension: Blood pressure that is lower than normal, which can cause dizziness or fainting.

in utero: Inside the womb, describing a baby before it is born.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

insomnia: Trouble falling asleep, staying asleep, or getting restful sleep.

intrauterine growth restriction: When a baby grows more slowly than expected in the womb and is smaller than normal at birth.

intravenous: Given directly into a vein through a needle or thin tube; often written as IV.

ischemia: Reduced blood flow to a part of the body, so that area does not get enough oxygen.

lactation: The making and release of milk from a mother's breasts after giving birth.

leukopenia: A low level of white blood cells, the cells that help the body fight off infections.

maintenance dose: The regular ongoing dose taken to keep a steady, effective amount of medicine in the body over time.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

Medication Guide: An FDA-approved handout written for patients that explains important safety information about certain medicines in plain language.

myalgia: Muscle pain or aching.

myocardial infarction: The medical term for a heart attack, when blood flow to part of the heart muscle is blocked.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

neonatal: Relating to a newborn baby during its first four weeks of life.

open-label: A study in which both the patients and their doctors know which treatment each person is receiving.

organogenesis: The early stage of pregnancy when the developing baby's organs are first forming.

overall survival: In a study, the length of time that patients stay alive after starting a treatment.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

placebo: An inactive treatment with no real medicine in it, such as a sugar pill, used for comparison in a study.

placebo-controlled: Describes a study that compares people taking the real medicine against people taking a dummy pill with no active ingredient.

Prescribing Information: The official, detailed document approved by the FDA that tells health professionals how to use a prescription medicine.

primary endpoint: The main result a study is set up to measure in order to decide whether a treatment works.

prophylaxis: Treatment given to prevent an infection or illness before it starts, rather than to treat one that is already present.

pruritus: Itching of the skin.

pyrexia: A raised body temperature; a fever.

randomized: Assigned to a treatment group purely by chance, like a coin flip, so the groups being compared start out fair and similar.

relative risk: A number comparing the chance of an event in one group with the chance of that same event in another group.

seizure: A sudden burst of abnormal electrical activity in the brain that can cause shaking, staring, confusion, or loss of awareness.

serum creatinine: A waste product measured in a blood test; higher levels can mean the kidneys are not filtering as well as normal.

single-dose vial: A small container holding one dose of medicine, meant to be used once and then thrown away.

stomatitis: Soreness, swelling, or sores on the lining inside the mouth.

subcutaneous: An injection placed into the fatty layer just under the skin; often written as subcut or SC.

teratogenic: Able to cause physical birth defects in a developing baby when a medicine is taken during pregnancy.

thromboembolism: A blood clot that forms in one place and travels through the bloodstream to block a vessel somewhere else.

thrombosis: The forming of a blood clot inside a blood vessel, which can block normal blood flow.

upper respiratory tract infection: An infection of the nose, sinuses, or throat, such as the common cold.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

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

🔗 Related NDC lookups

🧪 All Epoetin Alfa NDCsSame ingredient 🏭 All Amgen, labeler NDCsLabeler code 55513 📚 All Erythropoiesis-stimulating Agent NDCsDrug class 🧾 J0885 billing & NDC crosswalkJ-code

💊 Related drugs in this class

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Epoetin Alfa-Epbx 00069-1305-10 Darbepoetin Alfa In Polysorbat 55513-0002-04 Methoxy Peg-Epoetin Beta 59353-0400-09

Where does this data come from?

Other drugs sharing this product’s First Databank therapeutic class (HIC3). Each links to that NDC’s page in our directory.