Generic Name
Epoetin
Brand Names
Epogen, Procrit, Retacrit
FDA approval date: June 01, 1989
Classification: Erythropoiesis-stimulating Agent
Form: Injection, Solution
What is Epogen (Epoetin)?
Epogen is an erythropoiesis-stimulating agent indicated for: Treatment of anemia due to: - Chronic Kidney Disease in patients on dialysis and not on dialysis.
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Brand Information
EPOGEN (epoetin alfa)
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, ESA 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 RBCtransfusions [see Dosage and Administration (2.4)].
- Use ESAs only for anemia frommyelosuppressive 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:
1DOSAGE 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).
2CONTRAINDICATIONS
Epogen is contraindicated in patients with:
- Uncontrolled hypertension
- Pure red cell aplasia (PRCA) that begins after treatment with Epogen or other erythropoietin protein drugs
- Serious allergic reactions to Epogen
Epogen from multiple-dose vials contains benzyl alcohol and is contraindicated in:
- Neonates, infants, pregnant women, and lactating women
3ADVERSE REACTIONS
The following serious adverse reactions are discussed in greater detail in other sections of the label:
- Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism
- Increased Mortality and/or Increased Risk of Tumor Progression or Recurrence in Patients with Cancer
- Hypertension
- Seizures
- PRCA
- Serious Allergic Reactions
- Severe Cutaneous Reactions
3.1Clinical 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:
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)
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:
Additional serious adverse reactions that occurred in less than 5% of epoetin alfa-treated patients not on dialysis and greater than placebo were erythema (0.8% Epogen and 0% placebo) and myocardial infarction (0.8% Epogen and 0% placebo)
Pediatric Patients
In pediatric patients with CKD on dialysis, the pattern of adverse reactions was similar to that found in adults.
Zidovudine-treated Patients withHIV Infection
A total of 297 zidovudine-treated patients with HIV infection were studied in 4 placebo-controlled studies. A total of 144 (48%) patients were randomly assigned to receive Epogen and 153 (52%) patients were randomly assigned to receive placebo. Epogen was administered at doses between 100 and 200 Units/kg 3 times weekly subcutaneously for up to 12 weeks.
For the combined Epogen treatment groups, a total of 141 (98%) men and 3 (2%) women between the ages of 24 and 64 years were enrolled. The racial distribution of the combined Epogen treatment groups was as follows: 129 (90%) white, 8 (6%) black, 1 (1%) Asian, and 6 (4%) other.
In double-blind, placebo-controlled studies of 3 months duration involving approximately 300 zidovudine-treated patients with HIV infection, adverse reactions with an incidence of ≥ 1% in patients treated with Epogen were:
Patients with Cancer on Chemotherapy
The data below were obtained in Study C1, a 16-week, double-blind, placebo-controlled study that enrolled 344 patients with anemia secondary to chemotherapy. There were 333 patients who were evaluable for safety; 168 of 174 patients (97%) randomized to Epogen received at least 1 dose of study drug, and 165 of 170 patients (97%) randomized to placebo received at least 1 placebo dose. For the once weekly Epogen-treatment group, a total of 76 men (45%) and 92 women (55%) between the ages of 20 and 88 years were treated. The racial distribution of the Epogen-treatment group was 158 white (94%) and 10 black (6%). Epogen was administered once weekly for an average of 13 weeks at a dose of 20,000 to 60,000 IU subcutaneously (mean weekly dose was 49,000 IU).
The adverse reactions with a reported incidence of ≥ 5% in Epogen-treated patients that occurred at a higher frequency than in placebo-treated patients are shown in the table below:
Surgery Patients
Four hundred sixty-one patients undergoing major orthopedic surgery were studied in a placebo-controlled study (S1) and a comparative dosing study (2 dosing regimens, S2). A total of 358 patients were randomly assigned to receive Epogen and 103 (22%) patients were randomly assigned to receive placebo. Epogen was administered daily at a dose of 100 to 300 IU/kg subcutaneously for 15 days or at 600 IU/kg once weekly for 4 weeks.
For the combined Epogen treatment groups, a total of 90 (25%) men and 268 (75%) women between the ages of 29 and 89 years were enrolled. The racial distribution of the combined Epogen treatment groups was as follows: 288 (80%) white, 64 (18%) black, 1 (< 1%) Asian, and 5 (1%) other.
The adverse reactions with a reported incidence of ≥ 1% in Epogen-treated patients that occurred at a higher frequency than in placebo-treated patients are shown in the table below:
3.2Postmarketing Experience
The following adverse reactions have been identified during post-approval use of Epogen.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
- Seizures
- PRCA
- Serious Allergic Reactions
- Injection Site Reactions, including irritation and pain
- Porphyria
- Severe Cutaneous Reactions
3.3Immunogenicity
As with all therapeutic proteins, there is a potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors, including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to epoetin alfa with the incidence of antibodies to other products may be misleading.
Neutralizing antibodies to epoetin alfa that cross-react with endogenous erythropoietin and other ESAs
4OVERDOSAGE
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
5DESCRIPTION
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).
6HOW SUPPLIED/STORAGE AND HANDLING
Epogen (epoetin alfa) injection is a sterile, clear, and colorless solution available as:
Preservative-free,single-dose vials (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,multiple-dosevial: 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,multiple-dose vial: 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.
7PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (
Inform patients:
- Of the increased risks of mortality, serious cardiovascular reactions, thromboembolic reactions, stroke, and tumor progression
- 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
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
Manufactured by:
Amgen Inc.
One Amgen Center Drive
Thousand Oaks, CA 91320-1799 U.S.A.
U.S. License Number 1080
Amgen Inc.
One Amgen Center Drive
Thousand Oaks, CA 91320-1799 U.S.A.
U.S. License Number 1080
©1989-2018, 2024 Amgen Inc. All rights reserved.
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8PRINCIPAL DISPLAY PANEL - 2000 Units/mL Vial Package
10 x 2000 Units/mL Single Dose Vials
AMGEN
EPOGEN
2000
9PRINCIPAL DISPLAY PANEL - 3000 Units/mL Vial Package
10 x 3000 Units/mL Single Dose Vials
AMGEN
3000
10PRINCIPAL DISPLAY PANEL - 4000 Units/mL Vial Package
10 x 4000 Units/mL Single Dose Vials
AMGEN
4000
11PRINCIPAL DISPLAY PANEL - 10,000 Units/mL Vial Package
10 x 10,000 Units/mL Single Dose Vials
AMGEN
10,000
12PRINCIPAL DISPLAY PANEL - 2 mL Vial Package
10 x 2 mL Multiple Dose Vials 20,000 Units/2 mL (10,000 Units/mL)
13PRINCIPAL DISPLAY PANEL - 1 mL Vial Package
10 x 20,000 Units/mL Multiple Dose Vials
