EPOGEN/PROCRIT
Epogen (epoetin alfa) is an erythropoiesis-stimulating agent indicated for the treatment of anemia associated with chronic kidney disease, zidovudine therapy in HIV patients, and myelosuppressive chemotherapy. It is also utilized to reduce the need for allogeneic red blood cell transfusions in patients undergoing elective, noncardiac, and nonvascular surgery. The drug'
Details
- Status
- Prescription
- First Approved
- 1989-06-01
- Routes
- SINGLE-USE, MULTIDOSE
- Dosage Forms
- VIAL
EPOGEN/PROCRIT Approval History
What EPOGEN/PROCRIT Treats
4 indicationsEPOGEN/PROCRIT is approved for 4 conditions since its original approval in 1989. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Anemia
- Chronic Kidney Disease
- Human Immunodeficiency Virus
- Myelosuppression
EPOGEN/PROCRIT Boxed 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 i...
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 K
EPOGEN/PROCRIT Biosimilars
1 FDA-approvedThese 1 alternatives require prescriber approval to substitute for EPOGEN/PROCRIT.
What are biosimilars? Lower-cost alternatives to EPOGEN/PROCRIT with no clinically meaningful differences.
Auto-substitute OK = FDA "interchangeable" designation — pharmacist can switch without calling the doctor.
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Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
EPOGEN/PROCRIT FDA Label Details
ProIndications & Usage
FDA Label (PDF)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 . - Zidovudine in patients with Human Immunodeficiency Virus (HIV) infection . - The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy . Reduction of allogeneic red blood cell (RBC) transfusions in patients undergoing elective, noncardiac, nonvascular surgery . Limitations of Use Epogen has not been shown to improve quality of life, fa...
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 adv...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.