RETACRIT (epoetin alfa-epbx)
RETACRIT is indicated for the treatment of Anemia; Chronic Kidney Disease; Human Immunodeficiency Virus Infection.
How RETACRIT Works
RETACRIT functions as an erythropoiesis-stimulating agent that mimics the biological activity of endogenous erythropoietin. It works by stimulating the process of erythropoiesis, which is the production of red blood cells within the body. By activating the same mechanism as the body's natural hormone, the drug increases red blood cell levels to treat anemia resulting from various clinical conditions.
Details
- Status
- Prescription
- First Approved
- 2018-05-15
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
RETACRIT Approval History
What RETACRIT Treats
3 indicationsRETACRIT is approved for 3 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Anemia
- Chronic Kidney Disease
- Human Immunodeficiency Virus Infection
RETACRIT Boxed Warning
ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE 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 cardiovascul...
WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE 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, ESA dose, or dosing strategy that does not increase these risks ( 2.2 ). • Use the lowest RETACRIT 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 ). 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 [s
RETACRIT is a lower-cost alternative to Epogen/Procrit with no clinically meaningful differences. Requires prescriber approval to substitute.
RETACRIT Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Active Pipeline
Ongoing clinical trials by development phase
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.
RETACRIT FDA Label Details
Indications & Usage
FDA Label (PDF)RETACRIT is indicated for the treatment of Anemia; Chronic Kidney Disease; Human Immunodeficiency Virus Infection.
WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR ...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.