RETACRIT
RETACRIT is an erythropoiesis-stimulating agent (ESA) indicated for the treatment of anemia associated with chronic kidney disease, zidovudine therapy in patients with HIV, and myelosuppressive chemotherapy. It is also used to reduce the need for allogeneic red blood cell transfusions in patients undergoing elective, noncardiac, and nonvascular surgeries. The therapeutic role of this medication is to decrease the requirement for blood transfusions, though it is not indicated for the immediate correction of anemia or for patients undergoing curative cancer treatment.
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.
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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
ProIndications & Usage
FDA Label (PDF)RETACRIT is an erythropoiesis-stimulating agent (ESA) indicated for: • Treatment of anemia due to o Chronic Kidney Disease (CKD) in patients on dialysis and not on dialysis . o Zidovudine in patients with Human Immunodeficiency Virus (HIV) infection . o 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 RETACRIT has not been shown to improve quality of l...
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.