MIRCERA
Mircera is an erythropoiesis-stimulating agent (ESA) indicated for the treatment of anemia associated with chronic kidney disease (CKD). The medication is approved for use in adult patients regardless of dialysis status and in pediatric patients aged 3 months to 17 years who are converting from another ESA after stabilizing their hemoglobin levels. It is not recommended for the treatment of anemia caused by cancer chemotherapy or as a replacement for immediate red blood cell transfusions.
How MIRCERA Works
Mircera acts as an erythropoietin receptor activator that stimulates red blood cell production by interacting with erythroid progenitor cells. It serves as a replacement for endogenous erythropoietin, a primary growth factor for erythroid development that is typically produced by the kidneys but becomes deficient in patients with chronic kidney disease. This agent is designed with a longer half-life and greater in vivo activity compared to natural erythropoietin to effectively address the primary cause of anemia in these patients.
Details
- Status
- Prescription
- First Approved
- 2007-11-14
- Routes
- INJECTION
- Dosage Forms
- SOLUTION
MIRCERA Approval History
What MIRCERA Treats
2 indicationsMIRCERA is approved for 2 conditions since its original approval in 2007. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Anemia
- Chronic Kidney Disease
MIRCERA 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 cardiovascula...
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 ( 5.1 ). • Use the lowest Mircera dose sufficient to reduce the need for red blood cell (RBC) transfusions ( 5.1 ). Cancer: • Mircera is not indicated and is not recommended for the treatment of anemia due to cancer chemotherapy. A dose-ranging study of Mircera was terminated early because of more deaths among patients receiving Mircera than another ESA ( 5.2 ). • ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers ( 5.2 ). Chronic Kidney Disease [see Warnings and Precautions ( 5.1 )] • 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. • No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks. • Use the lowest Mircera dose sufficient to reduce the need for red blood cell (RBC) transfusions. Cancer [see Warnings and Precautions ( 5.2 )] • Mircera is not indicated and is not recommended for the treatment of anemia due to ca
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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.
MIRCERA FDA Label Details
ProIndications & Usage
FDA Label (PDF)Mircera is an erythropoiesis-stimulating agent (ESA) indicated for the treatment of anemia associated with chronic kidney disease (CKD) in: • adult patients on dialysis and adult patients not on dialysis . • pediatric patients 3 months to 17 years of age on dialysis or not on dialysis who are converting from another ESA after their hemoglobin level was stabilized with an ESA . Limitations of Use Mircera is not indicated and is not recommended for use: • In the treatment of anemia due to cancer chemotherapy . • As a substitute for RBC transfusions in patients who require immediate correction of...
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.