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Neorecormon (EPOETIN BETA)
Neorecormon works by binding to the erythropoietin receptor, mimicking the action of natural erythropoietin to stimulate red blood cell production.
Neorecormon (EPOETIN BETA) is a recombinant erythropoietin analogue developed by Roche Registration Limited. It targets the erythropoietin receptor to stimulate red blood cell production. Neorecormon is approved for treating anemia caused by chemotherapy in nonmyeloid cancer patients, chronic kidney disease, and prevention of anemia in premature babies. The commercial status of Neorecormon is patented, as it is owned by Roche Registration Limited. Key safety considerations include potential increased risk of thromboembolic events and pure red cell aplasia.
At a glance
| Generic name | EPOETIN BETA |
|---|---|
| Sponsor | Roche Registration Limited |
| Target | Erythropoietin receptor |
| Modality | Recombinant protein |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 1997 |
Mechanism of action
Think of Neorecormon like a key that unlocks a lock on your bone marrow. When it binds to the erythropoietin receptor, it sends a signal to your bone marrow to produce more red blood cells, which helps to increase your red blood cell count and alleviate anemia.
Approved indications
- Anemia due to chemotherapy for nonmyeloid cancer
- Anemia in chronic kidney disease
- Prevention of anaemia in premature babies
Boxed warnings
- 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 cancer chemotherapy. A dose-ranging study of Mircera was terminated early because of more deaths among patients receiving Mircera than another ESA. • ESAs have shown 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.
Common side effects
- Hypertension
- Diarrhea
- Nasopharyngitis
- Upper Respiratory Tract Infection
- Headache
- Muscle Spasms
- Procedural Hypotension
- Fluid Overload
- Vomiting
- Back Pain
- Cough
- Hypotension
Serious adverse events
- Serious Gastrointestinal Hemorrhage
- Serious Hemorrhagic Adverse Reactions (all types)
Key clinical trials
- MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial) (PHASE2)
- Vafseo Outcomes In-Center Experience (PHASE3)
- Efficacy of Erythropoietin to Improve Survival and Neurological Outcome in Hypoxic Ischemic Encephalopathy (PHASE3)
- A Study to Evaluate the Safety and Effectiveness of Luspatercept for the Treatment of Transfusion-dependent (TD) Anemia Associated With Myelodysplastic Syndromes (MDS) & Beta-thalassemia (β-Thal) in India (PHASE4)
- Correction of Anaemia and Progression of Renal Failure on Transplanted Patients (PHASE4)
- A Study of Monthly Subcutaneous Mircera for the Treatment of Chronic Renal Anemia in Predialysis Patients Not Treated With ESA. (PHASE3)
- A Study of Subcutaneous Mircera for the Maintenance Treatment of Dialysis Patients With Chronic Renal Anemia. (PHASE3)
- Study of the Efficacy and Safety of BCD-131 and Mircera® in the Treatment of Anemia in Patients With Chronic Kidney Disease on Dialysis (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Neorecormon CI brief — competitive landscape report
- Neorecormon updates RSS · CI watch RSS
- Roche Registration Limited portfolio CI