Last reviewed 2026-04-20 · How we verify

Mircera (METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA)

Mircera activates erythropoietin receptors, increasing red cell production in response to hypoxia.

At a glance

Mechanism of action

Mircera is designed to mimic the action of erythropoietin, a hormone that stimulates red blood cell production. It binds to erythropoietin receptors on erythroid progenitor cells, enhancing their activity and increasing red cell production, which is often impaired in patients with chronic kidney disease (CKD).

Approved indications

• Anemia in chronic kidney disease

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
• Headache
• Upper Respiratory Tract Infection
• Hypotension
• Vomiting
• Constipation
• Urinary Tract Infection
• Muscle Spasms
• Back Pain
• Pain in Extremity

Key clinical trials

• Vafseo Outcomes In-Center Experience (PHASE3)
• 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)
• A Study of MIRCERA in Participants With Chronic Kidney Disease Stage 3-4 and Not on Dialysis
• 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)
• Study Evaluating the Efficacy and Safety of Dose Conversion From a Long-acting Erythropoiesis-stimulating Agent (Mircera®) to Three Times Weekly Oral Vadadustat for the Maintenance Treatment of Anemia in Hemodialysis Subjects (PHASE3)
• A Study of Intermittent Oral Dosing of ASP1517 in Non-Dialysis Chronic Kidney Disease Patients With Anemia (PHASE3)
• A Study of AND017 to Treat Anemia in Chronic Kidney Disease Patients on Dialysis (PHASE2)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Mircera CI brief — competitive landscape report
• Mircera updates RSS · CI watch RSS