Epoetin Beta

Mircera is an erythropoietin receptor activator with greater activity in vivo as well as increased half-life, in contrast to erythropoietin. A primary growth factor for erythroid development, erythropoietin is produced in the kidney and released into the bloodstream in response to hypoxia.

• 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 ( 1.1 ). • 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 ( 1.1 ).ICD-10: D64.9, N18.9

• Mircera is contraindicated in patients with: • Uncontrolled hypertension [see Warnings and Precautions ( 5.3 )] • Pure red cell aplasia (PRCA) that begins after treatment with Mircera or other erythropoietin protein drugs [see Warnings and Precautions ( 5.6 )] • History of serious or severe allergic reactions to Mircera (e.g., anaphylactic reactions, angioedema, bronchospasm, skin rash, and urticaria) [see Warnings and Precautions ( 5.7 , 5.8 )] . • Uncontrolled hypertension ( 4 ).contraindicated

Mircera is administered by subcutaneous or intravenous injection ( 2.2 ). Adult Patients • Initial Treatment: (patients not currently treated with an ESA): • CKD patients on dialysis: 0.6 mcg/kg body weight administered once every two weeks ( 2.2 ). • CKD patients not on dialysis: 1.2 mcg/kg body weight administered once every month as a single subcutaneous injection. Alternatively, a starting dose of 0.6 mcg/kg body weight may be administered once every two weeks as a single intravenous or subcutaneous injection ( 2.2 ). • Conversion from Another ESA: • Dosed once monthly or once every two weeks based on total weekly epoetin alfa or darbepoetin alfa dose at time of conversion ( 2.2 ). Pediatric Patients • Conversion from another ESA: dosed once every 4 weeks based on total weekly epoetin alfa or darbepoetin alfa dose at time of conversion ( 2.2 ). • In patients less than 6 years of age, maintain the same route of administration as the previous ESA when switching from another ESA to Mircera. 2.1 Important Dosing Information Evaluation of Iron Stores and Nutritional Factors Evaluate the iron status in all patients before and during treatment. Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. The majority of patients with CKD will require supplemental iron during the course of ESA therapy.

• Hypertension: Control hypertension prior to initiating and during treatment with Mircera ( 5.3 ). • Seizures: Seizures have occurred in CKD patients participating in Mircera clinical studies. Increase monitoring of these patients for changes in seizure frequency or premonitory symptoms ( 5.4 ). • PRCA: If severe anemia and low reticulocyte count develop during Mircera treatment, withhold Mircera and evaluate for PRCA ( 5.6 ). • Serious Allergic Reactions: Discontinue Mircera and manage reactions ( 5.7 ). • Severe Cutaneous Reactions: Discontinue Mircera ( 5.8 ). 5.1 Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism • In controlled clinical trials of patients with CKD comparing higher hemoglobin targets (13 to 14 g/dL) to lower targets (9 to 11.3 g/dL), ESAs increased the risk of death, myocardial infarction, stroke, congestive heart failure, thrombosis of hemodialysis vascular access, and other thromboembolic events in the higher target groups. • Using ESAs to target a hemoglobin level of greater than 11 g/dL increases the risk of serious adverse cardiovascular reactions and has not been shown to provide additional benefit [see Clinical Studies ( 14 )] . Use caution in patients with coexistent cardiovascular disease and stroke [see Dosage and Administration ( 2.2 )] . Patients with CKD and an insufficient hemoglobin response to ESA therapy may be at even greater risk for cardiovascular reactions and mortality than other patients. A rate of hemoglobin rise of greater than 1 g/dL over 2 weeks may contribute to these risks.

The following serious adverse reactions are discussed in greater detail in other sections of the labeling: • Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism [see Warnings and Precautions ( 5.1 )] • Increased Mortality and/or Tumor Progression in Patients with Cancer [see Warnings and Precautions ( 5.2 )] • Hypertension [see Warnings and Precautions ( 5.3 )] • Seizures [see Warnings and Precautions ( 5.4 )] • Pure Red Cell Aplasia [see Warnings and Precautions ( 5.6 )] • Serious Allergic Reactions [see Warnings and Precautions ( 5.7 )] • Severe Cutaneous Reactions [see Warnings and Precautions ( 5.8 )] The most common adverse reactions (≥ 10%) are hypertension, diarrhea, nasopharyngitis ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact Vifor (International) Inc. at 1-800-576-8295, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of Mircera cannot be directly compared to rates in the clinical trials of other drugs and may not reflect the rates observed in practice. Adult Patients The data described below reflect exposure to Mircera in 2737 patients, including 1451 exposed for 6 months and 1144 exposed for greater than one year. Mircera was studied primarily in active-controlled studies (n=1789 received Mircera, and n=948 received another ESA) and in long-term follow up studies.

8.1 Pregnancy Risk Summary Available data from a small number of published case reports and postmarketing experience with Mircera use in pregnancy are insufficient to identify a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Chronic kidney disease is associated with maternal and embryo-fetal risks (see Clinical Considerations) . In animal reproduction studies, administration of methoxy polyethylene glycol-epoetin beta to rats and rabbits during pregnancy and lactation adversely affected offspring at doses 17-fold and greater than the recommended human dose (see Data) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Disease Associated Maternal and/or Embryo-Fetal Risk Pregnancy in women with chronic kidney disease has been associated with adverse outcomes including hypertension, pre-eclampsia, miscarriage, premature birth, low-birth-weight, polyhydramnios, and intrauterine growth restriction.

Metabolism

The pharmacokinetics of methoxy polyethylene glycol-epoetin beta were studied in adult anemic patients with CKD including patients on dialysis and those not on dialysis. Parameters are presented as the geometric mean [% coefficient of variation (%CV)] unless otherwise specified.

Mircera overdosage can elevate hemoglobin levels above the desired level, which should be managed with discontinuation or reduction of Mircera dosage and/or with phlebotomy, as clinically indicated [see Pharmacodynamics ( 12.2 )]. Cases of severe hypertension have been observed following overdose with ESAs [see Warnings and Precautions ( 5.3 )].

• Nov 14, 2007BLABLA125164Hoffman-la Roche

1. 1Drug Hypersensitivity2,96127%
2. 2Death1,57114%
3. 3Dyspnoea1,10810%
4. 4Nausea8157.5%
5. 5Pruritus7817.2%
6. 6Vomiting6766.2%
7. 7Haemoglobin Decreased5835.3%
8. 8Flushing5094.7%
9. 9Anaemia3463.2%
10. 10Feeling Hot3353.1%
11. 11Unresponsive To Stimuli3253.0%
12. 12No Adverse Event3122.9%
13. 13Dizziness2902.7%
14. 14Hypotension2762.5%
15. 15Rash2762.5%

The 10 most recently updated of 193 ClinicalTrials.gov registrations naming Epoetin Beta as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Effects of Intravenous Injection of Erythropoietin on Hepcidin Pharmacokinetics in Healthy Volunteers
  Completed · Interventional · 14 enrolled · Rennes University Hospital
  NCT00687518updated 2026-06-12
• MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial)
  Recruiting · Phase 2 · Interventional · 2,000 enrolled · National Cancer Institute (NCI)
  NCT05564390updated 2026-06-11
• A Phase 3 Study of Efepoetin Alfa for Treatment of Anemia in Patients With Chronic Kidney Disease on Dialysis
  Recruiting · Phase 3 · Interventional · 429 enrolled · Genexine, Inc.
  NCT06466785updated 2026-05-22
• Impact of Medically Supervised Performance-Enhancing Substances (PES) on Elite Athletes
  Enrolling by invitation · Interventional · 60 enrolled · Enhanced Emirates Limited
  NCT07568574updated 2026-05-06
• Vafseo Outcomes In-Center Experience
  Active not recruiting · Phase 3 · Interventional · 2,200 enrolled · USRC Kidney Research
  NCT06520826updated 2026-03-10
• Efficacy of Erythropoietin to Improve Survival and Neurological Outcome in Hypoxic Ischemic Encephalopathy
  Completed · Phase 3 · Interventional · 120 enrolled · Assistance Publique - Hôpitaux de Paris
  NCT01732146updated 2025-11-20
• 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
  Active not recruiting · Phase 4 · Interventional · 85 enrolled · Bristol-Myers Squibb
  NCT05891249updated 2025-10-20
• Correction of Anaemia and Progression of Renal Failure on Transplanted Patients
  Completed · Phase 4 · Interventional · 128 enrolled · Centre Hospitalier Universitaire, Amiens
  NCT00396435updated 2025-09-23
• A Study of Monthly Subcutaneous Mircera for the Treatment of Chronic Renal Anemia in Predialysis Patients Not Treated With ESA.
  Completed · Phase 3 · Interventional · 75 enrolled · Hoffmann-La Roche
  NCT00661388updated 2025-09-11
• A Study of Subcutaneous Mircera for the Maintenance Treatment of Dialysis Patients With Chronic Renal Anemia.
  Completed · Phase 3 · Interventional · 233 enrolled · Hoffmann-La Roche
  NCT00560404updated 2025-09-11

Frequently asked questions

How does Epoetin Beta work?

Mircera is an erythropoietin receptor activator with greater activity in vivo as well as increased half-life, in contrast to erythropoietin. A primary growth factor for erythroid development, erythropoietin is produced in the kidney and released into the bloodstream in response to hypoxia.

What is Epoetin Beta used for?

According to FDA labeling, Epoetin Beta carries indications including: 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 ( 1.1 ). • 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 ( 1.1 ).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What are the contraindications for Epoetin Beta?

Epoetin Beta labeling lists contraindications including: Mircera is contraindicated in patients with: • Uncontrolled hypertension [see Warnings and Precautions ( 5.3 )] • Pure red cell aplasia (PRCA) that begins after treatment with Mircera or other erythropoietin protein drugs [see Warnings and Precautions ( 5.6 )] • History of serious or severe allergic reactions to Mircera (e.g., anaphylactic reactions, angioedema, bronchospasm, skin rash, and urticaria) [see Warnings and Precautions ( 5.7 , 5.8 )] . • Uncontrolled hypertension ( 4 ).. Always consult the full prescribing information and a clinician.