Methoxy Polyethylene Glycol-Epoetin Beta (1 brand name, 1 dosage form, 1 route)
Available dosage forms: SOLUTION.
Routes of administration: INJECTION.
Brand Names
- MIRCERA
Contraindications
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)].
Adverse Reactions
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)]
Mechanism of Action
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. In responding to hypoxia, erythropoietin interacts with erythroid progenitor cells to increase red cell production. Production of endogenous erythropoietin is impaired in patients with CKD and erythropoietin deficiency is the primary cause of their anemia.
Overdosage
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)].