Mircera Adverse Reactions

Clinical Trials: The safety data base for MIRCERA from controlled clinical trials comprised 3042 CKD patients where 1939 were treated with MIRCERA and 1103 with an ESA.
Based on the results of 1939 patients, approximately 6% of patients treated with MIRCERA are expected to experience adverse drug reactions (ADRs). The most frequent reported adverse reaction was hypertension (common).
The following descriptors are used to describe the frequency of ADRs attributed to treatment with MIRCERA in controlled clinical trials: Common (≥1/100 and <1/10), Uncommon (≥1/1000 and <1/100), and Rare (≥1/10,000 and <1/1000). (See Table 2.)

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All other events attributed to MIRCERA were reported with rare frequency and were in the majority of mild to moderate severity. These events were consistent with comorbidities known in the population.
Laboratory Abnormalities: During treatment with MIRCERA, a slight decrease in platelet counts, remaining within the normal range, was observed in clinical studies.
A platelet count below 100 x 10⁹/L was observed in 7.5% of patients treated with MIRCERA and 4.4% of patients treated with other ESAs.
Post Marketing: Neutralizing anti-erythropoietin antibody-mediated pure red cell aplasia (AEAB-PRCA) associated with MIRCERA therapy has been reported during post marketing experience (see also Precautions).
Stevens-Johnson syndrome/toxic epidermal necrolysis has been reported.
Laboratory Abnormalities: See Post Marketing as previously mentioned.