Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 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 )] 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.
The population was 18 to 92 years of age, 58% male, and the percentage of Caucasian, Black (including African Americans), Asian and Hispanic patients were 73%, 20%, 5%, and 9%, respectively.
Approximately 85% of the patients were receiving dialysis.
Most patients received Mircera using dosing regimens of once every two or four weeks, administered subcutaneously or intravenously.
The most commonly reported adverse reactions in ≥10% of patients were hypertension [see Warnings and Precautions ( 5.3 )] , diarrhea, and nasopharyngitis.
5 WARNINGS AND PRECAUTIONS • 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 ).
Like all medications, Mircera can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: