Mircera 50

• Anemia associated with chronic kidney disease (CKD)
• Anemia in patients on dialysis
• Anemia in patients not on dialysis

Adult Dose:

• Patients on Dialysis (Starting): 0.6 mcg/kg, once every two weeks (IV/SC)
• Patients NOT on Dialysis (Starting): 1.2 mcg/kg, once a month (SC); OR 0.6 mcg/kg, once every two weeks (IV/SC)
• Conversion from Other ESAs: Dose is based on the patient's previous weekly dose of epoetin or darbepoetin alfa
• Dose Adjustment: Can be increased or decreased by 25-50% monthly

Pediatric Dose: Safety and efficacy not established in patients under 18 years.

Common (>10%):

• Hypertension (13%)
• Diarrhea (11%)
• Nasopharyngitis (11%)

Uncommon (1-10%):

• Headache (9%)
• Upper respiratory tract infection (9%)
• Cough (6%)
• Hypotension (5%)
• Urinary tract infection (5%)

Rare:

• Seizures
• Pure Red Cell Aplasia (PRCA)
• Allergic reactions
• Stevens-Johnson syndrome
• Toxic epidermal necrolysis

• Monitor blood pressure closely before, during, and after treatment - ensure adequate control
• Assess iron status and provide iron supplementation if ferritin <100 µg/L or transferrin saturation <20%
• If hemoglobin rises >1 g/dL in any 2-week period, reduce the dose
• If Pure Red Cell Aplasia (PRCA) is diagnosed, discontinue MIRCERA and do not switch to another ESA
• Caution in hemoglobinopathies, seizures, platelet level >500 x 109/L