Description
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
- pediatric patients 5 to 17 years of age on hemodialysis who are converting
- from another ESA after their hemoglobin level was stabilized with an ESA
- Not recommended for use In the treatment of anemia due to cancer chemotherapy
How to use:
- 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.
- Following initiation of therapy and after each dose adjustment, monitor hemoglobin weekly until the hemoglobin level is stable and sufficient to minimize the need for RBC transfusion.
Caution & Warnings:
IMPORTANT SAFETY INFORMATION
- Chronic Kidney Disease:
- In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and
- stroke when administered erythropoiesis-stimulating agents (ESAs) to target a hemoglobin level of greater than 11 g/dL.
- No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks.
- Use the lowest Mircera dose sufficient to reduce the need for red blood cell (RBC) transfusions.
- Cancer:
- Mircera is not indicated and is not recommended for the treatment of anemia due to cancer chemotherapy.
- A dose-ranging study of Mircera was terminated early because of more deaths among patients receiving Mircera
- than another ESA.
- ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in clinical studies in
- patients with past, non-small cell lung, head and neck, lymphoid, and cervical cancers
CONTRAINDICATIONS
Mircera is contraindicated in patients with:
- Uncontrolled hypertension
- Pure red cell aplasia (PRCA) that begins after treatment with Mircera or other erythropoietin protein drugs
- History of serious or severe allergic reactions to Mircera (e.g. anaphylactic reactions, angioedema, bronchospasm, pruritus, skin rash, and urticaria)
Ingredients:
- methoxy polyethylene glycol-epoetin beta 50mcg/0.3ml
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