Product 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