Methoxy Polyethylene Glycol-epoetin Beta
Class: Hematopoietic Agents
Chemical Name: Methoxy Polyethylene Glycol-epoetin Beta
CAS Number: 677324-53-7
Brands: Mircera
Warning
Warning: Erythropoiesis-stimulating agents (ESAs) increase the risk of death, myocardial infarction, stroke, venous thromboembolism, thrombosis of vascular access and tumor progression or recurrence.
See full prescribing information for complete boxed warning
- Chronic Kidney Disease
In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered 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 methoxy polyethylene glycol-epoetin beta dose sufficient to reduce the need for red blood cell (RBC) transfusions.
- Cancer
Methoxy polyethylene glycol-epoetin beta is not indicated and is not recommended for the treatment of anemia due to cancer chemotherapy. A dose-ranging study of methoxy polyethylene glycol-epoetin beta was terminated early because of more deaths among patients receiving methoxy polyethylene glycol-epoetin beta than another ESA.
ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers.
Introduction
Methoxy polyethylene glycol-epoetin beta is a hematopoietic agent.
Uses for Methoxy Polyethylene Glycol-epoetin Beta
Methoxy polyethylene glycol-epoetin beta has the following uses:
Methoxy polyethylene glycol-epoetin beta 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.
Methoxy polyethylene glycol-epoetin beta also is indicated for the treatment of anemia associated with CKD in 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.
Methoxy polyethylene glycol-epoetin beta has the following limitations of use:
Methoxy polyethylene glycol-epoetin beta is not indicated and is not recommended for use in the treatment of anemia due to cancer chemotherapy or as a substitute for RBC transfusions in patients who require immediate correction of anemia.
Methoxy polyethylene glycol-epoetin beta has not been shown to improve quality of life, fatigue, or patient well-being.
Methoxy Polyethylene Glycol-epoetin Beta Dosage and Administration
General
Methoxy polyethylene glycol-epoetin beta is available in the following dosage form(s) and strength(s):
Injection: 30 mcg, 50 mcg, 75 mcg, 100 mcg, 120 mcg, 150 mcg, 200 mcg, or 250 mcg in 0.3 mL solution (in single-dose prefilled syringes).
Injection: 360 mcg in 0.6 mL s.
