What is the generic name?

METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA

What is the Trade Name for METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA?

Mircera

What are the Indications for METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA?

• 1 INDICATIONS AND USAGE Mircera is an erythropoiesis-stimulating agent (ESA) indicated for the treatment of anemia associated with chronic kidney disease (CKD) in: ‚Ä¢ adult patients on dialysis and adult patients not on dialysis ( 1.1 ). ‚Ä¢ 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 ( 1.1 ). Limitations of Use Mircera is not indicated and is not recommended for use: ‚Ä¢ In the treatment of anemia due to cancer chemotherapy ( 5.2 ). ‚Ä¢ As a substitute for RBC transfusions in patients who require immediate correction of anemia ( 12.2 ). Mircera has not been shown to improve quality of life, fatigue, or patient well-being. 1.1 Anemia Due to Chronic Kidney Disease Mircera is indicated for the treatment of anemia associated with chronic kidney disease (CKD) in: ‚Ä¢ adult patients on dialysis and adult patients not on dialysis. ‚Ä¢ 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. Limitations of Use Mircera is not indicated and is not recommended: ‚Ä¢ In the treatment of anemia due to cancer chemotherapy [see Warnings and Precautions ( 5.2 )] . ‚Ä¢ As a substitute for RBC transfusions in patients who require immediate correction of anemia [see Clinical Pharmacology ( 12.2 )] . Mircera has not been shown to improve symptoms, physical functioning, or health-related quality of life.

References: https://open.fda.gov/