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Mircera

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Mircera

Mircera®
(methoxy polyethylene glycol-epoetin beta) Injectable Solution

WARNING

ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS, AND TUMOR PROGRESSION OR RECURRENCE

Chronic Kidney Disease

[see WARNINGS AND PRECAUTIONS]

  • 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

[see WARNINGS AND PRECAUTIONS]

  • 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 have shown 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.

DRUG DESCRIPTION

Mircera, methoxy polyethylene glycol-epoetin beta, is an ESA which differs from erythropoietin through formation of a chemical bond between either the N-terminal amino group or the s-amino group of any lysine present in erythropoietin, predominantly Lys52 and Lys45, and methoxy polyethylene glycol (PEG) butanoic acid (approximately 30,000 daltons). This results in a total molecular weight of approximately 60,000 daltons. Mircera is formulated as a sterile, preservative-free protein solution for intravenous or subcutaneous administration.

Injectable solutions of Mircera in prefilled syringes are formulated in an aqueous solution containing sodium phosphate, sodium sulphate, mannitol, methionine and poloxamer 188. The solution is clear, colorless to slightly yellowish and the pH is 6.2 ± 0.2.

Last reviewed on RxList: 10/16/2014
This monograph has been modified to include the generic and brand name in many instances.

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