"The U.S. Food and Drug Administration today expanded the approved use of Stivarga (regorafenib) to treat patients with advanced gastrointestinal stromal tumors (GIST) that cannot be surgically removed and no longer respond to other FDA-approved t"...
(methoxy polyethylene glycol-epoetin beta)
WARNINGS: INCREASED MORTALITY, SERIOUS CARDIOVASCULAR AND THROMBOEMBOLIC EVENTS, and TUMOR PROGRESSION
Renal failure: Patients experienced greater risks for death and serious cardiovascular events when administered erythropoiesis-stimulating agents (ESAs) to target higher versus lower hemoglobin levels (13.5 vs. 11.3 g/dL; 14 vs. 10 g/dL) in two clinical studies. Individualize dosing to achieve and maintain hemoglobin levels within the range of 10 to 12 g/dL [see Warnings and PRECAUTIONS].
Cancer: Mircera (methoxy polyethylene glycol-epoetin beta) is not indicated for the treatment of anemia due to cancer chemotherapy. A dose- ranging study of Mircera (methoxy polyethylene glycol-epoetin beta) was terminated early because of significantly more deaths among patients receiving Mircera (methoxy polyethylene glycol-epoetin beta) than another ESA. In other studies of ESAs in patients with cancer:
- ESAs shortened overall survival and/or time-to-tumor progression in clinical studies in patients with advanced breast, head and neck, lymphoid and non-small cell lung malignancies when dose to a target hemoglobin of ≥ 12 g/dL.
- The risks of shortened survival and tumor promotion have not been excluded when ESAs are dosed to target a hemoglobin of < 12 g/dL [see Warnings and PRECAUTIONS].
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 e-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 (methoxy polyethylene glycol-epoetin beta) is formulated as a sterile, preservative-free protein solution for IV or SC administration.
Injectable solutions of Mircera (methoxy polyethylene glycol-epoetin beta) in vials and 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: 12/20/2007
This monograph has been modified to include the generic and brand name in many instances.
Additional Mircera Information
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