Webb22 juli 2024 · Mircera 360 mcg in 0.6 mL is formulated in an aqueous solution containing mannitol (18 mg), methionine (0.894 mg), poloxamer 188 (0.06 mg), sodium phosphate monobasic monohydrate (0.828 mg), and sodium sulfate (3.408 mg). The solution is clear, colorless to slightly yellowish and the pH is 6.2 ± 0.2. Webb15 maj 2024 · Pfizer Inc. (NYSE:PFE) today announced the United States (U.S.) Food and Drug Administration (FDA) approved RETACRIT® (epoetin alfa-epbx), a biosimilar to Epogen® and Procrit® (epoetin alfa)1, for all indications of the reference product. RETACRIT is now the first and only biosimilar erythropoiesis-stimulating agent (ESA) to …
RATIONALE FOR INCLUSION IN PA PROGRAM - Caremark
WebbProcrit $25.72‡ $30.00 57% savings Potential Cost Savings With RETACRIT—Wholesale Acquisition Cost (WAC)† Represents a 57% Discount per 1000 Units vs Procrit3 * Biosimilars have no clinically meaningful differences from their reference product in terms of safety, purity, or potency.4 WebbRETACRIT (epoetin alfa-epbx) is biosimilar* to EPOGEN/PROCRIT (epoetin alfa) WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, … hearth and patio waldorf md
HIGHLIGHTS OF PRESCRIBING INFORMATION
WebbApprovals may be subject to dosing limits in accordance with FDA-approved labeling, accepted compendia, and/or evidence-based practice guidelines. ... Procrit [package insert]. Thousand Oaks, CA: Amgen Inc.; December 2013. 4. … Webb3 maj 2024 · † FDA approved indication(s); ‡ Compendia recommended indication(s); Ф Orphan Drug – applicable to Procrit/Epogen only IV. Renewal Criteria 1-3,6,7 Coverage can be renewed based upon the following criteria: • Patient continues to meet universal and other indication-specific relevant criteria identified in section III; AND WebbContinued . . . Retacrit™ (epoetin alfa-epbx) – New biosimilar approval • On May 15, 2024, the FDA announced the approval of Retacrit (epoetin alfa-epbx), Hospira/Pfizer’s biosimilar to Amgen’s Epogen® (epoetin alfa) and Janssen’s Procrit® (epoetin alfa). — Retacrit is the first FDA-approved biosimilar to Epogen and Procrit. hearth and patio warwick ri