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In comparative studies, RETACRIT showed comparable incidence of most common AEs.
No clinically meaningful differences were noted between RETACRIT and Epogen/Procrit in the incidence of AEs of special interest, including severe and serious AEs.
No new safety signals were identified in RETACRIT compared to the known AE profile of Epogen/Procrit.
Studies in support of biosimilarity
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WARNINGS: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE
CHRONIC KIDNEY DISEASE
CANCER
PERISURGERY
CONTRAINDICATIONS
RETACRIT® is contraindicated in patients with:
RETACRIT® from multiple-dose vials contains benzyl alcohol and is contraindicated in:
INCREASED MORTALITY, MYOCARDIAL INFARCTION, STROKE, AND THROMBOEMBOLISM
INCREASED MORTALITY AND/OR INCREASED RISK OF TUMOR PROGRESSION OR RECURRENCE IN PATIENTS WITH CANCER
HYPERTENSION
SEIZURES
LACK OR LOSS OF HEMOGLOBIN RESPONSE TO RETACRIT®
PURE RED CELL APLASIA
SERIOUS ALLERGIC REACTIONS
SEVERE CUTANEOUS REACTIONS
RISK OF SERIOUS ADVERSE REACTIONS DUE TO BENZYL ALCOHOL PRESERVATIVE
RISK IN PATIENTS WITH PHENYLKETONURIA
DIALYSIS MANAGEMENT
ANEMIA IN PATIENTS WITH CHRONIC KIDNEY DISEASE
ANEMIA DUE TO CHEMOTHERAPY IN PATIENTS WITH CANCER
SURGERY/PERISURGERY
ANEMIA DUE TO ZIDOVUDINE IN PATIENTS WITH HIV INFECTION