PROCRIT® is indicated for the treatment of anemia due to chronic kidney disease (CKD), including patients on dialysis and not on dialysis, to decrease the need for red blood cell (RBC) transfusion.
PROCRIT® has not been shown to improve quality of life, fatigue, or patient well-being.
PROCRIT® is not indicated for use:
Evaluate the iron status in all patients before and during treatment. Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. The majority of patients with CKD will require supplemental iron during the course of ESA therapy.
Correct or exclude other causes of anemia (eg, vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.) before initiating PROCRIT®. Following initiation of therapy and after each dose adjustment, monitor hemoglobin (Hb) weekly until the Hb level is stable and sufficient to minimize the need for RBC transfusion.
In pregnant women, lactating women, neonates, and infants, use only single-dose vials (the benzyl alcohol–free formulation). Do not mix PROCRIT® with bacteriostatic saline (which also contains benzyl alcohol) when administering PROCRIT® to these patient populations.
In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered ESAs to target an Hb level of greater than 11 g/dL. No trial has identified an Hb target level, ESA dose, or dosing strategy that does not increase these risks.
Individualize dosing and use the lowest dose of PROCRIT® sufficient to reduce the need for RBC transfusions. Physicians and patients should weigh the possible benefits of decreasing transfusions against the increased risks of death and other serious cardiovascular adverse reactions.
When initiating or adjusting therapy, monitor Hb levels at least weekly until stable, then monitor at least monthly. When adjusting therapy, consider Hb rate of rise, rate of decline, ESA responsiveness, and Hb variability. A single Hb excursion may not require a dosing change.
When treating patients who have chronic kidney disease and cancer, physicians should refer to Warnings and Precautions (sections 5.1 and 5.2) of the FULL PRESCRIBING INFORMATION.
ESA=erythropoiesis-stimulating agent.
PROCRIT® starting dose (range):
TIW=3 times weekly.
50 to 100 Units/kg TIW, intravenously (IV) or subcutaneously (SC)
Monitor Hb at least weekly after initiation and following a dosage adjustment until stable, then monitor at least monthly
PROCRIT® is contraindicated in patients with uncontrolled hypertension, pure red cell aplasia (PRCA) that begins after treatment with PROCRIT® or other erythropoietin protein drugs, or serious allergic reactions to PROCRIT®. PROCRIT® from multiple-dose vials contains benzyl alcohol and is contraindicated in neonates, infants, pregnant women, and lactating women.1 Please see the FULL PRESCRIBING INFORMATION to learn more.