Elective surgery
  • PROCRIT® is the ONLY ESA marketed for the treatment of patients (Hb >10 g/dL to ≤13 g/dL) who are at high risk for perioperative blood loss from elective, noncardiac, nonvascular surgery to reduce the need for allogeneic blood transfusions
    • – Not indicated for patients who are willing to donate autologous blood
divider
Reduced transfusion rates1,2
PROCRIT® reduced transfusion rates with both weekly and daily dosing regimens1,2
Patients with pretreatment Hb >10 g/dL to ≤13 g/dL requiring allogeneic transfusions (%)
  • PROCRIT® significantly reduced transfusion requirements compared with placebo in patients with Hb >10 g/dL to ≤13 g/dL (P=0.024)1
Patients with pretreatment Hb >10 g/dL to ≤13 g/dL requiring allogeneic transfusions (%)

Study designs
Study Patients Design Treatment Endpoints
de Andrade
et al1
  • 316 patients scheduled for major elective orthopedic hip or knee surgery
  • Expected to require ≥2 units of blood and not able or willing to participate in an autologous blood donation program
  • Randomized, multicenter, placebo-controlled, double-blind parallel-group trial
  • Stratification:
    • Hb ≤10 g/dL (n=2)
    • Hb >10 g/dL to ≤13 g/dL (n=96)
    • Hb >13 g/dL to ≤15 g/dL (n=218)
  • PROCRIT® 300 U/kg SC daily*
  • PROCRIT® 100 U/kg SC daily*
  • Equivalent volume of placebo
  • All patients received oral iron and low-dose anticoagulation therapy (warfarin or warfarin derivative)
  • Primary efficacy: reduction in transfusion requirements
  • Secondary efficacy: mean number of units transfused per patient, Hb, HCT, and reticulocyte counts
Goldberg
et al2
  • 145 patients who were scheduled for major elective orthopedic hip or kneee replacement surgery
  • Pretreatment Hb level of ≥10 g/dL to ≤13 g/dL who were not participating in an autologous program
  • Multicenter, open-label, randomized, parallel-group trial
  • PROCRIT® 300 U/kg SC daily*
  • PROCRIT® 600 U/kg SC weekly
  • All patients received oral iron and standard anticoagulation therapy
  • Primary efficacy variables: mean change in Hb and absolute reticulocyte counts from prestudy to presurgery
  • Other efficacy variables: proportions of patients tranfused, mean change in Hb and absolute reticulocyte counts presurgery to postsurgery Day 1, total number of units transfused per patient, reasons for transfusions, pretransfusion Hb levels and time to hospital discharge

*Daily regimen (100 or 300 U/kg SC): for 15 days, starting 10 days prior to, day of, and 4 days after surgery.1,2
Weekly regimen (600 U/kg SC): once weekly, beginning 3 weeks prior to surgery, with fourth dose on day of surgery.2
divider
Hb values and reticulocyte counts1
Mean Hb values in patients with Hb >10 g/dL to ≤13 g/dL1
Mean reticulocyte counts in patients with Hb >10 g/dL to ≤13 g/dL1
  • PROCRIT® significantly increased mean Hb and reticulocyte counts during the presurgery period in patients with Hb >10 g/dL to ≤13 g/dL (P=0.0001)1
divider
Selected safety profile3
Adverse reactions occurring in ≥1% of surgery patients3*
Event
PROCRIT®-treated patients 300 U/kg SC (n=112)
PROCRIT®-treated patients 100 U/kg SC (n=101)
Placebo-treated patients (n=103)
PROCRIT®-treated patients 600 U/kg SC (n=73)
PROCRIT®-treated patients 300 U/kg SC (n=72)
Nausea 47% 43% 45% 45% 56%
Vomiting 21% 12% 14% 19% 28%
Pruritus 16% 16% 14% 12% 21%
Headache 13% 11% 9% 10% 18%
Injection site pain 13% 9% 8% 12% 11%
Chills 7% 4% 1% 1% 0%
Deep vain thrombosis 6% 3% 3% 0% 0%
Cough 5% 4% 0% 4% 4%
Hypertension 5% 3% 5% 5% 6%
Rash 2% 2% 1% 3% 3%
Edema 1% 2% 2% 1% 3%

*Adverse reactions with a reported incidence ≥1% in PROCRIT®-treated patients that occurred at a higher frequency than in placebo-treated patients.3
Study including patients undergoing orthopedic surgery treated with PROCRIT® or placebo for 15 days.3
Study including patients undergoing orthopedic surgery treated with PROCRIT® 600 U/kg SC weekly x 4 weeks or 300 U/kg SC daily x 15 days.3
§ Deep vein thromboses were determined by clinical symptoms.3
  • 100-U/kg SC dosing appears for safety profile consideration. This is unapproved dosing
divider

References
  1. de Andrade JR, Jove M, Landon G, et al. Baseline hemoglobin as a predictor of risk of transfusion and response to epoetin alfa in orthopedic surgery patients. Am J Orthop. 1996;25:533-542.
  2. Goldberg MA, McCutchen JW, Jove M, et al. A safety and efficacy comparison study of two dosing regimens of epoetin alfa in patients undergoing major orthopedic surgery. Am J Orthop. 1996;25:544-552.
  3. PROCRIT® (epoetin alfa) Prescribing Information. Janssen Products, LP.
 
Indications and Important Safety Information
EXPAND    Expand ISI
Indications
Expand ISI
Important Safety Information
Expand ISI