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elective surgery

elective surgery

Reduction of allogeneic red blood cell (RBC) transfusions in patients undergoing elective, noncardiac, nonvascular surgery1

PROCRIT® is indicated to reduce the need for allogeneic RBC transfusions among patients with perioperative hemoglobin (Hb) >10 to ≤13 g/dL who are at high risk for perioperative blood loss from elective, noncardiac, nonvascular surgery. PROCRIT® is not indicated for patients who are willing to donate autologous blood preoperatively.1

PROCRIT® has not been shown to improve quality of life, fatigue, or patient well-being.

PROCRIT® is not indicated for use:

Reduced transfusion rates2,3

PROCRIT® reduced transfusion rates with both weekly and daily dosing regimens2,3

Daily dosing vs placebo1,2

Procrit 16% - Placebo 45%
Procrit 16% - Placebo 45%

Daily dosing vs weekly dosing1,3

Daily dosing vs weekly dosing
Daily dosing vs weekly dosing

Study design

STUDY PATIENTS DESIGN TREATMENT ENDPOINTS
de Andrade et al2
  • 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 objective: reduction in transfusion requirements
  • Secondary efficacy objectives: mean number of units transfused per patient, Hb, Hct, and reticulocyte counts
Goldberg et al3
  • 145 patients who were scheduled for major elective orthopedic hip or knee replacement surgery
  • Pretreatment Hb level of ≥10 g/dL to ≤13 g/dL who were not participating in an autologous blood donation 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 transfused, 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
STUDY de Andrade et al2 Goldberg et al3
PATIENTS
  • 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
  • 145 patients who were scheduled for major elective orthopedic hip or knee replacement surgery
  • Pretreatment Hb level of ≥10 g/dL to ≤13 g/dL who were not participating in an autologous blood donation program
DESIGN
  • 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)
  • Multicenter, open-label, randomized, parallel-group trial
TREATMENT
  • 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)
  • PROCRIT® 300 U/kg SC daily*
  • PROCRIT® 600 U/kg SC weekly
  • All patients received oral iron and standard anticoagulation therapy
ENDPOINTS
  • Primary efficacy objective: reduction in transfusion requirements
  • Secondary efficacy objectives: mean number of units transfused per patient, Hb, Hct, and reticulocyte counts
  • Primary efficacy variables: mean change in Hb and absolute reticulocyte counts from prestudy to presurgery
  • Other efficacy variables: proportions of patients transfused, 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.2,3

Weekly regimen (600 U/kg SC): once weekly, beginning 3 weeks prior to surgery, with fourth dose on day of surgery.3

SC=subcutaneously.

Hb values and reticulocyte counts2

Mean Hb values in patients with Hb >10 g/dL to ≤13 g/dL

Image Graph Mean Hb values in patients with Hb >10 g/dL to ≤13 g/dL

Adapted with permission from de Andrade et al. Am J Orthop. 1996;25:533-542.

Mean reticulocyte counts in patients with Hb >10 g/dL to ≤13 g/dL

Image Graph Mean reticulocyte counts in patients with Hb >10 g/dL to ≤13 g/dL

Adapted with permission from de Andrade et al. Am J Orthop. 1996;25:533-542.

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).

Selected safety profile1

WARNINGS: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE

Perisurgery:

Due to increased risk of deep venous thrombosis (DVT), DVT prophylaxis is recommended.

Expand the Important Safety Information at the bottom of the page to see the complete Boxed Warnings.

The adverse reactions with a reported incidence of ≥1% in PROCRIT®-treated patients that occurred at a higher frequency than in placebo-treated patients are shown in the table below:

Adverse reactions in surgery patients1

EVENT          
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 vein 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%
           
color references for the table

Study including patients undergoing orthopedic surgery treated with PROCRIT® or placebo for 15 days.

§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.

||Deep vein thromboses were determined by clinical symptoms.

References

  1. PROCRIT® (epoetin alfa) Prescribing Information. Janssen Products, LP.
  2. 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.
  3. 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.
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