PROCRIT SUMMARY
Erythropoietin is a glycoprotein which stimulates red blood cell production. It is produced in the kidney and stimulates the division and differentiation of committed erythroid progenitors in the bone marrow. PROCRIT® (Epoetin alfa), a 165 amino acid glycoprotein manufactured by recombinant DNA technology, has the same biological effects as endogenous erythropoietin.
PROCRIT® is indicated for the treatment of anemia associated with CRF, including patients on dialysis (ESRD) and patients not on dialysis. PROCRIT® is indicated to elevate or maintain the red blood cell level (as manifested by the hematocrit or hemoglobin determinations) and to decrease the need for transfusions in these patients.
Non-dialysis patients with symptomatic anemia considered for therapy should have a hemoglobin less than 10 g/dL.
PROCRIT® is not intended for patients who require immediate correction of severe anemia. PROCRIT® may obviate the need for maintenance transfusions but is not a substitute for emergency transfusion.
Prior to initiation of therapy, the patient's iron stores should be evaluated. Transferrin saturation should be at least 20% and ferritin at least 100 ng/mL. Blood pressure should be adequately controlled prior to initiation of PROCRIT® therapy, and must be closely monitored and controlled during therapy.
PROCRIT® should be administered under the guidance of a qualified physician (see DOSAGE AND ADMINISTRATION).
PROCRIT® is indicated for the treatment of anemia related to therapy with zidovudine in HIV-infected patients. PROCRIT® is indicated to elevate or maintain the red blood cell level (as manifested by the hematocrit or hemoglobin determinations) and to decrease the need for transfusions in these patients. PROCRIT® is not indicated for the treatment of anemia in HIV-infected patients due to other factors such as iron or folate deficiencies, hemolysis, or gastrointestinal bleeding, which should be managed appropriately.
PROCRIT®, at a dose of 100 Units/kg TIW, is effective in decreasing the transfusion requirement and increasing the red blood cell level of anemic, HIV-infected patients treated with zidovudine, when the endogenous serum erythropoietin level is
PROCRIT® is indicated for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitantly administered chemotherapy. PROCRIT® is indicated to decrease the need for transfusions in patients who will be receiving concomitant chemotherapy for a minimum of 2 months. PROCRIT® is not indicated for the treatment of anemia in cancer patients due to other factors such as iron or folate deficiencies, hemolysis, or gastrointestinal bleeding, which should be managed appropriately.
PROCRIT® is indicated for the treatment of anemic patients (hemoglobin > 10 to 18-20 PROCRIT® is indicated for patients at high risk for perioperative transfusions with significant, anticipated blood loss. PROCRIT® is not indicated for anemic patients who are willing to donate autologous blood. The safety of the perioperative use of PROCRIT® has been studied only in patients who are receiving anticoagulant prophylaxis.
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NEWS HIGHLIGHTSMedia Articles Related to Procrit (Epoetin Alfa)
Anemia Drugs May Cause Deadly Blood Clots (HealthDay)
Source: Y! Health News Search RSS Feed [2009.11.10]
HealthDay - TUESDAY, Nov. 10 (HealthDay News) -- New research on cancer
patients adds to the controversy surrounding anemia drugs such as Procrit
and Aranesp, concluding that they increase the risk of venous
thromboembolism, potentially fatal blood clots.
ASN: No Clinical Benefit for ESA in Anemic Patients with Diabetes, CKD (CME/CE)
Source: MedPage Today Endocrinology [2009.10.30]
SAN DIEGO (MedPage Today) -- For patients with type 2 diabetes, chronic kidney disease, and anemia, darbepoetin alfa (Aranesp) failed to improve most clinical outcomes compared with placebo and nearly doubled the risk of stroke, a large, multicenter trial showed.
FDA approves extended dosing of Aranesp
Source: The Doctors Lounge - Hematology
FDA has approved every-3-week dosing of Aranesp (darbepoetin alfa) for treatment of chemotherapy - induced anemia.
Published Studies Related to Procrit (Epoetin Alfa)
A Randomized Controlled Study of Weekly and Biweekly Dosing of Epoetin Alfa in CKD Patients With Anemia. [2009.09.17]
BACKGROUND AND OBJECTIVES: In clinical practice, physicians often use once-weekly (QW) and biweekly (Q2W) dosing of epoetin alfa to treat anemia in patients with chronic kidney disease (CKD). Although the literature supports this practice, previous studies were limited by short treatment duration, lack of randomization, or absence of the approved three times per week (TIW) dosing arm. This randomized trial evaluated extended dosing regimens of epoetin alfa, comparing QW and Q2W to TIW dosing in anemic CKD subjects. The primary objective was to show that treatment with epoetin alfa at QW and Q2W intervals was not inferior to TIW dosing... CONCLUSIONS: Administration of epoetin alfa at QW and Q2W intervals are potential alternatives to TIW dosing for the treatment of anemia in stage 3 to 4 CKD subjects.
Biosimilarity of HX575 (human recombinant epoetin alfa) and epoetin beta after multiple subcutaneous administration. [2009.06]
OBJECTIVE: To compare the steady-state pharmacokinetics and pharmacodynamics following multiple subcutaneous administration of a new erythropoiesis stimulating agent (HX575, Binocrit, Sandoz GmbH, Holzkirchen, Germany) with that of epoetin beta (NeoRecormon, Roche Ltd., Welwyn Garden City, UK)... CONCLUSIONS: HX575 and epoetin beta were bioequivalent with respect to their steady-state pharmacokinetic profile and pharmacodynamic action. These results support the conclusion that HX575 and epoetin beta will be equally efficacious and may be interchangeable as therapy.
A risk model for severe anemia to select cancer patients for primary prophylaxis with epoetin alpha: a prospective randomized controlled trial of the ELYPSE study group. [2009.06]
BACKGROUND: Epoetin (EPO) administration reduces the need for transfusion. Identifying patients at high risk of anemia requiring red blood cell (RBC) transfusion is needed. This multicentric phase III trial tested epoetin alpha (EPOalpha) administration according to our risk model on the basis of three clinical parameters: hemoglobin (Hb) <12 g/dl, lymphocytes <or=700/microl, and/or performance status (PS) >1... CONCLUSION: Patients at high risk for RBC transfusion according to the ELYPSE model could be given prophylactic EPO with significantly reduced RBC transfusions and no significant impact on side-effects, progression-free survival, and OS.
Bioequivalence of HX575 (recombinant human epoetin alfa) and a comparator epoetin alfa after multiple intravenous administrations: an open-label randomised controlled trial. [2009.05.22]
BACKGROUND: HX575 is a human recombinant epoetin alfa that was approved for use in Europe in 2007 under the European Medicines Agency biosimilar approval pathway. Therefore, in order to demonstrate the bioequivalence of HX575 to an existing epoetin alfa, the pharmacokinetic and pharmacodynamic response to steady state circulating concentrations of HX575 and a comparator epoetin alfa were compared following multiple intravenous administrations... CONCLUSION: HX575 and the comparator epoetin alfa were bioequivalent at steady state circulating drug concentrations with respect to their pharmacokinetic profile and pharmacodynamic action. This supports the conclusion that HX575 and the comparator epoetin alfa, when administered intraveneously, will be equally efficacious and may be interchangeable as therapy.
HX575, recombinant human epoetin alfa, for the treatment of chemotherapy-associated symptomatic anaemia in patients with solid tumours. [2009.04]
BACKGROUND: Recombinant human epoetin alfa, HX575, is the first biosimilar erythropoiesis-stimulating agent (ESA) with European marketing authorisation. The primary objective of this double-blind, randomised, multicentre study was to assess the efficacy and safety of HX575 in treating chemotherapy-associated symptomatic anaemia in patients with solid tumours... CONCLUSIONS: In treating chemotherapy-associated symptomatic anaemia in patients with solid tumours, the biosimilar ESA, HX575, is efficacious with a safety profile as expected for the therapeutic area. Copyright 2009 S. Karger AG, Basel.
Clinical Trials Related to Procrit (Epoetin Alfa)
Using Iron With Procrit in Advanced Lung Cancer Patients With Chemotherapy-Induced Anemia [Suspended]
The purpose of this study is to find a better, more convenient way to improve anemia results
by increasing the amount of medication given at 3 week intervals. Researchers want to know if
giving a higher dose of Procrit® and intravenous (IV) iron once every 3 weeks would give
better results in treating anemia without the need for more office visits.
An Open-Label Study to Evaluate the Effect of Every Other Week PROCRIT® (Epoetin Alfa) Dosing (40,000-60,000 Units) On Maintaining Quality of Life and Target Hemoglobin Levels in Anemic HIV-Infected Patients (CHAMPS II) [Completed]
The objective of this study was to treat anemic (Hemoglobin (Hb) < 12 g/dL) HIV-infected
subjects with once weekly (QW) PROCRIT (Epoetin alfa) to a target Hb of > 13 g/dL and then to
assess if the target Hb level and improvements in Quality of Life (QOL) could be maintained
with every other week (Q2W) PROCRIT (Epoetin alfa) dosing.
Early and Standard Intervention With 120,000 Units of PROCRIT (Epoetin Alfa) Every Three Weeks in Patients Receiving Chemotherapy [Completed]
The purpose of this study is to evaluate the safety and efficacy of PROCRIT (Epoetin alfa)
when administered at 120,000 Units once every three weeks by comparing early dosing (Hb
11g/dL-12g/dL) vs. standard dosing (Hb< 11g/dL).
The Safety and Effectiveness of PROCRIT (Epoetin Alfa) in Reducing the Number of Blood Transfusions Required by Patients Undergoing Elective Major Abdominal and/or Pelvic Surgery [Terminated]
The primary objective of this study is to compare the effect of giving PROCRIT (Epoetin alfa)
to patients before, during and after elective major abdominal surgery (perioperatively) to
that of patients receiving Standard of Care (SOC) on the proportion of patients receiving
pRBC (packed red blood cell) transfusions from day of surgery to the day of hospital
discharge. Standard of Care is defined as the treatment of patients according to the
hospital or institution's policy, but where patients will not receive PROCRIT (Epoetin alfa)
or any other erythropoiesis-stimulating agents (ESAs) (agents that stimulate the production
of red blood cells in the bone marrow).
Epoetin Alfa for HIV-Associated Neuropathy Trial [Terminated]
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Page last updated: 2009-11-10
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