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.
|
