1 INDICATIONS AND USAGE
RETACRIT is an erythropoiesis-stimulating agent (ESA) indicated for:
Treatment of anemia due to
oChronic Kidney Disease (CKD) in patients on dialysis and not on dialysis (1.1).
oZidovudine in patients with HIV-infection (1.2).
oThe effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy (1.3).
Reduction of allogeneic RBC transfusions in patients undergoing elective, noncardiac, nonvascular surgery (1.4).
Limitations of Use
RETACRIT has not been shown to improve quality of life, fatigue, or patient well-being (1.5).
RETACRIT is not indicated for use:
In patients with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy (1.5).
In patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure (1.5).
In patients with cancer receiving myelosuppressive chemotherapy in whom the anemia can be managed by transfusion (1.5).
In patients scheduled for surgery who are willing to donate autologous blood (1.5).
In patients undergoing cardiac or vascular surgery (1.5).
As a substitute for RBC transfusions in patients who require immediate correction of anemia (1.5).
1.1 Anemia Due to Chronic Kidney Disease
RETACRIT 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.
1.2 Anemia Due to Zidovudine in Patients with HIV-infection
RETACRIT is indicated for the treatment of anemia due to zidovudine administered at
4,200 mg/week in patients with HIV-infection with endogenous serum erythropoietin levels of
500 mUnits/mL.
1.3 Anemia Due to Chemotherapy in Patients with Cancer
RETACRIT is indicated for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy.
1.4 Reduction of Allogeneic Red Blood Cell Transfusions in Patients Undergoing Elective, Noncardiac, Nonvascular Surgery
RETACRIT is indicated to reduce the need for allogeneic RBC transfusions among patients with perioperative hemoglobin > 10 to
13 g/dL who are at high risk for perioperative blood loss from elective, noncardiac, nonvascular surgery. RETACRIT is not indicated for patients who are willing to donate autologous blood pre-operatively.
1.5 Limitations of Use
RETACRIT has not been shown to improve quality of life, fatigue, or patient well-being.
RETACRIT is not indicated for use:
In patients with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy.
In patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure.
In patients with cancer receiving myelosuppressive chemotherapy in whom the anemia can be managed by transfusion.
In patients scheduled for surgery who are willing to donate autologous blood.
In patients undergoing cardiac or vascular surgery.
As a substitute for RBC transfusions in patients who require immediate correction of anemia.