EPOGEN- erythropoietin solution
Amgen Inc
WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE
Chronic Kidney Disease:
In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target a hemoglobin level of greater than 11 g/dL [see Warnings and Precautions ( 5.1 )] .
No trial has identified a hemoglobin target level, E SA dose, or dosing strategy that does not increase these risks.
Use the lowest Epogen dose sufficient to reduce the need for red blood cell (RBC) transfusions [see Warnings and Precautions ( 5.1 )] .
Cancer:
ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in clinical studies of patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers [see Warnings and Precautions ( 5.2 )].
To decrease these risks, as well as the risk of serious cardiovascular and thromboembolic reactions, use the lowest dose needed to avoid RBC transfusions [see Dosage and Administration ( 2.4 )].
Use ESAs only for anemia from myelosuppressive chemotherapy [see Indications and Usage ( 1.3 )].
ESAs are not indicated for patients receiving myelosuppressive chemotherapy when the anticipated outcome is cure [see Indications and Usage ( 1.5 )].
Discontinue following the completion of a chemotherapy course [see Dosage and Administration ( 2.4 )].
Perisurgery:
Due to increased risk of Deep Venous Thrombosis (DVT), DVT prophylaxis is recommended [see Dosage and Administration ( 2.5 ), Warnings and Precautions ( 5.1 )].
1 INDICATIONS AND USAGE
1.1 Anemia Due to Chronic Kidney Disease
Epogen 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 HIV-infected Patients
Epogen is indicated for the treatment of anemia due to zidovudine administered at ? 4200 mg/week in HIV-infected patients with endogenous serum erythropoietin levels of ? 500 mUnits/mL.
1.3 Anemia Due to Chemotherapy in Patients With Cancer
Epogen 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
Epogen 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. Epogen is not indicated for patients who are willing to donate autologous blood pre-operatively.
1.5 Limitations of Use
Epogen has not been shown to improve quality of life, fatigue, or patient well-being.
Epogen 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.
2 DOSAGE AND ADMINISTRATION
2.1 Evaluation of Iron Stores and Nutritional Factors
Evaluate the iron status in all patients before and during treatment and maintain iron repletion. Correct or exclude other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.) before initiating Epogen [see Warnings and Precautions ( 5.10)].
2.2 Patients with Chronic Kidney Disease
In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target a hemoglobin level of greater than 11 g/dL. No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks. Individualize dosing and use the lowest dose of Epogen sufficient to reduce the need for RBC transfusions [see Warnings and Precautions ( 5.1)]. Physicians and patients should weigh the possible benefits of decreasing transfusions against the increased risks of death and other serious cardiovascular adverse events [see Boxed Warning and Clinical Studies ( 14) ] .