Aranesp®(darbepoetin alfa)

Anemia & Chronic Renal Failure
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Anemia from Concomitant Chemotherapy in Nonmyeloid Malignancies
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Anemia & Chronic Kidney Failure
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Anemia While Receiving Chemotherapy
to Treat Certain Types of Cancer
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Aranesp^® is indicated for the treatment of anemia associated with chronic renal failure (CRF), including patients on dialysis and patients not on dialysis.

Aranesp^® is indicated for the treatment of anemia due to the effect of concomitantly administered chemotherapy based on studies that have shown a reduction in the need for red blood cell transfusions in patients with metastatic, non-myeloid malignancies. Studies to determine whether Aranesp^® increases mortality or decreases progression-free/recurrence-free survival are ongoing.

Aranesp^® is not indicated for use in patients receiving hormonal agents, therapeutic biologic products, or radiotherapy unless receiving concomitant myelosuppressive chemotherapy.
Aranesp^® is not indicated for patients receiving myelosuppressive therapy when the anticipated outcome is cure due to the absence of studies that adequately characterize the impact of Aranesp^® on progression-free and overall survival.
Aranesp^® use has not been demonstrated in controlled clinical trials to improve symptoms of anemia, quality of life, fatigue, or patient well-being.

Important Safety Information, including Boxed WARNINGS

WARNINGS: INCREASED MORTALITY, SERIOUS CARDIOVASCULAR EVENTS, THROMBOEMBOLIC EVENTS, STROKE and INCREASED RISK OF TUMOR PROGRESSION OR RECURRENCE

Chronic Renal Failure:

In clinical studies, patients experienced greater risks for death, serious cardiovascular events, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target hemoglobin levels of 13 g/dL and above.
Individualize dosing to achieve and maintain hemoglobin levels within the range of 10 to 12 g/dL

Cancer:

ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in some clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers.
To decrease these risks, as well as the risk of serious cardio- and thrombovascular events, use the lowest dose needed to avoid red blood cell transfusion.
Use ESAs only for treatment of anemia due to concomitant myelosuppressive chemotherapy.
ESAs are not indicated for patients receiving myelosuppressive therapy when the anticipated outcome is cure.
Discontinue following the completion of a chemotherapy course.

Aranesp^® is contraindicated in patients with uncontrolled hypertension.
Patients with chronic renal failure (CRF) participating in clinical studies experienced greater risks for death, serious cardiovascular events, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target hemoglobin levels of 13 g/dL and above.
Patients with CRF and an insufficient hemoglobin response to ESA therapy may be at even greater risk for cardiovascular events and mortality than other patients.
Aranesp^® and other ESAs increased the risks for death and serious cardiovascular events in controlled clinical trials of patients with cancer.
These events included myocardial infarction, stroke, congestive heart failure, and hemodialysis vascular access thrombosis.
A rate of hemoglobin rise of > 1 g/dL over 2 weeks may contribute to these risks.
Cases of pure red cell aplasia (PRCA) and of severe anemia, with or without other cytopenias, associated with neutralizing antibodies to erythropoietin have been reported in patients treated with Aranesp^®.
- This has been reported predominantly in patients with CRF receiving ESAs by subcutaneous administration.
- PRCA has also been reported in patients receiving ESAs while undergoing treatment for hepatitis C with interferon and ribavirin.
- A sudden loss of response to Aranesp^®, accompanied by severe anemia and low reticulocyte count, should be evaluated.
- If anti-erythropoietin antibody-associated anemia is suspected, withhold Aranesp^® and other ESAs. Aranesp^® should be permanently discontinued in patients with antibody-mediated anemia. Patients should not be switched to other ESAs as antibodies may cross-react.
Seizures have occurred in patients with CRF participating in Aranesp^® clinical trials.
The most commonly reported side effects in clinical trials in patients with CRF were infection, hypertension, hypotension, and muscle spasm.
The most commonly reported side effects in clinical trials in patients with anemia due to concomitant chemotherapy were fatigue, edema, nausea, vomiting, diarrhea, fever and dyspnea.