FDA Approves Extended Dosing of Aranesp® to Treat Chemotherapy-Induced Anemia; Every-Three-Week Dosing Can Provide Added Convenience, Potentially Reducing Number of Clinic Visits and Injections for Anemia Treatment

Business Wire, March 27, 2006

Important Safety Information

Aranesp is contraindicated in patients with uncontrolled hypertension. Erythropoietic therapies may increase the risk of thrombotic events and other serious events. The target hemoglobin (Hb) should not exceed 12 g/dL. If the Hb increase exceeds 1.0 g/dL in any 2-week period, dose reductions are recommended. In a study with another erythropoietic product, where the target Hb was 12-14 g/dL, an increased incidence of thrombotic events, disease progression and mortality was seen.

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 predominately in patients with CRF receiving Aranesp by subcutaneous administration. 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 erythropoietic proteins. Aranesp should be permanently discontinued in patients with antibody-mediated anemia. Patients should not be switched to other erythropoietic proteins.

The most commonly reported side effects in clinical trials were fatigue, edema, nausea, vomiting, diarrhea, fever and dyspnea.

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