Aranesp ``145 Study'' Shows No Difference in Survival in Patients,with Small-Cell Lung Cancer ( ree-weekdosing in these patients. Im...)

Aranesp ``145 Study'' Shows No Difference in Survival in Patients,with Small-Cell Lung Cancer

ree-week dosing in these patients.

Important Safety Information including boxed WARNING

Use the lowest dose of Aranesp that will gradually increase the hemoglobin concentration to the lowest level sufficient to avoid the need for red blood cell transfusion.

Aranesp and other erythropoiesis-stimulating agents (ESAs) increased the risk for death and for serious cardiovascular events when administered to target a hemoglobin of greater than 12 g/dL.

Cancer Patients: Use of ESAs

-- Shortened the time to tumor progression in patients with advanced head and neck cancer receiving radiation therapy when administered to target a hemoglobin of greater than 12 g/dL,

-- Shortened overall survival and increased deaths attributed to disease progression at 4 months in patients with metastatic breast cancer receiving chemotherapy when administered to target a hemoglobin of greater than 12 g/dL,

-- Increased the risk of death when administered to target a hemoglobin of 12 g/dL in patients with active malignant disease receiving neither chemotherapy or radiation therapy. ESAs are not indicated for this population.

Patients receiving ESAs pre-operatively for reduction of allogeneic red blood cell transfusions: A higher incidence of deep venous thrombosis was documented in patients receiving Epoetin alfa who were not receiving prophylactic anticoagulation. Aranesp is not approved for this indication.

Aranesp is contraindicated in patients with uncontrolled hypertension. Aranesp and other erythropoietic therapies increase the risk of serious arterial and venous thromboembolic events, including myocardial infarction, stroke, congestive heart failure, and hemodialysis graft occlusion. A rate of hemoglobin rise of greater than 1 g/dL over 2 weeks may also contribute to these risks. To reduce cardiovascular risks, the hemoglobin (Hb) concentration should not exceed 12 g/dL, the rate of hemoglobin increase should not exceed 1 g/dL
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( ree-weekdosing in these patients. Im...)Aranesp ``145 Study'' Shows No Difference in Survival in Patients,with Small-Cell Lung Cancer,Health