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Amgen Highlights Key Clinical Data to be Presented at European Society for Medical Oncology Congress
Date:10/5/2010

condary AML. The safety and efficacy of Neulasta administration in de novo AML patients aged < 55 years with cytogenetics t(15;17) have not been established.

Neulasta should be discontinued following preliminary signs of ARDS.  Spleen size should be carefully monitored and caution exercised when administering in patients with sickle cell disease.  Safety and efficacy of Neulasta for mobilisation of blood progenitor cells in patients or healthy donors has not been adequately evaluated.  

Other adverse events of special importance associated with Neulasta include bone pain, allergic-type reactions including anaphylaxis (pegfilgrastim should be permanently discontinued in patients who experience a serious allergic reaction) and very rare cases of splenic rupture including fatal cases.  Neulasta should be administered approximately 24 hours after administration of cytotoxic chemotherapy.

About AranespAranesp was approved by the FDA in 2001 for the treatment of anemia associated with CRF for patients on dialysis and patients not on dialysis. The European Commission granted marketing authorization for the same indication in 2001 and subsequently updated it for CRF patients with symptomatic anemia in 2008.

In 2002, the FDA approved Aranesp for the treatment of anemia caused by concomitantly administered chemotherapy in patients with nonmyeloid malignancies. The European Commission authorized the treatment of anemia caused by concomitantly administered chemotherapy in patients with non-haematological malignancies in 2002 and extended it to include non-myeloid malignancies in patients receiving chemotherapy in 2003.

Important U.S. Product Safety InformationAranesp 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
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