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

PCs); long-term treatment to increase neutrophil counts and reduce incidence and duration of infection-related events in patients with severe congenital, cyclic, or idiopathic neutropenia treatment of persistent neutropenia in patients with advanced HIV infection.  

NEUPOGEN is contraindicated in patients with hypersensitivity to filgrastim or excipients. Not to be used for escalation of cytotoxic chemotherapy doses above established regimens or administered to patients with severe congenital neutropenia (Kostman's Syndrome) with abnormal cytogenetics.

Administer NEUPOGEN with caution in secondary AML. Safety and efficacy of NEUPOGEN not established in de novo AML patients < 55 years with good cytogenetics (t(8;21), t(15;17) and inv(16)).  The onset of pulmonary signs (cough, fever, dyspnoea) in association with radiological signs of pulmonary infiltrates and deterioration in pulmonary function may be preliminary signs of Acute Respiratory Distress Syndrome (ARDS). Discontinue NEUPOGEN and give appropriate treatment.

Other adverse events of special importance associated with NEUPOGEN include GvHD and fatalities in patients receiving G-CSF after allogeneic bone marrow transplantation, very rare cases of splenic rupture reported in healthy donors and patients, and hypersensitivity-type reactions in cancer patients. NEUPOGEN should be permanently discontinued in patients who experience a serious allergic reaction.  NEUPOGEN is not recommended in period 24 hours before to 24 hours after chemotherapy.

Neulasta is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).

Neulasta is contraindicated in patients with hypersensitivity to pegfilgrastim or excipients.

Neulasta should not be used in patients with MDS, CML and se
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