Serious allergic reactions, including anaphylaxis, can occur in patients receiving Neulasta or NEUPOGEN. Permanently discontinue Neulasta or NEUPOGEN in patients with serious allergic reactions.
Splenic rupture, including fatal cases, can occur following the administration of Neulasta and NEUPOGEN.
Acute respiratory distress syndrome (ARDS) can occur in patients receiving Neulasta or NEUPOGEN.
Alveolar hemorrhage, manifesting as pulmonary infiltrates and hemoptysis requiring hospitalization, has been reported in healthy donors undergoing peripheral blood progenitor cell mobilization, an unapproved use of NEUPOGEN. Hemoptysis resolved with discontinuation of NEUPOGEN.
Bone pain and pain in extremity occurred at a higher incidence in Neulasta-treated patients as compared with placebo-treated patients. In clinical trials involving NEUPOGEN, bone pain was most frequently reported adverse event.
Important European Product Safety InformationFor full prescribing information please see the Summary of Product Characteristics for each product.
NEUPOGEN is indicated for reduction in duration of neutropenia and incidence of febrile neutropenia after established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes); reduction in duration of neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia. The safety and efficacy of NEUPOGEN are similar in adults and children receiving cytotoxic chemotherapy. NEUPOGEN is indicated for mobilisation of peripheral blood progenitor cells (PBPCs); 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
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