Document 1086
 DOCN  M9471086
 TI    Clinical trial and post-marketing safety profile of Filgrastim in
       oncology patients (Neupogen) (Meeting abstract).
 DT    9409
 AU    McLeish S; Decoster G; Rich W; Amgen Inc., Thousand Oaks, CA 91320-1789
 SO    Proc Annu Meet Am Soc Clin Oncol; 13:A543 1994. Unique Identifier :
       AIDSLINE ICDB/94600539
 AB    Filgrastim (Neupogen) is widely used in oncology patients to decrease
       the incidence of infection as manifested by febrile neutropenia. We have
       reviewed the safety profile for Filgrastim from pre-marketing studies in
       oncology patients. This included data from 638 patients who participated
       in 14 clinical studies. These cancer patients received standard or high
       dose chemotherapy (CT) with or without autologous bone-marrow
       transplantation. The most frequent adverse event (AE) reported was
       mild/moderate musculoskeletal (bone) pain in 14% at doses of 0.35 to
       11.5 ug/kg/day and in 24% at doses of 23 to 115 ug/kg/day. There were
       reversible elevations in serum uric acid, lactate dehydrogenase, and
       alkaline phosphatase, but no clinical sequelae, unexpected tumor
       progression, or negative effect on the benefits of CT. Patients did not
       develop flu-like symptoms, fluid retention, pericarditis, or hypoxia as
       reported with other cytokines. Now we have reviewed post-marketing
       safety reports to assess the safety profile in a larger population. From
       February 1991 to October 1993, greater than 339,000 patients have been
       treated with Filgrastim. In this period, there have been only 733 AEs
       reported spontaneously to the manufacturer under a worldwide
       post-marketing safety surveillance program. Seventy-five percent of
       these reports are in the oncology setting; other indications included
       HIV infection, severe chronic neutropenia, and drug induced
       agranulocytosis. Reports were originated by health professionals (88%),
       consumers (9%), and literature reports (3%). The two most frequently
       reported clinical events were bone pain (reporting frequency, 1/4100)
       and rash (reporting frequency, 1/5250). There have also been rare
       reports of systemic allergic-type reactions (reporting frequency less
       than 1/7000). Two years after marketing approval, the safety profile of
       Filgrastim remains comparable with that seen in clinical trials and
       Filgrastim appears to be well tolerated.
 DE    Antineoplastic Agents/ADVERSE EFFECTS  Bone Marrow Transplantation
       Granulocyte Colony-Stimulating Factor/*ADVERSE EFFECTS/  THERAPEUTIC USE
       Human  Neutropenia/THERAPY  Transplantation, Autologous  MEETING
       ABSTRACT  CLINICAL TRIAL

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