Important note: Information in this article was accurate in 1994. The state of the art may have changed since the publication date.
Clinical trial and post-marketing safety profile of Filgrastim in oncology patients (Neupogen) (Meeting abstract).
Proc Annu Meet Am Soc Clin Oncol; 13:A543 1994. Unique Identifier : AIDSLINE ICDB/94600539 McLeish S; Decoster G; Rich W; Amgen Inc., Thousand Oaks, CA 91320-1789
Abstract:
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.
Keywords: Antineoplastic Agents/ADVERSE EFFECTS Bone Marrow Transplantation Granulocyte Colony-Stimulating Factor/*ADVERSE EFFECTS/ THERAPEUTIC USE Human Neutropenia/THERAPY Transplantation, Autologous ABSTRACT CLINICAL TRIAL
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Important note: Information in this article was accurate in 1994. The state of the art may have changed since the publication date.
