|
There has been no evidence for development of antibodies to erythropoietin in patients tested to date, including those receiving PROCRIT for over 4 years. Nevertheless, if an anaphylactoid reaction occurs, PROCRIT should be immediately discontinued and appropriate therapy initiated. Zidovudine-Treated HIV-Infected Patients Adverse events reported in clinical trials with PROCRIT in zidovudine-treated HIV-infected patients were consistent with the progression of HIV infection. In double-blind, placebo-controlled studies of three-months duration involving approximately 300 zidovudine-treated HIV-infected patients, adverse events with an incidence of 10% in either patients treated with PROCRIT or placebo-treated patients were: Text Continues Below
There were no statistically significant differences between treatment groups in the incidence of the above events. In the 297 patients studied, PROCRIT was not associated with significant increases in opportunistic infections or mortality. 25 In 71 patients from this group treated with PROCRIT at 150 Units/ kg (T. I. W.), serum p24 antigen levels did not appear to increase. 27 Preliminary data showed no enhancement of HIV replication in infected cell lines in vitro. 25 Peripheral white blood cell and platelet counts are unchanged following PROCRIT therapy. Allergic Reactions: Two zidovudine-treated HIV-infected patients had urticarial reactions within 48 hours of their first exposure to study medication. One patient was treated with PROCRIT and one was treated with placebo (PROCRIT vehicle alone). Both patients had positive immediate skin tests against their study medication with a negative saline control. The basis for this apparent pre-existing hypersensitivity to components of the PROCRIT formulation is unknown, but may be related to HIV-induced immuno-suppression or prior exposure to blood products. Page: << Prev | 1 | 2 | 3 | 4 | 5 | Next >>
|
.gif)
