No serious adverse effect of romurtide has been reported since its clinical application with the standard regimen of subcutaneous injection of 200 |xg once a day for 10 days. In phase II and III clinical studies, 704 cancer patients were enrolled to analyze the effectiveness and safety of romurtide. Side-effects caused by romurtide administration were observed in 275 patients (39.1%), mostly fever and a transient skin reaction at the injection site. Other signs and symptoms in 3.6% included skin rash, loss of appetite and nausea. The febrile responses could be controlled by antipyretics without intervention on its effectiveness. In phase II clinical trials of L-MTP-PE for osteosarcoma, the recommended dose was 6 mg m Despite such a high dose, the side-effects were moderate, including chills (80% of the patients), fever (70%), malaise (60%) and nausea (55%), and 24 week therapy was accomplished. It seems likely that the serious side-effects observed in animals, such as arthritis in rats, uveitis in rabbits and necrosis at the injection site in guinea pigs, arc-strictly specics dependent and humans may not be a high responder to the potency of MDP and its derivatives for inducing such reactions.
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