Safety Information
Indium 111 ProstaScint images should be interpreted only by physicians who have had specific training in Indium 111 ProstaScint image interpretation and proper patient preparation is mandatory to obtain optimal images for interpretation (see PRECAUTIONS, Imaging Precautions in the full prescribing information).
Indium 111 ProstaScint should not be used in patients who are hypersensitive to products of murine origin or Indium 111 chloride. Allergic reactions, including anaphylaxis, can occur in patients who receive murine antibodies. Although serious reactions of this type have not been observed in clinical trials after Indium 111 ProstaScint administration, medications for the treatment of hypersensitivity reactions should be available during administration of this agent. Indium 111 ProstaScint may induce human anti-mouse antibodies which can interfere with some immunoassays, including those used to assay PSA and digoxin. Patients should be advised to discuss prior use of murine-protein based products with their doctors.
In clinical trials, adverse reactions were observed in 4% of 529 patients. The most common adverse reactions are increased levels of bilirubin in the blood, elevated blood pressure or low blood pressure, which occurred in less than 1% of patients.
Confirmatory studies should be used in conjunction with ProstaScint® scan results to determine appropriate patient management.
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