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warnings
WARNINGS Patient management should not be based on Indium In 111 ProstaScint ® (capromab pendetide) scan results without appropriate confirmatory studies since in the pivotal trials, there was a high rate of false positive and false negative image interpretations (See PRECAUTIONS ). Indium In 111 ProstaScint ® images should be interpreted only by physicians who have had specific training in Indium In 111 ProstaScint ® image interpretation (see PRECAUTIONS, Imaging Precautions ). 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 In 111 ProstaScint ® administration, medications for the treatment of hypersensitivity reactions should be available during administration of this agent. Indium In 111 ProstaScint ® may induce human anti-mouse antibodies which may interfere with some immunoassays, including those used to assay PSA and digoxin (see PRECAUTIONS, Drug/Laboratory Test Interactions ).
ADVERSE REACTIONS ProstaScint ® (capromab pendetide) was generally well tolerated in the clinical trials. After administration of 529 single doses of Indium In 111 ProstaScint ® , adverse reactions were observed in 4% of patients. The most commonly reported adverse reactions were increases in bilirubin, hypotension, and hypertension, which occurred in 1% of patients. Elevated liver enzymes and injection site reactions occurred in slightly less than 1% of patients. Other adverse reactions, listed in order of decreasing frequency, were: pruritus, fever, rash, headache, myalgia, asthenia, burning sensation in thigh, shortness of breath, and alteration of taste. Most adverse reactions were mild and readily reversible. Data from repeat administration in 61 patients revealed a similar incidence of adverse reactions (5%). No deaths were attributable to Indium In 111 ProstaScint ® administration.