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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.
Read the ProstaScint Kit (capromab pendetide) Side Effects Center for a complete guide to possible side effects
The effect of surgical and/or medical androgen ablation on the imaging performance of Indium In 111 ProstaScint® has not been studied. Preliminary data suggest hormone ablation may increase PSMA expression, with concurrent decrease in tumor expression of PSA.3 The use of ProstaScint® in this patient population cannot be recommended at this time.
Drug/Laboratory Test Interactions
The presence of HAMA in serum as a result of ProstaScint®may interfere with some antibody-based immunoassays (such as PSA and digoxin). When present, this interference generally results in falsely high values. When following PSA levels, assay methods resistant to HAMA interference should be utilized. PSA assays which were found to be resistant to HAMA interference were Hybritech Tandem-R and Abbott IMX.
When patients have received Indium In 111 ProstaScint®, the clinical laboratory should be notified to take appropriate measures to avoid interference by HAMA with clinical laboratory testing procedures. These methods include the use of non-murinebased immunoassays, HAMA removal by adsorption, or sample pre-treatment to block HAMA activity.
3. Wright, GL, Jr; et al. Expression of Prostate-Specific Membrane Antigen in Normal, Benign, and Malignant Prostate Tissues. Urol Oncol. 1995; 1:18-28.
Last reviewed on RxList: 7/9/2012
This monograph has been modified to include the generic and brand name in many instances.
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