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ProstaScint Indications for Use:
Indium In 111 ProstaScint (Capromab Pendetide) is indicated as a diagnostic imaging agent in newly-diagnosed patients with biopsy-proven prostate cancer, thought to be clinically-localized after standard diagnostic evaluation (eg chest x-ray, bone scan, CT scan, or MRI), who are at high-risk for pelvic lymph node metastases. It is not indicated for patients who are not at high risk.

ProstaScint Indications for Use:

Indium In 111 ProstaScint (Capromab Pendetide) is indicated as a diagnostic imaging agent in newly-diagnosed patients with biopsy-proven prostate cancer, thought to be clinically-localized after standard diagnostic evaluation (eg chest x-ray, bone scan, CT scan, or MRI), who are at high-risk for pelvic lymph node metastases. It is not indicated for patients who are not at high risk.

Indium In 111 ProstaScint is also indicated as a diagnostic imaging agent in post-prostatectomy patients with a rising PSA and a negative or equivocal standard metastatic evaluation in whom there is a high clinical suspicion of occult metastatic disease. The imaging performance of Indium In 111 ProstaScint following radiation therapy has not been studied.

The information provided by Indium In 111 ProstaScint imaging should be considered in conjunction with other diagnostic information. Scans that are positive for metastatic disease should be confirmed histologically in patients who are otherwise candidates for surgery or radiation therapy unless medically contraindicated. Scans that are negative for metastatic disease should not be used in lieu of histological confirmation.

ProstaScint is not indicated as a screening tool for carcinoma of the prostate nor for readministration for the purpose of assessment in response to therapy.

Contraindications:
Indium In 111 ProstaScint should not be used in patients who are hypersensitive to this or any other product of murine origin or to Indium In 111 chloride.

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).

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