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ProstaScint

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ProstaScint Kit

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 Drug/Laboratory Test Interactions).

PRECAUTIONS

General

There were high rates of false positive and false negative image interpretations in the pivotal trials (see Clinical Studies). False positive scan interpretations may result in: (1) inappropriate surgical intervention to confirm scan results; (2) inappropriate denial of curative therapy if results are not confirmed; or (3) inadequate surgical staging if only areas of uptake are sampled. Surgical sampling should not be limited to the areas of positive uptake, unless histologic examination of these areas is diagnostic. Due to the potential for false negative scan interpretations, negative images should not be used in lieu of histologic confirmation. Proper patient preparation is mandatory to obtain optimal images for interpretation (see Imaging Precautions, below).

Bone scans are more sensitive than ProstaScint® (capromab pendetide) for the detection of metastases to bone, and Indium In 111 ProstaScint® should not replace bone scan for the evaluation of skeletal metastases.

Imaging Precautions

Radiopharmaceuticals should be used only by physicians and other professionals who are qualified by training and experience in the safe use and handling of radionuclides. Indium In 111 ProstaScint® images should be interpreted only by physicians who have had specific training in the interpretation of Indium In 111 ProstaScint® images.

There may be Indium In 111 ProstaScint® clearance and imaging localization observed in the bowel, blood pool, kidneys, and urinary bladder. When obtaining all 72120 hour planar and Single-Photon Emission Computed Tomography (SPECT) images, the bladder should be catheterized and irrigated. The administration of a cathartic is required the evening before imaging the patient, and a cleansing enema should be administered within an hour prior to each 72-120 hour imaging session.

The contents of the kit are not radioactive. However, after the Indium In 111 chloride is added, appropriate shielding of Indium In 111 ProstaScint® (capromab pendetide) must be maintained. Care should be taken to minimize radiation exposure to patients and medical personnel, consistent with proper hospital and patient management procedures.

Each ProstaScint® kit is a unit of use package. The contents of the kit are to be used only to prepare Indium In 111 ProstaScint®-- unlabeled ProstaScint® should NOT be administered directly to the patient. After radiolabeling with Indium In 111, the entire Indium In 111 ProstaScint® dose must be administered to the patient for whom it was prescribed. Reducing the dose of Indium In 111, unlabeled ProstaScint®, or Indium In 111 ProstaScint® may adversely impact imaging results and is not recommended.

The components of the kit are sterile and pyrogen-free and contain no preservative. Indium In 111 ProstaScint® should be used within 8 hours after radiolabeling. It is essential to follow the directions for preparation carefully and to adhere to strict aseptic procedures during preparation of the radiolabeled product.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic or mutagenic potential of Indium In 111 ProstaScint® or to evaluate its effect on fertility.

Pregnancy

ProstaScint® is not indicated for use in women.

Pediatric Use

The safety and effectiveness of Indium In 111 ProstaScint®in pediatric patients have not been established. ProstaScint® is not indicated for use in children.

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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