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| Primary information |
|---|
| ID | 10436 |
| Therapeutic ID | Th1075 |
| Protein Name | Capromab |
| Sequence | NA
|
| Molecular Weight | NA |
| Chemical Formula | NA |
| Isoelectric Point | NA |
| Hydrophobicity | NA |
| Melting point | 61 °C (FAB fragment), 71 °C (whole mAb) |
| Half-life | NA |
| Description | Capromab is a Murine IgG1 monoclonal antibody that recognizes prostate specific membrane antigen from prostate cancer cells and normal prostate tissue. It is linked to pendetide, a derivative of DTPA. Pendetide acts as a chelating agent for the radionuclide indium-111. Capromab is used to image the extent of prostate cancer. |
| Indication/Disease | For diagnosis of prostate cancer and detection of intra-pelvic metastases. |
| Pharmacodynamics | Binds to the prostate-specific membrane antigen, which is a cell surface protein generally overexpressed in prostate tissues and prostate cancers. The radioactive Indium 111, which is covalently attached to the antibody, allows radiodiagnostic detection of PSMA expressing cells and tumors. |
| Mechanism of Action | Binds selectively to cell-surface prostate-specific membrane antigen (PSMA) expressed on prostate tissues and tumors. |
| Toxicity | NA |
| Metabolism | Most likely removed by opsonization via the reticuloendothelial system or by human antimurine antibody production |
| Absorption | NA |
| 4 ± 2.1 L |
| Clearance | 42 +/- 22 mL/hr |
| Categories | Indicators, Reagents and Diagnostic Agents |
| Patents Number | NA |
| Date of Issue | NA |
| Date of Expiry | NA |
| Drug Interaction | NA |
| Target | NA |
| Brand Name | ProstaScint |
| Company | Jazz Pharmaceuticals, Inc. |
| Brand Description | Jazz Pharmaceuticals, Inc. |
| Prescribed For | 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 (e.g. chest x-ray, bone scan, CT scan, or MRI), who are at high-risk for pelvic lymph node metastases. ProstaScint is not indicated as a screening tool for carcinoma of the prostate nor for readministration for the purpose of assessment of response to treatment. |
| Chemical Name | NA |
| Formulation | Each ProstaScint kit consists of two vials which contain all of the non-radioactive ingredients necessary to produce a single unit dose of Indium In 111 ProstaScint, an immunoscintigraphic agent for administration by Intravenous infusion only. The ProstaScint vial contains 0.5 mg of capromab pendetide in 1 mL of sodium phosphate buffered saline solution adjusted to pH 6; a sterile, pyrogen-free, clear, colorless solution that may contain some translucent particles. The vial of sodium acetate buffer contains 82 mg of sodium acetate in 2 mL of Water for Injection adjusted to pH 5-7 with glacial acetic acid; it is a sterile, pyrogen-free, clear, and colorless solution. Neither solution contains a preservative. Each kit also includes one sterile 0.22 μm Millex GV filter, prescribing information, and two identification labels. |
| Physical Appearance | Indium In 111 ProstaScint is a sterile, pyrogen-free, clear, colorless solution that may contain some translucent particles. |
| Route of Administration | Intravenous infusion |
| Recommended Dosage | he recommended dose of ProstaScint (capromab pendetide) is 0.5 mg radiolabeled with 5 mCi of Indium In 111 chloride. Each dose is administered intravenously over 5 minutes and should not be mixed with any other medication during its administration. Indium In 111 ProstaScint may be readministered following infiltration or a technically inadequate scan; however, it is not indicated for readministration for the purpose of assessment of response to treatment . |
| Contraindication | Indium In 111 ProstaScint (capromab pendetide) should not be used in patients who are hypersensitive to this or any other product of murine origin or to Indium In 111 chloride. |
| Side Effects | 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. |
| Useful Link 1 | Link |
| Useful Link 2 | NA |
| Remarks | NA |