Adult Dosing

Diagnostic imaging agent in newly-diagnosed prostate cancer

• 0.5 mg radiolabeled with 5 mCi of Indium In 111 chloride IV over 5 minutes

Diagnostic imaging agent in post-prostatectomy patients

• 0.5 mg radiolabeled with 5 mCi of Indium In 111 chloride IV over 5 minutes

• Note:

• Measure dose of the radiolabel in a dose calibrator prior to administration

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Capromab 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
• Capromab is 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

• Hypersensitivity to any of the ingredients of the product
• Hypersensitivity to any other product of murine origin

• N/A

Renal Dose Adjustment

• Renal impairment: No dose adjustment

Hepatic Dose Adjustment

• Hepatic impairment: No dose adjustment

See Supplemental Patient Information

• Due to high rates of false positive and false negative image interpretations in the pivotal trials, patient management should not be based on Indium In 111 capromab scan results without appropriate confirmatory studies
• Image interpretation should only be done by physicians who have had specific training
• Medications for the treatment of hypersensitivity reactions should be available during administration of this agent

Supplemental Patient Information

• Capromab use may adversely affect the future ability to diagnose recurrence of tumor, the ability to perform certain other laboratory tests, or to use other murine-based products
• Discuss prior use of murine-antibody based products with physicians

Pregnancy Category:NR

Breastfeeding: Safety unknown.

• METABOLIC: Increases in bilirubin, elevated liver enzymes
• CV: Increased hypotension and hypertension
• LOCAL: Injection site reactions
• DERM: Pruritus, rash
• MUSC: Myalgia
• RESP: Shortness of breath
• GI: Alteration of taste
• HYPERSENSITIVITY: Allergic reactions, including anaphylaxis
• MISC: Fever, headache, burning sensation in thigh, asthenia

• Murine monoclonal antibody; it localizes or binds specifically to a prostate-specific membrane glycoprotein (PSMA) that is only expressed by prostatic epithelial cells (benign and malignant)
• Metabolism: Unknown
• Excreted in urine (10%)
• Half-life: 67 +/- 11 hrs

US Trade Name(s)

• ProstaScint

US Availability

ProstaScint

• SOLN for INJ: 0.5 mg/mL (vial)

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Radiologic

Radiopharmaceuticals, Diagnostic