Version May 2024
Diagnostic imaging: IV: 0.5 mg radiolabeled with 5 mCi of Indium 111 chloride. May be readministered if infiltration or a technically inadequate scan occurs.
There are no dosage adjustments provided in the manufacturer’s labeling.
There are no dosage adjustments provided in the manufacturer’s labeling.
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%: Immunologic: Antibody development (HAMA; single infusion: >8 ng/mL 8%; >100 ng/mL 1%; repeat infusion: 19%)
1% to 10%:
Cardiovascular: Hypertension (1%), hypotension (1%)
Hepatic: Increased serum bilirubin (1%)
<1%: Burning sensation (thigh), dysgeusia, dyspnea, fever, headache, increased liver enzymes, injection site reaction, myalgia, pruritus, skin rash, weakness
Hypersensitivity to Indium 111 capromab pendetide, other products of murine origin, Indium In 111 chloride, or any component of the formulation
Concerns related to adverse effects:
• Hypersensitivity: Allergic reactions, including anaphylaxis, can occur in patients who receive murine antibodies. Medications for the treatment of hypersensitivity reactions should be available for immediate use.
• Human antimurine antibodies (HAMA): Treatment may result in the development of HAMA; increased adverse reactions, interference with murine-antibody based immunoassays, and compromised efficacy of murine antibody-based agents may occur. Patients should be informed to discuss prior use of murine-antibody based products and that the use of this agent may hinder the ability for future use of murine-based products, to diagnose recurrence of tumor, or perform some other laboratory tests.
Special handling:
• Radiopharmaceutical: Use appropriate precautions for handling, disposal, and minimizing exposure to patients and healthcare personnel. Use only under supervision of individuals with experience/training in the handling of radioactive materials approved by the applicable regulatory authority. Note: Contents of kit are not radioactive; however, adequate shielding is required after addition of radioactive material.
Other Warnings/Precautions:
• Appropriate use: Not intended to be used as a screening tool for prostate cancer. Should not be readministered to assess response to treatment. Due to the high rate of false positive or false negative imagine interpretations, other appropriate tests should be done for confirmation of results. Do use this in replace of a bone scan for evaluation of skeletal metastases. Prior to each 72 to 120 hour imaging session, patients should receive a cathartic the evening before and a cleansing enema within an hour before the test; the patient’s bladder should also be catheterized and irrigated.
ProstaScint may contain a significant amount of sodium.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Kit, Intravenous [preservative free]:
ProstaScint: Capromab pendetide 0.5 mg per vial [to be combined with Indium In 111 (not included)] [DSC] [pyrogen free; contains mouse (murine) and/or hamster protein]
No
IV: For IV administration. Administer over 5 minutes. Do not mix with any other medications. Administer a cathartic the evening before the imaging and a cleansing enema within 1 hour prior to each 72- to 120-hour imaging session. The bladder should also be catheterized and irrigated. The first imaging session should be done approximately 30 minutes following the infusion. The second imaging session should be done 72 to 120 hours after the infusion. Refer to manufacturer’s prescribing information for additional imaging information.
Radiopharmaceutical; use appropriate precautions for handling and disposal.
Diagnostic imaging: Diagnostic imaging agent indicated in patients newly diagnosed with biopsy-proven prostate cancer (clinically localized after standard diagnostic evaluation) who are at high risk for pelvic lymph node metastases and in patients postprostatectomy with a rising PSA and negative standard metastatic evaluation, but a high clinical suspicion of metastatic disease
Radiopharmaceutical: Use appropriate precaution for handling, disposal, and minimizing exposure to patients and healthcare personnel. Use under supervision of experienced personnel. Should be stored in original lead container or adequate radiation shield.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Antiandrogens: May diminish the diagnostic effect of Indium 111 Capromab Pendetide. Risk X: Avoid combination
Antigonadotropic Agents: May diminish the diagnostic effect of Indium 111 Capromab Pendetide. Risk X: Avoid combination
Corticosteroids (Systemic): May diminish the diagnostic effect of Indium 111 Capromab Pendetide. Risk X: Avoid combination
Estrogen Derivatives: May diminish the diagnostic effect of Indium 111 Capromab Pendetide. Risk X: Avoid combination
Luteinizing Hormone-Releasing Hormone Analogs: May diminish the diagnostic effect of Indium 111 Capromab Pendetide. Risk X: Avoid combination
Animal reproductive studies have not been conducted. Not recommended for use in women.
Not indicated for use in women.
Capromab pendetide is a murine IgG1 kappa monoclonal antibody that is directed against the glycoprotein Prostate Specific Membrane Antigen (PSMA), which is expressed by prostate epithelium.
Distribution: Vd: ~2 to 6 L
Metabolism: Decays by electron capture
Half-life elimination: Physical: 67.2 hours; Terminal: ~56 to 78 hours
Excretion: Urine (10% over 72 hours)
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