Capromab Pendetide Dosage

Usual Adult Dose for Radiographic Exam

0.5 mg capromab pendetide radiolabeled with 5 mCi of Indium In 111 chloride administered intravenously over 5 minutes

Comments:

• The patient dose of the radiolabel should be measured in a dose calibrator prior to administration.
• Each dose is administered intravenously over 5 minutes and should not be mixed with any other medication during its administration.
• This drug 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.
• The imaging performance of this drug following radiation therapy has not been studied.

Uses:

• 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. It is not indicated in patients who are not at high risk.
• Diagnostic imaging agent in postprostatectomy patients with a rising PSA (Prostate Specific Antigen) and a negative or equivocal standard metastatic evaluation with high clinical suspicion of occult metastatic disease.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• For intravenous use only.
• Each kit is a unit package for a single use only.
• Unlabeled drug should NOT be administered directly to the patient.
• After radiolabeling with Indium In 111, the entire Indium In 111 capromab dose should be administered to the patient. Reducing the dose of Indium In 111, unlabeled capromab, or Indium In 111 capromab can adversely impact imaging results and is not recommended.
• The manufacturer product information should be consulted.

Storage requirements:

• Store at 2C to 8C (36F to 46F). Do not freeze. Store upright.

Preparation techniques:

• Use only the contents of the kit to prepare Indium In 111 capromab pendetide; use within 8 hours after radiolabeling.
• The components of the kit are sterile and pyrogen-free and contain no preservative.
• Each kit consists of two vials which contain all of the non-radioactive ingredients necessary to produce a single unit dose of Indium In 111 capromab.
• Visual inspection for particulate matter and discoloration prior to administration is recommended.
• It is essential to follow the directions for preparation carefully and to adhere to strict aseptic procedures during preparation of the radiolabeled product. The manufacturer product information should be consulted.

General:

• This drug is not indicated as a screening tool for carcinoma of the prostate nor for readministration for the purpose of assessment of response to treatment.
• The information provided by Indium In 111 capromab 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.

Patient advice:

• This product could 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.
• Patients should discuss with their physicians prior use of murine-antibody based products.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer