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capromab pendetide
Overview
What is ProstaScint Kit for the Preparation of Indium In 111 Capromab Pendetide?
ProstaScint (capromab pendetide) is the murine monoclonal antibody, 7E11-C5.3, conjugated to the linker-chelator, glycyl-tyrosyl-(N, ε-diethylenetriaminepentaacetic acid)-lysine hydrochloride (GYK-DTPA-HCl). The 7E11-C5.3 antibody is of the IgG1, kappa subclass (IgG1κ). This antibody is directed against a glycoprotein expressed by prostate epithelium known as Prostate Specific Membrane Antigen (PSMA). The PSMA epitope recognized by monoclonal antibody (MAb) 7E11-C5.3 is located in the cytoplasmic domain. Expression of this glycoprotein has not been demonstrated on any other adenocarcinomas or transitional cell cancers tested. The antibody is produced by serum-free cultivation of cells, and purified by sequential protein isolation and chromatographic separation procedures.
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 injection 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.
The sodium acetate solution must be added to the sterile, non-pyrogenic high purity Indium In 111 Chloride solution to buffer it prior to radiolabeling ProstaScint. The immunoscintigraphic agent Indium In 111 Capromab Pendetide (Indium In 111 ProstaScint) is formed after radiolabeling with Indium In 111.
What does ProstaScint Kit for the Preparation of Indium In 111 Capromab Pendetide look like?
What are the available doses of ProstaScint Kit for the Preparation of Indium In 111 Capromab Pendetide?
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What should I talk to my health care provider before I take ProstaScint Kit for the Preparation of Indium In 111 Capromab Pendetide?
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How should I use ProstaScint Kit for the Preparation of Indium In 111 Capromab Pendetide?
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 (see ). It is not indicated in patients who are not at high risk.
Indium In 111 ProstaScint is also 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. The imaging performance of Indium In 111 ProstaScint following radiation therapy has not been studied.
The information provided by Indium In 111 ProstaScint 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.
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.
The patient dose of the radiolabel must be measured in a dose calibrator prior to administration.
The 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 (see ).
Each ProstaScint kit is a unit dose package. After radiolabeling with Indium In 111, the entire Indium In 111 ProstaScint dose should be administered to the patient. Reducing the dose of Indium In 111, unlabeled ProstaScint, or Indium In 111 ProstaScint may adversely impact imaging results and is, therefore, not recommended. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
What interacts with ProstaScint Kit for the Preparation of Indium In 111 Capromab Pendetide?
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What are the warnings of ProstaScint Kit for the Preparation of Indium In 111 Capromab Pendetide?
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What are the precautions of ProstaScint Kit for the Preparation of Indium In 111 Capromab Pendetide?
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What are the side effects of ProstaScint Kit for the Preparation of Indium In 111 Capromab Pendetide?
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What should I look out for while using ProstaScint Kit for the Preparation of Indium In 111 Capromab Pendetide?
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.
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 ).
Indium In 111 ProstaScint images should be interpreted only by physicians who have had specific training in Indium In 111 ProstaScint image interpretation (see ).
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 ).
What might happen if I take too much ProstaScint Kit for the Preparation of Indium In 111 Capromab Pendetide?
The maximum amount of Indium In 111 ProstaScint (capromab pendetide) that can be safely administered has not been determined. In clinical studies, single doses of 10 mg of Indium In 111 ProstaScint were administered to 20 patients with prostate cancer; the type and frequency of adverse reactions at this dose were similar to those observed with lower doses. The maximum Indium In 111 dose administered with ProstaScint in a clinical study was 6.5 mCi.
How should I store and handle ProstaScint Kit for the Preparation of Indium In 111 Capromab Pendetide?
Store at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature].PHARMACIST:A Schedule CII Narcotic.Manufactured for: a Subsidiary of Qualitest PharmaceuticalsHuntsville, AL 358111-800-444-4011 Rev. 08/14Store at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature].PHARMACIST:A Schedule CII Narcotic.Manufactured for: a Subsidiary of Qualitest PharmaceuticalsHuntsville, AL 358111-800-444-4011 Rev. 08/14Store at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature].PHARMACIST:A Schedule CII Narcotic.Manufactured for: a Subsidiary of Qualitest PharmaceuticalsHuntsville, AL 358111-800-444-4011 Rev. 08/14Store at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature].PHARMACIST:A Schedule CII Narcotic.Manufactured for: a Subsidiary of Qualitest PharmaceuticalsHuntsville, AL 358111-800-444-4011 Rev. 08/14Store at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature].PHARMACIST:A Schedule CII Narcotic.Manufactured for: a Subsidiary of Qualitest PharmaceuticalsHuntsville, AL 358111-800-444-4011 Rev. 08/14Store at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature].PHARMACIST:A Schedule CII Narcotic.Manufactured for: a Subsidiary of Qualitest PharmaceuticalsHuntsville, AL 358111-800-444-4011 Rev. 08/14Store at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature].PHARMACIST:A Schedule CII Narcotic.Manufactured for: a Subsidiary of Qualitest PharmaceuticalsHuntsville, AL 358111-800-444-4011 Rev. 08/14The ProstaScint (capromab pendetide) kit (NDC No. 57902-817-01) for the preparation of Indium In 111 labeled Capromab Pendetide includes one vial containing 0.5 mg of ProstaScint® per 1 mL of sodium phosphate buffered saline and one 2 mL vial of sodium acetate solution, 0.5 M. These solutions are sterile and pyrogen free and contain no preservatives. Each kit also includes one sterile 0.22 μm Millex GV filter, prescribing information, and two identification labels.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Prostate Specific Membrane Antigen is expressed in many primary and metastatic prostate cancer lesions, and immunohistologic studies have shown 7E11-C5.3 to be reactive with > 95% of the prostate adenocarcinomas evaluated. In general, PSMA expression by prostate cancer cells is either unchanged or increased in patients treated with hormonal therapy (see ). The 7E11-C5.3 antibody is immunoreactive with normal and hypertrophic adult prostate tissue. In clinical studies of patients with prostate cancer, Indium In 111 ProstaScint (capromab pendetide) localized to the prostate, and some known primary and metastatic tumor sites.
Non-antigen-dependent localization, suspected to be secondary to catabolism, has been observed in the liver, spleen, and bone marrow. Although there is variation among individuals, there may also be localization and imaging activity in the bowel, blood pool, kidneys, urinary bladder, and genitalia. Intracellular localization of 7E11-C5.3 has been observed in histochemically prepared tissue sections from normal adult skeletal and cardiac muscle, although primate studies revealed no specific localization to these tissues.
Non-Clinical Toxicology
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.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 ).
Indium In 111 ProstaScint images should be interpreted only by physicians who have had specific training in Indium In 111 ProstaScint image interpretation (see ).
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 ).
The effect of surgical and/or medical androgen ablation on the imaging performance of Indium In 111 ProstaScint has not been studied. Preliminary data suggest hormone ablation may increase PSMA expression, with concurrent decrease in tumor expression of PSA. The use of ProstaScint in this patient population cannot be recommended at this time.
There were high rates of false positive and false negative image interpretations in the pivotal trials (see ). 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 , 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.
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.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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