606-0870a ref f prostascint_p2.ai

EUSAPharma
606-0870A Rev F
Proof No.:
Manufactured by EUSA Pharma (USA), Inc.
Langhorne, PA 19047
License 1829
ProstaScint® is a registered trademark of
2010 EUSA Pharma (USA), Inc.
Printed in USA 606-0870A Rev F
Revised 12/2010
ProstaScint® Kit
TABLE 3 - INDIUM IN 111
TABLE 4 - COMPARISON OF INDIUM
Repeat Scans
(capromab pendetide)
PHYSICAL DECAY CHART, HALF-LIFE
IN 111 PROSTASCINT® AND
Sixty-one patients received a total of 74 repeat infusions of 67.2 HOURS (2.8 DAYS)
HISTOPATHOLOGIC RESULTS FOR
upon repeat infusion (5%) was comparable to that observed after Kit for the Preparation of Indium In 111 Capromab
PRESURGICAL PATIENTS
single infusion (4 %). Human anti-mouse antibody (HAMA) levels Pendetide
were detected (at levels >8ng/mL) by radioimmune assay (RIA) after single infusion in 8% (20/239) of patients while 1% of For Intravenous Use Only
patients had levels greater than 100 ng/mL. Serum HAMA levels were detected by RIA after repeat infusion in 19% (5/27) of patients. DESCRIPTION
Biodistribution was unaltered on 65 of 70 (93%) evaluable ProstaScint® (capromab pendetide) is the murine monoclonal repeat scans. The efficacy of repeat Indium In 111 ProstaScint® antibody, 7E11-C5.3, conjugated to the linker-chelator, glycyl- tyrosyl-(N, -diethylenetriaminepentaacetic acid)-lysine hydrochloride INDICATIONS AND USAGE
(GYK-DTPA-HCl). The 7E11-C5.3 antibody is of the IgG1, kappa Indium In 111 ProstaScint® (capromab pendetide) is indicated TEXT SIZES
subclass (IgG1 ). This antibody is directed against a glycoprotein as a diagnostic imaging agent in newly-diagnosed patients with expressed by prostate epithelium known as Prostate Specific biopsy-proven prostate cancer, thought to be clinically-localized Membrane Antigen (PSMA). The PSMA epitope recognized by Sixty-five patients (43%) had positive Indium In 111 after standard diagnostic evaluation (e.g. chest x-ray, bone scan, monoclonal antibody (MAb) 7E11-C5.3 is located in the cytoplasmic ProstaScint® (capromab pendetide) images for pelvic lymph CT scan, or MRI), who are at high-risk for pelvic lymph node domain. Expression of this glycoprotein has not been demonstrated metastases (see CLINICAL PHARMACOLOGY, Imaging
on any other adenocarcinomas or transitional cell cancers tested. metastatic prostate cancer at surgery. Eighty-seven patients Performance in Newly-Diagnosed Patients). It is not indicated
Artwork Approval Signature Box
The antibody is produced by serum-free in vitro cultivation of cells, (57%) had negative Indium In 111 ProstaScint® images: Of these and purified by sequential protein isolation and chromatographic 28% (24 patients) did have metastatic prostate cancer at surgery. Indium In 111 ProstaScint® is also indicated as a diagnostic The overall accuracy of Indium In 111 ProstaScint® CLINICAL PHARMACOLOGY
imaging agent in post-prostatectomy patients with a rising PSA Proofreader
Each ProstaScint® kit consists of two vials which contain all immunoscintigraphy, as measured against pelvic lymph node and a negative or equivocal standard metastatic evaluation in of the non-radioactive ingredients necessary to produce a single Pharmacodynamics
whom there is a high clinical suspicion of occult metastatic Site Packaging
unit dose of Indium In 111 ProstaScint®, an immunoscintigraphic A retrospective subset analysis suggested that a positive Prostate Specific Membrane Antigen is expressed in many Indium In 111 ProstaScint® scan in patients with a Gleason score agent for administration by intravenous injection only. The primary and metastatic prostate cancer lesions, and in vitro ProstaScint® following radiation therapy has not been studied. ≥7 and a PSA ≥ 40 contained additional information regarding ProstaScint® vial contains 0.5 mg of capromab pendetide in immunohistologic studies have shown 7E11-C5.3 to be reactive The information provided by Indium In 111 ProstaScint® Regulatory
the likelihood that tumor metastases would be found at the with > 95% of the prostate adenocarcinomas evaluated. In imaging should be considered in conjunction with other diagnostic scheduled staging pelvic lymphadenectomy. information. Scans that are positive for metastatic disease pH 6; a sterile, pyrogen-free, clear, colorless solution that may general, PSMA expression by prostate cancer cells is either unchanged or increased in patients treated with hormonal therapy should be confirmed histologically in patients who are otherwise Market Affiliate
contain some translucent particles. The vial of sodium acetate (see PRECAUTIONS, Drug Interactions). The 7E11-C5.3 antibody Imaging Performance in Patients with
candidates for surgery or radiation therapy unless medically buffer contains 82 mg of sodium acetate in 2 mL of Water for is immunoreactive with normal and hypertrophic adult prostate Occult Recurrent or Residual Disease
contraindicated. Scans that are negative for metastatic disease Injection adjusted to pH 5-7 with glacial acetic acid; it is a sterile, tissue. In clinical studies of patients with prostate cancer, Indium should not be used in lieu of histological confirmation. pyrogen-free, clear, and colorless solution. Neither solution In 111 ProstaScint® phase 3 trial, 183 patients with a high clinical suspicion of residual ProstaScint® is not indicated as a screening tool for carcinoma of or recurrent prostate cancer following radical prostatectomy contains a preservative. Each kit also includes one sterile prostate, and some known primary and metastatic tumor sites. the prostate nor for readministration for the purpose of assessment were evaluated. Patients with a rising PSA, a negative bone scan, 0.22 µm Millex® GV filter, prescribing information, and two Non-antigen-dependent localization, suspected to be second- and negative or equivocal standard diagnostic techniques, (e.g. ary to catabolism, has been observed in the liver, spleen, and bone marrow. Although there is variation among individuals, transrectal ultrasound, CT scan, or MRI) underwent Indium In CONTRAINDICATIONS
The sodium acetate solution must be added to the sterile, there may also be localization and imaging activity in the bowel, 111 ProstaScint® (capromab pendetide) immunoscintigraphy non-pyrogenic high purity Indium In 111 Chloride solution to blood pool, kidneys, urinary bladder, and genitalia. Intracellular prior to biopsy of the prostatic fossa. The Indium In 111 Indium In 111 ProstaScint® (capromab pendetide) should not be PAGE 1 OF 2
buffer it prior to radiolabeling ProstaScint®. The immunoscinti- localization of 7E11-C5.3 has been observed in histochemically ProstaScint® images were interpreted on-site, and the reader used in patients who are hypersensitive to this or any other graphic agent Indium In 111 Capromab Pendetide (Indium In 111 prepared tissue sections from normal adult skeletal and cardiac had access to all clinical data. The interpretations were correlated product of murine origin or to Indium In 111 chloride. ProstaScint®) is formed after radiolabeling with Indium In 111. muscle, although primate studies revealed no specific localization with the results of histopathologic analysis of the prostatic fossa WARNINGS
One hundred fifty-eight patients had an interpretable scan and Physical Characteristics of Indium In 111
prostatic fossa biopsy. Twenty-nine scans were classified as true Patient management should not be based on Indium In 111 Indium In 111 decays by electron capture with a physical half-life Pharmacokinetics
ProstaScint® (capromab pendetide) scan results without Based on data obtained from clinical studies, Indium In 111 positive, 29 as false positive, 70 as true negative, and 30 as false of 67.2 hours (2.8 days).1 The energies of the photons that are appropriate confirmatory studies since in the pivotal trials, there ProstaScint® demonstrated a monoexponential elimination negative. The results are summarized in TABLE 5. useful for detection and imaging studies are listed in TABLE 1. was a high rate of false positive and false negative image pattern with a terminal-phase half life of 67 ± 11 hours (mean ± SD). TABLE 5 - INDIUM IN 111 PROSTASCINT®
TABLE 1 - INDIUM IN 111 PRINCIPAL
Approximately 10% of the administered radioisotope dose is AND HISTOPATHOLOGIC RESULTS
Indium In 111 ProstaScint® images should be interpreted only RADIATION EMISSION DATA1
excreted in the urine during the 72 hours following intravenous FOR RECURRENT OR RESIDUAL
by physicians who have had specific training in Indium In 111 infusion. The pharmacokinetics of Indium In 111 ProstaScint® DISEASE PATIENTS
ProstaScint® image interpretation (see PRECAUTIONS, Imaging are characterized by slow serum clearance rate (42 ± 22 mL/hr) and small volume of distribution (4 ± 2.1 L). Allergic reactions, including anaphylaxis, can occur in patients who receive murine antibodies. Although serious reactions of CLINICAL STUDIES
this type have not been observed in clinical trials after Indium In Indium In 111 ProstaScint® (capromab pendetide) has been 111 ProstaScint® administration, medications for the treatment External Radiation
administered in single doses to over 600 patients in clinical studies, of hypersensitivity reactions should be available during adminis- and in repeat administrations (2 to 4 infusions) to 61 patients. A The exposure rate constant for 37 MBq (1 mCi) of Indium In 111 0.5 mg dose was determined to be the lowest effective dose. The is 8.3 x 10-4 C/kg/hr (3.21 R/hr). The first half-value thickness of Indium In 111 ProstaScint® may induce human anti-mouse imaging performance of Indium In 111 ProstaScint® (capromab lead (Pb) for Indium In 111 is 0.023 cm. A range of values for antibodies which may interfere with some immunoassays, pendetide) was evaluated in a phase 2 and a phase 3 trial in the relative attenuation of the radiation emitted by this radio- including those used to assay PSA and digoxin (see PRECAU- each of two clinical settings: (1) patients with clinically-localized TIONS, Drug/Laboratory Test Interactions). nuclide that results from the interposition of various thicknesses prostate cancer who were at high risk for metastases and (2) of Pb is shown in TABLE 2. For example, the use of 0.834 cm of patients with a high clinical suspicion for occult recurrent or PRECAUTIONS
lead will decrease the external radiation exposure by a factor of Fifty-eight patients (37%) had positive Indium In 111 ProstaScint® (capromab pendetide) images in the prostatic Imaging Performance in Newly-Diagnosed Patients
fossa: Of these 50% (29 patients) did not have recurrent prostate There were high rates of false positive and false negative image TABLE 2 - INDIUM IN 111 RADIATION
In one of two open label, multi-center, uncontrolled pivotal phase interpretations in the pivotal trials (see Clinical Studies). False ATTENUATION OF LEAD SHIELDING2
cancer on biopsy. One hundred patients (63%) had negative 3 trials, 160 patients with a tissue diagnosis of prostate cancer Indium In 111 ProstaScint® images: Of these 30% (30 patients) positive scan interpretations may result in: (1) inappropriate who were considered at high risk for lymph node metastases had recurrent prostate cancer on biopsy. The overall accuracy of surgical intervention to confirm scan results; (2) inappropriate Indium In 111 ProstaScint® immunoscintigraphy, as measured denial of curative therapy if results are not confirmed; or (3) prior to scheduled staging pelvic lymphadenectomy. High risk against prostatic fossa biopsy, was 63% (99/158). inadequate surgical staging if only areas of uptake are sampled. was defined as at least one of the following: (1) prostate specific Surgical sampling should not be limited to the areas of positive antigen (PSA) ≥10x the upper limit of normal & Gleason score fossa in 29 (18%) patients, to prostatic fossa and extrafossa uptake, unless histologic examination of these areas is diagnostic. ≥7; (2) prostatic acid phosphatase above the upper limit of sites in 29 (18%) patients, and to only extrafossa sites in 39 Due to the potential for false negative scan interpretations, negative normal; (3) equivocal evidence of lymph node metastases on (25%) patients. The study was not designed to evaluate images should not be used in lieu of histologic confirmation. CT or ultrasound & PSA ≥8x the upper limit of normal; (4) extrafossa sites of uptake. Three extrafossa sites of uptake were Proper patient preparation is mandatory to obtain optimal images Gleason score ≥8; or (5) clinical stage C & Gleason score ≥6. All biopsied, one of which was positive for metastatic prostate cancer. for interpretation (see Imaging Precautions, below). patients had been evaluated for metastatic disease using standard These estimates of attenuation do not take into consideration Bone scans are more sensitive than ProstaScint® (capromab non-invasive imaging techniques, and were considered to have the presence of longer-lived contaminants with higher energy ProstaScint® Results in Patients with Distant Metastases
pendetide) for the detection of metastases to bone, and Indium clinically-localized prostate cancer. The Indium In 111 ProstaScint® In 111 ProstaScint® should not replace bone scan for the Clinical trials have not specifically studied the ability of Indium In images were interpreted on-site, and the reader had access to all To allow correction for physical decay of Indium In 111, the frac- 111 ProstaScint® (capromab pendetide) to image distant (extra- clinical data. The interpretations were correlated with the results tions that remain at selected intervals before and after the time pelvic) metastases, and a limited number of patients with distant of surgical staging; however, a correlation of specific areas of (primarily bone) metastases were enrolled. Thirteen patients out Imaging Precautions
Indium In 111 ProstaScint® uptake to specific sites of tumor of 16 (81%) with CT evidence of distant soft tissue disease had other professionals who are qualified by training and experience One hundred fifty-two patients had an interpretable scan and positive extrafossa Indium In 111 ProstaScint® scans. Thirty- in the safe use and handling of radionuclides. Indium In 111 surgical staging. Forty scans were classified as true positive, 25 five out of 61 patients (57%) with bone scan evidence of disease ProstaScint® images should be interpreted only by physicians as false positive, 63 as true negative, and 24 as false negative. The had positive Indium In 111 ProstaScint® skeletal uptake; however, who have had specific training in the interpretation of Indium In results for immunoscintigraphy are summarized in TABLE 4.
Indium In 111 ProstaScint® imaging did not identify most sites of abnormal bone uptake on bone scan, nor did it demonstrate There may be Indium In 111 ProstaScint® clearance and any new sites of metastasis that were not seen on bone scan. imaging localization observed in the bowel, blood pool, kidneys, The Indium In 111 ProstaScint® scan did, however, demonstrate and urinary bladder. When obtaining all 72-120 hour planar and sites of bone marrow metastases that were not seen on bone scan in 2 of 43 patients in the phase 1 study.
EUSAPharma
606-0870A Rev F
Proof No.:
Product Name ProstaScintMarket USAComponent LeafletNo. of Colours OneProfile Not Single-Photon Emission Computed Tomography (SPECT) Pediatric Use
Directions for
Radiolabeling
ProstaScint®
(capromab
Image Acquisition and Interpretation
images, the bladder should be catheterized and irrigated. The The safety and effectiveness of Indium In 111 ProstaScint® in pendetide) with Indium In 111 Chloride
Images should be acquired using a large field of view gamma administration of a cathartic is required the evening before imaging pediatric patients have not been established. ProstaScint® is not Proper aseptic techniques and precautions for handling radioac- camera equipped with a parallel hole medium energy collimator. The the patient, and a cleansing enema should be administered tive materials should be employed. Waterproof gloves should be gamma camera should be calibrated using the 172 and 247 within an hour prior to each 72-120 hour imaging session. worn during the radiolabeling procedure. The preparation of the keV photopeaks for Indium In 111 with a 15-20% symmetric The contents of the kit are not radioactive. However, after the ADVERSE REACTIONS
product should be done by the following procedure. Indium In 111 chloride is added, appropriate shielding of Indium ProstaScint® (capromab pendetide) was generally well tolerated Whole body or spot planar views of the pelvis, abdomen, and In 111 ProstaScint® (capromab pendetide) must be maintained. in the clinical trials. After administration of 529 single doses of A I ndium In 111 Chloride from GE Healthcare, Inc. or thorax should be performed between 72 and 120 hours following Care should be taken to minimize radiation exposure to patients Indium In 111 ProstaScint®, adverse reactions were observed in Indium In 111 ProstaScint® (capromab pendetide) infusion. A and medical personnel, consistent with proper hospital and 4% of patients. The most commonly reported adverse reactions B. One sterile 1 mL syringe, one sterile 3 mL syringe cathartic is required the evening before imaging and a cleansing were increases in bilirubin, hypotension, and hypertension, enema should be administered within an hour prior to each Each ProstaScint® kit is a unit of use package. The contents which occurred in 1% of patients. Elevated liver enzymes and D. Dose calibrator set for Indium In 111 72-120 hour imaging session. In addition, the bladder should be of the kit are to be used only to prepare Indium In 111 injection site reactions occurred in slightly less than 1% of E. Biodex Dark Green Chromatography strips ProstaScint® – unlabeled ProstaScint should patients. Other adverse reactions, listed in order of decreasing F. Developing chamber for chromatography (e.g. scintillation Whole body acquisition should be carried out from skull directly to the patient. After radiolabeling with Indium In 111, the frequency, were: pruritus, fever, rash, headache, myalgia, asthenia, through mid-femur. The total scan time over this area should be entire Indium In 111 ProstaScint® dose must be administered to burning sensation in thigh, shortness of breath, and alteration of TEXT SIZES
no less than 35 minutes using a 128x512 or 256x1024 matrix. the patient for whom it was prescribed. Reducing the dose in taste. Most adverse reactions were mild and readily reversible. Planar images should be acquired in anterior and posterior Indium In 111, unlabeled ProstaScint®, or Indium In 111 Data from repeat administration in 61 patients revealed a similar views for 7.5 minutes per view using a 128x128 or 256x256 ProstaScint® may adversely impact imaging results and is not incidence of adverse reactions (5%). No deaths were attributable matrix. Due to uptake of Indium In 111 ProstaScint® by the liver, to Indium In 111 ProstaScint® administration. planar images obtained with the liver in the field of view must be The components of the kit are sterile and pyrogen-free and acquired with adequate counts to allow the detection of lesions in Artwork Approval Signature Box
contain no preservative. Indium In 111 ProstaScint® should be OVERDOSAGE
M 0.05 M solution of diethylenetriamine pentaacetic acid the adjacent extrahepatic abdomen and pelvis. This may result in used within 8 hours after radiolabeling. It is essential to follow The maximum amount of Indium In 111 ProstaScint® (capromab pixel overflow with image degradation in the region of the liver. the directions for preparation carefully and to adhere to strict pendetide) that can be safely administered has not been deter- Two SPECT imaging sessions are necessary. The first SPECT Proofreader
aseptic procedures during preparation of the radiolabeled product. mined. In clinical studies, single doses of 10 mg of Indium In 2. Sterile, pyrogen-free Indium In 111 Chloride solution must session should be of the pelvis and be performed approximately 111 ProstaScint® were administered to 20 patients with prostate be utilized in the preparation of the Indium In 111 30 minutes after infusion to obtain a blood pool image. The Information for Patients
cancer; the type and frequency of adverse reactions at this dose ProstaScint®. The use of high purity Indium In 111 Chloride second SPECT session should include both the pelvis and Site Packaging
Murine monoclonal antibodies (MAbs) are foreign proteins, and were similar to those observed with lower doses. The maximum manufactured by GE Healthcare, Inc. or by Covidien, Inc. is abdomen, including the lower liver margin through the prostatic their administration can induce HAMA. While limited data exist Indium In 111 dose administered with ProstaScint® in a clinical fossa and be performed between 72 and 120 hours after infusion required. The Indium In 111 Chloride should be used only concerning the clinical significance of HAMA, the presence of for detection of benign and malignant prostate tissue sites. to radiolabel ProstaScint® and should not be injected directly Regulatory
HAMA may interfere with murine-antibody based immunoassays, Depending upon the capability of the camera field of view to into the patient. The Indium In 111 Chloride should not be or could compromise the efficacy of diagnostic or therapeutic DOSAGE AND ADMINISTRATION
include both pelvis and abdomen, either one or two separate murine antibody-based agents and increase the risk of adverse The patient dose of the radiolabel must be measured in a dose acquisitions may be necessary during the second session. Market Affiliate
3. Before radiolabeling, bring the refrigerated ProstaScint® reactions. For these reasons, patients should be informed that T resolve imaging ambiguities possibly resulting from activ- (capromab pendetide) to room temperature. Note: the use of this product could adversely affect the future ability to ity in blood pool, stool or urinary bladder, follow-up imaging ProstaScint® is a protein solution which may develop diagnose recurrence of their tumor, the ability to perform certain pendetide) is 0.5 mg radiolabeled with 5 mCi of Indium In 111 sessions with full patient preparation should be performed. translucent particulates. These particulates will be removed chloride. Each dose is administered intravenously over 5 minutes The SPECT Images should be acquired using a 64x64 or Patients should be advised to discuss prior use of murine- and should not be mixed with any other medication during its 128x128 matrix for a minimum of 60 or 120 stops, respectively, 4. Clean the rubber stopper of each vial with an alcohol wipe. antibody based products with their physicians (see Heterologous administration. Indium In 111 ProstaScint® may be readminis- over 360 degrees rotation for approximately 25 seconds per view With a sterile 1 mL syringe add 0.1 mL of sodium acetate tered following infiltration or a technically inadequate scan; how- at the first session and 50 seconds per view at the second solution to the shielded vial of Indium In 111 chloride and ever, it is not indicated for readministration for the purpose of session. Reconstruction should be performed using a Heterologous Protein Administration
mix. Retain remaining sodium acetate for use in Step 7. assessment of response to treatment (see INDICATIONS AND Butterworth filter or equivalent in the transverse, coronal and Indium In 111 ProstaScint® (capromab pendetide) has been 5. With the same 1 mL syringe, withdraw between 6 and 7 mCi sagittal views. An order of 5 and cut off of 0.5 may be used as a PAGE 2 OF 2
shown to induce HAMA to murine IgG infrequently and with low of the buffered Indium In 111 chloride and add to the Each ProstaScint® kit is a unit dose package. After radiolabel- starting point. Slice thickness should be in the range of 6 to 12 mm. peak levels after single administration. HAMA levels were detected ing with Indium In 111, the entire Indium In 111 ProstaScint® Following Indium In 111 ProstaScint® (capromab pendetide) (at >8 ng/mL) by RIA after single infusion in 8% (20/239) of Swirl gently to mix, and assay contents in a dose calibrator. dose should be administered to the patient. Reducing the dose administration, some of the radiolabel localizes in normal liver, patients, while 1% of patients had levels greater than 100 ng/mL. On one of the labels provided, record the patient s of Indium In 111, unlabeled ProstaScint®, or Indium In 111 In addition, serum HAMA levels were detected by RIA after repeat tion, the date, time of preparation, and activity in the vial. ProstaScint® may adversely impact imaging results and is, there- It has been reported that Indium In 111 labeled antibodies may localize non-specifically in colostomy sites, degenerative While limited data exist concerning the clinical significance of fore, not recommended. Parenteral drug products should be 6. Allow the labeling reaction to proceed at room temperature joint disease, abdominal aneurysms, post-operative bowel HAMA, detectable serum levels can alter the clearance and tissue inspected visually for particulate matter and discoloration prior to adhesions, and local inflammatory lesions, including those biodistribution of MAbs. The development of persistently elevated administration, whenever solution and container permit. 7. With a 3 mL syringe, add the remaining sodium acetate to typically associated with inflammatory bowel disease or secondary serum HAMA levels could compromise the efficacy of diagnostic Radiation Dosimetry
to surgery or radiation. Indium In 111 ProstaScint® can demon- or therapeutic murine antibody-based agents. In repeat adminis- The estimated absorbed radiation doses to an average adult strate apparent localization to sites of tortuous blood vessels. tration trials, 93% (65/70) of the evaluable repeat infusions were 8. Aseptically attach the 0.22 µm Millex® GV sterile filter patient from an intravenous injection of ProstaScint® associated with normal tissue distribution of the MAb conjugate. (provided) and a sterile hypodermic needle to a 10 mL with 5 mCi of Indium In 111 are shown in TABLE 6. Total dose tic information should aid in the interpretation of the images. Pre-infusion serum HAMA levels were generally not predictive of sterile disposable syringe and withdraw the contents of the estimates include absorbed radiation doses from both Indium In The diagnostic images acquired with Indium In 111 111 and the Indium In 114m radiocontaminant. A level of 0.06% ProstaScint® should be interpreted in conjunction with other When considering the administration of Indium In 111 needle immersed in the solution to avoid creating an air-lock of Indium In 114m was utilized for the dose estimates presented in ProstaScint® to patients who have previously received other 9. Remove the filter and needle. Aseptically attach a fresh HOW SUPPLIED
the potential for assay interference and increased clearance and TABLE 6 - ESTIMATED AVERAGE
sterile hypodermic needle to the syringe. Assay syringe and The ProstaScint® (capromab pendetide) kit (NDC No. 57902- altered biodistribution, which may interfere with the quality or ABSORBED RADIATION DOSE
contents in a dose calibrator. The syringe should contain not 817-01) for the preparation of Indium In 111 labeled Capromab sensitivity of the imaging study. Prior to administration of murine IN ADULT PATIENTS FROM INTRAVENOUS
less than 4 mCi (148 MBq) of Indium In 111 ProstaScint®. Pendetide includes one vial containing 0.5 mg of ProstaScint® antibodies, including Indium In 111 ProstaScint® (capromab ADMINISTRATION OF PROSTASCINT®
Radiochemical purity (RCP) by Instant Thin Layer per 1 mL of sodium phosphate buffered saline and one 2 mL vial pendetide), the physician should review the patient history to LABELED WITH 5 mCi (185 MBq) OF
Chromatography (ITLC) can be determined by the following of sodium acetate solution, 0.5 M. These solutions are sterile and determine whether the patient has previously received such INDIUM IN 111 CHLORIDEa
pyrogen free and contain no preservatives. Each kit also includes A. Mix equal parts (several drops of each) of Indium In 111 one sterile 0.22 µm Millex® GV filter, prescribing information, Drug Interactions
Allow the mixture to stand at room temperature for one The effect of surgical and/or medical androgen ablation on the minute. Spot a small drop of the mixture onto an ITLC strip imaging performance of Indium In 111 ProstaScint® has not Store at 2° to 8°C (36° to 46°F). Do not freeze. Store upright. been studied. Preliminary data suggest hormone ablation may Add 0.9% sodium chloride solution to the developing chamber increase PSMA expression, with concurrent decrease in tumor to a depth of about 0.5 cm. Place the strip in a chromatography REFERENCES
expression of PSA.3 The use of ProstaScint® in this patient chamber with the origin at the bottom (ensure the strip does 1. Kocher, DC: Radioactive decay data tables. DOE/TIC
population cannot be recommended at this time. not bend or touch the walls of the chamber) and allow the Drug/Laboratory Test Interactions
solvent to migrate to about 0.5 cm from the end of the strip. A The presence of HAMA in serum as a result of ProstaScint® may small dot made with a felt tip pen at this distance can help Radiopharmaceutical Internal Dose Information Center, 1984. interfere with some antibody-based immunoassays (such as PSA indicate the arrival of the solvent front. Remove from the and digoxin). When present, this interference generally results in chamber and cut the strip in half and measure the counts per Membrane Antigen in Normal, Benign, and Malignant Prostate falsely high values. When following PSA levels, assay methods minute (CPM) of both halves with a gamma ray detector.
Tissues. Urol Oncol. 1995; 1:18-28.
resistant to HAMA interference should be utilized. PSA assays which were found to be resistant to HAMA interference were EUSA Pharma (USA) Customer Service: (800) 833-3533
When patients have received Indium In 111 ProstaScint®, the clinical laboratory should be notified to take appropriate measures D. If the radiochemical purity is <90%, the ITLC procedure to avoid interference by HAMA with clinical laboratory testing should be repeated. If repeat testing remains <90%, the procedures. These methods include the use of non-murine- based immunoassays, HAMA removal by adsorption, or sample 11. On the second label provided in the kit, record the patient’s identification, the date, time of assay, and activity in the Carcinogenesis, Mutagenesis, Impairment of Fertility
syringe. Affix this label to the syringe shield. Long-term animal studies have not been performed to evaluate 12. Indium In 111 ProstaScint® should be used within 8 hours the carcinogenic or mutagenic potential of Indium In 111 ProstaScint® or to evaluate its effect on fertility. Discard vials, needles, and syringes in accordance with aBased on data from 21 patients who received doses of local, state, and federal regulations governing radioactive Pregnancy
ProstaScint® labeled with a mean (± SD) Indium In 111 dose of ProstaScint® is not indicated for use in women.

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