Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/3029
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NeutroSpec (Kit)
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Adults: To prepare NeutroSpecthe reaction vial containing fanolesomab is reconstituted with sodium pertechnetate Tc 99m Injection, USP solution prior to use. . Fanolesomab is not intended for direct administration to the patient without reconstitution and labeling with sodium pertechnetate Tc 99m Injection, USP. NeutroSpec[Technetium (99m Tc) fanolesomab] is intended for a single intravenous (IV) administration through an intravenous access that has been demonstrated to be patent, e.g., butterfly, running IV line, or equivalent injection system to assure that no dose infiltration occurs. Following administration, flush the injection line with an appropriate volume of saline to assure administration of the total dose. For imaging, 75 to 125 mcg of fanolesomab is labeled with 10 to 20 mCi (370 to 740 MBq) and administered as a single dose of NeutroSpec. Planar imaging should be performed using a large field of view camera fitted with a low-energy, parallel-hole, high-resolution collimator. The camera should be positioned so that the lower edge of the liver is at the upper end of the field of view at the midline of the patient. Dynamic image acquisition over the lower abdomen should begin at the time of injection and consist of 10 sequential four-minute images. Following dynamic image acquisition, the patient should ambulate for approximately 10 to 15 minutes and void. Static planar images should then be collected, including supine anterior, posterior, 10���25 degree RAO and LAO views of the lower abdomen, followed by a standing anterior image of the lower abdomen. After the camera has been positioned (as described above), it is recommended that a total of one million counts be collected for the anterior supine image. All remaining images should be collected for the same duration of time required for the anterior supine image.<br/>Children (Five years and older): NeutroSpecis administered in a single dose of 0.21 mCi/kg to a maximum of 20 mCi. Recommended imaging times and procedures are the same as for adults. Dose adjustment has not been established in patients with renal insufficiency, in geriatric patients or in pediatric patients under five years of age.<br/>Image Interpretation: The biodistribution of the NeutroSpecradiopharmaceutical is imaged in the blood pool, reticuloendothelial system (liver, spleen, bone marrow), and urinary excretion organs (kidneys and urinary tract). Imaging of the uterus has been noted, consistent with blood pool activity of NeutroSpec. In the 200-patient clinical trial , based on the average of the three blinded reader interpretations, 75% of the 59 true positive cases of appendicitis were identified (range 66-81%). Among those with a blinded diagnosis of appendicitis, 76% displayed uptake of radiotracer activity in the appendix within 30 minutes following injection and 98% did so by 60 minutes following injection. In the trial the acquisition of image collection was performed for a 90 minute period. The image finding of a persistent or intensifying uptake in the right lower quadrant (appendix zone) that is seen before the completion of the entire imaging sequence may be considered a positive study, and imaging may be terminated at this time. In the case of a negative image finding at 30 and 60 minutes, collection to 90 minutes is recommended prior to termination of the study. A diagnostic abnormality is characterized by the presence of an irregular, asymmetric uptake of radiotracer localized in the right lower quadrant of the abdomen. The abnormal localization of radiotracer remains constant or increases in intensity in follow up imaging.
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NeutroSpec[Kit for the Preparation of Technetium (99m Tc) fanolesomab] is a radiodiagnostic agent consisting of a murine IgM monoclonal antibody, formulated to be labeled with technetium Tc 99m. Each NeutroSpeckit contains all the excipients needed to reconstitute and to radiolabel this imaging agent with sodium pertechnetate Tc 99m Injection, USP. The murine monoclonal antibody fanolesomab is produced in suspension culture of hybridoma cells. NeutroSpec[Technetium (99m Tc) fanolesomab] is an in vivo diagnostic radiopharmaceutical that can be visualized by nuclear medicine instrumentation. Each NeutroSpeckit contains a single use vial of fanolesomab as a sterile, non-pyrogenic, lyophilized mixture of 0.25 mg fanolesomab; 12.5 mg maltose monohydrate; 0.522 mg sodium potassium tartrate tetrahydrate, USP; 0.221 mg succinic acid; 54 mcg stannous tartrate (minimum stannous 7 mcg; maximum total stannous and stannic tin 24 mcg); 28 mcg glycine, USP; and 9.3 mcg disodium edetate dihydrate, USP. The lyophilized powder contains no preservatives and has no US standard of potency. When sterile, pyrogen-free sodium pertechnetate Tc 99m Injection, USP in isotonic saline (no preservatives) is added to the single use fanolesomab vial, a Tc 99m complex of fanolesomab is formed with an approximate pH of 6.2.<br/>Physical Characteristics of Technetium Tc 99m: Technetium 99m decays by isomeric transition with a physical half-life of 6.02 hours. The photon that is useful for imaging studies is listed in Table 1.<br/>External Radiation: The specific gamma-ray constant for technetium Tc 99m is 5.4��C��kg��MBq��h(0.78 R/mCi��h) at 1 cm. The first half-value thickness of lead for Tc 99m is 0.017 cm. A range of values for the relative attenuation of the radiation emitted by this radionuclide that results from the interposition of various thicknesses of lead is shown in Table 2. For example, the use of a 0.25 cm thickness of lead will decrease the external radiation exposure by a factor of 1,000. To correct for physical decay of this radionuclide, the fractions that remain at selected time intervals after the time of calibration are shown in Table 3.
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Pharmacodynamics: Fanolesomab is directed against the carbohydrate moiety 3-fucosyl-N-acetyllactosamine that defines the cluster of differentiation 15 (CD15) antigen. NeutroSpec[Technetium (99m Tc) fanolesomab] radiolabels human white blood cells and myeloid precursors. The CD15 antigen is expressed on the surface of polymorphonuclear neutrophils (PMNs), eosinophils and monocytes. Monocytes and eosinophils constitute approximately 5% of circulating leukocytes; therefore, most of the circulating blood cellular activity resides on PMNs. In blood cell fractions isolated from healthy volunteerswho had received NeutroSpec, radioactivity was associated with PMNs (25%) or plasma (72%) when measured one hour after injection. The binding of fanolesomab to its antigenic sites on human PMNs has an apparent K= 1.6��10M. Cross-reactivity studies indicate the presence of CD15 antigenic sites on many human tissues.<br/>Pharmacokinetics: In a study of 10 healthy volunteers, following intravenous injection of NeutroSpec, blood concentrations of radioactivity decreased rapidly with an initial half-life of 0.3 hours and a second phase half-life of approximately eight hours. Whole-body scintigraphy at two hours post-injection indicated that the liver had the highest radioactivity uptake and retention (50% of the injected dose), followed by the kidney, spleen and red marrow. Over the 26���33 hours after injection, 38% of the injected dose of radioactivity was recovered in urine.
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NeutroSpecshould not be administered to patients who are hypersensitive to any murine proteins or other component of the product.
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NeutroSpecKit for the Preparation of Technetium (99m Tc) fanolesomab The NeutroSpeckit contains five individual kits each containing:
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Repeat Administration: NeutroSpechas not been studied in repeat administration to patients. Murine monoclonal antibodies are frequently immunogenic. The development of human anti-mouse antibodies (HAMA) can alter the pharmacokinetics, biodistribution, safety, and imaging performance properties of the administered agent.<br/>Use in Patients with Neutropenia: The biodistribution and the imaging performance of NeutroSpecin neutropenic patients have not been studied. NeutroSpecinduces transient neutropenia and a downward shift in white blood cell counts. . The safety and effectiveness of NeutroSpecin patients with neutropenia have not been established.<br/>General Use and Handling: NeutroSpec[Technetium (99m Tc) fanolesomab], like other radioactive medical products, must be handled with care and appropriate safety measures should be used to minimize radiation exposure to clinical personnel. Care should also be taken to minimize radiation exposure to the patient consistent with proper patient management. Radiopharmaceuticals should be used by or under the control of personnel who are qualified by specific training and experience in the safe use and handling of radionuclides, and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radionuclides.<br/>Information for patients: Murine monoclonal antibodies such as fanolesomab are foreign proteins and their administration can induce hypersensitivity reactions. Patients should be informed that the use of this product could affect their future use of other murine based products, and should be advised to discuss prior use of murine antibody based products with their health care provider. To minimize the radiation-absorbed dose to the bladder, adequate hydration should be encouraged to permit frequent voiding during the first few hours after injection. To help protect themselves and others in their environment, patients should take the following precautions for 12 hours after injection. Whenever possible, a toilet should be used, rather than a urinal and the toilet should be flushed several times after each use. Spilled urine should be cleaned up completely. After each voiding or fecal elimination, patients should thoroughly wash their hands. If blood, urine or feces soil clothing, the clothing should be washed separately.<br/>Carcinogenesis, Mutagenesis, Impairment of Fertility: Studies have not been conducted to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.<br/>Pregnancy: Pregnancy Category C. Animal reproductive studies have not been conducted with NeutroSpec. It is also not known whether NeutroSpeccan cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. NeutroSpecshould not be used during pregnancy unless the potential benefit to the patient justifies the potential risk to the fetus.<br/>Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when NeutroSpecis administered to a nursing woman. Whenever possible, infant formula should be substituted for breast milk until the radioactivity has cleared from the body of the nursing woman.<br/>Pediatric Use: In clinical studies of NeutroSpec, 29 (5%) patients were 5���11 years old and 32 (6%) were 12���16 years old. No overall differences in safety or effectiveness were observed between these patients and patients in other age brackets, however, this number of patients is too few to exclude differences.<br/>Geriatric Use: In clinical studies of NeutroSpec, 64 (12%) patients were 65 years or older. No overall differences in safety or effectiveness were observed between these patients and younger patients, but this number of patients is too few to exclude differences.
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There is no experience with overdosage in clinical trials.
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Technetium (99m Tc) fanolesomab
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NeutroSpec (Kit)
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The data described below reflect exposure to NeutroSpecin 523 patients and normal volunteers receiving a mean antibody dose of 121 mcg (33���250 mcg) and a mean radioactive dose of 15 mCi (1-33 mCi). The median patient age was 35 years (5-91 years); 53% of patients were women and 61% of patients were Caucasians. Two patients enrolled in studies of post surgical infection or abscess had serious adverse events associated with fatality (hypotension and worsening of sepsis). Underlying medical conditions may have also contributed to the fatality and the relationship of the fatality to NeutroSpec���cannot be determined. Overall, 49 adverse events occurred in 37 (7%) of the 523 patients exposed to NeutroSpec. Four of these events were classified as severe (hypotension, worsening of sepsis, chest pressure and decreased SaOpain). The most frequently reported adverse events were flushing (n=10, 2%) and dyspnea (n=5, 1%). Other less common adverse events (<1%) included syncope, dizziness, hypotension, chest pressure, paresthesia, nausea, injection site burning/erythema, pain, and headache. Because clinical trials are conducted under widely varying controlled conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug, and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.<br/>Laboratory Test Values: NeutroSpecinduced transient decreases in neutrophil counts in a study of 10 healthy volunteers. Neutrophil counts began to decrease within 3 to 5 minutes post-injection and returned to pre-injection values within four hours. Downward shifts in neutrophil counts have been observed in 18% of patients (28/151).Three of 284 patients were observed to develop transient elevations of AST and ALT after NeutroSpecadministration.<br/>Immunogenicity: The incidence of antibody development in patients receiving NeutroSpechas not been adequately determined because the assay was not directly quantitative and its ability to detect low titers could not be assured. Human anti-mouse antibody (HAMA) response following a single NeutroSpecadministration was evaluated in a total of 54 patients 3-16 weeks post injection. None of the patients had a positive HAMA response. In 30 healthy volunteers who were exposed to two administrations of fanolesomab separated by two weeks, fanolesomab induced HAMA response in five volunteers. Immunogenicity data are highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody positivity in an assay may be influenced by several factors, including sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to NeutroSpecwith the incidence of antibodies to other products may be misleading.
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Hypersensitivity Reactions: Allergic reactions, including anaphylaxis, can occur in patients who receive murine antibodies such as fanolesomab. CenolateAscorbic Acid, USP injection (diluent) contains sodium hydrosulfite, a sulfite that may cause allergic reactions, including anaphylaxis. Serious hypersensitivity reactions were not observed in the 523 patients who received NeutroSpecin the clinical studies. Emergency resuscitation personnel and equipment for the treatment of hypersensitivity reactions should be immediately available during administration of this agent.
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NeutroSpec[Technetium (99m Tc) fanolesomab] is indicated for scintigraphic imaging of patients with equivocal signs and symptoms of appendicitis who are five years of age or older.
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NeutroSpec
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