Neutrospec
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Questions & Answers
Side Effects & Adverse Reactions
Allergic reactions, including anaphylaxis, can occur in patients who receive murine antibodies such as fanolesomab.
CenolateTM Ascorbic 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 NeutroSpecTM in the clinical studies. Emergency resuscitation personnel and equipment for the treatment of hypersensitivity reactions should be immediately available during administration of this agent.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
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Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
NeutroSpecTM [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.
History
There is currently no drug history available for this drug.
Other Information
NeutroSpecTM [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 NeutroSpecTM kit 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. NeutroSpecTM [Technetium (99m Tc) fanolesomab] is an in vivo diagnostic radiopharmaceutical that can be visualized by nuclear medicine instrumentation.
Each NeutroSpecTM kit 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.
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.
| Radiation | Mean Percent per Disintegration | Mean Energy (keV) |
| Gamma-2 | 89.07 | 140.5 |
The specific gamma-ray constant for technetium Tc 99m is 5.4 μC·kg-1·MBq-1·h-1 (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.
| Lead Shield Thickness (cm) | Coefficient of Attenuation |
| 0.017 | 0.5 |
| 0.08 | 0.1 |
| 0.16 | 0.01 |
| 0.25 | 0.001 |
| 0.33 | 0.0001 |
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.
| *Calibration Time (time of preparation) |
|||
| Hours | Fraction Remaining | Hours | Fraction Remaining |
| 0* | 1.00 | 7 | 0.45 |
| 1 | 0.89 | 8 | 0.40 |
| 2 | 0.79 | 9 | 0.36 |
| 3 | 0.71 | 10 | 0.32 |
| 4 | 0.63 | 11 | 0.28 |
| 5 | 0.56 | 12 | 0.25 |
| 6 | 0.50 | 18 | 0.13 |
Sources
Neutrospec Manufacturers
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Mallinckrodt Inc.
![Neutrospec (Technetium (99m Tc) Fanolesomab) [Mallinckrodt Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Neutrospec | Mallinckrodt Inc.
AdultsTo prepare NeutroSpecTM the reaction vial containing fanolesomab is reconstituted with sodium pertechnetate Tc 99m Injection, USP solution prior to use. (See INSTRUCTIONS FOR PREPARATION).
Fanolesomab is not intended for direct administration to the patient without reconstitution and labeling with sodium pertechnetate Tc 99m Injection, USP. NeutroSpecTM [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 NeutroSpecTM.
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.
Children (Five years and older)NeutroSpecTM is 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.
Image InterpretationThe biodistribution of the NeutroSpecTM radiopharmaceutical 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 NeutroSpecTM.
In the 200-patient clinical trial (see CLINICAL STUDIES), 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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