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NeutroSpec
Overview
What is NeutroSpec?
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 NeutroSpec 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. NeutroSpec [Technetium (99m Tc) fanolesomab] is an diagnostic radiopharmaceutical that can be visualized by nuclear medicine instrumentation.
Each NeutroSpec 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.
What does NeutroSpec look like?
What are the available doses of NeutroSpec?
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What should I talk to my health care provider before I take NeutroSpec?
Sorry No records found
How should I use NeutroSpec?
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.
To prepare NeutroSpec the reaction vial containing fanolesomab is reconstituted with sodium pertechnetate Tc 99m Injection, USP solution prior to use. (See ).
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.
What interacts with NeutroSpec?
NeutroSpec should not be administered to patients who are hypersensitive to any murine proteins or other component of the product.
What are the warnings of NeutroSpec?
Hypersensitivity Reactions
Allergic reactions, including anaphylaxis, can occur in patients who receive murine antibodies such as fanolesomab.
Cenolate 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 NeutroSpec in the clinical studies. Emergency resuscitation personnel and equipment for the treatment of hypersensitivity reactions should be immediately available during administration of this agent.
What are the precautions of NeutroSpec?
Repeat Administration
NeutroSpec has 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.
Use in Patients with Neutropenia
The biodistribution and the imaging performance of NeutroSpec in neutropenic patients have not been studied. NeutroSpec induces transient neutropenia and a downward shift in white blood cell counts. (See . The safety and effectiveness of NeutroSpec in patients with neutropenia have not been established.
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.
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.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Studies have not been conducted to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.
Pregnancy
Pregnancy Category C. Animal reproductive studies have not been conducted with NeutroSpec. It is also not known whether NeutroSpec can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. NeutroSpec should not be used during pregnancy unless the potential benefit to the patient justifies the potential risk to the fetus.
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 NeutroSpec is 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.
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.
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.
What are the side effects of NeutroSpec?
The data described below reflect exposure to NeutroSpec in 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 SaO pain). 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.
Laboratory Test Values
NeutroSpec induced 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 NeutroSpec administration.
Immunogenicity
The incidence of antibody development in patients receiving NeutroSpec has 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 NeutroSpec administration 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 NeutroSpec with the incidence of antibodies to other products may be misleading.
What should I look out for while using NeutroSpec?
NeutroSpec should not be administered to patients who are hypersensitive to any murine proteins or other component of the product.
What might happen if I take too much NeutroSpec?
There is no experience with overdosage in clinical trials.
How should I store and handle NeutroSpec?
Store the kit at 2°-8°C (36°-46°F) and protect from light.ArrayStore the kit at 2°-8°C (36°-46°F) and protect from light.ArrayNeutroSpec Kit for the Preparation of Technetium (99m Tc) fanolesomabThe NeutroSpec kit contains five individual kits each containing:NeutroSpec Kit for the Preparation of Technetium (99m Tc) fanolesomabThe NeutroSpec kit contains five individual kits each containing:
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Fanolesomab is directed against the carbohydrate moiety 3-fucosyl--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 volunteers who 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 = 1.6 × 10 M.
Cross-reactivity studies indicate the presence of CD15 antigenic sites on many human tissues.
Non-Clinical Toxicology
NeutroSpec should not be administered to patients who are hypersensitive to any murine proteins or other component of the product.In vitro
Carbamazepine reduced plasma concentrations of trazodone when co-administered. Patients should be closely monitored to see if there is a need for an increased dose of trazodone when taking both drugs.
Increased serum digoxin or phenytoin levels have been reported to occur in patients receiving trazodone hydrochloride concurrently with either of those two drugs.
It is not known whether interactions will occur between monoamine oxidase (MAO) inhibitors and trazodone hydrochloride. Due to the absence of clinical experience, if MAO inhibitors are discontinued shortly before or are to be given concomitantly with trazodone hydrochloride, therapy should be initiated cautiously with gradual increase in dosage until optimum response is achieved.
NeutroSpec has 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.
The data described below reflect exposure to NeutroSpec in 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 SaO pain). 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.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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