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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.
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FDA Safety Alerts
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FDA Labeling Changes
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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.
There is currently no drug history available for this drug.
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)|
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|
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|