Generic name: SAMARIUM SM-153 LEXIDRONAM PENTASODIUM 50mCi in 1mL
Dosage form: injection, solution
Medically reviewed on March 22, 2018.
The recommended dose of QUADRAMET® is 1.0 mCi/kg, administered intravenously over a period of one minute through a secure in-dwelling catheter and followed with a saline flush. Dose adjustment in patients at the extremes of weight have not been studied. Caution should be exercised when determining the dose in very thin or very obese patients.
The dose should be measured by a suitable radioactivity calibration system, such as a radioisotope dose calibrator, immediately before administration.
The dose of radioactivity to be administered and the patient should be verified before administering QUADRAMET®. Patients should not be released until their radioactivity levels and exposure rates comply with federal and local regulations.
The patient should ingest (or receive by i.v. administration) a minimum of 500 mL (2 cups) of fluids prior to injection and should void as often as possible after injection to minimize radiation exposure to the bladder.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. The solution should not be used if it is cloudy or if it contains particulate matter.
QUADRAMET® contains calcium and may be incompatible with solutions that contain molecules that can complex with and form calcium precipitates.
QUADRAMET® should not be diluted or mixed with other solutions.
Thaw at room temperature before administration and use within 8 hours of thawing.
The estimated absorbed radiation doses to an average 70 kg adult patient from an i.v. injection of QUADRAMET® are shown in Table 7. The dosimetry estimates were based on clinical biodistribution studies using methods developed for radiation dose calculations by the Medical Internal Radiation Dose (MIRD) Committee of the Society of Nuclear Medicine.
Radiation exposure is based on a urinary voiding interval of 4.8 hours. Radiation dose estimates for bone and marrow assume that radioactivity is deposited on bone surfaces, as noted in autoradiograms of biopsy bone samples in 7 patients who received QUADRAMET®. Although electron emissions from 153Sm are abundant, with energies up to 810 keV, rapid blood clearance of QUADRAMET® and low energy and abundant photon emissions generally result in low radiation doses to those parts of the body where the complex does not localize.
When blastic osseous lesions are present, significantly enhanced localization of the radiopharmaceutical will occur, with correspondingly higher doses to the lesions compared with normal bones and other organs. (See Clinical Pharmacology, Skeletal Uptake and Pharmacodynamics Sections).
|RADIATION ABSORBED DOSES
70 kg ADULT
|Urinary Bladder Wall||3.60||0.097|
|Lower large intestine||0.037||0.010|
|Upper Large Intestine||0.020||0.0054|
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