"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
QUADRAMET® (samarium sm 153 lexidronam) is indicated for relief of pain in patients with confirmed osteoblastic metastatic bone lesions that enhance on radionuclide bone scan.
DOSAGE AND ADMINISTRATION
The recommended dose of QUADRAMET® (samarium sm 153 lexidronam) 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® (samarium sm 153 lexidronam) . 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® (samarium sm 153 lexidronam) contains calcium and may be incompatible with solutions that contain molecules that can complex with and form calcium precipitates.
QUADRAMET® (samarium sm 153 lexidronam) should not be diluted or mixed with other solutions.
Thaw at room temperature before administration and use within 8 hours of thawing.
Radiation Dosimetry: The estimated absorbed radiation doses to an average 70 kg adult patient from an i.v. injection of QUADRAMET® (samarium sm 153 lexidronam) 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® (samarium sm 153 lexidronam) . Although electron emissions from 153Sm are abundant, with energies up to 810 keV, rapid blood clearance of QUADRAMET® (samarium sm 153 lexidronam) 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).
TABLE 7: 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|
QUADRAMET® (samarium sm 153 lexidronam) is supplied frozen in a single-dose 10 mL glass vial containing 1850 ± 185 MBq/mL (50 ± 5 mCi/mL) of samarium-153, at calibration.
QUADRAMET® (samarium sm 153 lexidronam) is available in the following size:
NDC# 50419-209-03.................3mL fill size with total activity of 5550 MBq (150mCi).
The vial is shipped in a lead shield; a package insert is included.
The drug product expires 48 hours after the time of calibration noted on the label, or 8 hours after thawing, whichever is earlier.
Storage: Store frozen at -10° to -20°C in a lead shielded container.
Storage and disposal of QUADRAMET® (samarium sm 153 lexidronam) should be controlled in a manner that complies with the appropriate regulations of the governmen agency authorized to license the use of this radionuclide.
This radioactive drug is approved for distribution to persons licensed pursuant to the Code of Massachusetts Regulations 105 CMR 120.500 for the uses listed in 105 CMR 120.537 or under equivalent licenses of the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State.
THIS PRODUCT INFORMATION ISSUED September 2003. Mfd by: Bristol Myers Squibb, Medical Imaging, N. Billerica, MA 01862. Mfd for: Cytogen Corporation, Princeton, New Jersey, USA. For Product Inquiries, call 1-800-833-3533 FDA Rev date: 4/12/1999This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 10/8/2008
Additional Quadramet Information
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