"The U.S. Food and Drug Administration today approved the MemoryShape Breast Implant to increase breast size (augmentation) for use in women at least 22 years old and to rebuild breast tissue (reconstruction) in women of any age. The MemoryShape B"...
(samarium SM 153 lexidronam) Injection
Therapeutic – For Intravenous Administration
QUADRAMET® (samarium sm 153 lexidronam) is a therapeutic agent consisting of radioactive samarium and a tetraphosphonate chelator, ethylenediaminetetramethylenephosphonic acid (EDTMP). QUADRAMET® (samarium sm 153 lexidronam) is formulated as a sterile, non-pyrogenic, clear, colorless to light amber isotonic solution of samarium-153 lexidronam for intravenous administration.
QUADRAMET® (samarium sm 153 lexidronam) does not contain a preservative.
Each milliliter contains 35 mg EDTMP•H2O, 5.3 mg Ca [as Ca(OH)2], 14.1 mg Na [as NaOH], equivalent to 44 mg Ca/Na EDTMP (anhydrous calc.), 5-46 µg samarium (specific activity of approximately 1.0-11.0 mCi/µg Sm), and 1850 ± 185 MBq (50 ± 5 mCi) of samarium-153 at calibration.
The structural formula of samarium lexidronam pentasodium is:
The ionic formula is 153Sm+3 [CH2N(CH2PO3-2)2]2 and the ionic formula weight is 581.1 daltons (pentasodium form, 696).
The pH of the solution is 7.0 to 8.5.
QUADRAMET® (samarium sm 153 lexidronam) is supplied frozen in single-dose glass vials containing 3 mL with 5550 MBq (150 mCi) of samarium-153 at calibration.
Physical Characteristics: Samarium-153 is produced in high yield and purity by neutron irradiation of isotopically enriched samarium Sm 152 oxide (152 Sm2O3). It emits both medium-energy beta particles and a gamma photon, and has a physical half-life of 46.3 hours (1.93 days). Samarium-153 has average and maximum beta particle ranges in water of 0.5 mm and 3.0 mm, respectively. The primary radiation emissions of samarium-153 are shown in Table 1.
TABLE 1 - SAMARIUM-153 PRINCIPAL RADIATION EMISSION DATA
|Radiation Energy (keV)*||Abundance|
|* Maximum energies are listed for the beta emissions, the average beta particle energy is 233 keV.|
External Radiation: The specific gamma-ray constant for samarium-153 is 0.46 R/mCi-hr at 1 cm (1.24x10-5 mSv/MBq- hr at 1 Meter). The half-value thickness of lead (Pb) for samarium-153 is approximately 0.10 mm. The use of 1 mm of lead will decrease the external radiation exposure by a factor of approximately 1,000. QUADRAMET® (samarium sm 153 lexidronam) should be stored in a lead-shielded container and frozen until use. Radioactive decay factors to be applied to the stated value for radioactive concentration at calibration are given in Table 2. All radioactivity is calibrated to the reference date and time on the vial.
TABLE 2 - SAMARIUM-153 PHYSICAL DECAY CHART, HALF-LIFE 46.3
HOURS (1.93 DAYS)
|Time (hour)*||Factor||Time (hour)*||Factor|
|*Time = hours before (-) or after (+) calibration|
What are the precautions when taking samarium sm 153 lexidronam (Quadramet)?
Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart problems (e.g., heart failure, irregular heartbeat), kidney problems, urinary/bladder problems (e.g., incontinence), decreased bone marrow function, blood disorders (e.g., bleeding problems, low platelet count, blood clotting problems), weakened immune system, low blood calcium levels.
Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently...
Last reviewed on RxList: 10/8/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Quadramet Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.