"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"...
Patients who receive QUADRAMET® (samarium sm 153 lexidronam) should be advised that for several hours following administration, radioactivity will be present in excreted urine. To help protect themselves and others in their environment, precautions need to be taken for 12 hours following administration. 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 and patients should wash their hands thoroughly. If blood or urine gets onto clothing, the clothing should be washed separately, or stored for 1-2 weeks to allow for decay of the Sm-153.
Some patients have reported a transient increase in bone pain shortly after injection (flare reaction). This is usually mild and self-limiting and occurs within 72 hours of injection. Such reactions are usually responsive to analgesics.
Patients who respond to QUADRAMET® (samarium sm 153 lexidronam) might begin to notice the onset of pain relief one week after QUADRAMET® (samarium sm 153 lexidronam) . Maximal pain relief generally occurs at 3-4 weeks after injection of QUADRAMET® (samarium sm 153 lexidronam) . Patients who experience a reduction in pain may be encouraged to decrease their use of opioid analgesics.
Because of the potential for bone marrow suppression, beginning 2 weeks after QUADRAMET® (samarium sm 153 lexidronam) administration, blood counts should be monitored weekly for at least 8 weeks, or until recovery of adequate bone marrow function.
In a subset of 31 patients who had serum calcium monitored during the first 2 hours after QUADRAMET® (samarium sm 153 lexidronam) infusion, a clear pattern of calcium change was not identified. However, 10 (32%) patients had at least one serum calcium level that was below normal (7.16 to 8.28). The extent to which samarium-153-EDTMP is related to this hypocalcemia is not known. Caution should be exercised when administering QUADRAMET® (samarium sm 153 lexidronam) to patients at risk for developing hypocalcemia.
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
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