"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"...
Use of Metastron in patients with evidence of seriously compromised bone marrow from previous therapy or disease infiltration is not recommended unless the potential benefit of the treatment outweighs its risks. Bone marrow toxicity is to be expected following the administration of Metastron, particularly white blood cells and platelets. The extent of toxicity is variable. It is recommended that the patient's peripheral blood cell counts be monitored at least once every other week. Typically, platelets will be depressed by about 30% compared to pre-administration levels. The nadir of platelet depression in most patients is found between 12 and 16 weeks following administration of Metastron. White blood cells are usually depressed to a varying extent compared to pre-administration levels. Thereafter, recovery occurs slowly, typically reaching pre-administration levels six months after treatment unless the patient's disease or additional therapy intervenes.
In considering repeat administration of Metastron, the patient's hematologic response to the initial dose, current platelet level and other evidence of marrow depletion should be carefully evaluated.
Verification of dose and patient identification is necessary prior to administration because Metastron delivers a relatively high dose of radioactivity.
Metastron may cause fetal harm when administered to a pregnant woman. There are no adequate and well-controlled studies in pregnant women. If this drug is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant.
Metastron is not indicated for use in patients with cancer not involving bone. Metastron should be used with caution in patients with platelet counts below 60,000 and white cell counts below 2,400.
Radiopharmaceuticals should only be used by physicians who are qualified by training and experience in the safe use and handling of radionuclides and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides.
Metastron, like other radioactive drugs, must be handled with care and appropriate safety measures taken to minimize radiation to clinical personnel.
In view of the delayed onset of pain relief, typically 7 to 20 days post injection, administration of Metastron to patients with very short life expectancy is not recommended.
A calcium-like flushing sensation has been observed in patients following a rapid (less than 30 second injection) administration.
Special precautions, such as urinary catheterization, should be taken following administration to patients who are incontinent to minimize the risk of radioactive contamination of clothing, bed linen and the patient's environment.
Metastron is excreted primarily by the kidneys. In patients with renal dysfunction, the possible risks of administering Metastron should be weighed against the possible benefits.
Carcinogenesis, Mutagenesis, Impairment Of Fertility
Data from a repetitive dose animal study suggests that Strontium-89 Chloride is a potential carcinogen. Thirty-three of 40 rats injected with Strontium-89 Chloride in ten consecutive monthly doses of either 250 or 350 μCi/kg developed malignant bone tumors after a latency period of approximately 9 months. No neoplasia was observed in the control animals. Treatment with Strontium-89 Chloride should be restricted to patients with well documented metastatic bone disease.
Adequate studies with Strontium-89 Chloride have not been performed to evaluate mutagenic potential or effects on fertility.
Pregnancy Category D. See WARNINGS section.
Because Strontium acts as a calcium analog, secretion of Strontium-89 Chloride into human milk is likely. It is recommended that nursing be discontinued by mothers about to receive intravenous Strontium-89 Chloride. It is not known whether this drug is excreted in human milk.
Safety and effectiveness in pediatric patients below the age of 18 years have not been established.
Last reviewed on RxList: 1/24/2014
This monograph has been modified to include the generic and brand name in many instances.
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