additional therapy intervenes. in considering repeat administration of strontium-89 chloride injection, 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 strontium-89 delivers a relatively high dose of radioactivity. strontium-89 chloride injection 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. precautions strontium-89 chloride injection is not indicated for use in patients with cancer not involving bone. strontium-89 chloride injection 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. strontium chloride sr-89 injection, usp 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 strontium-89 chloride injection 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. strontium-89 chloride is excreted primarily by the kidneys. in patients with renal dysfunction, the possible risks of administering strontium-89 chloride injection 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: teratogenic effects. pregnancy category d. see warnings section. nursing mothers 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. pediatric use safety and effectiveness in children below the age of 18 years have not been established.

s sites of primary and metastatic bone involvement with minimal irradiation of soft tissues distant from the bone lesions. (the maximum range in tissue is 8 mm; maximum energy is 1.463 mev.) mean absorbed radiation doses are listed under the radiation dosimetry section. clinical trials have examined relief of pain in cancer patients who have received therapy for bone metastases (external radiation to indexed sites) but in whom persistent pain recurred. in a multi-center canadian placebo-controlled trial of 126 patients, pain relief occurred in more patients treated with a single injection of strontium-89 chloride than in patients treated with an injection of placebo. results are given in the following tables. table 2 compares the percentage and number of patients treated with strontium-89 chloride injection or placebo who had reduced pain and no increase in analgesic or radiotherapy re-treatment. table 2: comparison of the effects of strontium-89 and placebo, as adjunct to radiotherapy, on treatment outcome over time. months post-treatment 1 2 3 4 5 6 strontium-89 71.4% 78.9% 60.6% 59.3% 36.4% 63.6% (n=42) (n=38) (n=33) (n=27) (n=22) (n=22) placebo 61.4% 57.1% 55.9% 25.0% 31.8% 35.0% (n=44) (n=35) (n=34) (n=24) (n=22) (n=20) at each visit, treatment success, defined as a reduction in a patient’s pain score without any increase in analgesic intake and without any supplementary radiotherapy at the index site, was more frequent among patients assigned to strontium-89 chloride injection than to placebo. table 3 compares the number and percentage of patients treated with strontium-89 chloride injection or placebo as an adjunct to radiotherapy who were pain free without analgesic at the intervals shown. table 3: comparison of the effects of strontium-89 and placebo, as adjunct to radiotherapy, on reduction of pain score and analgesic score to zero. months post-treatment 1 2 3 4 5 6 9 strontium-89 6 5 5 3 4 4 2 14.3% 13.2% 15.2% 11.1% 18.2% 18.2% 18.2% (n=42) (n=38) (n=33) (n=27) (n=22) (n=22) (n=11) placebo 3 3 2 0 1 1 0 6.8% 8.6% 5.9% 4.5% 5% (n=44) (n=35) (n=34) (n=32) (n=22) (n=20) (n=17) the number of patients classified at each visit as treatment successes who were pain free at the index site and required no analgesics was consistently higher in the strontium-89 group. new pain sites were less frequent in patients treated with strontium-89. in another clinical trial, pain relief was greater in a group of patients treated with strontium-89 compared with a group treated with non-radioactive strontium-88.

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