Adult Dosing
Patients with confirmed osteoblastic metastatic bone lesions
- 1.0 mCi/kg IV administered over 1 min through a secure in-dwelling catheter followed by a saline flush
Notes:- Exercise caution while determining the dose in very thin or very obese patients
- Advise patients to ingest (or receive intravenously) a minimum of 500 mL of fluids prior to injection and to void as often as possible after injection to minimize radiation exposure to bladder
- Product contains calcium and thus may be incompatible with solutions containing molecules that can complex with and form calcium precipitates
- Do not dilute or mix with other solutions
- Measure the dose by a suitable radioactivity calibration system, such as a radioisotope dose calibrator, immediately before administration
- Evaluate the dose of radioactivity to be administered and the patient before administering therapy. Patients should not be released until their radioactivity levels and exposure rates comply with federal and local regulations
Pediatric Dosing
Patients with confirmed osteoblastic metastatic bone lesions
Children 
16 yrs of age
- 1.0 mCi/kg IV administered over 1 min through a secure in-dwelling catheter followed by a saline flush
Notes:- Exercise caution while determining the dose in very thin or very obese patients
- Advise patients to ingest (or receive intravenously) a minimum of 500 mL of fluids prior to injection and to void as often as possible after injection to minimize radiation exposure to bladder
- Product contains calcium and thus may be incompatible with solutions containing molecules that can complex with and form calcium precipitates
- Do not dilute or mix with other solutions
- Measure the dose by a suitable radioactivity calibration system, such as a radioisotope dose calibrator, immediately before administration
- Evaluate the dose of radioactivity to be administered and the patient before administering therapy. Patients should not be released until their radioactivity levels and exposure rates comply with federal and local regulations
[Outline]
See Supplemental Patient Information
- Therapy may cause bone marrow suppression. Consider the patient's current clinical and hematologic status and bone marrow response history to treatment with myelotoxic agents before therapy initiation
- Metastatic prostate and other cancers may be associated with disseminated intravascular coagulation (DIC); exercise caution in treating cancer patients whose platelet counts are falling or who have other clinical or laboratory findings suggesting DIC
- Do not administer concurrently with chemotherapy or external beam radiation therapy unless the clinical benefits outweigh the risks. Not recommended in patients with evidence of compromised bone marrow reserve from previous therapy or disease involvement unless the potential benefits outweigh the risks. Monitor blood counts weekly for at least 8 weeks or until recovery of adequate bone marrow function
- Therapy may cause fetal harm when administered to a pregnant woman. Confirm a negative pregnancy test in women of child-bearing potential before administration of the drug. Inform patients of the potential hazard to the fetus if the drug is used during pregnancy, or if a patient becomes pregnant after taking the drug. Advise women of child-bearing potential not to become pregnant soon after receiving the drug. Advise men and women patients to use an effective method of contraception after therapy administration
- Consider appropriate monitoring and additional supportive treatment in patients with a history of CHF or renal insufficiency
- Spinal cord compression frequently occurs in patients with known metastases to the cervical, thoracic or lumbar spine. Therapy administration for pain relief of metastatic bone cancer does not prevent the development of spinal cord compression. Hence, in clinically suspected cases of spinal cord compression, conduct appropriate diagnostic and therapeutic measures to avoid permanent disability
- Recommended to be used by physicians who are well trained and experienced 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
- Handle with care and undertake appropriate safety measures to minimize radiation exposure while using this drug
- Take special precautions like bladder catheterization in patients with incontinence to minimize the risk of radioactive contamination of clothing, bed linen, and the patient's environment
Cautions: Use cautiously in
- Women with childbearing potential
- Patients at risk for developing hypocalcemia
- Compromised bone marrow reserves
- Cancer patients
- Patients with ECG changes
Supplemental Patient Information
- Inform patients who receive therapy that radioactivity will be present in urine several hours following administartion of the drug. As a precautionary measure, instruct patients to use a toilet, rather than a urinal, for 12 hrs after administration and to flush the toilet several times after each use. Advise patients to clean the spilled urine completely and wash hands thoroughly
- Instruct patients to wash the clothing separately, if blood or urine gets onto clothing, or to store them for 1-2 weeks to allow for decay of the Sm-153
- Inform patients that a transient increase in bone pain may occur shortly after injection (flare reaction) but is usually mild and responsive to opioid analgesics
Pregnancy Category:D
Breastfeeding: It is unknown whether this product is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to continue nursing or to administer the drug. Manufacturer advises to substitute breast feedings with formula feedings during therapy administration.
