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IMPORTANT SAFETY INFORMATION:
WARNINGS:
Bone Marrow Suppression: Use of Strontium Chloride Sr-89 Injection, USP 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 Strontium Chloride Sr-89 Injection, USP, 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 Strontium Chloride Sr-89 Injection, USP. White blood cells are usually depressed to a varying extent compared to pre-administration levels. Thereafter, recovery occurs slowly, typically reaching pre-administration levels 6 months after treatment unless the patient’s disease or additional therapy intervenes.
In considering repeat administration of Strontium Chloride Sr-89 Injection, USP, 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 Chloride Sr-89 Injection, USP delivers a relatively high dose of radioactivity.
INDICATIONS AND USAGE: Strontium Chloride Sr-89 Injection, USP is indicated for the relief of bone pain in patients with painful skeletal metastases. The presence of bone metastases should be confirmed prior to therapy.
PRECAUTIONS:
Strontium-89 is not indicated for use in patients with cancer not involving bone and should be used with caution in patients with platelet counts below 60,000 and white cell counts below 2,400.
Strontium-89 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.
Strontium-89, like other radioactive drugs, must be handled with care and appropriate safety measures taken to minimize radiation to clinical personnel.
Strontium-89, is excreted primarily by the kidneys. In patients with renal dysfunction, the possible risks of administering Strontium-89 should be weighed against the possible benefits.
Pregnancy: Strontium-89 has teratogenic effects and is pregnancy category D.
Nursing mothers: It is recommended that nursing be discontinued by mothers about to receive IV strontium-89 chloride.
Pediatric Use
Safety and effectiveness in pediatric patients below the age of 18 years have not been established.
ADVERSE REACTIONS:
A single case of fatal septicemia following leukopenia was reported during clinical trials. Most severe reactions of marrow toxicity can be managed by conventional means.
A small number of patients have reported a transient increase in bone pain at 36 to 72 hours after injection. This is usually mild and self-limiting, and controllable with analgesics. A single patient reported chills and fever 12 hours after injection without long-term sequelae.
These are not all the possible side effects of Strontium Chloride SR-89 injection, USP. Call your health care provider for medical advice about side effects.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.
Please see complete Package Insert for Strontium Chloride Sr-89 Injection, USP.