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Indications and important safety information

INDICATION AND IMPORTANT SAFETY INFORMATION for Strontium Chloride Sr-89 Injection, USP

INDICATION:

Strontium89 (strontium chloride Sr-89 Injection, USP) is used for the relief of bone pain in patients with bone metastases. You should only use Strontium89 if you have been diagnosed with metastatic bone cancer.

Important Safety Information:

  • Strontium89 may affect bone marrow and may cause white blood cell and platelet counts to be lower than normal. To monitor these effects, your doctor will perform regular blood tests before and after your injection, usually at least every other week until your levels have recovered. This may take up to 6 months. Your doctor will decide if it is safe for you to get a repeat injection, 90 days later, if needed. If you already have seriously decreased bone marrow function, your doctor may decide that you should not receive Strontium89.
  • Tell your doctor if you are pregnant or planning to become pregnant. Strontium89 may cause
    harm to your unborn baby and should not be used if you are pregnant or planning to become
    pregnant. You should not nurse your baby while using Strontium89.
  • You should not use Strontium89 if you do not have cancer in your bone.
  • You should not use Strontium89 if you are younger than 18 years old.
  • You may feel flushed (your skin may get red and warm) right after your injection.
  • Side effects in clinical studies:
    • One patient died from a blood infection caused by a severely low white blood cell count.
    • A small number of patients reported a mild and brief increase in bone pain within 36 to 72 hours after injection that was controlled with oral pain medication.
    • One patient had chills and fever 12 hours after injection but recovered.

These are not all of the side effects of Strontium89. If you have any questions or concerns about side effects, you should contact your doctor.

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 full Prescribing Information.