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Important Safety Information

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Indication and important safety information

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.

ABOUT STRONTIUM89

Works at the site of pain

Before we explain how Strontium89 works, we need to explain what happens to bone when metastases (bone mets) are involved. When bones are working right, new bone is forming while old bone is dissolving. Bone mets can change this natural process by causing more bone formation than normal. This can lead to pain.

Non-narcotic and non-habit-forming, Strontium89 is unlike other pain treatments. It works by delivering a radioactive material to the site of the mets. Strontium89 clears quickly from the blood by seeking out areas of the bones that are growing rapidly, like areas of bone metastases. There, Strontium89 gives off radiation that kills cancer cells to help relieve pain directly at the site. Because Strontium89 targets the bone, it can treat multiple areas of bone affected by cancer while causing minimal risk of damage to surrounding healthy cells. It continues to work over a 3-month period.

Strontium89 may cause bone marrow side effects resulting in reduced white blood cell and platelet counts.

Safety with Strontium89

Side effects you should be aware of:

With any treatment, it’s natural to have concerns about the potential side effects. With nearly 30 years of clinical studies and real-world data, the safety of Strontium89 is well understood.

Blood-related side effects:

Bone marrow suppression has occurred in people receiving Strontium89. As a result, white blood cell and platelet counts may be lower after treatment. If this occurs, blood counts usually return to normal without additional treatment. However, your cancer care team may decide to treat these side effects with commonly used white blood cell and platelet increasing medications.

Additional side effects may include:

  • Mild and brief increase in bone pain within 36 to 72 hours after injection that was controlled by oral pain medication has been reported in a small number of patients.
  • A hot flush sensation after receiving Strontium89 has been reported.
These are not all of the side effects of Strontium89. If you have any questions or concerns about side effects, please 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.

If you have questions about Strontium89 or would like to report an adverse event,
Please call the Q BioMed Medical Information Line: (866) 844-2799 or email: qbiomedinfo@wrbcorp.com

Is Strontium89 right for you?

No treatment is right for everyone. Strontium89 should only be used in patients with confirmed bone mets. It doesn’t matter where your cancer started—breast, lung, prostate, or another origin. If you have bone mets, Strontium89 may be an option.

There are other factors you and your cancer care team will need to consider when deciding if treatment is appropriate.

Use with caution if:Do not use if:
Your platelet count is below 60,000You do not have bone mets
Your white cell count is below 2,400You are pregnant
You have a history of kidney diseaseYou are under 18 years of age
Since it is unknown if Strontium89 is excreted in breast milk, it is recommended that women stop nursing before treatment.

Before starting treatment, it’s important that you know and discuss all side effects with your cancer care team.

See a list of treatments that can be used with Strontium89

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What to expect before, during, and after treatment?

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Indication and important safety information

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.