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Important Safety Information

Full Prescibing 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.

POWERFUL RESULTS

More moments. Less pain.

Proof of powerful pain relief

Having metastatic cancer shouldn’t mean that you have to live in pain. Unfortunately, that’s the case for nearly half of patients with cancer-induced bone pain. Strontium89 is here to help change that. In study after study, Strontium89 was proven to deliver significant pain relief in patients with bone mets.

As many as 79% of patients had pain relief with Strontium89.

Twice as many patients treated with Strontium89 had NO PAIN for 3 months compared with placebo.

In its pivotal trial, after just one injection of Strontium89, 72% of 42 patients had a reduction in pain score compared with 61% of 44 patients taking placebo at 1 month, 79% of 38 patients had a reduction in pain score compared with 57% of 35 patients taking placebo at 2 months, and 61% of 33 patients had a reduction in pain score compared with 56% of 34 patients taking placebo at 3 months.

New pain sites were less frequent in patients treated with Strontium89

Percentage of patients free of new painful metastases at 3 months

59%

Strontium89

34%

Placebo

Although Strontium89 can be taken in with other types of treatments, it’s important to note that these patients achieved results without any increase in other pain medications and without added radiotherapy.

In clinical studies with Strontium89, patients experienced:

Relief within 7 to 20 days after injection

Relief that lasted 2 to 5 months

Decreased need for additional pain medications

The possibility for retreatment after 90 days

Retreatment possible after 90 days.

Strontium89 works well with other treatments

You or your loved one should never accept pain as a normal part of having cancer. Ask your cancer care team if Strontium89 can help.

Strontium89 external beam radiation therapy (EBRT)

Strontium89 chemotherapy

Strontium89 Androgen
deprivation therapy (ADT)/androgen suppression therapy (AST)
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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.