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For US Healthcare Professionals Only

Important Safety Information

Full Prescribing Information

Indication and important safety information

INDICATION 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.

WARNINGS

Use of Strontium89 Chloride Injection 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 Strontium89 Chloride Injection, 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 preadministration levels. The nadir of platelet depression in most patients is found between 12 and 16 weeks following administration of Strontium89 Chloride Injection. White blood cells are usually depressed to a varying extent compared to preadministration levels. Thereafter, recovery occurs slowly, typically reaching preadministration levels six months after treatment unless the patient’s disease or additional therapy intervenes. In considering repeat administration of Strontium89 Chloride Injection, 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 Strontium89 Chloride Injection delivers a relatively high dose of radioactivity.

Strontium89 Chloride Injection may cause fetal harm when administered to a pregnant woman. There are no adequate and well-controlled studies in pregnant women. If this drug is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant.

PRECAUTIONS

Strontium89 Chloride Injection is not indicated for use in patients with cancer not involving bone. Strontium89 Chloride Injection should be used with caution in patients with platelet counts below 60,000 and white cell counts below 2,400.

Radiopharmaceuticals 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 authorized to license the use of radionuclides.

Strontium89 Chloride Injection, like other radioactive drugs, must be handled with care and appropriate safety measures taken to minimize radiation to clinical personnel.

In view of the delayed onset of pain relief, typically 7 to 20 days post injection, administration of Strontium89 Chloride Injection to patients with very short life expectancy is not recommended.

A calcium-like flushing sensation has been observed in patients following a rapid (less than 30 second injection) administration.

Special precautions, such as urinary catheterization, should be taken following administration to patients who are incontinent to minimize the risk of radioactive contamination of clothing, bed linen, and the patient’s environment.

Strontium89 Chloride Injection is excreted primarily by the kidneys. In patients with renal dysfunction, the possible risks of administering Strontium89 Chloride Injection should be weighed against the possible benefits.

PREGNANCY

Teratogenic effects.

Pregnancy Category D. See Warnings section.

NURSING MOTHERS

Because Strontium acts as a calcium analog, secretion of Strontium-89 Chloride into human milk is likely. It is recommended that nursing be discontinued by mothers about to receive intravenous Strontium-89 Chloride. It is not known whether this drug is excreted in human milk.

PEDIATRIC USE

Safety and effectiveness in children 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.

Additional post-marketing reactions include hot flush.

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit
www.FDA.gov/medwatch or call (800) FDA-1088.

Please see full Prescribing Information for Strontium89 Chloride Injection.

Getting started with Strontium89

You’ve seen that Strontium89 has a range of data supporting its use in a multimodal approach to comprehensive pain palliation. You know that it’s available for patients across all 50 states in the US. But you may still have some questions. This section is intended to cover a few of the most important ones. If you have other questions, please contact a Q BioMed sales representative.

Who can administer Strontium89?

Radiopharmaceuticals 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 authorized to license the use of radionuclides.

What is the recommended dose of Strontium89?

The recommended dose of Strontium89 is 148 MBq, 4 mCi, administered by slow intravenous injection (1 to 2 minutes). Alternatively, a dose of 1.5 to 2.2 MBq/kg, 40 to 60 μCi/kg body weight may be used.

kg = kilogram; MBq = megabecquerel; mCi = millicurie; μCi= microcurie

Are there any contraindications to using Strontium89?

There are no known contraindications to using Strontium89.

What warnings should I consider before administering Strontium89?

Use of Strontium89 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 Strontium89, 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 Strontium89. White blood cells are usually depressed to a varying extent compared to pre-administration levels. Thereafter, recovery occurs slowly, typically reaching pre-administration levels six months after treatment unless the patient’s disease or additional therapy intervenes.

In considering repeat administration of Strontium89, 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 Strontium89 delivers a relatively high dose of radioactivity.

Strontium89 may cause fetal harm when administered to a pregnant woman. There are no adequate and well-controlled studies in pregnant women. If this drug is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant.

What precautions should I consider before administering Strontium89?

Strontium89 is not indicated for use in patients with cancer not involving bone. Strontium89 should be used with caution in patients with platelet counts below 60,000 and white cell counts below 2,400.

Radiopharmaceuticals 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 authorized to license the use of radionuclides.

Strontium89, like other radioactive drugs, must be handled with care and appropriate safety measures taken to minimize radiation to clinical personnel.

In view of the delayed onset of pain relief, typically 7 to 20 days post injection, administration of Strontium89 to patients with very short life expectancy is not recommended.

A calcium-like flushing sensation has been observed in patients following a rapid (less than 30 second injection) administration.

Special precautions, such as urinary catheterization, should be taken following administration to patients who are incontinent to minimize the risk of radioactive contamination of clothing, bed linen, and the patient’s environment.

Strontium89 is excreted primarily by the kidneys. In patients with renal dysfunction, the possible risks of administering Strontium89 should be weighed against the possible benefits.

Can Strontium89 be used concomitantly with medical marijuana?

There are no known contraindications to using Strontium89 with concomitant medical marijuana.

Can Strontium89 be used concomitantly with opioids?

There are no known contraindications to using Strontium89 with concomitant opioid medication. Clinical trials for regulatory approval allowed patients to use opioid analgesics if they had breakthrough pain after receiving Strontium89.

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Indication and important safety information

INDICATION 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.

WARNINGS

Use of Strontium89 Chloride Injection 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 Strontium89 Chloride Injection, 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 preadministration levels. The nadir of platelet depression in most patients is found between 12 and 16 weeks following administration of Strontium89 Chloride Injection. White blood cells are usually depressed to a varying extent compared to preadministration levels. Thereafter, recovery occurs slowly, typically reaching preadministration levels six months after treatment unless the patient’s disease or additional therapy intervenes. In considering repeat administration of Strontium89 Chloride Injection, 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 Strontium89 Chloride Injection delivers a relatively high dose of radioactivity.

Strontium89 Chloride Injection may cause fetal harm when administered to a pregnant woman. There are no adequate and well-controlled studies in pregnant women. If this drug is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant.

PRECAUTIONS

Strontium89 Chloride Injection is not indicated for use in patients with cancer not involving bone. Strontium89 Chloride Injection should be used with caution in patients with platelet counts below 60,000 and white cell counts below 2,400.

Radiopharmaceuticals 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 authorized to license the use of radionuclides.

Strontium89 Chloride Injection, like other radioactive drugs, must be handled with care and appropriate safety measures taken to minimize radiation to clinical personnel.

In view of the delayed onset of pain relief, typically 7 to 20 days post injection, administration of Strontium89 Chloride Injection to patients with very short life expectancy is not recommended.

A calcium-like flushing sensation has been observed in patients following a rapid (less than 30 second injection) administration.

Special precautions, such as urinary catheterization, should be taken following administration to patients who are incontinent to minimize the risk of radioactive contamination of clothing, bed linen, and the patient’s environment.

Strontium89 Chloride Injection is excreted primarily by the kidneys. In patients with renal dysfunction, the possible risks of administering Strontium89 Chloride Injection should be weighed against the possible benefits.

PREGNANCY

Teratogenic effects.

Pregnancy Category D. See Warnings section.

NURSING MOTHERS

Because Strontium89 Chloride Injection acts as a calcium analog, secretion of Strontium89 Chloride Injection into human milk is likely. It is recommended that nursing be discontinued by mothers about to receive intravenous Strontium89 Chloride Injection. It is not known whether this drug is excreted in human milk.

PEDIATRIC USE

Safety and effectiveness in children 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.

Additional post-marketing reactions include hot flush.

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit
www.FDA.gov/medwatch or call (800) FDA-1088.

Please see full Prescribing Information for Strontium89 Chloride Injection.