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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.

Comprehensive pain palliation is tolerable pain palliation

Demonstrated safety profile

    1. Bone marrow toxicity is to be expected, particularly in white blood cells and platelets. The extent of toxicity is variable.
    2. In randomized studies of Sr-89, the majority of hematologic toxicity was mild to moderate (Grade 2 or less).15,23
    3. In clinical trials, white blood cell counts and platelet counts remained within approximately 70% of pretreatment levels.24,25
    4. In patients that experience bone marrow suppression with Sr-89, effects are generally transient. 1,15

WARNING: 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 risk. Please see Warnings section in the Important Safety Information.

References

1. Bauman G, Charette M, Reid R, Sathya J. Radiopharmaceuticals for the palliation of painful bone metastasis-a systemic review. Radiother Oncol. 2005;75(3):258-270.

2. Fuster D, Herranz D, Vidal-Sicart S, et al. Usefulness of strontium-89 for bone pain palliation in metastatic breast cancer patients. Nucl Med Commun. 2000;21(7):623-626.

3. Kraeber-Bodéré F, Campion L, Rousseau C, Bourdin S, Chatal JF, Resche I. Treatment of bone metastases of prostate cancer with strontium-89 chloride: efficacy in relation to the degree of bone involvement. Eur J Nucl Med. 2000;27(10):1487-1493.

4. Turner SL, Gruenewald S, Spry N, Gebski V; Metastron Users Group. Less pain does equal better quality of life following strontium-89 therapy for metastatic prostate cancer. Br J Cancer. 2001;84(3):297-302.

5. Ashayeri E, Omogbehin A, Sridhar R, Shankar RA. Strontium 89 in the treatment of pain due to diffuse osseous metastases: a university hospital experience. J Natl Med Assoc. 2002;94(8):706-711.

6. Gunawardana DH, Lichtenstein M, Better N, Rosenthal M. Results of strontium-89 therapy in patients with prostate cancer resistant to chemotherapy. Clin Nucl Med.2004;29(2):81-85.

7. Liepe K, Kotzerke J. A comparative study of 188Re-HEDP, 186Re-HEDP, 153Sm- EDTMP and 89Sr in the treatment of painful skeletal metastases. Nucl Med Commun. 2007;28(8):623-630.

8. STRONTIUM CHLORIDE Sr-89 INJECTION, USP THERAPEUTIC [package insert]. Angleton, TX: IsoTherapeutics Group, LLC; 2020.

9. Porter AT, McEwan AJB, Powe JE, et al. Results of a randomized phase-III trial to evaluate the efficacy of strontium-89 adjuvant to local field external beam irradiation in the management of endocrine resistant metastatic prostate cancer. Int J Radiat Oncol Biol Phys. 1993;25(5):805-813.

10. Pons F, Herranz R, Garcia A, et al. Strontium-89 for palliation of pain from bone metastases in patients with prostate and breast cancer. Eur J Nucl Med. 1997;24(10):1210-1214.

11. Bączyk M, Milecki P, Martenka P, Sowiński J. Efficacy of samarium 153 and strontium 89 treatment for bone metastases in prostate cancer patients: monotherapy vs. treatment combined with external beam radiotherapy. Preliminary report. Rep Pract Oncol Radiother. 2007;12(4):211-216.

12. Bilen MA, Johnson MM, Mathew P, et al. Randomized phase 2 study of bone- targeted therapy containing strontium-89 in advanced castrate-sensitive prostate cancer. Cancer. 2015;121(1):69-76.

13. Tu SM, Millikan RE, Mengistu B, et al. Bone-targeted therapy for advanced androgen-independent carcinoma of the prostate: a randomised phase II trial [published correction appears in Lancet 2001 Apr 14;357(9263):1210]. Lancet. 2001;357(9253): 336-341.

14. Tu SM, Kim J, Pagliaro LC, et al. Therapy tolerance in selected patients with androgen-independent prostate cancer following strontium-89 combined with chemotherapy. J Clin Oncol. 2005;23(31):7904-7910.

15. Sciuto R, Festa A, Rea S, et al. Effects of low-dose cisplatin on 89Sr therapy for painful bone metastases from prostate cancer: a randomized clinical trial. J Nucl Med. 2002;43(1):79-86.

16. Yamada K, Yoshimura M, Kaise H, et al. Concurrent use of Sr-89 chloride with zoledronic acid is safe and effective for breast cancer patients with painful bone metastases. Exp Ther Med. 2012;3(2):226-230.

17. Stroto G, Klain M, Paone G et al. Combined therapy of Sr-89 and zoledronic acid in patients with painful bone metastases. Bone. 2006;39:35-41.

18. Baba K, Kaida H, Hattori C, et al. Tumoricidal effect and pain relief after concurrent therapy by strontium-89 chloride and zoledronic acid for bone metastases. Hell J Nucl Med. 2018;21(1):15-23.

19. Guerra Liberal FDC, Tavares AAS, Tavares JMRS. Palliative treatment of metastatic bone pain with radiopharmaceuticals: A perspective beyond Strontium-89 and Samarium-153. Appl Radiat Isot. 2016;110:87-99.

20. Henriksen G, Fisher DR, Roeske JC, Bruland ØS, Larsen RH. Targeting of osseous sites with alpha-emitting 223Ra: comparison with the beta-emitter 89Sr in mice. J Nucl Med. 2003;44(2):252-259.

21. Kassis AI. Therapeutic radionuclides: biophysical and radiobiologic principles. Semin Nucl Med. 2008;38(5):358-366.

22. Fischer M, Kampen WU. Radionuclide Therapy of Bone Metastases. Breast Care (Basel). 2012;7(2):100-107.

23. Smeland S, Erikstein B, Aas M, Skovlund E, Hess SL, Fosså SD. Role of strontium-89 as adjuvant to palliative external beam radiotherapy is questionable: results of a double-blind randomized study. Int J Radiat Oncol Biol Phys. 2003;56(5):1397-1404.

24. Lewington VJ, McEwan AJ, Ackery DM, et al. A prospective, randomised double- blind crossover study to examine the efficacy of strontium-89 in pain palliation in patients with advanced prostate cancer metastatic to bone. Eur J Cancer. 1991;27(8):954-958.

25. Quilty PM, Kirk D, Bolger JJ, et al. A comparison of the palliative effects of strontium-89 and external beam radiotherapy in metastatic prostate cancer. Radiother Oncol. 1994;31(1):33-40.

26. Lipton A, Uzzo R, Amato RJ, et al. The science and practice of bone health in oncology: managing bone loss and metastasis in patients with solid tumors. J Natl Compr Canc Netw. 2009;7 Suppl 7:S1-29; quiz S30.

27. Smith HS, Barkin RL. Painful boney metastases. Am J Ther. 2014;21(2):106-130.

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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.