For US Healthcare
Professionals Only
Important Safety Information
Full Prescribing Information
Patient Site
Efficacy
How it
Works
Safety
Getting
Started
Coding
and Billing

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 effective pain palliation

Proven pain relief

Strontium89: Proven pain relief, study after study

  • Multiple clinical studies have demonstrated significant palliative benefit in the management of painful bone metastases1-7
  • In its pivotal multicenter, Canadian, placebo-controlled trial of 126 patients, a greater percentage of Strontium89-treated patients experienced pain relief without an increase in analgesic or radiotherapy retreatment (vs. placebo)*8
  • In that trial, a greater percentage of Strontium89-treated patients experienced zero pain, and a significantly greater proportion of patients had no need for rescue analgesics (P<.05)†8,9

In its pivotal trial:

More patients with ZERO pain

More patients with ZERO need for analgesics

*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.8

In the pivotal trial, after just one injection of Strontium89, 14.3% of patients (6/42) had a reduction in pain score and analgesic score to zero compared with 6.8% of patients (3/44) taking placebo at 1 month, 13.2% of patients (5/38) had a reduction in pain score compared with 8.6% of patients (3/35) taking placebo at 2 months, and 15.2% of patients (5/33) had a reduction in pain score compared with 5.9% of patients (2/34) taking placebo at 3 months.8

FEWER NEW PAIN SITES

New pain sites were less frequent in patients treated with Strontium898,9

Pre-treatment
5 months post-treatment
Scans courtesy of University of Kansas Health System.

Pain relief that lasts

Duration of pain palliation with a single dose has been shown to range from 2 to 5 months in most patients3,8

Flexible pain relief for patients

Comparable safety and efficacy have been demonstrated with Strontium89 retreatment10

In a group of patients with breast cancer or prostate cancer retreated with a second dose of Sr-89 (n=16), 100% had a good or partial clinical response* indicating no statistically significant decrease in efficacy or safety compared to first treatment.
Strontium89 can be redosed every 90 days

Addition of Sr-89 to EBRT has been demonstrated to improve therapeutic efficacy.9,11

Addition of Sr-89 to EBRT has been demonstrated to improve therapeutic efficacy.

Strontium89 has been shown to be effective and well tolerated when used with other common cancer therapeutics.1,9,11-14

With chemotherapy: Multiple randomized clinical trials13,15 have evaluated the efficacy and safety of combination Sr-89 and chemotherapy.

For example, a randomized phase III trial (n=70) comparing equal groups of patients receiving either Sr-89 plus cisplatin (arm A) with Sr-89 plus placebo (arm B) found that overall pain relief occurred in 91% of patients in arm A and 63% of patients in arm B (P=≤.01), with a median duration of 120 days in arm A and 60 days in arm B (P=.002). Transient and moderate hematologic toxicity, as determined by WHO criteria, was apparent in both arms without significant differences.15

With zoledronic acid: Multiple recent studies16-18 have shown that concurrent use of Sr-89 with zoledronic acid is safe and effective.

For example, in a study of patients with various types of cancer and painful bone metastases (n=51), Baba et al. reported a 94% response rate in patients who received the combination and found that pain due to bone metastases was significantly improved (P<.001) across multiple types of primary cancer, including prostate, breast, and lung, with no grade III or higher bone marrow suppression.18

*63% of patients had a good response, 37% had a partial response. Three measures were used in the study: good – increase in Karnofsky status with decrease in pain score (≥4) or analgesic score (≥1), partial – increase in Karnofsky status and a decrease in pain score (2 or 3 points) without significant changes in the analgesic score, or no response. Pain Score = Severity X Frequency, where Severity was mild (1), moderate (2) or Severe (3) and Frequency was Occasional (1), Intermittent (2) and constant (3); Analgesic score: 0 – no analgesic, 1 non-opiate occasionally, 2 non-opiate regularly, 3 opiate occasionally, 4 opiate regularly.
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.

Request a Rep Call
Your information will be used only for purposes of arranging for a sales representative to contact you. For further information see our Privacy Policy.
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.