By
Kristin Marvin Keller ,
Chief Commercial Officer Q BioMed, Inc.
Today, longer life expectancy for patients with metastatic cancer has contributed to the increased importance of patient-centered management of pain due to bone metastases.1 Studies have shown that up to 45% of patients with cancer- induced bone pain report poor pain control2—increasing the demand for a multimodal pain strategy tailored to individual patient needs.3
After years of being unavailable, Q BioMed has re-established manufacturing and distribution capabilities for Strontium89. Today, under an exclusive distribution relationship with Jubilant Radiopharma, we are proud to reintroduce Strontium89 in all 50 states.
Please see Indication and Important Safety Information below.
Either alone or in combination with external beam radiation therapy (EBRT), numerous clinical studies have demonstrated significant palliative benefit with Strontium89 in the management of painful bone metastases.4-9 In a multicenter, placebo-controlled trial of 126 cancer patients with persistent pain after EBRT for bone metastases, pain relief occurred in more patients treated with a single injection of Strontium89 than in patients treated with an injection of placebo*, reducing pain scores to zero and eliminating the need for rescue analgesics in a greater percentage of patients.10† Because of its prolonged and targeted half-life, the duration of pain palliation has been shown to range from 2 to 5 months in most patients.5,10 Plus, Strontium89 can be readministered every 90 days.10
Strontium89 selectively targets and accumulates in metastatic bone lesions with minimal irradiation of surrounding normal tissue11,12 The uptake of strontium by bone occurs preferentially in sites of active osteogenesis11 with areas of metastatic involvement accumulating significantly greater concentrations of strontium than surrounding normal bone11—allowing for the treatment of multiple sites of bone pain with marginal damage to surrounding soft tissue.12
Hopefully, living longer with cancer doesn't have to mean longer with pain. For patients with painful bone metastases, Strontium89 is here to give patients a chance to reduce—or even eliminate—that pain.
We hope you'll consider bringing Strontium89 into your institution; for more information or to schedule a virtual sales call, talk to your JDR representative or visit Strontium89.com to schedule time.
[Footnotes]
*In its pivotal trial, after just one injection of Strontium89, 71% 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 and analgesic score to zero 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 and analgesic score to zero compared with 5.9% of patients (2/34) taking placebo at 3 months.
Indications and Important Safety Information
Indications 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 Strontium-89 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 Strontium-89 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 Strontium-89 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 Strontium-89 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 Strontium-89 Chloride Injection delivers a relatively high dose of radioactivity.
Strontium-89 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
Strontium-89 Chloride Injection is not indicated for use in patients with cancer not involving bone. Strontium-89 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.
Strontium-89 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 Strontium-89 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.
Strontium-89 Chloride Injection is excreted primarily by the kidneys. In patients with renal dysfunction, the possible risks of administering Strontium-89 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 1-800-FDA-1088.
Please see full Prescribing Information.
References:
1. 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;
2. Smith HS, Barkin RL. Painful boney metastases. Am J Ther. 2014;21(2):106-130;
3. Reuben DB, Tinetti ME. Goal-oriented patient care--an alternative health outcomes paradigm. N Engl J Med. 2012;366(9):777-779;
4. 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;
5. 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;
6. 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;
7. 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;
8. 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; 9. 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;
10. STRONTIUM CHLORIDE Sr-89 INJECTION, USP THERAPEUTIC [package insert]. Angleton, TX: IsoTherapeutics Group, LLC; 2020.
11. 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.
12. 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.