denosumab (Prolia, Xgeva)

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Indications

* not indicated for treatment of hypercalcemia of malignancy (GRS9)[7]

# disproportionate adverse effects including back pain & serious infections[18] (on list of medications to avoid)

Contraindications

Dosage

prefilled syringe: 1 mL 60 mg/mL (single use)

vial: 1 mL 60 mg/mL (single use)

* No dosage adjustment with renal failure

Monitor

Adverse effects

* Boxed Warning:

Drug interactions

Mechanism of action

Notes

More general terms

References

  1. ↑ McClung MR et al, Denosumab in postmenopausal women with low bone mineral density. N Engl J Med 2006; 354:821 PMID: https://www.ncbi.nlm.nih.gov/pubmed/16495394
  2. ↑ 2.0 2.1 Smith MR et al Denosumab in Men Receiving Androgen-Deprivation Therapy for Prostate Cancer N Eng J Med Aug 11, 2009 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/19671656 <Internet> http://content.nejm.org/cgi/content/full/NEJMoa0809003
    Cummings SR et al Denosumab for Prevention of Fractures in Postmenopausal Women with Osteoporosis N Eng J Med Aug 11, 2009 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/19671655 <Internet> http://content.nejm.org/cgi/content/full/NEJMoa0809493
    Khosla S Increasing Options for the Treatment of Osteoporosis N Eng J Med Aug 11, 2009 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/19671654 <Internet> http://content.nejm.org/cgi/content/full/NEJMe0905480
    FDA briefing document for advisory committee meeting http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ReproductiveHealthDrugsAdvisoryCommittee/UCM176595.pdf
  3. ↑ FDA Medwatch, June 1, 2010 FDA Approves New Injectable Osteoporosis Treatment for Postmenopausal Women http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm214150.htm
  4. ↑ Prescriber's Letter 17(8): 2010 COMMENTARY: New Drug: Prolia (Denosumab) MEDGUIDE: Drug Products with Medication Guides GUIDELINES: Diagnosis and Treatment of Osteoporosis (ICSI) GUIDELINES: Prevention and Treatment of Osteoporosis (NOF) GUIDELINES: Management of Osteoporosis in Postmenopausal Women (NAMS) Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=260803&pb=PRL (subscription needed) http://www.prescribersletter.com
  5. ↑ 5.0 5.1 FDA NEWS RELEASE, Nov. 19, 2010 FDA approves Xgeva to help prevent cancer-related bone injury http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm234346.htm
  6. ↑ 6.0 6.1 Deprecated Reference
  7. ↑ 7.0 7.1 7.2 Geriatric Review Syllabus, 8th edition (GRS8) Durso SC and Sullivan GN (eds) American Geriatrics Society, 2013
    Geriatric Review Syllabus, 9th edition (GRS9) Medinal-Walpole A, Pacala JT, Porter JF (eds) American Geriatrics Society, 2016
  8. ↑ Genant HK, Libanati C, Engelke K, Improvements in hip trabecular, subcortical, and cortical density and mass in postmenopausal women with osteoporosis Bone. 2013 Oct;56(2):482-8. PMID: https://www.ncbi.nlm.nih.gov/pubmed/23871852
  9. ↑ Keaveny TM, McClung MR, Genant HK Femoral and vertebral strength improvements in postmenopausal women with osteoporosis treated with denosumab. J Bone Miner Res. 2014 Jan;29(1):158-65. PMID: https://www.ncbi.nlm.nih.gov/pubmed/23794225
  10. ↑ 10.0 10.1 Jamal SA, Ljunggren O, Stehman-Breen C et al Effects of denosumab on fracture and bone mineral density by level of kidney function. J Bone Miner Res. 2011 Aug;26(8):1829-35 PMID: https://www.ncbi.nlm.nih.gov/pubmed/21491487
  11. ↑ 11.0 11.1 11.2 Stopeck AT, Lipton A, Body JJ et al Denosumab compared with zoledronic acid for the treatment of bone metastases in patients with advanced breast cancer: a randomized, double-blind study. J Clin Oncol. 2010 Dec 10;28(35):5132-9. PMID: https://www.ncbi.nlm.nih.gov/pubmed/21060033
  12. ↑ 12.0 12.1 12.2 Curtis JR et al. Risk of hospitalized infection among rheumatoid arthritis patients concurrently treated with a biologic agent and denosumab. Arthritis Rheumatol 2015 Jun; 67:1456 PMID: https://www.ncbi.nlm.nih.gov/pubmed/25708920
  13. ↑ Orwoll E, Teglbjerg CS, Langdahl BL et al A randomized, placebo-controlled study of the effects of denosumab for the treatment of men with low bone mineral density. J Clin Endocrinol Metab. 2012 Sep;97(9):3161-9. PMID: https://www.ncbi.nlm.nih.gov/pubmed/22723310
  14. ↑ Sidlauskas KM, Sutton EE, Biddle MA. Osteoporosis in men: epidemiology and treatment with denosumab. Clin Interv Aging. 2014 Apr 8;9:593-601. Review. PMID: https://www.ncbi.nlm.nih.gov/pubmed/24748777 Free PMC Article
  15. ↑ 15.0 15.1 Mirrakhimov AE.3. Hypercalcemia of Malignancy: An Update on Pathogenesis and Management. N Am J Med Sci. 2015 Nov;7(11):483-93. Review. PMID: https://www.ncbi.nlm.nih.gov/pubmed/26713296 Free PMC Article
  16. ↑ 16.0 16.1 Sternlicht H, Glezerman IG. Hypercalcemia of malignancy and new treatment options. Ther Clin Risk Manag. 2015 Dec 4;11:1779-88. Review. PMID: https://www.ncbi.nlm.nih.gov/pubmed/26675713 Free PMC Article
  17. ↑ Diab DL, Watts NB. Denosumab in osteoporosis. Expert Opin Drug Saf. 2014 Feb;13(2):247-53. PMID: https://www.ncbi.nlm.nih.gov/pubmed/24289327
  18. ↑ 18.0 18.1 18.2 Therapeutics Letter #108. Therapeutics Initiative Drugs to Avoid. http://www.ti.ubc.ca/2018/01/04/108-drugs-avoid/
  19. ↑ 19.0 19.1 19.2 Medical Knowledge Self Assessment Program (MKSAP) 18, 19 American College of Physicians, Philadelphia 2018, 2022
  20. ↑ 20.0 20.1 Qaseem A, Forciea MA, McLean RM et al Treatment of Low Bone Density or Osteoporosis to Prevent Fractures in Men and Women: A Clinical Practice Guideline Update from the American College of Physicians. Ann Intern Med. 2017. May 9. <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/28492856 <Internet> http://annals.org/aim/article/2625385/treatment-low-bone-density-osteoporosis-prevent-fractures-men-women-clinical
    Orwoll ES Clinical Practice Guidelines for Osteoporosis: Translating Data to Patients? Ann Intern Med. 2017. May 9. <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/28492858 <Internet> http://annals.org/aim/article/2625389/clinical-practice-guidelines-osteoporosis-translating-data-patients
  21. ↑ 21.0 21.1 Albert SG, Reddy S CLINICAL EVALUATION OF COST EFFICACY OF DRUGS FOR TREATMENT OF OSTEOPOROSIS: A META-ANALYSIS. Endocr Pract. 2017 Jul;23(7):841-856 PMID: https://www.ncbi.nlm.nih.gov/pubmed/28448754
  22. ↑ 22.0 22.1 Anastasilakis AD, Polyzos SA, Makras P et al. Clinical features of 24 patients with rebound-associated vertebral fractures after denosumab discontinuation: systemic review and additional cases. J Bone Miner Res. 2017;32(6):1291-1296 PMID: https://www.ncbi.nlm.nih.gov/pubmed/28240371 Free article https://asbmr.onlinelibrary.wiley.com/doi/10.1002/jbmr.3110
  23. ↑ 23.0 23.1 Bone HG, Wagman RB, Brandi ML et al.10 years of denosumab treatment in postmenopausal women with osteoporosis: results from the phase 3 randomized FREEDOM trial and open-label extension. Lancet Diabetes Endocrinol. 2017;5(7):513-523 PMID: https://www.ncbi.nlm.nih.gov/pubmed/28546097 https://www.thelancet.com/journals/landia/article/PIIS2213-8587(17)30138-9/fulltext
  24. ↑ 24.0 24.1 Cummings SR, Ferrari S, Eastell R et al. Vertebral fractures after discontinuation of denosumab: a post hoc analysis of the randomized placebo-controlled FREEDOM trial and its extension. J Bone Miner Res. 2018;33(2):190-198 PMID: https://www.ncbi.nlm.nih.gov/pubmed/29105841 Free article https://asbmr.onlinelibrary.wiley.com/doi/10.1002/jbmr.3337
  25. ↑ 25.0 25.1 Prolia Postmarketing Active Safety Surveillance Program http://www.proliasafety.com
    Monaco K Watch for Severe Hypocalcemia in Dialysis Patients on Prolia, FDA Warns. Agency said potential risk may require more frequent blood calcium monitoring. https://www.medpagetoday.com/nephrology/generalnephrology/101872
    US Food & Drug Administration FDA investigating risk of severe hypocalcemia in patients on dialysis receiving osteoporosis medicine Prolia (denosumab). FDA Drug Safety Communication. Nov 22, 2022 https://www.fda.gov/drugs/drug-safety-and-availability/fda-investigating-risk-severe-hypocalcemia-patients-dialysis-receiving-osteoporosis-medicine-prolia
  26. ↑ 26.0 26.1 Lyu H et al. Denosumab and incidence of type 2 diabetes among adults with osteoporosis: Population based cohort study. BMJ 2023 Apr 18; 381:e073435. PMID: https://www.ncbi.nlm.nih.gov/pubmed/37072150 PMCID: PMC10111187 Free PMC article https://www.bmj.com/content/381/bmj-2022-073435
  27. ↑ 27.0 27.1 FDA MedWatch - Prolia (denosumab): Drug Safety Communication. Jan 19, 2024 FDA adds Boxed Warning for increased risk of severe hypocalcemia in patients with advanced chronic kidney disease taking osteoporosis medicine Prolia (denosumab). https://www.fda.gov/drugs/drug-safety-and-availability/fda-adds-boxed-warning-increased-risk-severe-hypocalcemia-patients-advanced-chronic-kidney-disease
  28. ↑ 28.0 28.1 Henney AE, Riley DR, O'Connor B et al Denosumab, for osteoporosis, reduces the incidence of type 2 diabetes, risk of foot ulceration and all-cause mortality in adults, compared with bisphosphonates: An analysis of real-world, cohort data, with a systematic review and meta-analysis Diabetes Obes Metab. 2024 Jun 20. doi:http://dx.doi.org/ 10.1111/dom.15708. Online ahead of print. PMID: https://www.ncbi.nlm.nih.gov/pubmed/38899553 https://dom-pubs.onlinelibrary.wiley.com/doi/full/10.1111/dom.15708
  29. ↑ 29.0 29.1 Lee CC, Wang CY, Yen HK et al Zoledronate Sequential Therapy After Denosumab Discontinuation to Prevent Bone Mineral Density Reduction: A Randomized Clinical Trial. JAMA Netw Open. 2024 Nov 4;7(11):e2443899. PMID: https://www.ncbi.nlm.nih.gov/pubmed/39527056 PMCID: PMC11555552 Free PMC article https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2825942
    Watts NB. What to do when denosumab is stopped? JAMA Netw Open 2024 Nov; 7:e2443879. PMID: https://www.ncbi.nlm.nih.gov/pubmed/39527062 Free article https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2825948
  30. ↑ 30.0 30.1 30.2 Bird ST, Gelperin K, Smith ER et al The Effect of Denosumab on Risk for Emergently Treated Hypocalcemia by Stage of Chronic Kidney Disease : A Target Trial Emulation. Ann Intern Med. 2024 Nov 19. PMID: https://www.ncbi.nlm.nih.gov/pubmed/39556837 https://www.acpjournals.org/doi/10.7326/M24-0013
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