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romosozumab (Evenity)

Indications: - osteoporosis (FDA-approved April 2019) - lowers risk for vertebral fracture in postmenopausal women with osteoporosis* - increases bone mineral density at the hip in bisphosphonate non-responders [3] - conditionally recommended for women with very high risk of fracture [6] - 1 year of use maximum, follow with bisphosphonate [6] * industry-sponsored study [2,4] * more effective than bisphosphonates in preventing clinical & vertebral fractures [7] Dosage: - 70-210 mg SQ monthly Adverse effects: - atypical femoral fracture - osteonecrosis of the jaw [2] - may increase cardiovascular risk (2.5 vs 1.9% for alendronate in women with history of fragility fracture) [4] Mechanism of action: - binds to & inhibits sclerostin & increases bone formation & decreases bone resorption

Interactions

drug adverse effects of pharmaceutical monoclonal antibodies

General

pharmaceutical monoclonal antibody metabolic agent (metabolic modifier)

References

  1. McClung MR et al Romosozumab in Postmenopausal Women with Low Bone Mineral Density. N Engl J Med. Jan 1, 2014 PMID: 24382002 http://www.nejm.org/doi/full/10.1056/NEJMoa1305224 - Becker CB Sclerostin Inhibition for Osteoporosis - A New Approach. N Engl J Med. Jan 1, 2014 PMID: 24382003 http://www.nejm.org/doi/full/10.1056/NEJMe1315500
  2. Cosman F, Crittenden DB, Adachi JD et al Romosozumab Treatment in Postmenopausal Women with Osteoporosis. N Engl J Med. September 18, 2016 PMID: 27641143 Free Article http://www.nejm.org/doi/full/10.1056/NEJMoa1607948 - Rosen CJ Ingelfinger JR Building Better Bones with Biologics - A New Approach to Osteoporosis? N Engl J Med. September 18, 2016 PMID: 27641359 Free Article http://www.nejm.org/doi/full/10.1056/NEJMe1611863
  3. Langdahl BL, Libanati C, Crittenden DB, et al. Romosozumab (sclerostin monoclonal antibody) versus teriparatide in postmenopausal women with osteoporosis transitioning from oral bisphosphonate therapy: A randomised, open-label, phase 3 trial. Lancet 2017 Jul 26; PMID: 28755782 - Compston J. Bone-forming agents in non-responders to bisphosphonates. Lancet 2017 Jul 26 PMID: 28755781
  4. Saag KG, Petersen J, Brandi ML et al Romosozumab or Alendronate for Fracture Prevention in Women with Osteoporosis. N Engl J Med. September 11, 2017 PMID: 28892457 http://www.nejm.org/doi/full/10.1056/NEJMoa1708322
  5. Amgen And UCB Receive Positive Vote From FDA Advisory Committee In Favor Of Approval For EVENITY (romosozumab). Potential New Treatment Option for the Treatment of Postmenopausal Women With Osteoporosis at High Risk for Fracture. Amgen. Jan 16, 2019 https://www.prnewswire.com/news-releases/amgen-and-ucb-receive-positive-vote-from-fda-advisory-committee-in-favor-of-approval-for-evenity-romosozumab-300779812.html - FDA Advisory Committee. Briefing Information for the January 16, 2019 Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC). https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ReproductiveHealthDrugsAdvisoryCommittee/ucm629455.htm - FDA News Release. April 9, 2019 FDA approves new treatment for osteoporosis in postmenopausal women at high risk of fracture. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm635653.htm
  6. Qaseem A, et al. Pharmacologic Treatment of Primary Osteoporosis or Low Bone Mass to Prevent Fractures in Adults: A Living Clinical Guideline From the American College of Physicians. Ann Intern Med. 2023. Jan 3; [e-pub]. PMID: 36592456 https://www.acpjournals.org/doi/10.7326/M22-1034
  7. Handel MN et al Fracture risk reduction and safety by osteoporosis treatment compared with placebo or active comparator in postmenopausal women: systematic review, network meta- analysis, and meta-regression analysis of randomised clinical trials. BMJ. 2023. May 2;381:e068033 PMID: 37130601 PMCID: PMC10152340 Free PMC article https://www.bmj.com/content/381/bmj-2021-068033.short