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abaloparatide (Tymlos)

Indications: - osteoporosis* - FDA-approved for high-risk patients - prior osteoporotic fracture, multiple fracture risk factors, failure of intolerance of other osteoporosis therapies - osteoporosis in men [5] * reduces risk of vertebral fractures in postmenopausal women with osteoporosis [1] * more effective than bisphosphonates in preventing clinical & vertebral fractures [6] Dosage: - 80 ug SQ once daily into the periumbilical region of the abdomen Adverse effects: - hypercalcemia (3%), less common than with teriparatide (6%) Mechanism of action: - chimeric ligand for the parathyroid hormone type 1 receptor - synthetic analog of human PTH-related protein Notes: - FDA approved April 2017 - NICE recommends as option for postmenopausal osteoporosis August 2024 [7]

General

recombinant protein; chimer endocrine agent

Database Correlations

PUBCHEM cid=76943386

References

  1. Miller PD, Hattersley G, Riis BJ et al Effect of Abaloparatide vs Placebo on New Vertebral Fractures in Postmenopausal Women With Osteoporosis. A Randomized Clinical Trial. JAMA. 2016;316(7):722-733 PMID: 27533157 http://jama.jamanetwork.com/article.aspx?articleid=2544640 - Cappola AR, Shoback DM Osteoporosis Therapy in Postmenopausal Women With High Risk of Fracture. JAMA. 2016;316(7):715-716 PMID: 27533154 http://jama.jamanetwork.com/article.aspx?articleid=2544620
  2. Brooks M FDA Clears Abaloparatide for High-Risk Osteoporosis Patients. Medscape - Apr 28, 2017. http://www.medscape.com/viewarticle/879284 - Windle ML. FDA New Drug and Biologic Approvals -- 2017 Year-in-Review Medscape - Jan 11, 2018. https://reference.medscape.com/viewarticle/890871 - U.S. Food and Drug Administration. Novel Drug Approvals for 2017. https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm537040.htm
  3. Orciari Herman A, Sadoughi S, Sofair A New Injectable Osteoporosis Drug Approved Physician's First Watch, May 1, 2017 David G. Fairchild, MD, MPH, Editor-in-Chief Massachusetts Medical Society http://www.jwatch.org
  4. Cosman F, Miller PD, Williams GC et al Eighteen Months of Treatment With Subcutaneous Abaloparatide Followed by 6 Months of Treatment With Alendronate in Postmenopausal Women With Osteoporosis: Results of the ACTIVExtend Trial. Mayo Clin Proc. 2017 Feb;92(2):200-210. PMID: 28160873 Free Article
  5. Nainggolan L FDA Approves Abaloparatide (Tymlos) for Osteoporosis in Men. Medscape. Dec 22, 2022 https://www.medscape.com/viewarticle/986014
  6. 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
  7. Mahase E NICE recommends new treatment option for osteoporosis after menopause. BMJ 2024;386:q1769 Aug 8 PMID: 39117437 https://www.bmj.com/content/386/bmj.q1769
  8. Abaloparatide (Tymlos) prescribing information https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208743lbl.pdf