abaloparatide (Tymlos)
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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]
- FDA-approved for high-risk patients
* 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
More general terms
References
- ↑ 1.0 1.1 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 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/27533157 <Internet> 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 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/27533154 <Internet> http://jama.jamanetwork.com/article.aspx?articleid=2544620 - ↑ 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 - ↑ 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
- ↑ 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: https://www.ncbi.nlm.nih.gov/pubmed/28160873 Free Article
- ↑ 5.0 5.1 Nainggolan L FDA Approves Abaloparatide (Tymlos) for Osteoporosis in Men. Medscape. Dec 22, 2022 https://www.medscape.com/viewarticle/986014
- ↑ 6.0 6.1 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: https://www.ncbi.nlm.nih.gov/pubmed/37130601 PMCID: PMC10152340 Free PMC article https://www.bmj.com/content/381/bmj-2021-068033.short
- ↑ Abaloparatide (Tymlos) prescribing information https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208743lbl.pdf