Abaloparatide

(Tymlos®)

Tymlos®

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Drug updated on 5/17/2024

Dosage FormInjection (subcutaneous; 3120 mcg/1.56 mL)
Drug ClassHuman parathyroid hormone related peptide analogs
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy.
  • Indicated for the treatment to increase bone density in men with osteoporosis at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy.

Summary
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  • Abaloparatide (Tymlos) is indicated for the treatment of postmenopausal women and men with osteoporosis at high risk for fracture or for those who have failed or are intolerant to other available osteoporosis therapy. It has shown significant advantages in improving bone mineral density compared to teriparatide, especially among postmenopausal women.
  • Six studies were reviewed, providing a comprehensive analysis of abaloparatide's safety, effectiveness, and comparison to other osteoporosis treatments.
  • In terms of the safety profile, abaloparatide demonstrated a lower incidence of hypercalcemia than teriparatide but showed higher risks of nausea and palpitations compared to placebo. This suggests that, while offering a safer profile concerning hypercalcemia, a common concern in osteoporosis therapy, patient-specific considerations regarding side effects should be taken into account.
  • For men with osteoporosis, bisphosphonates, denosumab, teriparatide, and abaloparatide all showed significant improvements in bone mineral density compared to placebo, indicating that its effectiveness aligns with leading treatments for male patients as well.
  • Network meta-analytic comparisons revealed strong performance by abaloparatide across different time points, particularly during the early treatment period, suggesting its potential as an effective initial intervention strategy against fractures caused by osteoporosis.
  • While only zoledronate significantly reduced both vertebral and nonvertebral fractures in primary prevention among postmenopausal women, secondary prevention saw significant reductions from several drugs, including abaloparatide, making it a potent option, particularly for those who have already suffered from a fracture.

Product Monograph / Prescribing Information

Document TitleYearSource
Tymlos (abaloparatide) Prescribing Information.2023Radius Health, Inc., Waltham, MA

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines