Drug updated on 5/17/2024
Dosage Form | Injection (intravenous; 2.5 mg/0.5 ml, 5 mg/ml, 10 mg/2 ml) |
Drug Class | Calcium-sensing receptor agonists |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis.
Latest News
![loading GIF](/img/news-loading.gif)
Summary
- Etelcalcetide (Parsabiv) is indicated for secondary hyperparathyroidism in adult patients with chronic kidney disease on hemodialysis. It has the highest odds of achieving target parathyroid hormone levels compared to other calcimimetic agents, evocalcet and cinacalcet.
- Two studies were reviewed focusing on the safety and effectiveness of Etelcalcetide, particularly when compared to other calcimimetic agents for treating secondary hyperparathyroidism in adults undergoing dialysis.
- Compared to placebo, Etelcalcetide showed superior efficacy in achieving a reduction of at least 30% in PTH levels and bringing PTH levels down below 300 pg/mL. This reaffirms its effectiveness in substantially lowering PTH levels.
- A significant safety concern highlighted was an increased incidence of hypocalcemia associated with Etelcalcetide use as compared both placebo and other calcimimetic agents. Therefore, careful monitoring of calcium levels is required during treatment.
- Other side effects noted include higher incidences of nausea and vomiting relative to placebo; these are common but can impact patient compliance due to their effect on quality of life.
- Beyond impacting PTH levels, it also effectively reduces serum phosphate and the calcium phosphorus product - key factors in managing mineral bone disorder in CKD patients - thus offering additional benefits in managing a broader spectrum of SHPT-associated complications.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Parsabiv (Etelcalcetide) Prescribing Information. | 2021 | KAI Pharmaceuticals, Inc., Thousand Oaks, CA |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
Comparative effectiveness of calcimimetic agents for secondary hyperparathyroidism in adults: a systematic review and network meta-analysis. | 2020 | American Journal of Kidney Diseases |
Etelcalcetide versus placebo for secondary hyperparathyroidism in patients receiving hemodialysis: a meta-analysis of randomized controlled trials. | 2020 | Clinical Nephrology |
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
VA/DoD clinical practice guideline for the management of chronic kidney disease. | 2019 | The Management of Chronic Kidney Disease Work Group |