Etelcalcetide (Parsabiv): Uses, Evidence, and Side Effects

Key takeaways

• Etelcalcetide is FDA-approved under the brand name Parsabiv for secondary hyperparathyroidism in adults on hemodialysis.
• It works as a calcimimetic, binding the calcium-sensing receptor to reduce parathyroid hormone secretion.
• It is not recommended for parathyroid carcinoma, primary hyperparathyroidism, or chronic kidney disease without hemodialysis.
• At least 24 trials have studied the compound, including pediatric and pharmacokinetic research.
• Reported adverse events most often involve low calcium levels, dialysis access issues, and nausea.

What etelcalcetide is

Etelcalcetide is a calcimimetic agent, a type of drug that adjusts how the body's calcium-sensing receptor behaves. It binds to this receptor and boosts its response to calcium already circulating in the blood. Because the receptor sits on parathyroid chief cells, activating it tells the parathyroid gland to release less parathyroid hormone (PTH). This mechanism underlies its use in people whose kidneys can no longer help regulate PTH and calcium balance.

What etelcalcetide is approved for

Etelcalcetide, sold as Parsabiv, is approved to treat secondary hyperparathyroidism in adults with chronic kidney disease who are on hemodialysis. The label specifically limits its use: it has not been studied, and is not recommended, in patients with parathyroid carcinoma, primary hyperparathyroidism, or chronic kidney disease in patients who are not on hemodialysis. The label does not carry a boxed warning.

What the evidence shows

Etelcalcetide has been the subject of at least 24 registered clinical trials. One ongoing Phase 3 study is evaluating the drug in children with secondary hyperparathyroidism who are receiving hemodialysis. Separately, a completed Phase 1 trial examined the pharmacokinetics and excretion of radiolabeled etelcalcetide in patients with end-stage renal disease on dialysis, while a completed Phase 2 study looked at how PTH lowering with the drug affects calcification propensity in dialysis patients' serum.

Reported side effects

Reported adverse event data for etelcalcetide reflect counts of submitted reports, not confirmed incidence or direct causation. The most frequently reported issues relate to calcium regulation, including hypocalcaemia (151 reports), elevated blood parathyroid hormone (145), and decreased blood calcium (124). Dialysis-related access problems are also prominent, with shunt stenosis (204 reports) and shunt occlusion (128) both reported. Other frequently reported terms include underdose (247), nausea (192), and product storage error (149), the latter two pointing to handling and administration circumstances rather than a direct drug effect.