Is there an intravenous (IV) form of Cinacalcet (Cinacalcet hydrochloride) or a similar medication, such as etelcalcetide, available for a patient with chronic kidney disease (CKD) on dialysis and secondary hyperparathyroidism?

IV Calcimimetic for Secondary Hyperparathyroidism

Yes, etelcalcetide (Parsabiv) is an FDA-approved intravenous calcimimetic that is administered three times weekly at the end of hemodialysis sessions for patients with CKD stage 5D and secondary hyperparathyroidism. 1

Available IV Formulation

• Etelcalcetide is supplied as a ready-to-use sterile solution in single-dose vials containing 2.5 mg, 5 mg, or 10 mg for intravenous bolus administration 1
• The medication is administered intravenously three times per week at the end of each 3- to 6-hour hemodialysis session 1
• PTH levels decrease within 30 minutes post-dose, with steady-state plasma levels reached in 7-8 weeks and an effective half-life of 3-4 days 1

Comparison to Oral Cinacalcet

Etelcalcetide demonstrated superiority over oral cinacalcet in a head-to-head trial:

• 68.2% of patients on etelcalcetide achieved >30% PTH reduction compared to 57.7% on cinacalcet (difference 10.5%, P=.004 for superiority) 2
• 52.4% achieved >50% PTH reduction with etelcalcetide versus 40.2% with cinacalcet (P=.001) 2
• The IV route may improve adherence compared to daily oral dosing and potentially reduce gastrointestinal adverse effects 2

Clinical Context and Limitations

Neither etelcalcetide nor cinacalcet improves mortality or cardiovascular outcomes - their benefit is limited to preventing parathyroidectomy and managing mineral metabolism 3, 4:

• Cinacalcet shows no effect on all-cause mortality (RR 0.97,95% CI 0.89-1.05) 5, 3
• The primary indication is preventing surgical parathyroidectomy (RR 0.49,95% CI 0.40-0.59) in patients where surgery is contraindicated 3, 4

Safety Profile

Hypocalcemia is the most significant risk with IV calcimimetics:

• Decreased blood calcium occurred in 68.9% of etelcalcetide patients versus 59.8% with cinacalcet 2
• Cinacalcet increases hypocalcemia risk 7.38-fold (95% CI 5.43-10.03) 3
• Gastrointestinal side effects (nausea, vomiting) are common with oral cinacalcet but may be reduced with IV administration 2

Practical Considerations

Etelcalcetide is only appropriate for hemodialysis patients - it requires IV access and is administered during dialysis sessions 1. For patients unable to tolerate oral cinacalcet due to gastrointestinal side effects or adherence issues, etelcalcetide provides an effective alternative with superior PTH reduction 2.