ETELCALCETIDE INJ,SOLN

Clinical Criteria Summary

Serum calcium less than the lower limit normal (e.g., < 8.4 mg/dL, corrected for serum albumin)

Secondary hyperparathyroidism in a patient with chronic kidney disease (CKD) on chronic dialysis with elevated intact plasma parathyroid hormone (iPTH) level (e.g., greater than 400 pg/ml or significant trend upwards within two to nine times the upper limit normal for the assay) despite management with standard therapy as appropriate (e.g., dietary phosphate restriction, phosphate binders [calcium-based or non-calcium based], calcitriol or vitamin D analogs)
Hypercalcemia (e.g., > 12.5 mg/dl, or symptomatic and > 11.3 mg/dl; corrected for serum albumin) in a patient with primary hyperparathyroidism who is not a surgical candidate or with recurrence despite surgical intervention
Hypercalcemia (e.g., > 12.5 mg/dl, corrected for serum albumin) in a patient with parathyroid carcinoma despite standard therapy to control hypercalcemia prior to surgical intervention, or who is not a surgical candidate, or who has recurrence despite surgical intervention

Secondary hyperparathyroidism in adult patients with CKD on dialysis (Limitation: Not indicated for use in patients with CKD not on dialysis)
Hypercalcemia in adult patients with parathyroid carcinoma
Hypercalcemia in adult patients with primary hyperparathyroidism for whom parathyroidectomy would be indicated on the basis of serum calcium levels, but who are unable to undergo parathyroidectomy

Both agents lower serum calcium, leading to potentially severe hypocalcemia (can cause paresthesias, myalgias, muscle spasms, seizures, QT interval prolongation and ventricular arrhythmia); patients predisposed to QT interval prolongation, ventricular arrhythmias, or seizures are at increased risk
Close monitoring recommended for development of hypocalcemia, with adjustment of other therapies (e.g., phosphate binders, calcitriol or vitamin D analogs) as indicated
For secondary hyperparathyroidism with CKD on dialysis: Monitor serum calcium approximately monthly if receiving maintenance dose
For parathyroid carcinoma or primary hyperparathyroidism: Monitor corrected serum calcium every 2 months
If calcium is between 8.4 mg/dL and 7.5 mg/dL: Calcium-based phosphate binders and/or vitamin D sterols can be used to increase calcium
If calcium is below 7.5 mg/dL or patient has symptoms of hypocalcemia: Hold cinacalcet dose until calcium is 8.0 mg/dL; may resume at a lower dose once calcium is corrected

Refer to Product Information for detailed prescribing information
Selection between oral cinacalcet and IV etelcalcetide should depend on treatment response, tolerability, adherence, and cost
Patients adequately controlled on cinacalcet, who are tolerating therapy and adherent to the oral once daily treatment regimen, should remain on cinacalcet
Concurrent use of calcimimetics could result in severe, life-threatening hypocalcemia; cinacalcet and etelcalcetide should not be used as concomitant therapy

Long-term safety and efficacy in patients with CKD not on dialysis has not been established; however, individual cases treating a non-dialysis patient with markedly elevated iPTH might be considered
Patients treated with cinacalcet who are not on dialysis may be at increased risk for the development of hypocalcemia
Limited data show reduction in hypercalcemia and iPTH with cinacalcet in patients with hyperparathyroidism after kidney transplantation; appropriate treatment should be determined on a case by case basis

Refer to prescribing information for animal reproduction studies data to determine use in patients of child-bearing potential, and the need for contraceptive counseling and education on potential risk vs. benefit if patient were to become pregnant

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