g
◦Patients with PTH levels below the target range
◦In individuals with a corrected serum calcium below the lower limit of normal, but ≥7.5 mg/dL without symptoms of hypocalcemia, consider decreasing or temporarily discontinuing the drug or use concomitant therapies to increase corrected serum calcium
◦If the dose is stopped, then reinitiate at a lower dose when PTH is within the target range and hypocalcemia has been corrected
•Stop and treat hypocalcemia
◦Stop drug if the corrected serum calcium is <7.5 mg/dL or patients report symptoms of hypocalcemia
◦May reinitiate at a dose 5 mg lower than the last dose administered when corrected serum calcium is within normal limits, symptoms of hypocalcemia have resolved, and predisposing factors for hypocalcemia have been addressed
◦If the last administered dose was 2.5 mg or 5 mg, reinitiate at a dose of 2.5 mg
Switching from cinacalcet
•Discontinue cinacalcet for at least 7 days before starting etelcalcetide
•Initiate etelcalcetide at a starting dose of 5 mg IV bolus
•Ensure corrected serum calcium is at or above the lower limit of normal prior to initiation
Dosing Considerations
Limitations of use
•Has not been studied in adults with parathyroid carcinoma, primary hyperparathyroidism, or CKD who are not on hemodialysis
•Not recommended for use in these populations
Safety and efficacy not established
No clinically significant differences in safety, efficacy, or etelcalcetide plasma concentrations were observed between patients ≥65 yr and younger patients
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