Active Ingredient: Etelcalcetide
Etelcalcetide is indicated for the treatment of secondary hyperparathyroidism (SHPT) in adult patients with chronic kidney disease (CKD) on haemodialysis therapy.
For this indication, competent medicine agencies globally authorize below treatments:
Intravenous
2.5 - 15 mg
From 2.5 To 15 mg once every 2 day(s)
5 mg
The recommended initial dose of etelcalcetide is 5 mg administered by bolus injection 3 times per week. Corrected serum calcium should be at or above the lower limit of the normal range prior to administration of first dose of etelcalcetide, a dose increase, or reinitiation after a dose stop. Etelcalcetide should not be administered more frequently than 3 times per week.
Etelcalcetide should be titrated so that doses are individualised between 2.5 mg and 15 mg. The dose may be increased in 2.5 mg or 5 mg increments no more frequently than every 4 weeks to a maximum dose of 15 mg 3 times per week to achieve the desired parathyroid hormone (PTH) target.
PTH should be measured after 4 weeks from initiation or dose adjustment of etelcalcetide, and approximately every 1-3 months during maintenance. Dose adjustment may be necessary at any time during treatment including the maintenance phase.
If PTH is below 100 pg/mL (10.6 pmol/L), the dose should be reduced or temporarily stopped. If PTH does not return to >100 pg/mL following dose reduction, the dose should be stopped. For patients in whom the dose is stopped, etelcalcetide should be reinitiated at a lower dose once PTH returns to >150 pg/mL (15.9 pmol/L) and pre-dialysis serum corrected calcium (cCa) ≥8.3 mg/dL (2.08 mmol/L). If the patient’s last administered dose was 2.5 mg, etelcalcetide may be reinitiated at the 2.5 mg dose level if PTH is >300 pg/mL (31.8 pmol/L), and the most recent pre-dialysis serum cCa ≥8.3 mg/dL (2.08 mmol/L).
Additional recommendations related to the management of low calcium are provided in the table below.
Etelcalcetide may be used as part of a therapeutic regimen including phosphate binders and/or vitamin D sterols, as appropriate.
If a regularly scheduled haemodialysis treatment is missed, do not administer any missed doses. Etelcalcetide should be administered at the next haemodialysis treatment at the same dose. If doses are missed for more than 2 weeks, then etelcalcetide should be administered at 5 mg, (or 2.5 mg if that was the patient’s last administered dose), and titrated to achieve the desired PTH.
Serum calcium should be measured within 1 week of initiation or dose adjustment of etelcalcetide. Once the maintenance phase has been established for a patient, corrected serum calcium should be measured approximately every 4 weeks. In the studies total serum calcium was measured using Roche modular analysers. The lower limit of the normal range for corrected serum calcium was 8.3 mg/dL (2.08 mmol/L). Other laboratory assays may have different cut-offs for the lower limit of the normal range.
In the event that clinically meaningful decreases in corrected serum calcium levels below the lower limit of the normal range occur and/or symptoms of hypocalcaemia occur, the following management is recommended:
Etelcalcetide should not be initiated in patients until 7 days after the last dose of cinacalcet and the corrected serum calcium is at or above the lower limit of the normal range.
Etelcalcetide is administered into the venous line of the dialysis circuit at the end of the haemodialysis treatment during rinse-back or intravenously after rinse-back.
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