Dialysis Patients: Hectorol^Ò is indicated for the treatment of secondary hyperparathy-roidism in patients with chronic kidney disease on dialysis.

Pre-Dialysis Patients: Hectorol^Ò is indicated for the treatment of secondary hyper-parathyroidism in patients with Stage 3 or Stage 4 chronic kidney disease.

Adult Administration:

The optimal dose of Hectorol^Ò must be carefully determined for each patient. The following table provides the current recommended therapeutic target levels for iPTH in patients with chronic kidney disease:

From Table 15 of National Kidney Foundation. K/DOQI Clinical Practice Guidelines for Bone Metabolism and Disease in Chronic Kidney Disease. Am J Kidney Dis 42:S1-S202, 2003 (suppl 3)

Dialysis: The recommended initial dose of Hectorol^Ò is 10 mcg administered three times weekly at dialysis (approximately every other day). The initial dose should be adjusted, as needed, in order to lower blood iPTH into the range of 150 to 300 pg/mL. The dose may be increased at 8-week intervals by 2.5 mcg if iPTH is not lowered by 50% and fails to reach the target range. The maximum recommended dose of Hectorol^Ò is 20 mcg administered three times a week at dialysis for a total of 60 mcg per week. Drug administration should be suspended if iPTH falls below 100 pg/mL and restarted one week later at a dose that is at least 2.5 mcg lower than the last administered dose. During titration, iPTH, serum calcium, and serum phosphorus levels should be obtained weekly. If hypercalcemia, hyper-phosphatemia, or a serum calcium times serum phosphorus product greater than 55 mg²/dL² is noted, the dose of Hectorol^Ò should be decreased or suspended and/or the dose of phosphate binders should be appropriately adjusted. If suspended, the drug should be restarted at a dose that is at least 2.5 mcg lower.

Dosing must be individualized and based on iPTH levels with monitoring of serum calcium and serum phosphorus levels. The following is a suggested approach in dose titration:

Pre-dialysis: The recommended initial dose of Hectorol^Ò is 1 mcg administered once daily. The initial dose should be adjusted, as needed, in order to lower blood iPTH to within target ranges (see table below). The dose may be increased at 2-week intervals by 0.5 mcg to achieve the target range of iPTH. The maximum recommended dose of Hectorol^Ò is 3.5 mcg administered once per day.

Serum levels of calcium and phosphorus and plasma levels of iPTH should be monitored at least every two weeks for 3 months after initiation of Hectorol^Ò therapy or following dose-adjustments in Hectorol^Ò therapy, then monthly for 3 months, and every 3 months thereafter. If hypercalcemia, hyperphosphatemia, or a serum calcium times phosphorus product greater than 55 mg²/dL² is noted, the dose of Hectorol^Ò should be decreased or suspended and/or the dose of phosphate binders should be appropriately adjusted. If suspended, the drug should be restarted at a dose that is at least 0.5 mcg lower.

Dosing must be individualized and based on iPTH levels with monitoring of serum calcium and serum phosphorus levels. The following is a suggested approach in dose titration:

NDC 58468-0120-1
NDC 58468-0121-1

0.5 mcg doxercalciferol in soft gelatin, citrus orange, oval capsules, imprinted BCI; bottles of 50.

2.5 mcg doxercalciferol in soft gelatin, sunshine yellow, oval capsules, imprinted BCI; bottles of 50.

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