Hectorol^® is indicated for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis.

Adult Administration:

The optimal dose of Hectorol^® must be carefully determined for each patient.

The recommended initial dose of Hectorol^® is 4 mcg administered as a bolus dose three times weekly at the end of 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 1 to 2 mcg if iPTH is not lowered by 50% and fails to reach the target range. Dosages higher than 18 mcg weekly have not been studied. Drug administration should be suspended if iPTH falls below 100 pg/mL and restarted one week later at a dose that is at least 1 mcg lower than the last administered dose. During titration, iPTH, serum calcium, and serum phosphorus levels should be obtained weekly. If hypercalcemia, hyperphosphatemia, or a serum calcium times phosphorus product greater than 55 mg²/dL² is noted, the dose of Hectorol^® 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 1 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:

Hectorol^® (doxercalciferol) Injection is supplied in pre-scored amber glass ampules.

Store at 15° to 25°C (59° to 77°F). Protect from light.

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