Hectorol Injection (Doxercalciferol) - Indications and Dosage

INDICATIONS AND USAGE

Hectorol is indicated for the reduction of elevated iPTH levels in the management of secondary hyperparathyroidism in patients undergoing chronic renal dialysis.

DOSAGE AND ADMINISTRATION

Adult Administration:

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

The recommended initial dose of Hectorol is 4.0 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 1.0 - 2.0 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 which is at least 1.0 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 70 is noted, the drug should be immediately suspended until these parameters are appropriately lowered. Then, the drug should be restarted at a dose which is 1.0 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:

Discard unused portion.

HOW SUPPLIED

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

NDC number Volume mcg/ampule

64894-840-50 2 mL 4.0

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

Manufactured by Draxis Pharma, Inc. for

Bone Care International, Inc., Middleton, WI 53562

888-389-4242

PI-002A-02 12/03