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Hectorol

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Hectorol

INDICATIONS

Dialysis Patients: Hectorol (doxercalciferol liquid filled capsule) is indicated for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis.

Pre-Dialysis Patients: Hectorol (doxercalciferol liquid filled capsule) is indicated for the treatment of secondary hyperparathyroidism in patients with Stage 3 or Stage 4 chronic kidney disease.

DOSAGE AND ADMINISTRATION

Adult Administration

The optimal dose of Hectorol (doxercalciferol liquid filled capsule) must be carefully determined for each patient. Table 4 provides the current recommended therapeutic target levels for iPTH in patients with chronic kidney disease:

Table 4: Target Range of Intact Plasma PTH by Stage of CKD

CKD Stage GFR
(mL/min/1.73m2)
Target "intact" PTH
(pg/mL)
3 30-59 35-70
4 15-29 70-110
5 < 15 (or dialysis) 150-300
From Table 15 of National Kidney Foundation, K/DOQI Clinical Practice Guidelines for Bone Metabolism and Disease in Chronic Kidney Disease. Am J Kidney Dis42:Sl-S202, 2003 (suppl 3)

Dialysis

The recommended initial dose of Hectorol (doxercalciferol liquid filled capsule) 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 (doxercalciferol liquid filled capsule) 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, hyperphosphatemia, or a serum calcium times serum phosphorus product greater than 55 mg2/dL2 is noted, the dose of Hectorol (doxercalciferol liquid filled capsule) 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:

Table 5: Dialysis Dosing Recommendations

Initial Dosing
iPTH Level Hectorol® Dose
> 400 pg/mL 10 mcg three times per week at dialysis
Dose Titration
iPTH Level Hectorol Dose
Above 300 pg/mL Increase by 2.5 mcg at eight- week intervals as necessary
150-300pg/mL Maintain
< 100 pg/mL Suspend for one week, then resume at a dose that is at least 2.5 mcg lower

Pre-dialysis

The recommended initial dose of Hectorol (doxercalciferol liquid filled capsule) 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 (doxercalciferol liquid filled capsule) 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 (doxercalciferol liquid filled capsule) therapy or following dose adjustments in Hectorol (doxercalciferol liquid filled capsule) 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 (doxercalciferol liquid filled capsule) 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. Table 6 presents a suggested approach in dose titration:

Table 6: Pre-dialysis Dosing Recommendations

Initial Dosing
iPTH Level Hectorol Dose
> 70 pg/mL (Stage 3) 1 mcg once per day
> 110 pg/mL (Stage4) Dose Titration
iPTH Level Hectorol Dose
Above 70 pg/mL (Stage 3)
110 pg/mL (Stage4)
Increase by 0.5 mcg at two-week intervals as necessary
35 - 70 pg/mL (Stage 3)
70-110 pg/mL (Stage4)
Maintain
< 35 pg/mL (Stage 3)
< 70 pg/mL (Stage 4)
Suspend for one week, then resume at a dose that is at least 0.5 mcg lower

HOW SUPPLIED

NDC 58468-0120-1
0.5 mcg doxercalciferol in soft gelatin, salmon, oval capsules, imprinted g; foil induction sealed bottles of 50.

NDC 58468-0124-1
1 mcg doxercalciferol in soft gelatin, peach, oval capsules, imprinted g; foil induction sealed bottles of 50.

NDC 58468-0121-1
2.5 mcg doxercalciferol in soft gelatin, butter yellow, oval capsules, imprinted g; foil induction sealed bottles of 50.

Store at 25°C (77°F): excursions permitted to 15-30°C (59-86°F) [see USP controlled room temperature]

Manufactured by Catalent Pharma Solutions for Genzyme Corporation, 500 Kendall Street, Cambridge, MA 02142. 800-847-0069.

Last reviewed on RxList: 4/12/2011
This monograph has been modified to include the generic and brand name in many instances.

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