Hectorol
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Questions & Answers
Side Effects & Adverse Reactions
Overdosage of any form of vitamin D, including Hectorol, is dangerous (see OVERDOSAGE). Progressive hypercalcemia due to overdosage of vitamin D and its metabolites may be so severe as to require emergency attention. Acute hypercalcemia may exacerbate tendencies for cardiac arrhythmias and seizures and may potentiate the action of digitalis drugs. Chronic hypercalcemia can lead to generalized vascular calcification and other soft-tissue calcification. The serum calcium times serum phosphorus (Ca X P) product should be maintained at < 55 mg2/dL2 in patients with chronic kidney disease. Radiographic evaluation of suspect anatomical regions may be useful in the early detection of this condition.
Since doxercalciferol is a precursor for 1α,25-(OH)2D2, a potent metabolite of vitamin D2, pharmacologic doses of vitamin D and its derivatives should be withheld during Hectorol treatment to avoid possible additive effects and hypercalcemia.
Oral calcium-based or other non-aluminum-containing phosphate binders and a low phosphate diet should be used to control serum phosphorus levels in patients with chronic kidney disease. Uncontrolled serum phosphorus exacerbates secondary hyperparathyroidism and can lessen the effectiveness of Hectorol in reducing blood PTH levels. If hypercalcemia occurs after initiating Hectorol therapy, the dose of Hectorol and/or calcium-containing phosphate binders should be decreased. If hyperphosphatemia occurs after initiating Hectorol, the dose of Hectorol should be decreased and/or the dose of phosphate binders increased. (See dosing recommendations for Hectorol under DOSAGE AND ADMINISTRATION section.)
Magnesium-containing antacids and Hectorol should not be used concomitantly in patients on chronic renal dialysis because such use may lead to the development of hypermagnesemia.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Hectorol is indicated for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis.
Hectorol is indicated for the treatment of secondary hyperparathyroidism in patients with Stage 3 or Stage 4 chronic kidney disease.
History
There is currently no drug history available for this drug.
Other Information
Doxercalciferol, the active ingredient in Hectorol®, is a synthetic vitamin D2 analog that undergoes metabolic activation in vivo to form 1α,25-dihydroxyvitamin D2 (1α,25-(OH)2D2), a naturally occurring, biologically active form of vitamin D2. Hectorol is available as soft gelatin capsules containing 0.5 mcg, 1 mcg or 2.5 mcg doxercalciferol. Each capsule also contains fractionated triglyceride of coconut oil, ethanol, and butylated hydroxyanisole (BHA). The capsule shells contain gelatin, glycerin and titanium dioxide. In addition, the 0.5 mcg capsule shells contain yellow iron oxide and FD&C Red No. 40, the 1 mcg capsule shells contain FD&C Yellow No. 6, and the 2.5 mcg capsule shells contain yellow iron oxide.
Doxercalciferol is a colorless crystalline compound with a calculated molecular weight of 412.66 and a molecular formula of C28H44O2. It is soluble in oils and organic solvents, but is relatively insoluble in water. Chemically, doxercalciferol is (1α,3β,5Z,7E,22E)-9,10-secoergosta-5,7,10(19),22-tetraene-1,3-diol. The structural formula is presented in Figure 1 below:
Figure 1: Chemical Structure of Doxercalciferol
Other names frequently used for doxercalciferol are 1α-hydroxyvitamin D2, 1α-OH-D2, and 1α-hydroxyergocalciferol.
Sources
Hectorol Manufacturers
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Genzyme Corporation
![Hectorol (Doxercalciferol) Capsule, Liquid Filled Hectorol (Doxercalciferol) Capsule, Liquid Filled [Genzyme Corporation]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Hectorol | Genzyme Corporation
Adult Administration:The optimal dose of Hectorol 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)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)
3 30-59 35-70 4 15-29 70-110 5 < 15 (or dialysis) 150-300 Dialysis:The recommended initial dose of Hectorol 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 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 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 DosingiPTH Level
Hectorol® Dose
> 400 pg/mL
10 mcg three times per week at dialysis
Dose TitrationiPTH Level
Hectorol® Dose
Above 300 pg/mL
Increase by 2.5 mcg at eight-week intervals as necessary
150 - 300 pg/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 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 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 therapy or following dose adjustments in Hectorol 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 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 DosingiPTH Level
Hectorol® Dose
> 70 pg/mL (Stage 3)
1 mcg once per day
> 110 pg/mL (Stage 4)
Dose TitrationiPTH Level
Hectorol® Dose
Above 70 pg/mL (Stage 3)
Increase by 0.5 mcg at two-week intervals as necessary
110 pg/mL (Stage 4)
35 - 70 pg/mL (Stage 3)
Maintain
70 - 110 pg/mL (Stage 4)
< 35 pg/mL (Stage 3)
Suspend for one week, then resume at a dose that is at least 0.5 mcg lower
< 70 pg/mL (Stage 4)
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Remedyrepack Inc.
Hectorol | Remedyrepack Inc.
Adult Administration:
The optimal dose of Hectorol must be carefully determined for each patient. Table 4provides 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) TargetPTH
(pg/mL)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)330-5935-70415-2970-1105< 15 (or dialysis)150-300
Dialysis:
The recommended initial dose of Hectorol 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 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 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 HectorolDose> 400 pg/mL10 mcg three times per week at dialysis
Dose Titration iPTH Level HectorolDoseAbove 300 pg/mLIncrease by 2.5 mcg at eight-week intervals as necessary150 - 300 pg/mLMaintain< 100 pg/mLSuspend for one week, then resume at a dose that is at least 2.5 mcg lower
Pre-dialysis:
The recommended initial dose of Hectorol 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 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 therapy or following dose adjustments in Hectorol 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 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 6presents a suggested approach in dose titration:
Table 6: Pre-dialysis Dosing Recommendations
Initial Dosing iPTH Level HectorolDose> 70 pg/mL (Stage 3)1 mcg once per day> 110 pg/mL (Stage 4)
Dose Titration iPTH Level HectorolDoseAbove 70 pg/mL (Stage 3)Increase by 0.5 mcg at two-week intervals as necessary110 pg/mL (Stage 4)35 - 70 pg/mL (Stage 3)Maintain70 - 110 pg/mL (Stage 4)< 35 pg/mL (Stage 3)Suspend for one week, then resume at a dose that is at least 0.5 mcg lower
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Genzyme Corporation
Hectorol | Genzyme Corporation
Adult Administration:For intravenous use only. The optimal dose of Hectorol must be carefully determined for each patient.
The recommended initial dose of Hectorol is 4 mcg administered intravenously 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. Table 5 presents a suggested approach in dose titration.
Table 5: Initial Dosing iPTH Level Hectorol® Dose >400 pg/mL 4 mcg three times per week at the end of dialysis, or approximately every other day Dose Titration iPTH Level Hectorol® Dose Decrease by <50% and above 300 pg/mL Increase by 1 to 2 mcg at eight-week intervals as necessary Decrease by >50% and above 300 pg/mL Maintain 150 - 300 pg/mL Maintain <100 pg/mL Suspend for one week, then resume at a dose that is at least 1 mcg lowerMulti-Dose Vial
After initial vial use, the contents of the multi-dose vial remain stable up to 3 days when stored at 2–8°C (36-46°F). Discard unused portion of multi-dose vial after 3 days. (see HOW SUPPLIED and STORAGE section).
![Hectorol (Doxercalciferol) Capsule, Liquid Filled [Remedyrepack Inc. ]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=e28403e8-443e-40de-a823-db22ff9f8c99&name=MM2.jpg)
![Hectorol (Doxercalciferol) Injection, Solution [Genzyme Corporation]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=7efc3d9c-12f5-43f6-9a22-88d66cbe6f62&name=hectorol-figure-2.jpg)
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