Doxercalciferol label

Doxercalciferol

Doxercalciferol Recall

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Side Effects & Adverse Reactions

Overdosage of any form of vitamin D, including doxercalciferol, 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 doxercalciferol 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 doxercalciferol in reducing blood PTH levels. If hypercalcemia occurs after initiating doxercalciferol therapy, the dose of doxercalciferol and/or calcium-containing phosphate binders should be decreased. If hyperphosphatemia occurs after initiating doxercalciferol therapy, the dose of doxercalciferol should be decreased and/or the dose of phosphate binders increased. (See dosing recommendations for doxercalciferol under DOSAGE AND ADMINISTRATION section.)

Magnesium-containing antacids and doxercalciferol should not be used concomitantly in patients on chronic renal dialysis because such use may lead to the development of hypermagnesemia.

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FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

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Uses

Dialysis Patients

Doxercalciferol Capsules are indicated for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis.

Pre-Dialysis Patients

Doxercalciferol Capsules are indicated for the treatment of secondary hyperparathyroidism in patients with Stage 3 or Stage 4 chronic kidney disease.

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History

There is currently no drug history available for this drug.

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Other Information

Doxercalciferol, the active ingredient in Doxercalciferol Capsules, 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. Doxercalciferol Capsules are available as a soft gelatin capsule containing 0.5 mcg or 2.5 mcg doxercalciferol. Each capsule also contains butylated hydroxyanisole (BHA), dehydrated alcohol, and medium chain triglyceride. The capsule shells contain D&C Yellow No. 10 (0.5 mcg and 2.5 mcg), FD&C Yellow No. 6 (1 mcg only), FD&C Red No. 40 (0.5 mcg only), gelatin, glycerin, Opacode Black, purified water, and titanium dioxide. Opacode Black contains ammonium hydroxide, iron oxide black, isopropyl alcohol, N-butyl alcohol, propylene glycol, and shellac.

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 and has the following structural formula:

Structrual Formula Doxercalciferol

Other names frequently used for doxercalciferol are 1α-hydroxyvitamin D2, 1α-OH-D2, and 1α-hydroxyergocalciferol.

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Doxercalciferol Manufacturers

  • American Health Packaging
    Doxercalciferol | Topco Associates Llc
    No Recall

    Doxercalciferol | Topco Associates Llc

    Doxercalciferol | Topco Associates Llc
    • take only as directed – see Overdose warning • use dose cup • do not exceed 4 doses per 24 hrs

    adults & children 12 yrs & over

    30 mL (2 TBSP) every 4 hrs

    children 4 to under 12 yrs

    ask a doctor

    children under 4 yrs

    do not use

    Other information • each 30 mL dose cup contains: sodium 12 mg • store at 20°-25°C (68°-77°F)
  • Prasco Laboratories
    Doxercalciferol | Prasco Laboratories
    No Recall

    Doxercalciferol | Prasco Laboratories

    Doxercalciferol | Prasco Laboratories
    Adult Administration:

    The optimal dose of Doxercalciferol 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 Dis 42:S1-S202, 2003 (suppl 3)

    Dialysis:

    The recommended initial dose of Doxercalciferol Capsules 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 Doxercalciferol Capsules 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 Doxercalciferol 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

    Doxercalciferol Capsules Dose



    > 400 pg/mL

    10 mcg three times per week at dialysis



    Dose Titration

    iPTH Level

    Doxercalciferol Capsules 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 Doxercalciferol Capsules 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 Doxercalciferol Capsules 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 Doxercalciferol therapy or following dose adjustments in Doxercalciferol 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 Doxercalciferol 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

    Doxercalciferol Capsules Dose



    > 70 pg/mL (Stage 3)

    1 mcg once per day

    > 110 pg/mL (Stage 4)


    Dose Titration

    iPTH Level

    Doxercalciferol Capsules 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)

  • Prasco Laboratories
    Doxercalciferol | Prasco Laboratories
    No Recall

    Doxercalciferol | Prasco Laboratories

    Doxercalciferol | Prasco Laboratories
    Adult Administration:

    The optimal dose of Doxercalciferol 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 Dis 42:S1-S202, 2003 (suppl 3)

    Dialysis:

    The recommended initial dose of Doxercalciferol Capsules 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 Doxercalciferol Capsules 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 Doxercalciferol 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

    Doxercalciferol Capsules Dose



    > 400 pg/mL

    10 mcg three times per week at dialysis



    Dose Titration

    iPTH Level

    Doxercalciferol Capsules 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 Doxercalciferol Capsules 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 Doxercalciferol Capsules 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 Doxercalciferol therapy or following dose adjustments in Doxercalciferol 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 Doxercalciferol 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

    Doxercalciferol Capsules Dose



    > 70 pg/mL (Stage 3)

    1 mcg once per day

    > 110 pg/mL (Stage 4)



    Dose Titration

    iPTH Level

    Doxercalciferol Capsules 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)

  • West-ward Pharmaceutical Corp.
    Doxercalciferol | West-ward Pharmaceutical Corp.
    No Recall

    Doxercalciferol | West-ward Pharmaceutical Corp.

    Doxercalciferol | West-ward Pharmaceutical Corp.
    Adult Administration

    For intravenous use only. The optimal dose of doxercalciferol injection must be carefully determined for each patient.

    The recommended initial dose of doxercalciferol injection is 4 mcg administered intravenously as a bolus dose 3 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 mcg 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 doxercalciferol injection 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  Doxercalciferol Injection Dose  > 400 pg/mL  4 mcg 3 times per week at the end of dialysis, or approximately every other day    Dose Titration  iPTH Level  Doxercalciferol Injection Dose  Decrease by < 50% and above 300 pg/mL  Increase by 1 mcg to 2 mcg at 8-week intervals as necessary  Decrease by > 50% and above 300 pg/mL  Maintain  150 to 300 pg/mL  Maintain  < 100 pg/mL  Suspend for one week, then resume at a dose that is at least 1 mcg lower

    Discard unused portion.

  • Roxane Laboratories, Inc.
    Doxercalciferol | Roxane Laboratories, Inc.
    No Recall

    Doxercalciferol | Roxane Laboratories, Inc.

    Doxercalciferol | Roxane Laboratories, Inc.
    Adult Administration

    The optimal dose of Doxercalciferol Capsules 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/1.73 m2)

    Target "intact" PTH (pg/mL)

    3

    30 to 59

    35 to 70

    4

    15 to 29

    70 to 110

    5

    <15 (or dialysis)

    150 to 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 Dis 42:S1-S202, 2003 (suppl 3)

    Dialysis

    The recommended initial dose of Doxercalciferol Capsules 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 doxercalciferol 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 Doxercalciferol Capsules 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

    Doxercalciferol Dose

    >400 pg/mL

    10 mcg three times per week at dialysis

    Dose Titration

    iPTH Level

    Doxercalciferol Dose

    Above 300 pg/mL

    Increase by 2.5 mcg at eight-week intervals as necessary

    150 to 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 Doxercalciferol Capsules 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 Doxercalciferol Capsules 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 Doxercalciferol Capsules therapy or following dose adjustments in Doxercalciferol Capsules 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 Doxercalciferol Capsules 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

    Doxercalciferol Dose

    >70 pg/mL (Stage 3)

    1 mcg once per day

    >110 pg/mL (Stage 4)

    Dose Titration

    iPTH Level

    Doxercalciferol Dose

    Above 70 pg/mL (Stage 3)

    Increase by 0.5 mcg at two-week intervals as necessary

    110 pg/mL (Stage 4)

    35 to 70 pg/mL (Stage 3)

    Maintain

    70 to 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

    <70 pg/mL (Stage 4)

    mcg lower

  • Sandoz Inc
    Doxercalciferol | Sandoz Inc
    No Recall

    Doxercalciferol | Sandoz Inc

    Doxercalciferol | Sandoz Inc
    Adult Administration

    For intravenous use only. The optimal dose of doxercalciferol injection must be carefully determined for each patient.

    The recommended initial dose of doxercalciferol injection 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 doxercalciferol injection 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:

    Tablet 5: Initial Dosing

    iPTH Level

    Doxercalciferol Injection Dose

    >400 pg/mL

    4 mcg three times per week at the end of dialysis, or approximately every other day

    Dose Titration

    iPTH Level

    Doxercalciferol Injection 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 lower

    Discard unused portion.

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