A3661-20 Single Shot Epidural 20g Tuohy
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Questions & Answers
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 injection 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 undergoing dialysis. Uncontrolled serum phosphorus exacerbates secondary hyperparathyroidism and can lessen the effectiveness of doxercalciferol injection in reducing blood PTH levels. If hypercalcemia occurs after initiating doxercalciferol injection therapy, the dose of doxercalciferol injection and/or calcium- containing phosphate binders should be decreased. If hyperphosphatemia occurs after initiating doxercalciferol injection, the dose of doxercalciferol injection should be decreased and/or the dose of phosphate binders increased. (See dosing recommendations for doxercalciferol injection under DOSAGE AND ADMINISTRATION section.)
Magnesium-containing antacids and doxercalciferol injection 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
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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
Doxercalciferol Injection is indicated for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis.
History
There is currently no drug history available for this drug.
Other Information
Doxercalciferol, the active ingredient in Doxercalciferol Injection, 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 is available as a sterile, clear, colorless aqueous solution for intravenous injection. Doxercalciferol Injection is supplied in a stoppered 2 mL amber glass vial containing 4 mcg/2 mL. Each vial includes an aluminum seal and gray (4 mcg/2 mL) flip-off cap. Each milliliter (mL) of solution contains doxercalciferol, 2 mcg; alcohol 5% (v/v); Polysorbate 20, 10 mg; sodium chloride, 1.5 mg; butylated hydroxytoluene, 0.02 mg; sodium phosphate dibasic, heptahydrate, 14.4 mg; sodium phosphate monobasic, monohydrate, 1.8 mg; and disodium edetate, 1.1 mg.
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 structural formula presented in Figure 1.
Figure 1: Chemical Structure of Doxercalciferol
Other names frequently used for doxercalciferol are 1 α-hydroxyvitamin D2, 1α-OH-D2, and 1α-hydroxyergocalciferol.
Sources
A3661-20 Single Shot Epidural 20g Tuohy Manufacturers
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Smiths Medical Asd, Inc.
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A3661-20 Single Shot Epidural 20g Tuohy | Akorn, 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 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 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 to 300 pg/mL Maintain <100 pg/mL Suspend for one week, then resume at a dose that is at least 1 mcg lower
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