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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 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
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FDA Labeling Changes
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Doxercalciferol Capsules are indicated for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis.
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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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:
Other names frequently used for doxercalciferol are 1α-hydroxyvitamin D2, 1α-OH-D2, and 1α-hydroxyergocalciferol.