HECTOROL SUMMARY
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 a sterile, clear, colorless aqueous solution
for intravenous injection. Hectorol single-use injection is supplied in a stoppered 2 mL amber glass vial containing either 4 mcg/2 mL or 2 mcg/mL. Each vial includes an aluminum seal and
yellow (4 mcg/2 mL) or green (2 mcg/mL) flip-off cap. Each milliliter (mL) of solution contains
doxercalciferol, 2 mcg; ethanol, 100%, 0.05 mL; 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. Hectorol is also supplied as a multi-dose injection contained within a stoppered 2 mL amber glass vial containing 4 mcg/2 mL. Each vial includes an aluminum seal and an orange plastic flip-off cap. Each milliliter (mL) of solution contains doxercalciferol, 2 mcg; ethanol, 100%, 0.075 mL; 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.
Hectorol is indicated for the treatment of secondary
hyperparathyroidism in patients with chronic kidney disease on
dialysis.
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NEWS HIGHLIGHTS
Published Studies Related to Hectorol (Doxercalciferol)
Calcitriol and doxercalciferol are equivalent in controlling bone turnover, suppressing parathyroid hormone, and increasing fibroblast growth factor-23 in secondary hyperparathyroidism. [2011.01]
We compared the effects of calcitriol and doxercalciferol, in combination with either calcium carbonate or sevelamer, on bone, mineral, and fibroblast growth factor-23 (FGF-23) metabolism in patients with secondary hyperparathyroidism. A total of 60 pediatric patients treated with peritoneal dialysis were randomized to 8 months of therapy with either oral calcitriol or doxercalciferol, combined with either calcium carbonate or sevelamer...
A randomized trial of cholecalciferol versus doxercalciferol for lowering parathyroid hormone in chronic kidney disease. [2010.02]
BACKGROUND AND OBJECTIVES: The optimal treatment of secondary hyperparathyroidism in chronic kidney disease (CKD) is unknown... CONCLUSIONS: This prospective, randomized trial demonstrated a within-group reduction in PTH in the doxercalciferol-treated patients but no significant difference between the doxercalciferol and cholecalciferol patients. Larger, long-term studies are needed to demonstrate efficacy of mineral-related and non-mineral-related end points and safety.
Randomized, double-blinded phase II evaluation of docetaxel with or without doxercalciferol in patients with metastatic, androgen-independent prostate cancer. [2008.04.15]
CONCLUSIONS: Daily doxercalciferol with weekly docetaxel did not enhance PSA response rate or survival. Toxicity was similar between arms. Despite the disappointing results of this study, other vitamin D analogues remain under active investigation.
Doxercalciferol safely suppresses PTH levels in patients with secondary hyperparathyroidism associated with chronic kidney disease stages 3 and 4. [2004.05]
BACKGROUND: Calcitriol lowers parathyroid hormone (PTH) levels in patients with chronic kidney disease (CKD) stages 3 and 4, but its use is limited by a low therapeutic index and concerns regarding hypercalcemia and acceleration of kidney disease. We evaluated doxercalciferol (1alpha-hydroxyvitamin D2) as an alternative therapy in a randomized, double-blinded, placebo-controlled, multicenter trial... CONCLUSION: Doxercalciferol is safe and effective in controlling secondary hyperparathyroidism of patients with CKD stages 3 and 4.
Intermittent doxercalciferol (1alpha-hydroxyvitamin D(2)) therapy for secondary hyperparathyroidism. [2000.09]
Hypercalcemia and hyperphosphatemia frequently necessitate vitamin D withdrawal in hemodialysis patients with secondary hyperparathyroidism. In short-term trials, doxercalciferol (1alpha-hydroxyvitamin D(2) [1alphaD(2)]) suppressed intact parathyroid hormone (iPTH) effectively with minimal increases in serum calcium and phosphorus (P) levels...
Clinical Trials Related to Hectorol (Doxercalciferol)
A Phase 4, Conversion Study of Hectorol� Injection to Hectorol� Capsules in Stage 5 CKD Patients on Dialysis [Completed]
Hectorol is a safe and effective treatment of secondary hyperparathyroidism in hemodialysis
patients. Hectorol (doxercalciferol capsules) is indicated for the treatment of secondary
hyperparathyroidism in patients with chronic kidney disease on dialysis and in pre-dialysis
patients with Stage 3 or Stage 4 chronic kidney disease. Hectorol (doxercalciferol
injection) is indicated for the treatment of secondary hyperparathyroidism in patients with
chronic kidney disease on dialysis.
This protocol will determine clinically appropriate doses of Hectorol (doxercalciferol
capsules) when converting subject from Hectorol (doxercalciferol injection.) The study will
enroll hemodialysis patients that have been controlled on intravenous Hectorol. the
information gained from this study will be a useful guide for physicians in managing CKD
Stage 5 patients for whom a change from intravenous to oral vitamin D administration is
appropriate.
Comparison of I.V. CTAP201 and Doxercalciferol (Hectorol) in Subjects With Chronic Kidney Disease (CKD) and Secondary Hyperparathyroidism (SHPT) [Completed]
This study will compare CTAP201 with Doxercalciferol in patients with chronic kidney disease
(CKD) and secondary hyperparathyroidism (SHPT), undergoing regular hemodialysis, at
different dose strengths. This study will also investigate the levels of CTAP201 in the body
over time and determine the safety of CTAP201.
Pilot Study Evaluating Doxercalciferol Replacement Therapy in Kidney Transplant Recipients [Recruiting]
People with kidney transplants often develop bone disease. One reason for bone disease may
be overactivity of a gland in the neck called the parathyroid gland. Overactivity of the
parathyroid gland may be caused by lack of Vitamin D in the body. It has recently been
discovered that many patients with kidney transplants have low Vitamin D levels. The
investigators are examining the effects of doxercalciferol on parathyroid hormone levels,
proteinuria and bone turnover markers in people who have had a kidney transplant.
A Study of Zemplar� Injection and Hectorol� Injection on Intestinal Absorption of Calcium in Chronic Kidney Disease [Completed]
A Study to Evaluate the Safety and Effectiveness of Doxercalciferol Capsules in Participants With Moderate to Severe Psoriasis [Completed]
The purpose of this study was to evaluate the safety and effectiveness of an investigational
drug called doxercalciferol in participants with moderate to severe chronic plaque
psoriasis, in comparison with a placebo ("sugar pill"). All study related care was provided
including doctor visits, physical exams, laboratory tests and study medication. Total length
of participation was 28 weeks.
Reports of Suspected Hectorol (Doxercalciferol) Side Effects
Pancreatitis Acute (16),
Blood Calcium Increased (6),
Anaphylactic Reaction (5),
Amylase Increased (3),
Fall (3),
Muscle Rupture (3),
Fatigue (3),
Malaise (3),
Condition Aggravated (3),
Respiratory Distress (3), more >>
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Page last updated: 2011-12-09
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