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Medical Areas: Endocrinology | Nephrology
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Hectorol (Doxercalciferol) Injection
The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Bone Care International
Approval Status: Approved April 2000
Treatment Area: For the reduction of iPTH levels in mgmt. of secondary hyperparathyroidism in patients undergoing chronic renal dialysis
Hectorol is indicated for the prevention of excessive
parathyroid hormone production in patients with chronic renal
failure who are undergoing chronic hemodialysis.
(Hectorol is also being tested as a treatment for osteoporosis
and prostate cancer.)
Two clinical studies investigated the effects of Hectorol
Injection. The 70 patients involved in the studies all had chronic
renal disease and were on hemodialysis. All of these patients had
been treated with Hectorol Capsules in previous clinical studies.
The patients were given the investigational drug in an open-label
manner over a 12-week period. The drug was administered following
each of 3 dialysis sessions a week at a rate of 4.0 mcg per
injection. However, the dosage was adjusted in order to reach the
targeted iPTH levels of 150 to 300 pg/mL.
The Hectorol Injection resulted in statistically significant
decreases from baseline in mean iPTH levels. 92% of the
participants experienced at least a 30% decrease.
Approximately 74% of the patients treated achieved iPTH levels
less than or equal to 300 pg/mL. 51% of the patients had iPTH
levels less than 150 pg/mL at least on point in the study. However,
the dosages were decreased when this occurred.
In the first study, mean weekly doses ranged from 8.9 mcg to
12.5 mcg. In the second, the mean dosage range was from 9.1 mcg to
Hectorol is contraindicated in patients with a history of
hypercalcemia or evidence of vitamin D toxicity.
Hectorol should not be administered while the patient is taking
other forms of vitamin D, since vitamin D overdose is
Over 10% of patients taking Hectorol experienced one or more of
the following adverse reactions:
- Dyspnea (abnormal breathing [pattern, rate, etc.])
Mechanism of Action
Calcitriol regulates blood calcium at levels required for
essential body functions. Specifically, the biologically active
vitamin D metabolites control the intestinal absorption of dietary
calcium, the tubular reabsorption of calcium by the kidney and, in
conjunction with parathyroid hormone (PTH), the mobilization of
calcium from the skeleton. They act directly on bone cells
(osteoblasts) to stimulate skeletal growth, and on the parathyroid
glands to suppress PTH synthesis and secretion. These functions are
mediated by the interaction of these biologically active
metabolites with specific receptor proteins in the various target
tissues. In uremic patients, deficient production of biologically
active vitamin D metabolites (due to lack of or insufficient
25-hydroxyvitamin D-1-alpha-hydroxylase activity) leads to
secondary hyperparathyroidism, which contributes to the development
of metabolic bone disease in patients with renal failure. (From FDA
Visit the Bone Care
International web site to learn more about
about other products, research, and services provided by the
company that developed this drug.
Health care professionals and patients:
Visit the National Kidney
Foundation web site for more information about current
treatments, research, and news stories in the field of kidney