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Hectorol

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Hectorol

Hectorol

WARNINGS

Overdosage of any form of vitamin D, including Hectorol, 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 lα,25-(OH)2D2, a potent metabolite of vitamin DI, pharmacologic doses of vitamin D and its derivatives should be withheld during Hectorol (doxercalciferol liquid filled capsule) 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 Hectorol (doxercalciferol liquid filled capsule) in reducing blood PTH levels. If hypercalcemia occurs after initiating Hectorol (doxercalciferol liquid filled capsule) therapy, the dose of Hectorol (doxercalciferol liquid filled capsule) and/or calcium-containing phosphate binders should be decreased. If hyperphosphatemia occurs after initiating Hectorol (doxercalciferol liquid filled capsule) , the dose of Hectorol (doxercalciferol liquid filled capsule) should be decreased and/or the dose of phosphate binders increased. (See dosing recommendations for Hectorol under DOSAGE AND ADMINISTRATION section.)

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

PRECAUTIONS

General

Active vitamin D sterols should not be used as initial treatment of nutritional vitamin D deficiency (as defined by low 25-hydroxy vitamin D). Patients should be checked and treated for nutritional vitamin D deficiency prior to initiating treatment with Hectorol (doxercalciferol liquid filled capsule) .

The principal adverse effects of treatment with Hectorol (doxercalciferol liquid filled capsule) are hypercalcemia, hyperphosphatemia, hypercalciuria, and oversuppression of PTH (iPTH less than 150 pg/mL). Prolonged hypercalcemia can lead to calcification of soft tissues, including the heart and arteries, and hyperphosphatemia can exacerbate hyperparathyroidism. Hypercalciuria can accelerate the onset of renal failure through nephrocalcinosis. Oversuppression of PTH may lead to adynamic bone syndrome. All of these potential adverse effects should be managed by regular patient monitoring and appropriate dosage adjustments. During treatment with Hectorol (doxercalciferol liquid filled capsule) , patients usually require dose titration, as well as adjustment in co-therapy (i.e., dietary phosphate binders) in order to maximize PTH suppression while maintaining serum calcium and phosphorus within prescribed ranges.

Dialysis

In four adequate and well-controlled studies, the incidence of hypercalcemia and hyperphosphatemia increased during therapy with Hectorol (doxercalciferol liquid filled capsule) . The observed increases during Hectorol (doxercalciferol liquid filled capsule) treatment, although occurring at a low rate, underscore the importance of regular safety monitoring of serum calcium and phosphorus levels throughout treatment. Patients with higher pre-treatment serum levels of calcium ( > 10.5 mg/dL) or phosphorus ( > 6.9 mg/dL) were more likely to experience hypercalcemia or hyperphosphatemia. Therefore, Hectorol (doxercalciferol liquid filled capsule) should not be given to patients with a recent history of hypercalcemia or hyperphosphatemia, or evidence of vitamin D toxicity.

Pre-dialysis

In two clinical studies, the incidences of hypercalcemia and hyperphosphatemia during therapy with Hectorol (doxercalciferol liquid filled capsule) were similar to placebo therapy, and no episodes of hypercalciuria were observed. The baseline median 25-(OH) vitamin D levels of patients enrolled in these studies was 17.2 ng/mL. Ninety-three percent of patients had 25-(OH) vitamin D levels less than 30 ng/mL; 26% had 25-(OH) vitamin D levels ≥ 20 to < 30 ng/mL; 58% had levels > 10 to < 20 ng/mL; 7% had levels > 5 to < 10 ng/mL; and 2% had levels < 5 ng/mL. The incidences of hypercalcemia, hyperphosphatemia, and hypercalciuria in patients treated with Hectorol (doxercalciferol liquid filled capsule) for hyperparathyroidism related to pre-dialysis renal insufficiency has not been fully studied when 25-(OH) vitamin D levels are greater than or equal to 30 ng/mL.

Laboratory Tests

Serum or plasma iPTH and serum calcium, phosphorus, and alkaline phosphatase should be determined periodically. In the early phase of treatment for dialysis patients, iPTH, serum calcium, and serum phosphorus should be determined prior to initiation of Hectorol (doxercalciferol liquid filled capsule) treatment and weekly thereafter. For pre-dialysis patients, 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 Hectorol (doxercalciferol liquid filled capsule) therapy or following dose-adjustments in Hectorol (doxercalciferol liquid filled capsule) therapy, then monthly for 3 months, and every 3 months thereafter.

Carcinogenesis, Mutagenesis, Impairment of Fertility

In a 104-week carcinogenicity study in rats, there was an increased incidence of benign and malignant adrenal pheochromocytomas in both males and females at oral doses of 0.04, 0.13 and 0.39 mcg/kg/day ( ≤ 1 times the human exposure in pre-dialysis patients with a maximum recommended dose of 3.5 mcg/day or 24.5 mcg/week). This increased incidence of pheochromocytomas in rats may be due to altered calcium homeostasis by doxercalciferol. No evidence of genetic toxicity was observed in an in vitro bacterial mutagenicity assay (Ames test) or a mouse lymphoma gene mutation assay. Doxercalciferol caused structural chromatid and chromosome aberrations in an in vitro human lymphocyte clastogenicity assay with metabolic activation. However, doxercalciferol was negative in an in vivo mouse micronucleus clastogenicity assay. Doxercalciferol had no effect on male or female fertility in rats at oral doses up to 2.5 mcg/kg/day (approximately 3 times the maximum recommended human dose of 60 mcg/week based on mcg/m2 body surface area).

Use in Pregnancy

Pregnancy Category B

Reproduction studies in rats and rabbits, at doses up to 20 mcg/kg/day and 0.1 mcg/kg/day (approximately 25 times and less than the maximum recommended human dose of 60 mcg/week based on mcg/m2 body surface area, respectively) have revealed no teratogenic or fetotoxic effects due to doxercalciferol. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers

It is not known whether doxercalciferol is excreted in human milk. Because other vitamin D derivatives are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from doxercalciferol, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and efficacy of Hectorol (doxercalciferol liquid filled capsule) in pediatric patients have not been established.

Geriatric Use

Of the 138 patients treated with Hectorol (doxercalciferol liquid filled capsule) Capsules in two Phase 3 clinical studies, 30 patients were 65 years or over. In these studies, no overall differences in efficacy or safety were observed between patients 65 years or older and younger patients.

Hepatic Insufficiency

Since patients with hepatic insufficiency may not metabolize Hectorol (doxercalciferol liquid filled capsule) appropriately, the drug should be used with caution in patients with impaired hepatic function. More frequent monitoring of iPTH, calcium, and phosphorus levels should be done in such individuals.

Last reviewed on RxList: 4/12/2011
This monograph has been modified to include the generic and brand name in many instances.

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