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Capsules Prescribing Information
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Hectorol (doxercalciferol) is a vitamin D prohormone indicated for the treatment of secondary hyperparathyroidism (SHPT) in patients with stage 3 or stage 4 chronic kidney disease (capsules) and in patients with chronic kidney disease on dialysis (capsules and injection). Hectorol is available as: 0.5 mcg capsules, 2.5 mcg capsules and 4 mcg/2 mL solution for intravenous injection.

Hectorol is inactive upon administration. Hectorol is activated in the liver to become 1,25D. Activation in the liver results in a sustained release of active vitamin D into the bloodstream without a supraphysiologic spike. This increase in 1,25D results in suppression of PTH.

Hectorol Maintains 1,25D Levels within the Normal Physiologic Range[1] for up to 48 Hours[2]

References

1. Bailie GR, Johnson CA. Comparative review of the pharmacokinetics of vitamin D analogs. Seminars in Dialysis. 2002;15:352-357
2. Upton RA, Knutson JC, Bishop CW, et al. Pharmacokinetics of doxercalciferol, a new vitamin D analogue that lowers parathyroid hormone. Nephrol Dial Transplant. 2003;18:750-758.

hec_m_safety_info
Hectorol is indicated for the treatment of secondary hyperparathyroidism in patients with Stage 3 or Stage 4 chronic kidney disease (capsules) and in patients with chronic kidney disease on dialysis (capsules and injection)∙ Hectorol is contraindicated in patients with a tendency towards hypercalcemia or evidence of vitamin D toxicity ∙ Overdosage of any form of vitamin D is dangerous∙ 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 and soft tissue calcification∙ Pharmacologic doses of vitamin D and its derivatives should be withheld during Hectorol treatment to avoid possible additive effects and hypercalcemia∙ Magnesium-containing antacids and Hectorol should not be administered concomitantly∙ Adverse effects of Hectorol treatment are: hypercalcemia, hyperphosphatemia, hypercalciuria, and oversuppression of iPTH∙ Adverse events reported by ³ 5% of the Hectorol-treated predialysis patients included: infection, chest pain, constipation, dyspepsia, anemia, dehydration, depression, hypertonia, insomnia, paresthesia, increased cough, dyspnea and rhinitis ∙ Adverse events reported by ³ 5% of the Hectorol-treated dialysis patients included: headache, malaise, bradycardia, nausea/vomiting, edema, dizziness, dyspnea, and pruritus. See Hectorol Capsules Full Prescribing Information or Hectorol Injection Full Prescribing Information.


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