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CKD Stage 5 on Dialysis
Only Hectorol® (doxercalciferol capsules and injection) is clinically proven to maintain consistent serum concentrations of vitamin D hormone.[1,2]
Mean steady state concentrations of 1,25D were similar in normal subjects and in mild and severe hepatically impaired patients.[1]
Hectorol provides effective iPTH reduction. In a cross-over pivotal trial of Hectorol Capsules and Injection in Stage 5 CKD patients on dialysis:[3]
- 94% of patients who received Hectorol Injection achieved a ³30% reduction in PTH.[3]
- 95% of patients who received 2.5mcg Hectorol Capsules achieved
³ 30% reduction in PTH.[3]
In the same study, patients treated with Hectorol Injection experienced minimal changes in serum calcium and phosphorus levels.[3,4]
hec_m_safety_info
Important Treatment Considerations
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 or call Genzyme Medical Information at 1-800-847-0069.
References
References
1. 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.
2. Bailie GR, Johnson CA. Comparative review of the pharmacokinetics of vitamin D analogs. Seminars in Dialysis. 2002;15:352-357.
3. Maung HM, Elangovan L, Frazao JM, et al. Efficacy and side effects of intermittent intravenous and oral doxercalciferol (1-hydroxyvitamin D2) in dialysis patients with secondary hyperparathyroidism: a sequential comparison. Am J Kidney Dis. 2001;37:532-543.
4. Hectorol (doxercalciferol injection) Package Insert, Cambridge, MA: Genzyme Corp.; 2006.
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