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CKD Stages 3 and 4
Only Hectorol® (doxercalciferol capsules) is clinically proven to maintain consistent serum concentrations of vitamin D hormone.[1,2]
Hectorol effectively reduces iPTH in CKD Stage 3 and Stage 4 patients.[3]
In a 24-week pivotal trial in CKD Stage 3 and 4 patients, more than 70% of Hectorol-treated patients achieved a ³ 30% reduction in mean iPTH from baseline.[3]
In a clinical trail, serum calcium and phosphorus levels in Hectorol-treated patients did not differ significantly from those of placebo-controlled
patients.[3]
hec_m_safety_info
Important Information About Hectorol®
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). Important Treatment Considerations
- Hectorol is contraindicated in patients with a tendency towards hypercalcemia or current 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 ≥ 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 ≥ 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. Coburn JC, Maung HM, Elangovan L, et al. Doxercalciferol safely suppresses PTH levels in patients with secondary hyperparathyroidism associated with chronic kidney disease stages 3 and 4. Am J Kidney Dis. 2004;43:877-890.
4. Hectorol (doxercalciferol capsules) Package Insert, Cambridge, MA: Genzyme Corp.; 2008.
5. National Kidney Foundation, K/DOQI clinical practice guidelines for bone metabolism and disease in chronic kidney disease. Am J Kidney Dis. 2003;42(suppl 3):S1-S201.
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| Contact |
Genzyme Corporation
500 Kendall Street
Cambridge, MA 02142
T: 800 847 0069
F: 617 252 7600
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