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Hectorol® (doxercalciferol capsules and injection) 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).[1,2]
Only Hectorol® is clinically proven to maintain consistent serum concentrations of vitamin D hormone.[3,4]
Hectorol’s unique prohormone structure and hepatic activation are similar to the body’s natural metabolism of vitamin D.[4]
Activation of vitamin D[4,5]
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. Hectorol (doxercalciferol capsules) Package Insert, Cambridge, MA: Genzyme Corp.;2008.
2. Hectorol (doxercalciferol injection) Package Insert, Cambridge, MA: Genzyme Corp.;2006.
3. 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.
4. Bailie GR, Johnson CA. Comparative review of the pharmacokinetics of vitamin D analogs. Seminars in Dialysis. 2002;15:352-357.
5. Dusso AS, Brown AJ, Slatopolsky E. Vitamin D. Am J Physiol Renal Physiol. 2005;289:F8-F28.
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500 Kendall Street
Cambridge, MA 02142
T: 800 847 0069
F: 617 252 7600
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