Important Safety Information
Hectorol (doxercalciferol capsules and injection) is contraindicated in patients with a tendency toward hypercalcemia or current evidence of vitamin D toxicity. Overdosage of any form of vitamin D is dangerous. View additional Important Safety Information.

Stages 3 and 4

Proven iPTH Reduction with Hectorol® Capsules in Patients with SHPT

Hectorol Capsules reduce iPTH in CKD Stages 3 and 4 patients by repleting 1,25(OH)2D while maintaining serum calcium phosphorus product levels1

In a 24-week, double-blind, randomized, placebo-controlled, flexible-dose pivotal trial of 55 patients, those treated with Hectorol Capsules experienced significant reduction in iPTH as early as week 2 compared to placebo-treated patients.

Serum Calcium and Phosphorus Levels were Maintained within Normal Range1

Throughout a 24-week double-blind, randomized, placebo-controlled, flexible-dose, pivotal clinical trial of 55 patients, serum calcium and phosphorus levels in Hectorol-treated patients did not differ significantly from those of placebo-treated patients

  • At week 24, mean corrected calcium levels were 9.23 mg/dL in the Hectorol group versus 9.01 mg/dL in the placebo group (P=NS). Mean levels differed between the two treatment groups only at week 20 (P<0.005).
  • At week 24, mean corrected phosphorus levels were 4.27 mg/dL in the Hectorol group versus 3.92 mg/dL in the placebo group (P=0.047). Mean levels did not change significantly from baseline values with Hectorol, but they were slightly greater than the placebo treated group at week 2 and 24 (P<0.005).

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Product Resources

Product Resources

Product Resources

Indication

Hectorol (doxercalciferol capsules and injection) 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 Safety Information

  • 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

  1. Coburn JW, 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.

  2. National Kidney Foundation. KDOQI clinical practice guidelines for bone metabolism and disease in chronic kidney disease. Am J Kidney Dis.2003;42(suppl 3):S1-S201.