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

Hectorol® Capsule Dosing for Consistent Control of iPTH in Stages 3 and 4 CKD

  Daily dose
Initial dose per Prescribing Information1 1 mcg/day
Mean dose during 24-week trial2 1.6 mcg/day
Max dose per Prescribing Information1  3.5 mcg/day
 

Assess iPTH levels regularly and titrate the Hectorol dose  based on iPTH levels by 0.5 mcg at 2-week intervals as necessary to achieve KDOQI target goals

Appropriate Dosing is Important

  • In a retrospective analysis of the Hectorol® Registry Outcome in Chronic Kidney Disease (HeROICkdTM), an observational patient registry capturing information on adult patients with CKD Stages 3 or 4 throughout US clinics during a 9-month observation period, patients who started on Hectorol Capsules at less than the recommended initial dose (1 mcg/day for Stage 3 and Stage 4) did not experience the same effective reduction of iPTH.

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. Hectorol (doxercalciferol capsule) [package insert]. Cambridge, MA: Genzyme Corp.; Jan 2009.

  2. Kumar N, Lindberg J, David K, Morris J, Menoyo J. Real-world doxercalciferol treatment in SHPT CKD Stage 3 and 4: an analysis of change in iPTH and accordance to KDOQI recommendations. Am J Nephrol. 2009;29:71-78.

  3. 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.