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.

Dialysis

Hectorol® Dosing for Consistent Control of iPTH in CKD Patients on Dialysis

Hectorol®(doxercalciferol capsule and injection) dosing must be individualized and based on intact parathyroid hormone (iPTH) levels with monitoring of serum calcium and serum phosphorus levels.1,2

Hectorol Capsules Hectorol Injection
Dosage strengths: 0.5 mcg, 1 mcg, 2.5 mcg Dosage strengths: 2mcg/mL vial, 4 mcg/2 mL vial
Recommended starting dose is 10 mcg three times per week at dialysis for an iPTH level >400 pg/mL per the Package Insert * Recommended starting dose is 4 mcg three times a week for an iPTH level >400 pg/mL per the Package Insert *
Mean weekly dose at week 12 was 22.6 mcg/wk in a retrospective analysis of 64 dialysis patients in a pivotal trial3 Mean weekly dose at week 12 was 10.8 mcg/wk in a retrospective analysis of 64 hemodialysis patients in a pivotal trial3

*Please see the Package Insert for dosing instructions for patients with an iPTH level of <400 pg/mL.

Our Renal Clinical Consultant Team is a dedicated resource that can assist with Hectorol treatment protocol development and/or dosing questions.

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. 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.

  3. Hectorol (doxercalciferol injection) [package insert]. Cambridge, MA: Genzyme Corp.; Nov 2008.