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.

About Hectorol®

Consistent vitamin D: The way it's meant to be

Hectorol® (doxercalciferol capsules and injection) is a vitamin D2 analog 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).

Only Hectorol® is clinically proven to maintain consistent serum concentrations of vitamin D hormone.1,2

Hectorol Healthcare Stage 5-1

1,25D levels illustrated above were observed in osteopenic post-menopausal women with normal kidney and liver function treated with Hectorol Injection and in normal young adults treated with Hectorol Capsules.

Mean steady state concentrations of 1,25D were similar in normal subjects, in mildly and severely hepatically impaired patients, and renal patients administered Hectorol. 

  • Upton and colleagues (2003) investigated the pharmacokinetic properties of Hectorol Injection in a range of single and multiple doses administered to volunteers with and without renal and/or hepatic function1
  • Serial blood samples were assayed by high performance liquid chromatography radioimmunoassay for the metabolite 1,25-dihydroxyvitamin D [1,25(OH)2D2]1
  • Hectorol Injection data are based on a crossover study of 22 postmenopausal osteopenic women with normal kidney and liver function who were administered a single dose of Hectorol Injection or Hectorol Capsules1
  • Hectorol Capsule data are based on a crossover study of 24 normal subjects who were administered Hectorol Capsules (5 or 15 mg) every 48 hours for 5 doses1
Hectorol Is a Vitamin D Analog that is Uniquely Activated and Provides Consistent 1,25D Levels

Activation of vitamin D2,3

Hectorol Healthcare About 2

 

 Hectorol's unique prohormone structure and hepatic activation are similar to the body's natural metabolism of vitamin D.2

 The final step in converting vitamin D to the active hormone 1,25 dihydroxyvitamin D (1,25 dihydroxycholecalciferol [1,25 D3] or 1,25 dihydroxyergocalciferol [1,25 D2]) takes place in the kidney.2,4

The respective 1,25D compounds are released into the plasma where they travel to vitamin D receptors on target organs.2,41-α hydroxylase is present in tissues other than kidney, but the primary pathway for synthesis is in the kidney.2,4 Thus, the capacity to produce 1,25D diminishes with declining kidney function.5

 

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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. Upton RA, Knutson JC, Bishop CW, LeVan LW. 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 analogues. Semin Dial. 2002;15:352-357.

  3. Dusso AS, Brown AJ, Slatopolsky E. Vitamin D. Am J Physiol Renal Physiol. 2005;289:F8-F28.

  4. Drueke TB, Moe SM, Langman CB. Treatment approaches in CKD. In: Olgaard K, ed. Clinical guide to bone and mineral metabolism in CKD. New York, NY: National Kidney Foundation. 2006:111-137.

  5. Kidney Disease: Improving Global Outcomes (KDIGO) CKD-MBD Work Group. KDIGO clinical practice guidelines for the diagnosis, evaluation, prevention, and treatment of chronic kidney disease-mineral and bone disorder (CKD-MBD). Kidney Int. 2009; 76(suppl 113):S1-S130.