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

Proven iPTH reduction with Hectorol® Capsules and Injection in patients with SHPT on dialysis

Hectorol® reduced iPTH with low indicidence of hypercalcemia* and hyperphosphatemia† in Stage 5 CKD1 

 

In an open-label, sequential comparison study, patients with stage 5 chronic kidney disease (CKD) treated with intravenous (IV) doxercalciferol, iPTH levels were reduced with low incidence of hypercalcemia or hyperphosphatemia.

Maung et al assessed the efficacy and safety of IV doxercalciferol in 64 and 70 hemodialysis patients, respectively, with secondary hyperparathyroidism (SHPT) in an open-label, sequential comparison study.

64 of the 70 patients who entered the IV trial completed both IV and oral trials per protocol. Patients received Hectorol Injection in an open-label fashion for 12 weeks following an 8 week washout period.

The initial dose of Injection was 4 mcg 3 times per week (tiw) with a maximum dose of 5 mcg tiw.

Among those receiving IV doxercalciferol:

  • 94% of patients achieved a >30% decrease in iPTH from baseline
  • Doxercalciferol treatment showed a low incidence of hypercalcemia (0.9% of 813 measurements) and hyperphosphatemia (4.3% of 815 measurements)
  • Mean serum calcium was maintained in a range of 9.1 to 9.7 mg/dL despite use of calcium-based phosphate binders and no aluminum-based binders

*Hypercalcemia  >11.2 mg/dL
†Hyperphosphatemia  >8.0 mg/dL

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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. 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.