|
|
CKD Stage 5 on Dialysis
Only Hectorol® (doxercalciferol capsules and injection) is clinically proven to maintain consistent serum concentrations of vitamin D hormone.[1,2]
Mean steady state concentrations of 1,25D were similar in normal subjects and in mild and severe hepatically impaired patients.[1]
Hectorol provides effective iPTH reduction. In a cross-over pivotal trial of Hectorol Capsules and Injection in Stage 5 CKD patients on dialysis:[3]
- 94% of patients who received Hectorol Injection achieved a ³30% reduction in PTH.[3]
- 95% of patients who received 2.5mcg Hectorol Capsules achieved
³ 30% reduction in PTH.[3]
In the same study, patients treated with Hectorol Injection experienced minimal changes in serum calcium and phosphorus levels.[3,4]
hec_m_safety_info
Important Information About Hectorol®
Hectorol 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 Treatment Considerations
- 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
References
1. Upton RA, Knutson JC, Bishop CW, et al. 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 analogs. Seminars in Dialysis. 2002;15:352-357.
3. 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.
4. Hectorol (doxercalciferol injection) Package Insert, Cambridge, MA: Genzyme Corp.; 2006.
|
|
 |
|
|
|
| Contact |
Genzyme Corporation
500 Kendall Street
Cambridge, MA 02142
T: 800 847 0069
F: 617 252 7600
Email Us
|
 |
|
|
|
|
