Zemplar:

• indicated for the prevention and treatment of secondary hyperparathyroidism (SHPT) associated with chronic kidney disease (CKD) Stage 5³
• the most widely used injectable vitamin D therapy for the treatment of SHPT in the US-more than 200,000 dialysis patients treated since 1998^4,5
• vitamin D analog that maintained calcium and phosphorus within target range⁶
• shown to effectively suppress PTH without significant impact on calcium, phosphorus or Ca x P^1,2,7
• was shown to reduce PTH in dialysis patients with baseline mild to moderate hyperphosphatemia²
• formed through the removal of the 19th carbon group and modifications to the side chain of calcitriol, reducing the calcemic effect^1,3
• has been shown to be effective in a broad range of patients including difficult to treat calcitriol resistant, hyperphosphatemic and hypocalcemic patients.^2,7

Important Safety Information

ZEMPLAR is contraindicated in patients with evidence of vitamin D toxicity, hypercalcemia, or hypersensitivity to any product ingredient.

Chronic administration may place patients at risk for hypercalcemia, elevated Ca x P product, and metastatic calcification. Adynamic bone lesions may develop if PTH is over suppressed. Acute overdose may cause hypercalcemia and may require immediate medical attention.

Hypercalcemia may potentiate digitalis toxicity; use caution with these types of patients.

Withhold phosphate or vitamin D related compounds during treatment with ZEMPLAR.

PTH should be monitored at least every three months and more frequently at initiation and dosage changes. Calcium and phosphorus should be measured at least monthly and more frequently at initiation and during dosage changes. If clinically significant hypercalcemia develops, the dose should be reduced or interrupted.

Adverse events with greater than 5% frequency with ZEMPLAR vs placebo, regardless of causality, were nausea (13% vs. 8%), vomiting (8% vs. 4%), and edema (7% vs. 0%).

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References

1. Martin KJ, Gonzalez EA, Gellens M, et al. 19-nor-1-α-25-dihydroxyvitamin D₂ (paricalcitol) safely and effectively reduces the levels of intact parathyroid hormone in patients on hemodialysis. J Am Soc Nephrol. 1998;9:1427-1432.
2. Lindberg J, Martin KJ, Gonzalez EA, et al. A long-term, multicenter study of the efficacy and safety of paricalcitol in end-stage renal disease. Clin Nephrol. 2001;56:315-323.
3. ZEMPLAR Injection [package insert]. Lake Forest, IL: Abbott Laboratories; 2005.
4. IMS, May 2005.
5. Data on file, Abbott 2005.
6. Clinical data on file, 2003. Abbott Laboratories
7. Llach F, Yudd M. Paricalcitol in dialysis patients with calcitriol-resistant secondary hyperparathyroidism. Am J Kidney Dis. 2001;38(suppl 5):S45-S50.