Jane S. Ricciuti, RPh, MS


June 03, 2004

In This Article

Vitamin D

(paricalcitol) Injection

Manufacturer: Abbott

Drug Approval Classification: Supplemental New Drug Application (Approval Date: 03/31/04)

New Indication: This supplemental NDA provides for the use of Zemplar (paricalcitol) injection in pediatric patients with chronic kidney disease stage 5 (end-stage renal disease).

Clinical Summary: Paricalcitol was studied in a 12-week, randomized, double-blind, placebo-controlled study of 29 pediatric patients, aged 5-19 years, with end-stage renal disease on hemodialysis; nearly all patients had received some form of vitamin D prior to the study. Paricalcitol dose was adjusted in 0.04-mcg/kg increments based on the levels of serum iPTH, calcium, and Ca × P. No subjects in either the paricalcitol group or placebo group developed hypercalcemia (defined as at least 1 calcium value > 11.2 mg/dL) during the study.

Zemplar (Paricalcitol) Injection Labeling

Zemplar (Paricalcitol) Injection