PARICALCITOL

AbsorptionThe mean absolute bioavailability of Paricalcitol Capsules under low-fat fed condition ranged from 72% to 86% in healthy adult volunteers, CKD Stage 5 patients on HD, and CKD Stage 5 patients on PD. A food effect study in healthy adult volunteers indicated that the C max and AUC 0-∞, were unchanged when paricalcitol was administered with a high fat meal compared to fasting. Food delayed T max by about 2 hours. The AUC 0-∞ of paricalcitol increased proportionally over the dose range of...

14.1 Chronic Kidney Disease Stages 3 and 4 Adults The safety and efficacy of Paricalcitol Capsules were evaluated in three, 24-week, double blind, placebo-controlled, randomized, multicenter, Phase 3 Clinical studies in CKD Stages 3 and 4 patients. Two studies used an identical three times a week dosing design, and one study used a daily dosing design. A total of 107 patients received Paricalcitol Capsules and 113 patients received placebo. The mean age of the patients was 63 years, 68% were male, 71% were Caucasian, and 26% were African-American. The average baseline iPTH was 274 pg/mL (range...

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. 6.1 Clinical Trials Experience CKD Stages 3 and 4 Adults The safety of Paricalcitol Capsules has been evaluated in three 24-week (approximately six-month), double-blind, placebo-controlled, multicenter clinical studies involving 220 ...

Paricalcitol Capsules should not be given to patients with evidence of hypercalcemia or vitamin D toxicity [see Warnings and Precautions (5.1)]. Evidence of hypercalcemia (4). Evidence of vitamin D toxicity (4).

Excessive administration of vitamin D compounds. including Paricalcitol Capsules, can cause over suppression of PTH, hypercalcemia, hypercalciuria, hyperphosphatemia, and adynamic bone disease. 5.1 Hypercalcemia Progressive hypercalcemia due to overdosage of vitamin D and its metabolites may be so severe as to require emergency attention [see Overdosage (10) ] . Acute hypercalcemia may exacerbate tendencies for cardiac arrhythmias and seizures and may potentiate the action of digitalis. Chronic...

7 DRUG INTERACTIONS Table 5 shows the clinically significant drug interactions with Paricalcitol capsules.

Table 5Clinically Significant Drug Interactions with Paricalcitol CYP3A Inhibitors Clinical Impact Paricalcitol is partially metabolized by CYP3A. Hence, exposure of paricalcitol will increase upon coadministration with strong CYP3A inhibitors such as but not limited to: boceprevir, clarith...