Safety
Incidences of hypercalcemia and hyperphosphatemia were similar to placebo
When compared to placebo in CKD Stages 3 and 4 patients, clinical studies of Zemplar Capsules demonstrated:
*Two consecutive serum calcium values >10.5 mg/dL and two consecutive serum phosphorus values >5.5 mg/dL.
- Only 2/106 patients developed hypercalcemia with Zemplar Capsules
- 10% of the Zemplar Capsules-treated patients vs 12% of placebo-treated patients experienced hyper-phosphatemia
- There were no treatment-related adverse events associated with hypercalcemia or hyperphosphatemia in the Zemplar Capsules-treated patients
Incidences of elevated Ca x P product were similar to placebo
- No clinically significant difference in Ca x P between Zemplar Capsules and placebo
In clinical trials, if serum calcium was between 10.4 to 11.0 mg/dL, the dose was reduced irrespective of iPTH, and the dose was withheld if serum calcium was >11.0 mg/dL.
Excessive administration of vitamin D compounds can cause oversuppression of PTH, hypercalcemia, hypercalciuria, hyperphosphatemia, and adynamic bone disease. Progressive hypercalcemia due to overdosage of vitamin D may require immediate medical attention. Chronic hypercalcemia can lead to vascular and soft-tissue calcifications.
No increases in urinary calcium or urinary phosphorus were detected in Zemplar Capsules-treated patients compared to placebo
- No statistically significant change in urinary calcium from baseline to endpoint of study in Zemplar Capsules-treated patients
- Compared to placebo, there was no statistically significant difference in urinary calcium
Zemplar Capsules deliver PTH control with multiple dosing options
