• A vitamin D receptor activator specifically designed to reduce PTH. In clinical trials with individualized dosing and monitoring, mean calcium and phosphorus levels were maintained within normal limits
• 91% of Zemplar Capsules-treated patients (vs 13% of the placebo-treated patients) achieved two consecutive >30% iPTH reductions from baseline in three 24-week, double-blind, placebo-controlled, randomized, multicenter clinical trials in CKD stage 3 and 4 patients
• The incidences of hypercalcemia, hyperphosphatemia, and elevated Ca x P product in the Zemplar Capsules-treated patients were similar to the placebo-treated patients

Indication and Important Safety Information

Zemplar capsules are indicated for the prevention and treatment of secondary hyperparathyroidism associated with chronic kidney disease (CKD) Stage 3 and 4

Contraindicated in patients with evidence of vitamin D toxicity, hypercalcemia, or hypersensitivity to any product ingredient

Excessive administration of vitamin D compounds can cause oversuppression of PTH, hypercalcemia, hypercalciuria, hyperphosphatemia, and adynamic bone disease. High intake of calcium and phosphate may lead to similar abnormalities. Progressive hypercalcemia due to overdosage of vitamin D may require immediate medical attention. Chronic hypercalcemia can lead to vascular and soft-tissue calcifications

Withhold pharmacologic doses of vitamin D compounds during treatment with Zemplar

Hypercalcemia may potentiate digitalis toxicity, cardiac arrhythmias, and seizures; use caution with these types of patients. iPTH and serum calcium levels should be monitored closely and dose adjustments of Zemplar may be required if a patient initiates or discontinues therapy with any strong CYP3A4 inhibitor, such as ketoconazole

PTH, calcium and phosphorus levels should be monitored at least every 2 weeks for 3 months after initiation of Zemplar therapy or following dose adjustments, then monthly for 3 months, and every 3 months thereafter. Patient monitoring and individualized dose titration are required to maintain physiologic targets and optimum reduction/levels of PTH. The dose of Zemplar should be reduced or interrupted if hypercalcemia or elevated Ca x P is observed

Patients should be informed to comply with dosage instructions, to adhere to their diet and phosphorus restriction, to take prescribed phosphate binders, and should be knowledgeable about the symptoms of hypercalcemia

Adverse events reported by at least 5% of the Zemplar treated patients and at a frequency of at least twice that of placebo were: allergic reaction (6% vs 2%), rash (6% vs 3%), arthritis (5% vs 1%), and vertigo (5% vs 0%)

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