Important Safety Information
- Zemplar capsules are indicated for the prevention and treatment of secondary hyperparathyroidism (SHPT) 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, and 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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