Indication

ZEMPLAR^® (paricalcitol) Capsules are indicated for the prevention and treatment of secondary hyperparathyroidism associated with chronic kidney disease (CKD) Stage 3 and 4.¹

ZEMPLAR^® (paricalcitol) Injection is indicated for the prevention and treatment of secondary hyperparathyroidism associated with chronic kidney disease (CKD) Stage 5.²

Important Safety Information^1,2

ZEMPLAR Capsules and Injection are contraindicated in patients with evidence of vitamin D toxicity, hypercalcemia, or hypersensitivity to any product ingredient.

Excessive administration of vitamin D compounds can cause over suppression of parathyroid hormone (PTH), hypercalcemia, hypercalciuria, hyperphosphatemia, and adynamic bone disease. High intake of calcium and phosphate concomitant with vitamin D compounds may lead to similar abnormalities and patient monitoring and individualized dose titration is required. Progressive hypercalcemia due to overdosage of vitamin D may require emergency medical attention. Acute hypercalcemia may exacerbate tendencies for cardiac arrhythmias and seizures and may potentiate the action of digitalis. Use caution when digitalis compounds are prescribed concomitantly with ZEMPLAR. Chronic hypercalcemia can lead to vascular and soft-tissue calcifications. Chronic administration of ZEMPLAR Injection may place patients at risk for hypercalcemia, elevated Ca x P product, and metastatic calcification.

ZEMPLAR is partially metabolized by CYP3A. Care should be taken while dosing ZEMPLAR with ketoconazole and other strong cytochrome P450 3A inhibitors including atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin or voriconazole.

During ZEMPLAR Capsules therapy withhold pharmacologic doses of vitamin D compounds. PTH, calcium and phosphorus levels should be monitored at least every 2 weeks for 3 months after initiation 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 Capsules should be reduced or interrupted if hypercalcemia or elevated Ca x P is observed.

During ZEMPLAR Injection therapy withhold phosphate or vitamin D related compounds. PTH should be monitored at least every 3 months and more frequently at initiation and dosage changes. Calcium and phosphorus should be measured at least monthly and more frequently at initiation or following dosage changes. If clinically significant hypercalcemia develops or an elevated Ca x P product greater than 75 mg²/dL² is noted, the dose should be immediately reduced or interrupted.

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

Adverse events reported by at least 5% and at a frequency of at least twice that of placebo were allergic reaction, rash, arthritis and vertigo for the ZEMPLAR Capsules Stage 3 & 4 treated patients and chills, fever, sepsis, gastrointestinal bleeding, vomiting, edema, light-headedness, and pneumonia for the ZEMPLAR Injection Stage 5 treated patients.

Reference:

^®



Indication ZEMPLAR^® (paricalcitol) Capsules are indicated for the prevention and treatment of secondary hyperparathyroidism associated with chronic kidney disease (CKD) Stage 3 and 4.¹ ZEMPLAR^® (paricalcitol) Injection is indicated for the prevention and treatment of secondary hyperparathyroidism associated with chronic kidney disease (CKD) Stage 5.² Important Safety Information^1,2 ZEMPLAR Capsules and Injection are contraindicated in patients with evidence of vitamin D toxicity, hypercalcemia, or hypersensitivity to any product ingredient. Excessive administration of vitamin D compounds can cause over suppression of parathyroid hormone (PTH), hypercalcemia, hypercalciuria, hyperphosphatemia, and adynamic bone disease. High intake of calcium and phosphate concomitant with vitamin D compounds may lead to similar abnormalities and patient monitoring and individualized dose titration is required. Progressive hypercalcemia due to overdosage of vitamin D may require emergency medical attention. Acute hypercalcemia may exacerbate tendencies for cardiac arrhythmias and seizures and may potentiate the action of digitalis. Use caution when digitalis compounds are prescribed concomitantly with ZEMPLAR. Chronic hypercalcemia can lead to vascular and soft-tissue calcifications. Chronic administration of ZEMPLAR Injection may place patients at risk for hypercalcemia, elevated Ca x P product, and metastatic calcification. ZEMPLAR is partially metabolized by CYP3A. Care should be taken while dosing ZEMPLAR with ketoconazole and other strong cytochrome P450 3A inhibitors including atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin or voriconazole. During ZEMPLAR Capsules therapy withhold pharmacologic doses of vitamin D compounds. PTH, calcium and phosphorus levels should be monitored at least every 2 weeks for 3 months after initiation 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 Capsules should be reduced or interrupted if hypercalcemia or elevated Ca x P is observed. During ZEMPLAR Injection therapy withhold phosphate or vitamin D related compounds. PTH should be monitored at least every 3 months and more frequently at initiation and dosage changes. Calcium and phosphorus should be measured at least monthly and more frequently at initiation or following dosage changes. If clinically significant hypercalcemia develops or an elevated Ca x P product greater than 75 mg²/dL² is noted, the dose should be immediately reduced or interrupted. Patients should be informed to adhere to their diet and phosphorus restriction, to take prescribed phosphate binders and should be knowledgeable about the symptoms of hypercalcemia. While taking ZEMPLAR Capsules patients should be informed to comply with dosage instructions. Adverse events reported by at least 5% and at a frequency of at least twice that of placebo were allergic reaction, rash, arthritis and vertigo for the ZEMPLAR Capsules Stage 3 & 4 treated patients and chills, fever, sepsis, gastrointestinal bleeding, vomiting, edema, light-headedness, and pneumonia for the ZEMPLAR Injection Stage 5 treated patients. Reference: 1. ZEMPLAR^® (paricalcitol) Capsules [package insert]. North Chicago, IL; Abbott Laboratories. 2. ZEMPLAR^® (paricalcitol) Injection [package insert]. Lake Forest, IL; Abbott Laboratories.

Indication

Important Safety Information1,2

Important Safety Information^1,2