Indication

Secondary hyperparathyroidism

Administration

May be taken with or without food.

Adult Dose

Oral\r\nPrevention & Treatment of Secondary Hyperparathyroidism\r\nAssociated with Chronic Kidney Disease (Stage 3 & 4)\r\nPTH <500 pg/mL: 1 mcg PO qDay OR 2 mcg PO 3 times/week\r\nPTH >500 pg/mL: 2 mcg PO qDay OR 4 mcg PO 3 times/week\r\nDo not administer 3 times/week dosing no more frequently than every other day\r\nTitrate dose based on response.\r\n\r\nMonitoring parameters (Stage 3 & 4)\r\nSerum PTH at 2-4 week intervals\r\nPTH same or increased: Increase by 1 mcg/day OR 2 mcg three times/week\r\nPTH decreased <30%: Increase by 1 mcg/day OR 2 mcg three times/week\r\nPTH decreased >30% or <60%: Maintain current dose\r\nPTH decreased >60%: Decrease 1 mcg/day OR 2 mcg three times/week\r\nPTH <60 pg/mL: Decrease 1 mcg/day OR 2 mcg three times/week

Contraindication

Hypersensitivity, Hypercalcemia, hypervitaminosis D

Mode of Action

Synthetic vitamin D analog, reduces parathyroid hormone (PTH).

Precaution

Monitor serum calcium and phosphorus frequently; reduce dose or stop the drug if calcium (in mg/dL) times phosphorus (in mg/dL) product >75\r\nPatients receiving digitalis; digitalis toxicity is potentiated by hypercalcemia\r\nStrong CYP3A4 inhibitors may increase paricalcitol AUC. May increase serum creatinine in pre-dialysis patients. Hepatic impairment\r\n\r\nLactation: not known if distributed into breast milk, use caution

Side Effect

>10%\r\nNausea (13%)\r\n\r\n1-10%\r\nVomiting,Edema,Palpitation,Chills,Pneumonia,Lightheadedness,GI bleeding,Flu,Sepsis,Hypokalemia,Hypercalcemia,Increase in blood creatinine

Interaction

Digitalis; ketoconazole & other strong P450 3A inhibitors including atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole. May interfere absorption w/ cholestyramine (cap only). Increased risk of hypercalcemia w/ prescription-based phosphate or vit D-related medicinal products & Ca-containing prep or thiazide diuretics. Mg- & Al-containing prep (eg, antacids, phosphate-binders).