No

Vitamin D Analog

Prevention and treatment of secondary hyperparathyroidism associated with chronic renal failure. Has been evaluated only in hemodialysis patients.

C

Should not be given to patients with evidence of vitamin D toxicity, hypercalcemia, or hypersensitivity to any of the ingredients of this product

The most frequently reported adverse reactions with paricalcitol include nausea, vomiting, and edema. Chronic administration can place patients at risk of hypercalcemia, elevated calcium-phosphorus product and metastatic calcification; it should not be used in patients with evidence of hypercalcemia or vitamin D toxicity.

The three most frequently reported events in clinical studies were nausea, vomiting, and edema, which are commonly seen in hemodialysis patients.

1% to 10%:

Cardiovascular: Palpitations, peripheral edema (7%)

Central nervous system: Chills, malaise, fever, lightheadedness (5%)

Gastrointestinal: Vomiting (8%), GI bleeding (5%), xerostomia (3%)

Respiratory: Pneumonia (5%)

Miscellaneous: Flu-like symptoms, sepsis

Acute overdose may cause hypercalcemia; monitor serum calcium and phosphorus closely during titration of paricalcitol; dosage reduction/interruption may be required if hypercalcemia develops; chronic use may predispose to metastatic calcification; bone lesions may develop if parathyroid hormone is suppressed below normal

Phosphate or vitamin D-related compounds should not be taken concurrently; digitalis toxicity is potentiated by hypercalcemia

Synthetic vitamin D analog which has been shown to reduce PTH serum concentrations

Protein binding: >99%

Elimination: Hepatobiliary excretion (74%) in healthy subjects; urinary excretion (16%), metabolites represent 51% to 59%

Kinetics have not been investigated in geriatric, pediatric, or hepatically impaired patients

Adults: I.V.: 0.04-0.1 mcg/kg (2.8-7 mcg) given as a bolus dose no more frequently than every other day at any time during dialysis; doses as high as 0.24 mcg/kg (16.8 mcg) have been administered safely; usually start with 0.04 mcg/kg 3 times/week by I.V. bolus, increased by 0.04 mcg/kg every 2 weeks; the dose of paricalcitol should be adjusted based on serum PTH levels, as follows:

Serum PTH level decreased by <30%: Increase paricalcitol dose

Serum PTH level decreased by >30% and <60%: Maintain paricalcitol dose

Serum PTH level decrease by >60%: Decrease paricalcitol dose

Serum PTH level 1.5-3 times upper limit of normal: Maintain paricalcitol dose

Serum calcium and phosphorus should be monitored closely (eg, twice weekly) during dose titration; monitor for signs and symptoms of vitamin D intoxication; serum PTH; in trials, a mean PTH level reduction of 30% was achieved within 6 weeks

May cause dizziness

None reported

No information available to require special precautions

No effects or complications reported

Take as directed; do not increase dosage without consulting prescriber. Adhere to diet as recommended (do not take any other phosphate or vitamin D related compounds while taking paricalcitol). You may experience nausea or vomiting (small frequent meals, frequent mouth care, chewing gums, or sucking lozenges may help); swelling of extremities (elevate feet when sitting); lightheadedness or dizziness (use caution when driving or engaging in tasks requiring alertness until response to drug is known). Report persistent fever, gastric disturbances, abdominal pain or blood in stool, chest pain or palpitations, or signs of respiratory infection or flu. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to be pregnant. Consult prescriber if breast-feeding.

Injection: 5 mcg/mL (1 mL, 2 mL, 5 mL)