Paricalcitol (paricalcitol)

Paricalcitol dosage must be individualized carefully according to serum or plasma intact parathyroid hormone (iPTH) concentrations and serum calcium and phosphorus concentrations. In patients receiving oral paricalcitol, serum calcium, serum phosphorus, and serum or plasma iPTH concentrations should be monitored at least every 2 weeks for 3 months after initiation of therapy or after subsequent dosage changes, then monthly for 3 months (once the dosage is stabilized), and every 3 months thereafter. The manufacturer recommends that iPTH concentrations be determined every 3 months in patients receiving parenteral paricalcitol; more frequent monitoring may be necessary during dosage adjustments. In addition, the manufacturer recommends that serum calcium and phosphorus concentrations be monitored frequently (e.g., twice weekly) during the initial dosage adjustments and after subsequent dosage changes and at least monthly once the dosage is stabilized in patients receiving parenteral paricalcitol.

If use of a potent inhibitor of the cytochrome P-450 (CYP) 3A isoenzyme (e.g., atazanavir, clarithromycin, conivaptan, grapefruit juice, indinavir, itraconazole, ketoconazole, the fixed combination of lopinavir and ritonavir (lopinavir/ritonavir), nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telithromycin, voriconazole) is initiated or discontinued in a patient receiving paricalcitol, serum calcium and iPTH concentrations should be monitored closely; paricalcitol dosage adjustment may be necessary.

Dosage adjustment is not required in patients with mild to moderate hepatic impairment.

Nephrology experts state that the optimal iPTH concentration for patients with stage 3a (estimated glomerular filtration rate (eGFR) 45-59 mL/minute per 1.73 m2) to stage 5 (eGFR less than 15 mL/minute per 1.73 m2) chronic kidney disease (CKD) who are not undergoing dialysis is unknown, but modest increases in iPTH concentration may represent an appropriate adaptive response to declining renal function. For patients with stage 5 CKD undergoing dialysis, some experts suggest that iPTH concentrations may be maintained within a range of approximately 2-9 times the assay's upper limit of normal (ULN) (which may correspond to a range of approximately 130-600 pg/mL for commercially available assays ). Although some clinicians suggest that this range is too broad, available assays for PTH exhibit substantial variability; the previously recommended range of 150-300 pg/mL for patients with stage 5 CKD requiring dialysis was based on an assay that is no longer commercially available. Oversuppression of PTH may increase the risk of adynamic bone disease and should be avoided. (See Uses: Mineral and Bone Disorder Secondary to Chronic Renal Disease, in the Vitamin D Analogs General Statement 88:16.) Nephrology experts currently recommend that the individual values for serum calcium and phosphorus (evaluated together) be used instead of the mathematical construct of calcium times phosphorus product to guide clinical practice.

Paricalcitol is administered orally once daily or 3 times weekly; the drug may be given without regard to meals. When paricalcitol is administered 3 times weekly, the drug should be administered no more frequently than every other day.

Paricalcitol also is administered by direct IV injection at any time during dialysis; the drug should be administered IV no more frequently than every other day.

No dosing information is available for this tab.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

There is no enhanced messaging for this drug.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

There is no enhanced messaging for this drug.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

No enhanced messaging available.

No enhanced messaging available.

No enhanced messaging available.

No enhanced messaging available.

No enhanced messaging available.