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Paricalcitol (paricalcitol)

Vitamin D Injection Vial (Ml)

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Last reviewed · Source: First Databank (FDB) drug data

Overview

Paricalcitol (19-nor-1alpha-25-dihydroxyvitamin D2) is a synthetic vitamin D analog.

USES: Paricalcitol is a man-made active form of vitamin D, which is needed for building and keeping strong bones. Paricalcitol is used in patients with long-term kidney disease to treat or prevent high levels of a certain natural substance made by the body (parathyroid hormone). Too much parathyroid hormone can cause serious problems such as bone disorders.

Most people get enough vitamin D from exposure to the sun and from fortified food products (such as dairy products, vitamins). Before regular vitamin D can be used by the body, it needs to be changed to the active form by the liver and kidneys. People with kidney disease cannot make enough of the active form of vitamin D.

Vitamin D helps control parathyroid hormone and the levels of certain minerals (such as calcium, phosphorus) that are needed for building and keeping strong bones.

Generic name: paricalcitol
Pronunciation: (PAR-i-KAL-si-tol)
Drug class: Vitamin D
Therapeutic class: Metabolic Modifiers

Reference product & biosimilars

No reference, biosimilar or interchangeable associated with this drug.

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Indications

The following indications are listed for Paricalcitol:

  • Hyperparathyroidism Secondary To Chronic Renal Failure

Also known as: Hyperparathyroidism Secondary To Crf.

Dosing

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.

Drug interactions

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Contraindications

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Adverse reactions

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Precautions

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ICD codes

CodeTypeDescription
Hyperparathyroidism secondary to chronic renal failure
N25.81ICD10CMSecondary hyperparathyroidism of renal origin

ICD code information from First Databank (FDB).

Formulary status

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Last reviewed · Source: First Databank (FDB) drug data