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paricalcitol injection Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use PARICALCITOL INJECTION safely and effectively. See full prescribing information for PARICALCITOL INJECTION.

PARICALCITOL injection, for intravenous use
Initial U.S. Approval: 1998

RECENT MAJOR CHANGES

Indications and Usage (1)12/2019
Dosage and Administration (2)12/2019
Contraindications (4)12/2019
Warnings and Precautions (5)12/2019

INDICATIONS AND USAGE

Paricalcitol Injection is a vitamin D2 analog indicated for the prevention and treatment of secondary hyperparathyroidism in patients 5 years of age and older with chronic kidney disease on dialysis (1).

DOSAGE AND ADMINISTRATION

  • Ensure serum calcium is not above the upper limit of normal before initiating (2.1).
  • Administer Paricalcitol Injection intravenously through a hemodialysis vascular access at any time during dialysis (2.1).
  • Do not inject Paricalcitol Injection directly into a vein.

Adult Dose:

  • Initiate at 0.04 mcg/kg to 0.1 mcg/kg (2.8 mcg to 7 mcg) no more frequently than every other day (2.2).
  • Target maintenance dose to intact parathyroid hormone (PTH) levels within the desired therapeutic range and serum calcium within normal limits (2.2).
  • Monitor serum calcium frequently (e.g., twice weekly) and phosphorus and intact PTH levels every 2 to 4 weeks after dose initiation or adjustment (2.2).
  • See Table 1 in the full prescribing information for titration recommendations based upon intact PTH levels (2.2).
  • Suspend or decrease the dose for persistent abnormally low intact PTH or serum calcium consistently above the normal range (2.2).

Pediatric Dose:

  • Initiate Paricalcitol Injection as an intravenous bolus dose of:
    • 0.04 mcg/kg if baseline intact PTH is less than 500 pg/mL, or
    • 0.08 mcg/kg if baseline intact PTH is 500 pg/mL or greater (2.3)
  • Target maintenance dose to intact PTH levels within the desired therapeutic range and serum calcium within normal limits (2.3).
  • Monitor serum calcium frequently (e.g., twice weekly) and phosphorus and intact PTH levels every 2 to 4 weeks after dose initiation or adjustment (2.3).
  • See Table 2 in the full prescribing information for titration recommendations based upon intact PTH levels (2.3).
  • Suspend or decrease the dose for persistent abnormally low intact PTH or serum calcium consistently above the normal range (2.3).

DOSAGE FORMS AND STRENGTHS

Paricalcitol Injection is available as follows (3):

  • 2 mcg/mL multiple-dose vials
  • 5 mcg/mL multiple-dose vials
  • 10 mcg/2 mL (5 mcg/mL) multiple-dose vials

CONTRAINDICATIONS

  • Hypercalcemia (4)
  • Vitamin D toxicity (4)
  • Known hypersensitivity to paricalcitol or any inactive ingredient (4)

WARNINGS AND PRECAUTIONS

  • Hypercalcemia: Can occur during treatment with Paricalcitol Injection and can lead to cardiac arrhythmias and seizures. Severe hypercalcemia may require emergency attention. The risk may be increased when Paricalcitol Injection is used concomitantly with high dose calcium preparations, thiazide diuretics, or vitamin D compounds. Inform patients about symptoms of hypercalcemia and monitor serum calcium prior to initiation and during treatment and adjust dose accordingly (2,5.1).
  • Digitalis Toxicity: Risk increases with hypercalcemia. In patients using digitalis compounds, monitor both serum calcium and patients for signs and symptoms of digitalis toxicity. Monitor more frequently when initiating or adjusting the dose of Paricalcitol Injection (5.2).
  • Adynamic Bone Disease: May develop and increase risk of fractures if intact PTH levels are suppressed to abnormally low levels. Monitor intact PTH levels and adjust dose if needed (5.3).

ADVERSE REACTIONS

The most common adverse reactions (> 5% and more frequent than placebo) are nausea, vomiting, and edema (6.1).


To report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc. at 1-800-441-4100, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

Strong CYP3A Inhibitors: Coadministration with strong CYP3A inhibitors (e.g., ketoconazole) increases Paricalcitol Injection exposure. Dose adjustment may be necessary. Closely monitor intact PTH and serum calcium (2.4, 7).

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 1/2020

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