Medical Information
United States
 

In order to provide you with relevant and meaningful content we need to know more about you.

Please choose the category that best describes you.

Existe información en español para pacientes y cuidadores, para acceder, haga clic sobre “Select” al lado de “I am a U.S. Patient / Caregiver”.

This content is intended for U.S. Healthcare Professionals. Would you like to proceed?

paricalcitol injection Dosage and Administration

2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Information

  • Ensure serum calcium is not above the upper limit of normal before initiating treatment [see Warnings and Precautions (5.1)].
  • Administer Paricalcitol Injection intravenously through a hemodialysis vascular access port at any time during dialysis.
  • Do not inject Paricalcitol Injection directly into a vein.
  • Inspect Paricalcitol Injection visually prior to administration; the solution should appear clear and colorless. Do not use if the solution is not clear or particles are present.

2.2 Starting Dose and Dose Titration in Adults

  • Initiate Paricalcitol Injection as an intravenous bolus dose of 0.04 mcg/kg to 0.1 mcg/kg (2.8 mcg to 7 mcg) no more frequently than every other day at any time during dialysis.
  • Target the maintenance dose of Paricalcitol Injection to intact parathyroid hormone (PTH) levels within the desired therapeutic range and serum calcium within normal limits.
  • Monitor serum calcium frequently (e.g., twice weekly) and phosphorus and intact PTH levels every 2 to 4 weeks after initiation of therapy or dose adjustment.
  • Titrate the dose of Paricalcitol Injection based on intact PTH (see Table 1). Prior to raising the dose, ensure serum calcium is within normal limits. The maximum daily adult dose is 0.24 mcg/kg.
  • Suspend or decrease the dose if intact PTH is persistently and abnormally low to reduce the risk of adynamic bone disease [see Warnings and Precautions (5.3)] or if serum calcium is consistently above the normal range to reduce the risk of hypercalcemia [see Warnings and Precautions (5.1)]. If dose suspension is necessary, restart at a reduced dose after laboratory values have normalized.
Table 1. Recommended Paricalcitol Injection Adult Dose Titration Based Upon Intact PTH
Intact PTH Level at Follow-up VisitDosage Adjustment
*
The maximum daily adult dose is 0.24 mcg/kg
Above target and intact PTH increasedIncrease* by 2 mcg to 4 mcg every 2 to 4 weeks
Above target and intact PTH decreased by less than 30%Increase* by 2 mcg to 4 mcg every 2 to 4 weeks
Above target and intact PTH decreased by 30% to 60%No change
Above target and intact PTH decreased by more than 60%Decrease per clinical judgement
At target and intact PTH stableNo change

2.3 Starting Dose and Dose Titration for Pediatric Patients 5 Years of Age and Above

  • 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
  • Administer Paricalcitol Injection three times per week, no more frequently than every other day, at any time during dialysis.
  • Target the maintenance dose of Paricalcitol Injection to intact PTH levels within the desired therapeutic range and serum calcium within normal limits.
  • Monitor serum calcium frequently (e.g., twice weekly) and phosphorus and intact PTH levels every 2 to 4 weeks after initiation of therapy or dose adjustment.
  • Titrate the dose of Paricalcitol Injection based on intact PTH (see Table 2). Prior to raising the dose, ensure serum calcium is within normal limits.
  • Suspend or decrease the dose if intact PTH is persistently and abnormally low to reduce the risk of adynamic bone disease [see Warnings and Precautions (5.3)] or if serum calcium is consistently above the normal range to reduce the risk of hypercalcemia [see Warnings and Precautions (5.1)]. If dose suspension is necessary, restart at a reduced dose after laboratory values have normalized.
Table 2. Recommended Paricalcitol Injection Pediatric Dose Titration Based Upon Intact PTH - Patients 5 Years of Age and Older
Intact PTH Level at Follow-up VisitDosage Adjustment
Above target and intact PTH decreased by less than 30%Increase by 0.04 mcg/kg every 2 to 4 weeks
Intact PTH 150 pg/mL or greater and decreased by 30% to 60%No change
Intact PTH less than 150 pg/mL or decreased by more than 60%Decrease by 0.04 mcg/kg weekly, or by 50% if decreased dose equals zero

2.4 Drug Interactions that May Require Dosage Adjustments of Paricalcitol Injection

  • Increased monitoring of serum calcium and dose adjustment of Paricalcitol Injection may be necessary when given concomitantly with drugs that may increase the risk of hypercalcemia [see Drug Interactions (7)].
  • Increased monitoring of both serum calcium and intact PTH as well as dose adjustment of Paricalcitol Injection may be necessary when given concomitantly with strong CYP3A inhibitors [see Drug Interactions (7)].
Did you find an answer to your question? Yes No
Didn’t find what you were looking for? Contact us.
Report Adverse Event