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Zemplar Injection
  • Professionals
  • FDA PI

Zemplar Injection

Generic name: paricalcitol
Dosage form: injection, solution
Drug class:Vitamins

Medically reviewed by Drugs.com. Last updated on May 1, 2021.

Indications and Usage for Zemplar Injection

ZEMPLAR is indicated for the prevention and treatment of secondary hyperparathyroidism in patients 5 years of age and older with chronic kidney disease (CKD) on dialysis.

Zemplar Injection 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 ZEMPLAR intravenously through a hemodialysis vascular access port at any time during dialysis. ZEMPLAR may be administered intravenously if an access port is unavailable.
  • Inspect ZEMPLAR visually prior to administration; the solution should appear clear and colorless. Do not use if the solution is not clear or particles are present.
  • Discard unused portion of 2 mcg/mL and 5 mcg/mL single-dose vials.

2.2 Starting Dose and Dose Titration in Adults

  • Initiate ZEMPLAR 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 ZEMPLAR 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 intact PTH levels every 2 to 4 weeks after initiation of therapy or dose adjustment.
  • Titrate the dose of ZEMPLAR 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 a...