Zemplar Injection

Generic name: Paricalcitol

Drug class: Active form of vitamin D

Dosage form: Injection (solution)

Route of administration: Intravenous (IV) injection

Dose:

• Adults: Initial dose of 0.04 to 0.1 mcg/kg (2.8 to 7 mcg), administered as a bolus dose through a hemodialysis vascular access port at any time during dialysis. Maximum frequency: every other day. Dose adjustments may be made based on intact parathyroid hormone (iPTH) levels. Maximum recommended dose: 0.24 mcg/kg.
• Pediatric patients (5 years and older): For iPTH levels less than 500 pg/mL: initial dose of 0.04 mcg/kg three times per week. For iPTH levels 500 pg/mL or higher: initial dose of 0.08 mcg/kg three times per week. Dose adjustments may be made based on iPTH levels.

Mechanism of action: Paricalcitol is a synthetic analog of calcitriol, the active form of vitamin D. It binds to the vitamin D receptor, inhibiting parathyroid hormone (PTH) synthesis and secretion, thereby reducing elevated PTH levels in patients with chronic kidney disease on dialysis.

Drug usage cases:

• Prevention and treatment of secondary hyperparathyroidism associated with chronic kidney disease Stage 5 on dialysis.

Drug contraindications:

• Hypersensitivity to paricalcitol or any component of the formulation.
• Evidence of vitamin D toxicity.
• Hypercalcemia.

Side effects:

• Common: Diarrhea, nausea, vomiting, dizziness, high blood pressure, allergic reactions, and swelling.
• Serious: Hypercalcemia, hypercalciuria, hyperphosphatemia, suppression of PTH, and adynamic bone disease.

Warnings:

• Risk of hypercalcemia: Monitor serum calcium, phosphorus, and iPTH levels regularly.
• Use with caution in patients with severe hepatic impairment; safety has not been established.
• Not recommended during pregnancy and breastfeeding.

Use during pregnancy or breastfeeding: Paricalcitol is not recommended for use during pregnancy and breastfeeding due to potential risks to the fetus or nursing infant.