PARICALCITOL

PARICALCITOL
(par-i-cal'ci-tol)
Zemplar
Classifications: hormone; vitamin d analog;
Therapeutic: vitamin d analog

Prototype: Calcitriol
Pregnancy Category: C

Availability

2 mcg/mL, 5 mcg/mL vial; 1 mcg, 2 mcg, 4 mcg capsules

Action

Synthetic vitamin D analog that reduces parathyroid hormone (PTH) activity levels in chronic kidney failure (CRF) patients. Lowers serum levels of calcium and phosphate. In addition it decreases the parathyroid hormone as well as bone resorption in some patients.

Therapeutic Effect

Effectiveness indicated by iPTH levels <1.5–3 times the nonuremic upper limit of normal.

Uses

Prevention and treatment of secondary hyperparathyroidism associated with CRF.

Contraindications

Hypersensitivity to paricalcitol; hypercalcemia; evidence of vitamin D toxicity; concurrent administration of phosphate preparations and vitamin D; pregnancy (category C); children <5 y.

Cautious Use

Lactation; severe liver disease; concurrent administration of digitalis; abnormally low levels of PTH.

Route & Dosage

CRF-Associated Secondary Hyperparathyroidism
Adult: IV 0.04 mcg/kg–0.1 mcg/kg (max: 0.24 mcg/kg), no more than every other day during dialysis PO iPTH <500 pg/mL, 1 mcg/d or 2 mcg 3 times/wk;  iPTH >500 pg/mL, 2 mcg/d or 4 mcg 3 times/wk
Child (5–17 y): IV 0.04 mcg/kg 3 times/wk during dialysis

Administration

Oral
  • Give no more frequently than every other day when dosing 3 times/wk.
  • Store at 15–30° C (59–86° F).
Intravenous

PREPARE: Direct: Give undiluted.  

ADMINISTER: Direct: Give IV bolus dose anytime during dialysis.  

  • Store at 25° C (77° F). Discard unused portion of a single dose vial.

Adverse Effects (≥1%)

Body as a Whole: Chills, feeling unwell, fever, flu-like symptoms, sepsis, edema. CNS: Lightheadedness. CV: Palpitations. GI: Dry mouth, GI bleeding, nausea, vomiting. Respiratory: Pneumonia. Metabolic: Hypercalcemia.

Interactions

Drug: Hypercalcemia may increase risk of digoxin toxicity; may increase magnesium absorption and toxicity in renal failure. Herbal: Be cautious of vitamin D content in herbal and OTC products.

Pharmacokinetics

Distribution: >99% protein bound. Metabolism: Via CYP3A4. Elimination: Primarily in feces (74%). Half-Life: 15 h.

Nursing Implications

Assessment & Drug Effects

  • Monitor for S&S of hypercalcemia (see Appendix F).
  • Lab tests: Serum calcium and phosphate 2 times a wk during initiation of therapy; then monthly; serum PTH q3mo; periodic serum magnesium, alkaline phosphatase, 24-urinary calcium and phosphate. Increase frequency of lab tests during dosage adjustments.
  • Withhold drug and notify physician if hypercalcemia occurs.
  • Coadministered drugs: Monitor for digoxin toxicity if serum calcium level is elevated.

Patient & Family Education

  • Report immediately any of the following to the physician: Weakness, anorexia, nausea, vomiting, abdominal cramps, diarrhea, muscle or bone pain, or excessive thirst.
  • Adhere strictly to dietary regimen of calcium supplementation and phosphorus restriction to ensure successful therapy.
  • Avoid excessive use of aluminum-containing compounds such as antacids/vitamins.

Common adverse effects in italic, life-threatening effects underlined; generic names in bold; classifications in SMALL CAPS; Canadian drug name; Prototype drug

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