ZEMPLAR INJECTION Rx
Generic Name and Formulations:
Paricalcitol 2mcg/mL, 5mcg/mL; soln for IV inj; contains alcohol.
Indications for ZEMPLAR INJECTION:
Secondary hyperparathyroidism due to chronic kidney disease Stage 5.
Adults and Children:
Give as IV bolus inj during dialysis. ≥5yrs: Initially 0.04–0.1mcg/kg (2.8–7mcg) no more often than every other day; may increase in increments of 2–4mcg at 2–4 week intervals; max 0.24mcg/kg (16.8mcg). Titrate based on iPTH levels (see full labeling).
Vit. D toxicity. Hypercalcemia.
Risk of hypercalcemia. Monitor serum calcium, phosphorus, and iPTH at least every 2 weeks for 3 months after starting or dose changes, then monthly for 3 months, then every 3 months. If hypercalcemia or elevated Ca x P product occurs, reduce dose or stop until normal. Severe hepatic impairment. Pregnancy. Nursing mothers: not recommended.
Potentiated by potent CYP3A4 inhibitors (eg, ketoconazole, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole); monitor and dose adjustment may be needed. Caps: cholestyramine or mineral oil may impair absorption; separate dosing by ≥1hr before or 4–6hrs after. Avoid concomitant Vit. D, phosphate, calcium-containing products, or thiazide diuretics. Caution with concomitant digitalis compounds; increased toxicity. Concomitant aluminum-containing preparations (eg, antacids, phosphate binder); may cause aluminum bone toxicity.
Vit. D analog.
Diarrhea, nasopharyngitis, dizziness, vomiting, hypertension, hypersensitivity, nausea, edema; hypercalcemia, hypercalciuria, hyperphosphatemia, suppression of PTH, adynamic bone disease.
Caps—30; Vial 2mcg (1mL), 5mcg (1mL, 2mL)—25