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Zemplar Injection Generic Name & Formulations
Legal Class
Rx
General Description
Paricalcitol 2mcg/mL, 5mcg/mL; soln for IV inj; contains alcohol.
Pharmacological Class
Vit. D analog.
See Also
How Supplied
Caps—30; Single-dose vials (2mcg, 5mcg)—25; Multi-dose vials (5mcg)—25
Manufacturer
Generic Availability
YES
Zemplar Injection Indications
Indications
Secondary hyperparathyroidism due to chronic kidney disease (CKD) on dialysis.
Zemplar Injection Dosage and Administration
Adult
Give as IV bolus inj during dialysis. 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. Titrate based on iPTH levels (see full labeling).
Children
<5yrs: not established. Give as IV bolus inj during dialysis. ≥5yrs: iPTH <500pg/mL: initially 0.04mcg/kg 3 times weekly (no more often than every other day). iPTH ≥500pg/mL: initially 0.08mcg/kg 3 times weekly. Titrate based on iPTH levels (see full labeling).
Zemplar Injection Contraindications
Contraindications
Vit. D toxicity. Hypercalcemia.
Zemplar Injection Boxed Warnings
Not Applicable
Zemplar Injection Warnings/Precautions
Warnings/Precautions
Risk of hypercalcemia. Monitor serum calcium, phosphorus, and iPTH at least every 2 weeks for 3 months during initiation or after dose adjustments, then monthly for 3 months, then every 3 months thereafter. IV: monitor serum calcium twice weekly and iPTH every 2–4 weeks after initiation or dose adjustment. If hypercalcemia occurs, reduce dose or withhold until normal. Severe hepatic impairment: not studied. Pregnancy. Nursing mothers: not recommended.
Zemplar Injection Pharmacokinetics
See Literature
Zemplar Injection Interactions
Interactions
Potentiated by strong CYP3A4 inhibitors (eg, boceprevir, clarithromycin, conivaptan, grapefruit juice, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, 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. Increased risk of hypercalcemia with concomitant calcium-containing products (at high doses), thiazide diuretics, other Vit. D compounds, phosphate; monitor and may need to adjust paricalcitol dose. Caution with concomitant digitalis compounds; increased toxicity. Concomitant aluminum-containing preparations (eg, antacids, phosphate binders); may cause aluminum bone toxicity.
Zemplar Injection Adverse Reactions
Adverse Reactions
Diarrhea, nasopharyngitis, dizziness, vomiting, hypertension, hypersensitivity, nausea, edema; hypercalcemia, hypercalciuria, hyperphosphatemia, suppression of PTH, adynamic bone disease.
Zemplar Injection Clinical Trials
See Literature
Zemplar Injection Note
Not Applicable
Zemplar Injection Patient Counseling
See Literature
