ZEMPLAR CAPSULES Rx
Generic Name and Formulations:
Paricalcitol 1mcg, 2mcg; soft gel caps.
Indications for ZEMPLAR CAPSULES:
Secondary hyperparathyroidism due to chronic kidney disease (CKD) Stages 3 and 4, or with CKD Stage 5 in patients on hemodialysis or peritoneal dialysis.
Take without regard to food. CKD Stages 3/4: base initial dose on baseline intact parathyroid hormone (iPTH) levels. iPTH ≤500pg/mL: 1mcg daily or 2mcg 3 times weekly (every other day). iPTH >500pg/mL: 2mcg daily or 4mcg 3 times weekly. CKD Stage 5: base initial dose on baseline iPTH level (pg/mL)/80; give 3 times a week (every other day); treat only after baseline serum calcium adjusted to ≤9.5mg/dL. Dose titration: see full labeling.
Take without regard to food. <10yrs: not established. 10–16yrs: CKD Stages 3/4: initially 1mcg 3 times weekly (every other day). CKD Stage 5: base initial dose on baseline iPTH level (pg/mL)/120; give 3 times a week (every other day). Dose titration: 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