Secondary hyperparathyroidism or hypocalcemia:

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.

Adult:

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 (no more often than 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 (no more often than every other day); treat only after baseline serum calcium adjusted to ≤9.5mg/dL. Dose titration: see full labeling.

Children:

Take without regard to food. <10yrs: not established. 10–16yrs: CKD Stages 3/4: initially 1mcg 3 times weekly (no more often than every other day). CKD Stage 5: base initial dose on baseline iPTH level (pg/mL)/120; give 3 times a week (no more often than every other day). Dose titration: see full labeling.

Contraindications:

Vit. D toxicity. Hypercalcemia.

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.

Pharmacologic Class:

Vit. D analog.

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.

Adverse Reactions:

Diarrhea, nasopharyngitis, dizziness, vomiting, hypertension, hypersensitivity, nausea, edema; hypercalcemia, hypercalciuria, hyperphosphatemia, suppression of PTH, adynamic bone disease.

Generic Availability:

YES

How Supplied:

Caps—30; Single-dose vials (2mcg, 5mcg)—25; Multi-dose vials (5mcg)—25