Generic Name and Formulations:
Paricalcitol 1mcg, 2mcg, 4mcg; soft gel caps.

Company:
AbbVie

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 Dose for ZEMPLAR CAPSULES:
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 week (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.

Children's Dose for ZEMPLAR CAPSULES:
Not established.

See Also:
ZEMPLAR INJECTION

Pharmacological Class:
Vit. D analogue.

Contraindications:
Vit. D toxicity. Hypercalcemia.

Warnings/Precautions:
Severe hepatic impairment. 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. Pregnancy (Cat.C). Nursing mothers: not recommended.

Interactions:
Potentiated by potent CYP3A4 inhibitors (eg, ketoconazole); use with caution and monitor. Arrhythmias with digitalis if hypercalcemia occurs. Caps: cholestyramine or mineral oil may impair absorption. Avoid concomitant Vit. D, phosphate, calcium-containing products, or thiazide diuretics. Concomitant aluminum-containing preparations (eg, antacids, phosphate binder); may cause aluminum bone toxicity.

Adverse Reactions:
Diarrhea, hypertension, dizziness, vomiting; hypercalcemia, hypercalciuria, hyperphosphatemia, suppression of PTH, adynamic bone disease, hypervitaminosis D.

Generic Availability:
YES

How Supplied:
Caps—30; Vial (1mL, 2mL, 4mL)—1