Generic Name: paricalcitol
Dosage Form: capsule, liquid filled
Indications and Usage for Zemplar
Chronic Kidney Disease Stages 3 and 4
Zemplar Capsules are indicated for the prevention and treatment of secondary hyperparathyroidism associated with Chronic Kidney Disease (CKD) Stages 3 and 4.
Chronic Kidney Disease Stage 5
Zemplar Capsules are indicated for the prevention and treatment of secondary hyperparathyroidism associated with CKD Stage 5 in patients on hemodialysis (HD) or peritoneal dialysis (PD).
Zemplar Dosage and Administration
Chronic Kidney Disease Stages 3 and 4
Zemplar Capsules may be administered daily or three times a week. When dosing three times weekly, the dose should be administered not more frequently than every other day. The total weekly doses for both daily and three times a week dosage regimens are similar [see Clinical Studies (14.1)].
Zemplar Capsules may be taken without regard to food. No dosing adjustment is required in patients with mild and moderate hepatic impairment.
Initial Dose
The initial dose of Zemplar Capsules for CKD Stages 3 and 4 patients is based on baseline intact parathyroid hormone (iPTH) levels.
Baseline iPTH Level Daily Dose Three Times a Week Dose*
≤ 500 pg/mL 1 mcg 2 mcg
> 500 pg/mL 2 mcg 4 mcg
* To be administered not more often than every other day
Dose Titration
Dosing must be individualized and based on serum or plasma iPTH levels, with monitoring of serum calcium and serum phosphorus. The following is a suggested approach to dose titration.
Dose Adjustment at 2 to 4 Week Intervals
iPTH Level Relative to Baseline Zemplar Capsule Dose Daily Dosage Three Times a Week Dosage*
The same, increased or
decreased by < 30% Increase dose by 1 mcg 2 mcg
Decreased by ≥ 30% and ≤ 60% Maintain dose - -
Decreased by > 60% or
iPTH < 60 pg/mL Decrease dose by 1 mcg 2 mcg
* To be administered not more often than every other day
If a patient is taking the lowest dose, 1 mcg, on the daily regimen and a dose reduction is needed, the dose can be decreased to 1 mcg three times a week. If a further dose reduction is required, the drug should be withheld as needed and restarted at a lower dosing frequency. If a patient is on a calcium-based phosphate binder, the phosphate-binder dose may be decreased or withheld, or the patient may be switched to a non-calcium-based phosphate binder. If hypercalcemia or an elevated Ca x P is observed, the dose of Zemplar should be reduced or withheld until these parameters are normalized.
Serum calcium and phosphorus levels should be closely monitored after initiation of Zemplar Capsules, during dose titration periods and during co-administration with strong CYP3A inhibitors [see Warnings and Precautions (5.3), Drug Interactions (7) and Clinical Pharmacology (12.3)].
Chronic Kidney Disease Stage 5
Zemplar Capsules are to be administered three times a week, not more frequently than every other day.
Zemplar Capsules may be taken without regard to food. No dosing adjustment is required in patients with mild and moderate hepatic impairment.
Initial Dose
The initial dose of Zemplar Capsules in micrograms is based on a baseline iPTH level (pg/mL)/80. To minimize the risk of hypercalcemia patients should be treated only after their baseline serum calcium has been adjusted to 9.5 mg/dL or lower [see Clinical Pharmacology (12.2) and Clinical Studies (14
