1.1 Chronic Kidney Disease Stages 3 and 4
ZEMPLAR capsules are indicated in adults and pediatric patients 10 years of age and older for the prevention and treatment of secondary hyperparathyroidism associated with Chronic Kidney Disease (CKD) Stages 3 and 4.
1.2 Chronic Kidney Disease Stage 5
ZEMPLAR capsules are indicated in adults and pediatric patients 10 years of age and older for the prevention and treatment of secondary hyperparathyroidism associated with CKD Stage 5 in patients on hemodialysis (HD) or peritoneal dialysis (PD).
2 DOSAGE AND ADMINISTRATION
2.1 Chronic Kidney Disease Stages 3 and 4 in Adults
Administer ZEMPLAR capsules orally once daily or three times a week [see Clinical Studies].
When dosing three times weekly, do not administer more frequently than every other day.
2.2 Chronic Kidney Disease Stage 5 in Adults
Initial Dose
Administer the dose of ZEMPLAR capsules orally three times a week, no more frequently than every other day based upon the following formula:
Dose (micrograms) = baseline iPTH (pg/mL) divided by 80
Treat patients only after their baseline serum calcium has been adjusted to 9.5 mg/dL or lower to minimize the risk of hypercalcemia[see Clinical Pharmacology and Clinical Studies].
Dose Titration
Individualize the dose of ZEMPLAR based on iPTH, serum calcium and phosphorus levels. Titrate ZEMPLAR dose based on the following formula:
Dose (micrograms) = most recent iPTH level (pg/ml) divided by 80
If serum calcium is elevated, the dose should be decreased by 2 to 4 micrograms.
As iPTH approaches the target range, small, individualized dose adjustments may be necessary in order to achieve a stable iPTH. In situations where monitoring of iPTH, Ca or P occurs less frequently than once per week, a more modest initial and dose titration ratio (e.g., iPTH divided by 100) may be warranted.
2.3 Pediatric Patients (Ages 10 to 16 Years)
CKD Stages 3 and 4
Initial Dose
Administer ZEMPLAR 1 mcg capsule orally three times a week, no more frequently than every other day.
Dose Titration
Individualize and titrate ZEMPLAR dose based on iPTH, serum calcium and phosphorus levels to maintain an iPTH level within target range.
Every 4 weeks, each administered ZEMPLAR dose may be increased in 1 mcg increments, maintaining the three times per week regimen (e.g., increase from 1 mcg three times per week to 2 mcg three times per week). At any time, each administered dose may be decreased by 1 mcg. ZEMPLAR may be stopped if the patient requires reduction while receiving 1 mcg three times per week, resuming when appropriate.
CKD Stage 5
Initial Dose
Administer the dose of ZEMPLAR capsules orally three times a week, no more frequently than every other day based upon the following formula:
Dose* (micrograms) = baseline iPTH (pg/mL) divided by 120 * Round down to the nearest whole number
Dose Titration
Subsequent dosing should be individualized and based on iPTH, serum calcium and phosphorus levels to maintain an iPTH level within target range.
Every 4 weeks, each administered ZEMPLAR dose may be increased in 1 mcg increments, maintaining the three times per week regimen (e.g., increase from 1 mcg three times per week to 2 mcg three times per week). At any time, each administered dose may be decreased by 2 mcg.
ZEMPLAR may be stopped if the patient requires reduction while receiving 2 mcg three times per week or 1 mcg three times per week, resuming when appropriate.
DESCRIPTION
Paricalcitol, USP, the active ingredient in ZEMPLAR capsul |
