Zemplar Dosage

Chronic Kidney Disease Stages 3 and 4 in Adults

Administer ZEMPLAR capsules orally once daily or three times a week [see Clinical Studies (14.1)]. When dosing three times weekly, do not administer more frequently than every other day.

Initial Dose

Dose Titration

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.

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 (12.2) and Clinical Studies (14.2)].

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.

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.

Monitoring

Monitor serum calcium and phosphorus levels closely after initiation of ZEMPLAR, 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)].

If hypercalcemia is observed, the dose of ZEMPLAR should be reduced or withheld until these parameters are normalized.

Administration

ZEMPLAR capsules may be taken without regard to food.