Zemplar Dosage
Medically reviewed by Drugs.com. Last updated on Oct 22, 2020.
Generic name: PARICALCITOL 2ug
Dosage form: capsule, liquid filled
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.
Baseline iPTH Level | Daily Dose | Three Times a Week Dose* |
Less than or equal to 500 pg/mL | 1 mcg | 2 mcg |
More than 500 pg/mL | 2 mcg | 4 mcg |
* To be administered not more often than every other day |
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 less than 30% |
Increase dose by | 1 mcg | 2 mcg |
Decreased by more than or equal to 30% and less than or equal to 60% | Maintain dose | - | - |
Decreased by more than 60% or iPTH less than 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.
Chronic Kidney Disease Stage 5 in Adults
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)].
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)
Administer ZEMPLAR 1 mcg capsule orally three times a week, no more frequently than every other day.
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.
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
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.
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