Paricalcitol capsules may be taken without regard to food. Chronic Kidney Disease (CKD) Stages 3 and 4 in Adults: Administration of Paricalcitol soft gel capsules orally once daily or three times a week. When dosing three times weekly, do not administer more frequently than every other day.Initial Dose: Recommended Paricalcitol Starting Dose Based Upon Baseline PTH Level-Baseline intact parathyroid hormone (IPTH) Level: <500 pg/ml Daily Dose: 1 mcg Three Times a Week Dose*: 2 mcg
Baseline intact parathyroid hormone (IPTH) Level: >500 pg/ml Daily Dose: 2 mcg Three Times a Week Dose*: 4 mcg Dose Titration: Recommended Paricalcitol Dose Titration Base upon IPTH Level-IPTH Level Relative to Baseline: The same, increased or decreased by less than 30% Daily Dose: Increase dose by 1 mcg Three Times a Week Dose*: Increase dose by 2 mcg
IPTH Level Relative to Baseline: Decreased by more than or equal to 30% and less than or equal to 60% Daily Dose: Maintain dose Three Times a Week Dose*: Maintain dose
IPTH Level Relative to Baseline: Decreased by more than 60% or iPTH less than 60 pg/ml Daily Dose: Decrease dose by 1 mcg Three Times a Week Dose*: Decrease dose by 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:Initial Dose: Administer the dose of Paricalcitol capsules orally three times a week, no more frequently than every other day based upon the following formula: Dose (micrograms) baseline PTH (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.Dose Titration: Individualize and titrate Paricalcitol dose based on iPTH, serum calcium and phosphorus levels to maintain an iPTH level within target range. Every 4 weeks, each administered Paricalcitol 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. Paricalcitol 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 Paricalcitol 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 Paricalcitol 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 meg. Paricalcitol 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 Paricalcitol, during dose titration periods and during co-administration with strong CYP3A inhibitors. If hypercalcemia is observed, the dose of Paricalcitol should be reduced or withheld until these parameters are normalized.
