Paricap Soft Capsule

Adults:

Paricalcitol capsules may be taken with or without food. For adults with Chronic Kidney Disease (CKD) stages 3 and 4, Paricalcitol soft gel capsules are given by mouth either once daily or three times a week. When dosing three times weekly, do not administer more often than every other day. Initial dose: the recommended Paricalcitol starting dose is based upon the baseline intact parathyroid hormone (iPTH) level. If the baseline iPTH level is below 500 pg/ml, the daily dose is 1 mcg and the three times a week dose is 2 mcg. If the baseline iPTH level is above 500 pg/ml, the daily dose is 2 mcg and the three times a week dose is 4 mcg. Dose titration: the recommended Paricalcitol dose adjustment is based upon the iPTH level relative to baseline. If the iPTH level is the same, or has increased or decreased by less than 30 percent, increase the daily dose by 1 mcg or the three times a week dose by 2 mcg. If the iPTH level has decreased by 30 percent to 60 percent, maintain the current dose on either schedule. If the iPTH level has decreased by more than 60 percent, or the iPTH is below 60 pg/ml, decrease the daily dose by 1 mcg or the three times a week dose by 2 mcg. In every case, the three times a week dose is to be administered not more often than every other day. If a patient is taking the lowest daily dose of 1 mcg and a dose reduction is needed, the dose can be decreased to 1 mcg three times a week. If a further reduction is required, the drug should be withheld as needed and restarted at a lower dosing frequency. For adults with CKD stage 5, the initial dose of Paricalcitol capsules is given by mouth three times a week, no more often than every other day, based upon the following formula: dose in micrograms equals the baseline PTH in 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 the Paricalcitol dose based on iPTH, serum calcium and phosphorus levels so that the iPTH stays within the target range. Every 4 weeks, each administered Paricalcitol dose may be increased in 1 mcg steps while keeping the three times per week regimen (for example, 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 needs a reduction while receiving 1 mcg three times per week, and resumed when appropriate. An alternative CKD stage 5 initial dose: administer Paricalcitol capsules by mouth three times a week, no more often than every other day, based upon the following formula: dose in micrograms equals the baseline iPTH in pg/mL divided by 120, rounded down to the nearest whole number. Dose titration: later doses should be individualized and based on iPTH, serum calcium and phosphorus levels to keep the iPTH within the target range. Every 4 weeks, each administered Paricalcitol dose may be increased in 1 mcg steps while keeping the three times per week regimen (for example, 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. Paricalcitol may be stopped if the patient needs a reduction while receiving 2 mcg or 1 mcg three times per week, and resumed when appropriate. Monitoring: monitor serum calcium and phosphorus levels closely after starting Paricalcitol, during dose titration periods and during co-administration with strong CYP3A inhibitors. If hypercalcemia is observed, the Paricalcitol dose should be reduced or withheld until these values return to normal.