Paricalcitol Dosage

Usual Adult Dose for Secondary Hyperparathyroidism

Chronic kidney disease (CKD) stage 3 and 4:
Initial: dosage based on baseline intact parathyroid hormone level (iPTH):
iPTH <= 500 pg/mL: 1 mcg orally once a day or 2 mcg orally three times a week.
iPTH >500 pg/mL: 2 mcg orally once a day or 4 mcg orally three times a week.

Maintenance: dose may be adjusted at 2 to 4 week intervals based on relation of subsequent iPTH levels to baseline iPTH level:
If iPTH levels remain the same, increase, or decrease by less than 30%: increase daily dose by 1 mcg or increase 3 times a week dose by 2 mcg.
If iPTH levels decrease by >= 30% and <= 60 %: maintain current dose.
If iPTH levels decrease by > 60% or iPTH level < 60 pg/mL: decrease daily dose by 1 mcg or decrease 3 times a week dose by 2 mcg.
If patient is on lowest dose on the daily regimen and a dose reduction is necessary, decrease dose to 1 mcg 3 times a week. If a further dose reduction is necessary, withhold the drug as needed and restart at a lower dose when feasible.


Chronic kidney disease (CKD) Stage 5 with dialysis:
Initial: 0.04 to 0.1 mcg/kg administered as an IV bolus dose no more frequently than every other day at any time during dialysis.

Maintenance:
If parathyroid hormone (PTH) levels remain the same or increase, an additional increase in paricalcitol dosage is necessary.
If PTH levels have decreased <30%, increase the paricalcitol dose.
If PTH levels have decreased by >30% but <60%, maintain the current dose.
If PTH levels have decreased more than 60%, decrease the paricalcitol dose.
If PTH levels are 1.5 to 3 times the upper limit of normal, maintain the current dose.
When using paricalcitol injection, the dosage may be increased by 2 to 4 mcg at 2- to 4-week intervals as necessary to produce the desired results. In clinical studies, doses as high as 0.24 mcg/kg (16.8 mcg) have been safely administered.

Renal Dose Adjustments

Paricalcitol is indicated for use in patients with chronic kidney disease.

Liver Dose Adjustments

Patients with mild to moderate hepatic dysfunction require no dosing adjustment. There are no data concerning the pharmacokinetic disposition of paricalcitol in patients with severe liver disease.

Dialysis

Paricalcitol injectable is indicated for use in patients with chronic kidney disease (CKD) Stage 5 requiring hemodialysis.

Paricalcitol oral capsules are not approved by the FDA for use in patients with CKD requiring dialysis.

Other Comments

For paricalcitol injection, serum calcium and phosphorus should be determined (e.g., twice a week) during the initial phase of medication. Once a dosing regimen has been established, monthly calcium and phosphorus levels and quarterly PTH levels are recommended. If an elevated calcium or a calcium x phosphorus product greater than 75 is noted, at any time during therapy, the dosage should be reduced immediately or the drug discontinued until normal levels are obtained. Therapy should then be reinitiated at a lower dosage.

For oral paricalcitol capsules, serum calcium, serum phosphorous, and serum or plasma iPTH should be monitored at least every 2 weeks for 3 months following initiation of oral paricalcitol therapy, or following any dose adjustment in oral paricalcitol dosage, then every month for 3 months, then every 3 months thereafter until discontinuation of paricalcitol therapy. If hypercalcemia or an elevated calcium x phosphorous product is observed, the dose should be reduced or the drug discontinued until these parameters return to normal limits.

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