Paricalcitol

PARICALCITOL- paricalcitol capsule, liquid filled
Zydus Pharmaceuticals USA Inc

1 INDICATIONS AND USAGE

1.1 Chronic Kidney Disease Stages 3 and 4

Paricalcitol capsules are indicated in adults and pediatric patients 10 years of age and older for the prevention and treatment of secondary hyperparathyroidism associated with Chronic Kidney Disease (CKD) Stages 3 and 4.

1.2 Chronic Kidney Disease Stage 5

Paricalcitol capsules are indicated in adults and pediatric patients 10 years of age and older for the prevention and treatment of secondary hyperparathyroidism associated with CKD Stage 5 in patients on hemodialysis (HD) or peritoneal dialysis (PD).

2 DOSAGE AND ADMINISTRATION

2.1 Chronic Kidney Disease Stages 3 and 4 in Adults

Administer paricalcitol 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

Table 1. Recommended Paricalcitol Starting Dose Based upon Baseline iPTH Level

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 Titration

Table 2. Recommended Paricalcitol Dose Titration Base upon iPTH Level

Dose Adjustment at 2 to 4 Week Intervals
iPTH Level Relative to Baseline Paricalcitol Capsule Dose Daily Dosage Three Times a Week Dosage*
The same, increased ordecreased 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% oriPTH 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.

2.2 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 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 paricalcitol based on iPTH, serum calcium and phosphorus levels. Titrate paricalcitol 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.

2.3 Pediatric Patients (Ages 10 to 16 Years)

CKD Stages 3 and 4

Initial Dose

Administer paricalcitol 1 mcg capsule orally three times a week, no more frequently than every other day.

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 mcg. 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.

2.4 Monitoring

Monitor serum calcium and phosphorus levels closely after initiation of paricalcitol, 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 paricalcitol should be reduced or withheld until these parameters are normalized.

2.5 Administration

Paricalcitol capsules may be taken without regard to food.

3 DOSAGE FORMS AND STRENGTHS

Paricalcitol capsules are available as 1 mcg and 2 mcg soft gelatin capsules.

  • 1 mcg: oval, gray capsule imprinted with “ZA”
  • 1 mcg: oval, gray capsule imprinted with the “a” logo and “ZA”
  • 2 mcg: oval, orange-brown capsule imprinted with “ZF”
  • 2 mcg: oval, orange-brown capsule imprinted with the “a” logo and “ZF”

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