Zemplar
(Paricalcitol)Dosage & Administration
Initial Dosage: CKD Stages 3 and 4 (2.1 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.Initial Dose
Dose Titration
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. 2.3 Pediatric Patients (Ages 10 to 16 Years) CKD Stages 3 and 4 Initial Dose Administer ZEMPLAR 1 mcg capsule orally three times a week, no more frequently than every other day. Dose Titration 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. CKD Stage 5 Initial Dose 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 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 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. | |||||||||||||||||||||||||||||||||||||
| Adult: Baseline iPTH ≤ 500 pg/mL | 1 mcg orally daily or 2 mcg three times a week* | ||||||||||||||||||||||||||||||||||||
| Adult: Baseline iPTH > 500 pg/mL | 2 mcg orally daily or 4 mcg three times a week* | ||||||||||||||||||||||||||||||||||||
| Pediatric: Ages 10 to 16 years | 1 mcg orally three times a week* | ||||||||||||||||||||||||||||||||||||
Dose Titration: CKD Stages 3 and 4 (2.1 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.Initial Dose
Dose Titration
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. 2.3 Pediatric Patients (Ages 10 to 16 Years) CKD Stages 3 and 4 Initial Dose Administer ZEMPLAR 1 mcg capsule orally three times a week, no more frequently than every other day. Dose Titration 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. CKD Stage 5 Initial Dose 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 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 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. | |||||||||||||||||||||||||||||||||||||
| Adult: iPTH same, increased or decreased by < 30% relative to baseline | Increase dose by 1 mcg daily or 2 mcg three times a week* | ||||||||||||||||||||||||||||||||||||
| Adult: iPTH decreased by ≥ 30% and ≤ 60% relative to baseline | Maintain dose | ||||||||||||||||||||||||||||||||||||
| Adult: iPTH decreased by > 60% or iPTH < 60 pg/mL relative to baseline | Decrease dose by 1 mcg daily or 2 mcg three times a week* | ||||||||||||||||||||||||||||||||||||
| Pediatric: Ages 10 to 16 years | Increase each dose by 1 mcg three times a week every 4 weeks or decrease each dose by 1 mcg three times a week at any time based on iPTH, serum calcium and phosphorus levels.* | ||||||||||||||||||||||||||||||||||||
| * Not more frequently than every other day when dosing three times a week. | |||||||||||||||||||||||||||||||||||||
Initial Dosage: CKD Stage 5 (2.2 Chronic Kidney Disease Stage 5 in Adults Initial Dose 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 ) andClinical Studies ( 14.2 )] .Dose Titration 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. 2.3 Pediatric Patients (Ages 10 to 16 Years) CKD Stages 3 and 4 Initial Dose Administer ZEMPLAR 1 mcg capsule orally three times a week, no more frequently than every other day. Dose Titration 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. CKD Stage 5 Initial Dose 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 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 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. | |
| Adult | Dose (micrograms) = baseline iPTH (pg/mL) divided by 80. Administer dose orally three times a week.* |
| Pediatric: Ages 10 to 16 years | Dose (micrograms) = baseline iPTH (pg/mL) divided by 120. Administer dose orally three times a week.* |
Dose Titration: CKD Stage 5 (2.2 Chronic Kidney Disease Stage 5 in Adults Initial Dose 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 ) andClinical Studies ( 14.2 )] .Dose Titration 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. 2.3 Pediatric Patients (Ages 10 to 16 Years) CKD Stages 3 and 4 Initial Dose Administer ZEMPLAR 1 mcg capsule orally three times a week, no more frequently than every other day. Dose Titration 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. CKD Stage 5 Initial Dose 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 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 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. | |
| Adult | Dose in micrograms is based on most recent iPTH (pg/mL) divided by 80 with adjustments based on serum calcium and phosphorous levels. Dose three times a week.* |
| Pediatric: Ages 10 to 16 years | Increase each dose by 1 mcg three times a week every 4 weeks or decrease each dose by 2 mcg three times a week at any time based on iPTH, serum calcium and phosphorus levels.* |
| * Not more frequently than every other day. | |
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Zemplar Prescribing Information
ZEMPLAR is a vitamin D analog indicated in adults and pediatric patients 10 years and older for the prevention and treatment of secondary hyperparathyroidism associated with:
- Chronic kidney disease (CKD) Stages 3 and 4 ().1.1 Chronic Kidney Disease Stages 3 and 4
ZEMPLAR 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.
- CKD Stage 5 in patients on hemodialysis or peritoneal dialysis ().1.2 Chronic Kidney Disease Stage 5
ZEMPLAR 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).
Initial Dosage: CKD Stages 3 and 4 (2.1 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.Initial Dose
Dose Titration
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. 2.3 Pediatric Patients (Ages 10 to 16 Years) CKD Stages 3 and 4 Initial Dose Administer ZEMPLAR 1 mcg capsule orally three times a week, no more frequently than every other day. Dose Titration 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. CKD Stage 5 Initial Dose 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 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 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. | |||||||||||||||||||||||||||||||||||||
| Adult: Baseline iPTH ≤ 500 pg/mL | 1 mcg orally daily or 2 mcg three times a week* | ||||||||||||||||||||||||||||||||||||
| Adult: Baseline iPTH > 500 pg/mL | 2 mcg orally daily or 4 mcg three times a week* | ||||||||||||||||||||||||||||||||||||
| Pediatric: Ages 10 to 16 years | 1 mcg orally three times a week* | ||||||||||||||||||||||||||||||||||||
Dose Titration: CKD Stages 3 and 4 (2.1 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.Initial Dose
Dose Titration
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. 2.3 Pediatric Patients (Ages 10 to 16 Years) CKD Stages 3 and 4 Initial Dose Administer ZEMPLAR 1 mcg capsule orally three times a week, no more frequently than every other day. Dose Titration 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. CKD Stage 5 Initial Dose 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 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 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. | |||||||||||||||||||||||||||||||||||||
| Adult: iPTH same, increased or decreased by < 30% relative to baseline | Increase dose by 1 mcg daily or 2 mcg three times a week* | ||||||||||||||||||||||||||||||||||||
| Adult: iPTH decreased by ≥ 30% and ≤ 60% relative to baseline | Maintain dose | ||||||||||||||||||||||||||||||||||||
| Adult: iPTH decreased by > 60% or iPTH < 60 pg/mL relative to baseline | Decrease dose by 1 mcg daily or 2 mcg three times a week* | ||||||||||||||||||||||||||||||||||||
| Pediatric: Ages 10 to 16 years | Increase each dose by 1 mcg three times a week every 4 weeks or decrease each dose by 1 mcg three times a week at any time based on iPTH, serum calcium and phosphorus levels.* | ||||||||||||||||||||||||||||||||||||
| * Not more frequently than every other day when dosing three times a week. | |||||||||||||||||||||||||||||||||||||
Initial Dosage: CKD Stage 5 (2.2 Chronic Kidney Disease Stage 5 in Adults Initial Dose 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 ) andClinical Studies ( 14.2 )] .Dose Titration 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. 2.3 Pediatric Patients (Ages 10 to 16 Years) CKD Stages 3 and 4 Initial Dose Administer ZEMPLAR 1 mcg capsule orally three times a week, no more frequently than every other day. Dose Titration 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. CKD Stage 5 Initial Dose 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 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 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. | |
| Adult | Dose (micrograms) = baseline iPTH (pg/mL) divided by 80. Administer dose orally three times a week.* |
| Pediatric: Ages 10 to 16 years | Dose (micrograms) = baseline iPTH (pg/mL) divided by 120. Administer dose orally three times a week.* |
Dose Titration: CKD Stage 5 (2.2 Chronic Kidney Disease Stage 5 in Adults Initial Dose 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 ) andClinical Studies ( 14.2 )] .Dose Titration 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. 2.3 Pediatric Patients (Ages 10 to 16 Years) CKD Stages 3 and 4 Initial Dose Administer ZEMPLAR 1 mcg capsule orally three times a week, no more frequently than every other day. Dose Titration 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. CKD Stage 5 Initial Dose 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 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 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. | |
| Adult | Dose in micrograms is based on most recent iPTH (pg/mL) divided by 80 with adjustments based on serum calcium and phosphorous levels. Dose three times a week.* |
| Pediatric: Ages 10 to 16 years | Increase each dose by 1 mcg three times a week every 4 weeks or decrease each dose by 2 mcg three times a week at any time based on iPTH, serum calcium and phosphorus levels.* |
| * Not more frequently than every other day. | |
- CKD Stage 5: To avoid hypercalcemia only treat patients after their baseline serum calcium has been reduced to 9.5 mg/dL or lower ().2.2 Chronic Kidney Disease Stage 5 in AdultsInitial Dose
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)andClinical Studies (14.2)].Dose TitrationIndividualize 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.
ZEMPLAR 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”
Lactation: Breastfeeding not recommended (
There is no information available on the presence of paricalcitol in human milk, the effects of the drug on the breastfed infant or the effects of the drug on milk production. Studies in rats have shown that paricalcitol and/or its metabolites are present in the milk of lactating rats; however, due to specifies-specific differences in lactation physiology, animal data may not reliably predict drug levels in human milk
Following a single oral administration of 20 mcg/kg of radioactive [3H] paricalcitol to lactating rats, the concentrations of total radioactivity was determined. Lower levels of total radioactivity were present in the milk compared to that in the plasma of the dams indicating that low levels of [3H] paricalcitol and/or its metabolites are secreted into milk. Exposure of the pups to [3H] paricalcitol through milk was confirmed by the presence of radioactive material in the pups’ stomachs.
ZEMPLAR capsules should not be given to patients with evidence of
- hypercalcemia or
- vitamin D toxicity [see Warnings and Precautions (5.1 Hypercalcemia
Progressive hypercalcemia due to overdosage of vitamin D and its metabolites may be so severe as to require emergency attention
[see Overdosage (10)]. Acute hypercalcemia may exacerbate tendencies for cardiac arrhythmias and seizures and may potentiate the action of digitalis. Chronic hypercalcemia can lead to generalized vascular calcification and other soft-tissue calcification. Concomitant administration of high doses of calcium-containing preparations or thiazide diuretics with ZEMPLAR may increase the risk of hypercalcemia. High intake of calcium and phosphate concomitant with vitamin D compounds may lead to serum abnormalities requiring more frequent patient monitoring and individualized dose titration. Patients also should be informed about the symptoms of elevated calcium, which include feeling tired, difficulty thinking clearly, loss of appetite, nausea, vomiting, constipation, increased thirst, increased urination and weight loss.Prescription-based doses of vitamin D and its derivatives should be withheld during ZEMPLAR treatment to avoid hypercalcemia.
)].
Excessive administration of vitamin D compounds, including ZEMPLAR capsules, can cause over suppression of PTH, hypercalcemia, hypercalciuria, hyperphosphatemia, and adynamic bone disease.