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DRUG IMAGES
ZEMPLAR 2 MCG/ML VIAL
ZEMPLAR 5 MCG/ML VIAL
ZEMPLAR 10 MCG/2 ML VIAL
ZEMPLAR 2 MCG CAPSULE
ZEMPLAR 1 MCG CAPSULE
The following indications for ZEMPLAR (paricalcitol) have been approved by the FDA:
Indications:
Hyperparathyroidism secondary to chronic renal failure
Professional Synonyms:
Hyperparathyroidism secondary to CRF
Indications:
Hyperparathyroidism secondary to chronic renal failure
Professional Synonyms:
Hyperparathyroidism secondary to CRF
The following dosing information is available for ZEMPLAR (paricalcitol):
Paricalcitol dosage must be individualized carefully according to serum or plasma intact parathyroid hormone (iPTH) concentrations and serum calcium and phosphorus concentrations. In patients receiving oral paricalcitol, serum calcium, serum phosphorus, and serum or plasma iPTH concentrations should be monitored at least every 2 weeks for 3 months after initiation of therapy or after subsequent dosage changes, then monthly for 3 months (once the dosage is stabilized), and every 3 months thereafter. The manufacturer recommends that iPTH concentrations be determined every 3 months in patients receiving parenteral paricalcitol; more frequent monitoring may be necessary during dosage adjustments.
In addition, the manufacturer recommends that serum calcium and phosphorus concentrations be monitored frequently (e.g., twice weekly) during the initial dosage adjustments and after subsequent dosage changes and at least monthly once the dosage is stabilized in patients receiving parenteral paricalcitol.
If use of a potent inhibitor of the cytochrome P-450 (CYP) 3A isoenzyme (e.g., atazanavir, clarithromycin, conivaptan, grapefruit juice, indinavir, itraconazole, ketoconazole, the fixed combination of lopinavir and ritonavir (lopinavir/ritonavir), nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telithromycin, voriconazole) is initiated or discontinued in a patient receiving paricalcitol, serum calcium and iPTH concentrations should be monitored closely; paricalcitol dosage adjustment may be necessary.
Dosage adjustment is not required in patients with mild to moderate hepatic impairment.
Nephrology experts state that the optimal iPTH concentration for patients with stage 3a (estimated glomerular filtration rate (eGFR) 45-59 mL/minute per 1.73 m2) to stage 5 (eGFR less than 15 mL/minute per 1.73 m2) chronic kidney disease (CKD) who are not undergoing dialysis is unknown, but modest increases in iPTH concentration may represent an appropriate adaptive response to declining renal function. For patients with stage 5 CKD undergoing dialysis, some experts suggest that iPTH concentrations may be maintained within a range of approximately 2-9 times the assay's upper limit of normal (ULN) (which may correspond to a range of approximately 130-600 pg/mL for commercially available assays ).
Although some clinicians suggest that this range is too broad, available assays for PTH exhibit substantial variability; the previously recommended range of 150-300 pg/mL for patients with stage 5 CKD requiring dialysis was based on an assay that is no longer commercially available. Oversuppression of PTH may increase the risk of adynamic bone disease and should be avoided. (See Uses: Mineral and Bone Disorder Secondary to Chronic Renal Disease, in the Vitamin D Analogs General Statement 88:16.) Nephrology experts currently recommend that the individual values for serum calcium and phosphorus (evaluated together) be used instead of the mathematical construct of calcium times phosphorus product to guide clinical practice.
The manufacturer states that the initial oral dosage of paricalcitol for the prevention and treatment of secondary hyperparathyroidism in adults with stage 3 or 4 CKD and a baseline serum iPTH concentration of 500 pg/mL or less is 1 mcg daily or 2 mcg 3 times weekly, while the initial dosage of paricalcitol for this indication in adults with stage 3 or 4 CKD and a baseline serum iPTH concentration exceeding 500 pg/mL is 2 mcg daily or 4 mcg 3 times weekly. Dosage of paricalcitol should be adjusted according to the patient's serum or plasma iPTH concentrations. If response is inadequate (i.e., iPTH concentration increases, remains unchanged, or is not reduced by at least 30%), the manufacturer states that dosage of paricalcitol may be increased by 1 mcg daily (e.g., from 1 mcg daily to 2 mcg daily) or 2 mcg 3 times weekly (e.g., from 2 mcg 3 times weekly to 4 mcg 3 times weekly) at 2- to 4-week intervals.
The manufacturer states that dosage of paricalcitol should be maintained in patients whose iPTH concentrations have decreased by 30-60% from baseline values. Dosage of paricalcitol should be reduced as iPTH concentrations decline in response to therapy; if iPTH concentrations decrease by more than 60% or if iPTH concentrations decline to less than 60 pg/mL, the manufacturer states that the dosage of paricalcitol should be reduced by 1 mcg daily or 2 mcg 3 times weekly at 2- to 4-week intervals. Patients receiving the lowest dosage with the daily regimen (i.e., 1 mcg daily) who require a dosage reduction may receive 1 mcg 3 times weekly; if further dosage reduction is needed, paricalcitol therapy should be withheld as needed and reinitiated at a lower dosage by altering the dosing interval.
The manufacturer states that the initial oral dose of paricalcitol (in mcg) for the prevention and treatment of secondary hyperparathyroidism in adults with stage 5 CKD undergoing hemodialysis or peritoneal dialysis may be calculated by dividing the baseline iPTH concentration (in pg/mL) by 80; the calculated dose should be administered 3 times weekly. To minimize the risk of hypercalcemia, therapy should be initiated only in those with an adjusted baseline serum calcium concentration of 9.5 mg/dL or less.
Dosage of paricalcitol should be individualized according to the patient's serum or plasma iPTH concentrations, serum calcium concentrations, and serum phosphorus concentrations. The manufacturer states that the new dose of paricalcitol (in mcg) may be calculated by dividing the most recent iPTH concentration (in pg/mL) by 80. If serum calcium concentrations are elevated, the dose should be decreased by 2-4 mcg.
As the iPTH concentration approaches the target range, small individualized dosage adjustments may be necessary to achieve a stable iPTH concentration. In situations where iPTH, calcium, or phosphorus is monitored less frequently than once weekly, the manufacturer states that a more modest initial and dose-titration ratio (e.g., iPTH concentration divided by 100) may be appropriate.
The initial oral dosage of paricalcitol for the prevention and treatment of secondary hyperparathyroidism in pediatric patients 10-16 years of age with stage 3 or 4 CKD is 1 mcg 3 times weekly. Dosage of paricalcitol should be individualized according to the patient's serum or plasma iPTH concentrations, serum calcium concentrations, and serum phosphorus concentrations to maintain the iPTH concentration within the target range. Dosage may be increased in increments of 1 mcg 3 times weekly (i.e., from 1 mcg 3 times weekly to 2 mcg 3 times weekly) at intervals of 4 weeks.
At any time during therapy, the administered dose may be decreased by 1 mcg. If dosage reduction is needed in a patient receiving the lowest dosage (1 mcg 3 times weekly), paricalcitol therapy should be withheld as needed and resumed when appropriate.
The manufacturer states that the initial oral dose of paricalcitol (in mcg) for the prevention and treatment of secondary hyperparathyroidism in pediatric patients 10-16 years of age with stage 5 CKD undergoing hemodialysis or peritoneal dialysis may be calculated by dividing the baseline iPTH concentration (in pg/mL) by 120; the calculated dose should be rounded down to the nearest whole number and administered 3 times weekly. Dosage of paricalcitol should be individualized according to the patient's serum or plasma iPTH concentrations, serum calcium concentrations, and serum phosphorus concentrations to maintain the iPTH concentration within the target range. Dosage may be increased in increments of 1 mcg 3 times weekly (i.e., from 1 mcg 3 times weekly to 2 mcg 3 times weekly) at intervals of 4 weeks.
At any time during therapy, the administered dose may be decreased by 2 mcg. If dosage reduction is needed in a patient receiving 1 or 2 mcg 3 times weekly, paricalcitol therapy may be withheld as needed and resumed when appropriate.
If hypercalcemia is observed, the dosage of paricalcitol should be reduced or therapy withheld until the concentration has normalized.
The initial dosage of IV paricalcitol for the prevention and treatment of secondary hyperparathyroidism in patients with stage 5 CKD is 0.04-0.1 mcg/kg (2.8-7 mcg) at dialysis (no more frequently than every other day).
The manufacturer states that dosage of paricalcitol should be adjusted according the patient's iPTH concentrations with the goal of reducing iPTH concentrations to no more than 1.5-3 times the upper limit of normal. If response is inadequate (i.e., iPTH concentration increases, remains the same, or is not reduced by at least 30%), the manufacturer states that dosage of paricalcitol may be increased by 2-4 mcg per dose at 2- to 4-week intervals.
The manufacturer states that dosage of paricalcitol should be maintained in patients whose iPTH concentrations have decreased by more than 30 to less than 60% of baseline values or in those with iPTH concentrations 1.5-3 times the upper limit of normal. Dosage of paricalcitol should be reduced as iPTH concentrations decline in response to therapy; if iPTH concentrations decrease by more than 60%, the dosage of paricalcitol should be reduced.
If serum calcium concentrations are elevated, or the serum calcium (in mg/dL) times serum phosphorus (in mg/dL) product (Ca x P) exceeds 75, dosage of paricalcitol should be reduced immediately or therapy withheld. Once these parameters have normalized, therapy can be reinitiated at a lower dosage. In patients receiving a calcium-containing phosphate binder, the dosage of the phosphate binder should be reduced or withheld; alternatively, the patient can be switched to a non-calcium-containing phosphate binder.
In the clinical studies used to establish safety and efficacy of paricalcitol, adults received an initial dosage of 0.04 mcg/kg given 3 times weekly; dose was then increased by 0.04 mcg/kg every 2 weeks until the iPTH concentrations were reduced by 30% or declined to less than 100 pg/mL, the fifth dose escalation reached 0.24
mcg/kg, the serum calcium times serum phosphorous product (Ca x P) was more than 75 within any 2-week period, or serum calcium concentrations were greater than 11.5 mg/dL at any time. In these studies, dose of paricalcitol was reduced by 0.04
mcg/kg if iPTH concentrations decreased to less than 100 pg/mL, serum calcium concentrations were greater than 11.5 mg/dL, or serum calcium times serum phosphorus product (Ca x P) exceeded 75. Dose of paricalcitol was maintained when PTH concentrations decreased by 30% or more (but remained above 100 pg/mL), serum calcium concentrations were less than 11.5
mg/dL, and the serum calcium times serum phosphorus product was acceptable (75 or less).
In a clinical study that evaluated the safety and efficacy of paricalcitol in children 5-19 years of age with end-stage renal disease (ESRD) on hemodialysis, pediatric patients with baseline iPTH concentrations less than 500 pg/mL received an initial dosage of 0.04 mcg/kg administered 3 times weekly while those with baseline iPTH concentrations of at least 500 pg/mL received an initial dosage of 0.08 mcg/kg administered 3 times weekly.
The initial dose was then adjusted in increments of 0.04 mcg/kg based on serum concentrations of iPTH, calcium, and calcium times serum phosphorous product (Ca x P). The mean dose in this study was 4.6
mcg (range: 0.8-9.6 mcg).
In addition, the manufacturer recommends that serum calcium and phosphorus concentrations be monitored frequently (e.g., twice weekly) during the initial dosage adjustments and after subsequent dosage changes and at least monthly once the dosage is stabilized in patients receiving parenteral paricalcitol.
If use of a potent inhibitor of the cytochrome P-450 (CYP) 3A isoenzyme (e.g., atazanavir, clarithromycin, conivaptan, grapefruit juice, indinavir, itraconazole, ketoconazole, the fixed combination of lopinavir and ritonavir (lopinavir/ritonavir), nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telithromycin, voriconazole) is initiated or discontinued in a patient receiving paricalcitol, serum calcium and iPTH concentrations should be monitored closely; paricalcitol dosage adjustment may be necessary.
Dosage adjustment is not required in patients with mild to moderate hepatic impairment.
Nephrology experts state that the optimal iPTH concentration for patients with stage 3a (estimated glomerular filtration rate (eGFR) 45-59 mL/minute per 1.73 m2) to stage 5 (eGFR less than 15 mL/minute per 1.73 m2) chronic kidney disease (CKD) who are not undergoing dialysis is unknown, but modest increases in iPTH concentration may represent an appropriate adaptive response to declining renal function. For patients with stage 5 CKD undergoing dialysis, some experts suggest that iPTH concentrations may be maintained within a range of approximately 2-9 times the assay's upper limit of normal (ULN) (which may correspond to a range of approximately 130-600 pg/mL for commercially available assays ).
Although some clinicians suggest that this range is too broad, available assays for PTH exhibit substantial variability; the previously recommended range of 150-300 pg/mL for patients with stage 5 CKD requiring dialysis was based on an assay that is no longer commercially available. Oversuppression of PTH may increase the risk of adynamic bone disease and should be avoided. (See Uses: Mineral and Bone Disorder Secondary to Chronic Renal Disease, in the Vitamin D Analogs General Statement 88:16.) Nephrology experts currently recommend that the individual values for serum calcium and phosphorus (evaluated together) be used instead of the mathematical construct of calcium times phosphorus product to guide clinical practice.
The manufacturer states that the initial oral dosage of paricalcitol for the prevention and treatment of secondary hyperparathyroidism in adults with stage 3 or 4 CKD and a baseline serum iPTH concentration of 500 pg/mL or less is 1 mcg daily or 2 mcg 3 times weekly, while the initial dosage of paricalcitol for this indication in adults with stage 3 or 4 CKD and a baseline serum iPTH concentration exceeding 500 pg/mL is 2 mcg daily or 4 mcg 3 times weekly. Dosage of paricalcitol should be adjusted according to the patient's serum or plasma iPTH concentrations. If response is inadequate (i.e., iPTH concentration increases, remains unchanged, or is not reduced by at least 30%), the manufacturer states that dosage of paricalcitol may be increased by 1 mcg daily (e.g., from 1 mcg daily to 2 mcg daily) or 2 mcg 3 times weekly (e.g., from 2 mcg 3 times weekly to 4 mcg 3 times weekly) at 2- to 4-week intervals.
The manufacturer states that dosage of paricalcitol should be maintained in patients whose iPTH concentrations have decreased by 30-60% from baseline values. Dosage of paricalcitol should be reduced as iPTH concentrations decline in response to therapy; if iPTH concentrations decrease by more than 60% or if iPTH concentrations decline to less than 60 pg/mL, the manufacturer states that the dosage of paricalcitol should be reduced by 1 mcg daily or 2 mcg 3 times weekly at 2- to 4-week intervals. Patients receiving the lowest dosage with the daily regimen (i.e., 1 mcg daily) who require a dosage reduction may receive 1 mcg 3 times weekly; if further dosage reduction is needed, paricalcitol therapy should be withheld as needed and reinitiated at a lower dosage by altering the dosing interval.
The manufacturer states that the initial oral dose of paricalcitol (in mcg) for the prevention and treatment of secondary hyperparathyroidism in adults with stage 5 CKD undergoing hemodialysis or peritoneal dialysis may be calculated by dividing the baseline iPTH concentration (in pg/mL) by 80; the calculated dose should be administered 3 times weekly. To minimize the risk of hypercalcemia, therapy should be initiated only in those with an adjusted baseline serum calcium concentration of 9.5 mg/dL or less.
Dosage of paricalcitol should be individualized according to the patient's serum or plasma iPTH concentrations, serum calcium concentrations, and serum phosphorus concentrations. The manufacturer states that the new dose of paricalcitol (in mcg) may be calculated by dividing the most recent iPTH concentration (in pg/mL) by 80. If serum calcium concentrations are elevated, the dose should be decreased by 2-4 mcg.
As the iPTH concentration approaches the target range, small individualized dosage adjustments may be necessary to achieve a stable iPTH concentration. In situations where iPTH, calcium, or phosphorus is monitored less frequently than once weekly, the manufacturer states that a more modest initial and dose-titration ratio (e.g., iPTH concentration divided by 100) may be appropriate.
The initial oral dosage of paricalcitol for the prevention and treatment of secondary hyperparathyroidism in pediatric patients 10-16 years of age with stage 3 or 4 CKD is 1 mcg 3 times weekly. Dosage of paricalcitol should be individualized according to the patient's serum or plasma iPTH concentrations, serum calcium concentrations, and serum phosphorus concentrations to maintain the iPTH concentration within the target range. Dosage may be increased in increments of 1 mcg 3 times weekly (i.e., from 1 mcg 3 times weekly to 2 mcg 3 times weekly) at intervals of 4 weeks.
At any time during therapy, the administered dose may be decreased by 1 mcg. If dosage reduction is needed in a patient receiving the lowest dosage (1 mcg 3 times weekly), paricalcitol therapy should be withheld as needed and resumed when appropriate.
The manufacturer states that the initial oral dose of paricalcitol (in mcg) for the prevention and treatment of secondary hyperparathyroidism in pediatric patients 10-16 years of age with stage 5 CKD undergoing hemodialysis or peritoneal dialysis may be calculated by dividing the baseline iPTH concentration (in pg/mL) by 120; the calculated dose should be rounded down to the nearest whole number and administered 3 times weekly. Dosage of paricalcitol should be individualized according to the patient's serum or plasma iPTH concentrations, serum calcium concentrations, and serum phosphorus concentrations to maintain the iPTH concentration within the target range. Dosage may be increased in increments of 1 mcg 3 times weekly (i.e., from 1 mcg 3 times weekly to 2 mcg 3 times weekly) at intervals of 4 weeks.
At any time during therapy, the administered dose may be decreased by 2 mcg. If dosage reduction is needed in a patient receiving 1 or 2 mcg 3 times weekly, paricalcitol therapy may be withheld as needed and resumed when appropriate.
If hypercalcemia is observed, the dosage of paricalcitol should be reduced or therapy withheld until the concentration has normalized.
The initial dosage of IV paricalcitol for the prevention and treatment of secondary hyperparathyroidism in patients with stage 5 CKD is 0.04-0.1 mcg/kg (2.8-7 mcg) at dialysis (no more frequently than every other day).
The manufacturer states that dosage of paricalcitol should be adjusted according the patient's iPTH concentrations with the goal of reducing iPTH concentrations to no more than 1.5-3 times the upper limit of normal. If response is inadequate (i.e., iPTH concentration increases, remains the same, or is not reduced by at least 30%), the manufacturer states that dosage of paricalcitol may be increased by 2-4 mcg per dose at 2- to 4-week intervals.
The manufacturer states that dosage of paricalcitol should be maintained in patients whose iPTH concentrations have decreased by more than 30 to less than 60% of baseline values or in those with iPTH concentrations 1.5-3 times the upper limit of normal. Dosage of paricalcitol should be reduced as iPTH concentrations decline in response to therapy; if iPTH concentrations decrease by more than 60%, the dosage of paricalcitol should be reduced.
If serum calcium concentrations are elevated, or the serum calcium (in mg/dL) times serum phosphorus (in mg/dL) product (Ca x P) exceeds 75, dosage of paricalcitol should be reduced immediately or therapy withheld. Once these parameters have normalized, therapy can be reinitiated at a lower dosage. In patients receiving a calcium-containing phosphate binder, the dosage of the phosphate binder should be reduced or withheld; alternatively, the patient can be switched to a non-calcium-containing phosphate binder.
In the clinical studies used to establish safety and efficacy of paricalcitol, adults received an initial dosage of 0.04 mcg/kg given 3 times weekly; dose was then increased by 0.04 mcg/kg every 2 weeks until the iPTH concentrations were reduced by 30% or declined to less than 100 pg/mL, the fifth dose escalation reached 0.24
mcg/kg, the serum calcium times serum phosphorous product (Ca x P) was more than 75 within any 2-week period, or serum calcium concentrations were greater than 11.5 mg/dL at any time. In these studies, dose of paricalcitol was reduced by 0.04
mcg/kg if iPTH concentrations decreased to less than 100 pg/mL, serum calcium concentrations were greater than 11.5 mg/dL, or serum calcium times serum phosphorus product (Ca x P) exceeded 75. Dose of paricalcitol was maintained when PTH concentrations decreased by 30% or more (but remained above 100 pg/mL), serum calcium concentrations were less than 11.5
mg/dL, and the serum calcium times serum phosphorus product was acceptable (75 or less).
In a clinical study that evaluated the safety and efficacy of paricalcitol in children 5-19 years of age with end-stage renal disease (ESRD) on hemodialysis, pediatric patients with baseline iPTH concentrations less than 500 pg/mL received an initial dosage of 0.04 mcg/kg administered 3 times weekly while those with baseline iPTH concentrations of at least 500 pg/mL received an initial dosage of 0.08 mcg/kg administered 3 times weekly.
The initial dose was then adjusted in increments of 0.04 mcg/kg based on serum concentrations of iPTH, calcium, and calcium times serum phosphorous product (Ca x P). The mean dose in this study was 4.6
mcg (range: 0.8-9.6 mcg).
Paricalcitol is administered orally once daily or 3 times weekly; the drug may be given without regard to meals. When paricalcitol is administered 3 times weekly, the drug should be administered no more frequently than every other day. Paricalcitol also is administered by direct IV injection at any time during dialysis; the drug should be administered IV no more frequently than every other day.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| ZEMPLAR 1 MCG CAPSULE | Maintenance | Adults take 1 capsule (1 mcg) by oral route once daily |
| ZEMPLAR 2 MCG CAPSULE | Maintenance | Adults take 1 capsule (2 mcg) by oral route once daily |
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| PARICALCITOL 1 MCG CAPSULE | Maintenance | Adults take 1 capsule (1 mcg) by oral route once daily |
| PARICALCITOL 2 MCG CAPSULE | Maintenance | Adults take 1 capsule (2 mcg) by oral route once daily |
The following drug interaction information is available for ZEMPLAR (paricalcitol):
There are 1 contraindications.
These drug combinations generally should not be dispensed or administered to the same patient. A manufacturer label warning that indicates the contraindication warrants inclusion of a drug combination in this category, regardless of clinical evidence or lack of clinical evidence to support the contraindication.
| Drug Interaction | Drug Names |
|---|---|
| Burosumab/Oral Phosphates; Active Vitamin D Analogs SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient. MECHANISM OF ACTION: Both burosumab and phosphates or vitamin D may increase serum phosphate levels. This combination may lead to greater increases in serum phosphate than anticipated. CLINICAL EFFECTS: The combination of burosumab with oral phosphates or active vitamin D analogs may result in hyperphosphatemia and may increase the risk of nephrocalcinosis.(1) PREDISPOSING FACTORS: Patients with renal impairment have alterations in mineral metabolism that may increase the risk of hyperphosphatemia.(1) PATIENT MANAGEMENT: The concomitant use of burosumab with oral phosphates or active vitamin D analogs is contraindicated. Discontinue oral phosphate and/or active vitamin D analogs one week before starting burosumab.(1) DISCUSSION: Burosumab restores dysfunctional renal phosphate reabsorption and renal production of 1,25-dihydroxyvitamin D to treat X-linked hypophosphatemia. Additional oral phosphates and/or active vitamin D analogs may raise serum phosphate higher than anticipated. |
CRYSVITA |
There are 0 severe interactions.
There are 3 moderate interactions.
The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.
| Drug Interaction | Drug Names |
|---|---|
| Orlistat/Fat Soluble Vitamins SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: The acetate ester forms of vitamin A and vitamin E must undergo hydrolysis for absorption from the gastrointestinal tract.(1) The enzyme responsible for this hydrolysis is inhibited by orlistat.(2) CLINICAL EFFECTS: Orlistat may reduce absorption of fat soluble vitamins, leading to a deficiency state. PREDISPOSING FACTORS: A pre-existing deficiency of fat soluble vitamins (A,D,E and K) or chronic malabsorption syndrome. PATIENT MANAGEMENT: The inhibition of fat soluble vitamin absorption by orlistat should be borne in mind during implementation of a vitamin supplementation strategy. Patients should be strongly encouraged to take a multivitamin supplement which contains fat soluble vitamins, particularly Vitamin D as it appears most susceptible to this interaction.(4,5) Multivitamin supplements should be taken at least two hours before or after the dose of orlistat, or at bedtime.(4) Patients with chronic malabsorption syndromes should not receive orlistat.(4) DISCUSSION: Adult patients taking orlistat without supplementation showed a greater reduction in vitamin A,D,E and beta-carotene levels compared to placebo during two or more consecutive visits in studies of 1-2 years duration; these patients had normal baseline values prior to orlistat therapy. Low vitamin values in orlistat patients were as follows: low Vitamin D 12%, low beta-carotene 6.1%, low Vitamin E 5.8%, low Vitamin A 2.2%.(4) A pharmacokinetic interaction study showed a 30% reduction in beta-carotene supplement absorption and a 60% decreased in vitamin E acetate absorption with concomitant orlistat.(4) In a study, orlistat produced the vitamin net concentration by approximately 43%.(1) In a study, no statistically significant decrease in vitamin A absorption was observed with concurrent orlistat.(2) In a study, mean vitamin D levels were significantly reduced compared with baseline after one month of orlistat therapy despite multivitamin supplementation.(5) |
ORLISTAT, XENICAL |
| Paricalcitol/Cholestyramine SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Cholestyramine may impair intestinal absorption of fat-soluble vitamins. Paricalcitol is an analogue of a fat-soluble vitamin and therefore cholestyramine may interfere with absorption of paricalcitol.(1) CLINICAL EFFECTS: Concurrent use may result in decreased levels and clinical effects of paricalcitol.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The US manufacturer of paricalcitol capsules recommends that paricalcitol be taken at least 1 hour before or 4-6 hours after taking cholestyramine.(1) DISCUSSION: The manufacturer recommends that administration of paricalcitol capsules be separated from concurrent administration with drugs that impair intestinal absorption of fat-soluble vitamins.(1) |
CHOLESTYRAMINE, CHOLESTYRAMINE LIGHT, CHOLESTYRAMINE RESIN, PREVALITE, QUESTRAN, QUESTRAN LIGHT |
| Colesevelam/Fat Soluble Vitamins SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Colesevelam may decrease the absorption of fat-soluble vitamins A, D, E, and K.(1) CLINICAL EFFECTS: Colesevelam may reduce absorption of fat soluble vitamins, leading to a deficiency state. PREDISPOSING FACTORS: A pre-existing deficiency of fat soluble vitamins (A,D,E and K) or chronic malabsorption syndrome. PATIENT MANAGEMENT: The inhibition of fat soluble vitamin absorption by colesevelam should be borne in mind during implementation of a vitamin supplementation strategy. Oral multivitamin supplements should be taken at least four hours before the dose of colesevelam.(1) DISCUSSION: Colesevelam may decrease the absorption of fat-soluble vitamins A, D, E, and K.(1) |
COLESEVELAM HCL, WELCHOL |
The following contraindication information is available for ZEMPLAR (paricalcitol):
Drug contraindication overview.
No enhanced Contraindications information available for this drug.
No enhanced Contraindications information available for this drug.
There are 1 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Hypervitaminosis D |
There are 2 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Hypercalcemia |
| Hyperphosphatemia |
There are 1 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Digitalis toxicity |
The following adverse reaction information is available for ZEMPLAR (paricalcitol):
Adverse reaction overview.
No enhanced Common Adverse Effects information available for this drug.
No enhanced Common Adverse Effects information available for this drug.
There are 36 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Hypertension Skin rash Vertigo |
Arthritis Bacterial sepsis Chest pain Dehydration Fungal infection Gastrointestinal hemorrhage Hypervolemia Hypoglycemic disorder Hypotension Pneumonia Skin ulcer Urinary tract infection |
| Rare/Very Rare |
|---|
|
Abnormal hepatic function tests Adynamic bone disease Anemia Angioedema Anorexia Atrial flutter Cardiac arrest Cardiac arrhythmia Cerebrovascular accident Glaucoma Hypercalcemia Hyperkalemia Hyperphosphatemia Hypertension Hypocalcemia Hypoparathyroidism Hypotension Laryngeal edema Pulmonary edema Rectal bleeding Syncope |
There are 75 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Diarrhea Dizziness Edema Nausea Sore throat Vomiting |
Abdominal pain with cramps Back pain Chills Constipation Cough Cramps in legs Depression Edema Fever Headache disorder Insomnia Malaise Muscle spasm Pain Palpitations Pruritus of skin Sinusitis Symptoms of anxiety Xerostomia |
| Rare/Very Rare |
|---|
|
Acne vulgaris Acute abdominal pain Acute cognitive impairment Agitation Alopecia Anorexia Arthralgia Chest pain Conjunctival hyperemia Conjunctivitis Constipation Cough Delirium Diarrhea Dizziness Dysgeusia Dysphagia Dyspnea Earache Erectile dysfunction Facial edema Fatigue Gait abnormality Gastritis General weakness Headache disorder Hirsutism Hypoesthesia Influenza Injection site sequelae Insomnia Lymphadenopathy Mastalgia Muscle fasciculation Myalgia Myoclonus Nervousness Night sweats Pain Paresthesia Pharyngitis Photophobia Polydipsia Pruritus of skin Skin rash Syncope Upper respiratory infection Urticaria Wheezing Xerostomia |
The following precautions are available for ZEMPLAR (paricalcitol):
No enhanced Pediatric Use information available for this drug.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
No enhanced Pregnancy information available for this drug.
No enhanced Lactation information available for this drug.
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for ZEMPLAR (paricalcitol):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for ZEMPLAR (paricalcitol)'s list of indications:
| Hyperparathyroidism secondary to chronic renal failure | |
| N25.81 | Secondary hyperparathyroidism of renal origin |
Formulary Reference Tool