:*4 mcg: oval, yellow capsule imprinted with "PA4"
:*4 mcg: oval, yellow capsule imprinted with "PA4"
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
|offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
|offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
|fdaLIADPed======Condition1=====
|fdaLIADPed======Condition1=====
Line 122:
Line 116:
<!--Contraindications-->
<!--Contraindications-->
|contraindications=* Condition1
|contraindications=* Paricalcitol capsules should not be given to patients with evidence of
<!--Warnings-->
|warnings=* Description
====Precautions====
* Description
<!--Adverse Reactions-->
<!--Clinical Trials Experience-->
|clinicalTrials=There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label.
=====Body as a Whole=====
=====Cardiovascular=====
=====Digestive=====
=====Endocrine=====
=====Hematologic and Lymphatic=====
=====Metabolic and Nutritional=====
=====Musculoskeletal=====
=====Neurologic=====
=====Respiratory=====
=====Skin and Hypersensitivy Reactions=====
=====Special Senses=====
=====Urogenital=====
:*[[Hypercalcemia]] or
:* Vitamin D toxicity
|warnings=* Excessive administration of vitamin D compounds, including paricalcitol capsules, can cause over suppression of PTH, hypercalcemia, hypercalciuria, hyperphosphatemia, and adynamic bone disease.
=====Miscellaneous=====
'''Hypercalcemia'''
* Progressive [[hypercalcemia]] due to overdosage of vitamin D and its metabolites may be so severe as to require emergency attention. 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 diueretics with paricalcitol 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 paricalcitol treatment to avoid [[hypercalcemia]].
<!--Postmarketing Experience-->
'''Digitalis Toxicity'''
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
=====Body as a Whole=====
* Digitalis toxicity is potentiated by [[hypercalcemia]] of any cause. Use caution when paricalcitol capsules are prescribed concomitantly with digitalis compounds.
'''Laboratory Tests'''
* During the initial dosing or following any dose adjustment of medication, serum calcium, serum phosphorus, and serum or plasma iPTH should be monitored at least every two weeks for 3 months, then monthly for 3 months, and every 3 months thereafter.
=====Cardiovascular=====
* In pre-dialysis patients, paricalcitol capsules may increase serum creatinine and therefore decrease the estimated GFR (eGFR). Similar effects have also been seen with calcitriol.
'''Aluminum Overload and Toxicity'''
* Aluminum-containing preparations (e.g., antacids, phosphate binders) should not be administered chronically with paricalcitol, as increased blood levels of aluminum and aluminum bone toxicity may occur.
|clinicalTrials=* Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
=====Digestive=====
'''CKD Stages 3 and 4'''
* The safety of paricalcitol capsules has been evaluated in three 24-week (approximately six-month), double-blind, placebo-controlled, multicenter clinical studies involving 220 CKD Stages 3 and 4 patients. Six percent (6%) of paricalcitol capsules treated patients and 4% of placebo treated patients discontinued from clinical studies due to an adverse event. Adverse events occurring in the paricalcitol capsules group at a frequency of 2% or greater and more frequently than in the placebo group are presented below:
[[File:XXXXX.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
=====Endocrine=====
* The following adverse reactions, with a causal relationship to paricalcitol, occurred in <2% of the paricalcitol treated patients in the above double-blind, placebo-controlled clinical trial data set.
''Gastrointestinal Disorders'': Dry mouth
''Investigations'': Hepatic enzyme abnormal
=====Hematologic and Lymphatic=====
''Nervous System Disorders'': Dysgeusia
''Skin and Subcutaneous Tissue Disorders'': [[Urticaria]]
'''CKD Stage 5'''
=====Metabolic and Nutritional=====
* The safety of paricalcitol capsules has been evaluated in one 12-week, double-blind, placebo-controlled, multicenter clinical study involving 88 CKD Stage 5 patients. Sixty-one patients received paricalcitol capsules and 27 patients received placebo.
* The proportion of patients who terminated prematurely from the study due to adverse events was 7% for paricalcitol capsules treated patients and 7% for placebo patients.
* Adverse events occurring in the paricalcitol capsules group at a frequency of 2% or greater and more frequently than in the placebo group are as follows:
=====Musculoskeletal=====
[[File:XXXXX.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
* The following adverse reactions, with a causal relationship to paricalcitol, occurred in <2% of the paricalcitol treated patients in the above double-blind, placebo-controlled clinical trial data set.
''Metabolism and Nutrition Disorders'': Decreased appetite, [[hypercalcemia]], [[hypocalcemia]]
''Reproductive System and Breast Disorders'': Breast tenderness
''Skin and Subcutaneous Tissue Disorders'': [[Acne]]
=====Respiratory=====
=====Skin and Hypersensitivy Reactions=====
=====Special Senses=====
|postmarketing=* The following additional adverse reactions have been reported during post-approval use and post-approval clinical trials with the active ingredient in paricalcitol capsules:
=====Urogenital=====
'''Immune System Disorders''': [[angioedema]] (including laryngeal edema)
'''Metabolism and Nutrition Disorders''': [[hypercalcemia]]
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Overview
Paricalcitol (capsule) is an endocrine metabolic agent that is FDA approved for the treatment of chronic kidney disease stages 3,4 and 5. Common adverse reactions include edema, hypertension, diarrhea, nausea, vomiting,dizziness, headache.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Indications
Chronic Kidney Disease Stages 3 and 4
Paricalcitol capsules are indicated for the prevention and treatment of secondary hyperparathyroidism associated with Chronic Kidney Disease (CKD) Stages 3 and 4.
Chronic Kidney Disease Stage 5
Paricalcitol capsules are indicated for the prevention and treatment of secondary hyperparathyroidism associated with CKD Stage 5 in patients on hemodialysis (HD) or peritoneal dialysis (PD).
Dosage
Chronic Kidney Disease Stages 3 and 4
Paricalcitol capsules may be administered daily or three times a week. When dosing three times weekly, the dose should be administered not more frequently than every other day. The total weekly doses for both daily and three times a week dosage regimens are similar.
Paricalcitol capsules may be taken without regard to food. No dosing adjustment is required in patients with mild and moderate hepatic impairment.
Initial Dose
The initial dose of paricalcitol capsules for CKD Stages 3 and 4 patients is based on baseline intact parathyroid hormone (iPTH) levels.
This image is provided by the National Library of Medicine.
Dose Titration
Dosing must be individualized and based on serum or plasma iPTH levels, with monitoring of serum calcium and serum phosphorus. The following is a suggested approach to dose titration.
This image is provided by the National Library of Medicine.
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. If a patient is on a calcium-based phosphate binder, the phosphate-binder dose may be decreased or withheld, or the patient may be switched to a non-calcium-based phosphate binder. If hypercalcemia or an elevated Ca x P is observed, the dose of paricalcitol should be reduced or withheld until these parameters are normalized.
Serum calcium and phosphorus levels should be closely monitored after initiation of paricalcitol capsules, during dose titration periods and during co-administration with strong CYP3A inhibitors.
Chronic Kidney Disease Stage 5
Paricalcitol capsules are to be administered three times a week, not more frequently than every other day.
Paricalcitol capsules may be taken without regard to food. No dosing adjustment is required in patients with mild and moderate hepatic impairment.
Initial Dose
The initial dose of paricalcitol capsules in micrograms is based on a baseline iPTH level (pg/mL)/80. To minimize the risk of hypercalcemia patients should be treated only after their baseline serum calcium has been adjusted to 9.5 mg/dL or lower.
Dose Titration
Subsequent dosing should be individualized and based on iPTH, serum calcium and phosphorus levels. A suggested dose titration of paricalcitol capsules is based on the following formula:
Titration dose (micrograms) = most recent iPTH level (pg/ml)/80
Serum calcium and phosphorus levels should be closely monitored after initiation, during dose titration periods, and with co-administration of strong P450 3A inhibitors. If an elevated serum calcium or elevated Ca x P is observed and the patient is on a calcium-based phosphate binder, the binder dose may be decreased or withheld, or the patient may be switched to a non-calcium-based phosphate binder. If serum calcium or Ca x P are elevated, the dose should be decreased by 2 to 4 micrograms lower than that calculated by the most recent iPTH/80. If further adjustment is required, the dose of paricalcitol capsules should be reduced or withheld until these parameters are normalized.
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/100) may be warranted.
DOSAGE FORMS AND STRENGTHS
Paricalcitol capsules are available as 1 mcg, 2 mcg, and 4 mcg soft gelatin capsules.
1 mcg: oval, gray capsule imprinted with "PA1"
2 mcg: oval, orange-brown capsule imprinted with "PA2"
4 mcg: oval, yellow capsule imprinted with "PA4"
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Paricalcitol (capsule) in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Paricalcitol (capsule) in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Condition1
Dosing Information
Dosage
Condition2
There is limited information regarding FDA-Labeled Use of Paricalcitol (capsule) in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
Condition1
Developed by:
Class of Recommendation:
Strength of Evidence:
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Paricalcitol (capsule) in pediatric patients.
Non–Guideline-Supported Use
Condition1
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Paricalcitol (capsule) in pediatric patients.
Contraindications
Paricalcitol capsules should not be given to patients with evidence of
Excessive administration of vitamin D compounds, including paricalcitol capsules, can cause over suppression of PTH, hypercalcemia, hypercalciuria, hyperphosphatemia, and adynamic bone disease.
Hypercalcemia
Progressive hypercalcemia due to overdosage of vitamin D and its metabolites may be so severe as to require emergency attention. 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 diueretics with paricalcitol 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 paricalcitol treatment to avoid hypercalcemia.
Digitalis Toxicity
Digitalis toxicity is potentiated by hypercalcemia of any cause. Use caution when paricalcitol capsules are prescribed concomitantly with digitalis compounds.
Laboratory Tests
During the initial dosing or following any dose adjustment of medication, serum calcium, serum phosphorus, and serum or plasma iPTH should be monitored at least every two weeks for 3 months, then monthly for 3 months, and every 3 months thereafter.
In pre-dialysis patients, paricalcitol capsules may increase serum creatinine and therefore decrease the estimated GFR (eGFR). Similar effects have also been seen with calcitriol.
Aluminum Overload and Toxicity
Aluminum-containing preparations (e.g., antacids, phosphate binders) should not be administered chronically with paricalcitol, as increased blood levels of aluminum and aluminum bone toxicity may occur.
Adverse Reactions
Clinical Trials Experience
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
CKD Stages 3 and 4
The safety of paricalcitol capsules has been evaluated in three 24-week (approximately six-month), double-blind, placebo-controlled, multicenter clinical studies involving 220 CKD Stages 3 and 4 patients. Six percent (6%) of paricalcitol capsules treated patients and 4% of placebo treated patients discontinued from clinical studies due to an adverse event. Adverse events occurring in the paricalcitol capsules group at a frequency of 2% or greater and more frequently than in the placebo group are presented below:
File:XXXXX.pngThis image is provided by the National Library of Medicine.
The following adverse reactions, with a causal relationship to paricalcitol, occurred in <2% of the paricalcitol treated patients in the above double-blind, placebo-controlled clinical trial data set.
The safety of paricalcitol capsules has been evaluated in one 12-week, double-blind, placebo-controlled, multicenter clinical study involving 88 CKD Stage 5 patients. Sixty-one patients received paricalcitol capsules and 27 patients received placebo.
The proportion of patients who terminated prematurely from the study due to adverse events was 7% for paricalcitol capsules treated patients and 7% for placebo patients.
Adverse events occurring in the paricalcitol capsules group at a frequency of 2% or greater and more frequently than in the placebo group are as follows:
File:XXXXX.pngThis image is provided by the National Library of Medicine.
The following adverse reactions, with a causal relationship to paricalcitol, occurred in <2% of the paricalcitol treated patients in the above double-blind, placebo-controlled clinical trial data set.
The following additional adverse reactions have been reported during post-approval use and post-approval clinical trials with the active ingredient in paricalcitol capsules:
Immune System Disorders: angioedema (including laryngeal edema)
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