Paricalcitol (capsule)

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Paricalcitol (capsule)
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]

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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

  • Condition1

Warnings

  • Description

Precautions

  • Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Paricalcitol (capsule) 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
Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Paricalcitol (capsule) 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
Miscellaneous

Drug Interactions

  • Drug
  • Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Paricalcitol (capsule) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Paricalcitol (capsule) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Paricalcitol (capsule) with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Paricalcitol (capsule) with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Paricalcitol (capsule) with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Paricalcitol (capsule) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Paricalcitol (capsule) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Paricalcitol (capsule) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Paricalcitol (capsule) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Paricalcitol (capsule) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Paricalcitol (capsule) in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

There is limited information regarding Monitoring of Paricalcitol (capsule) in the drug label.

  • Description

IV Compatibility

There is limited information regarding IV Compatibility of Paricalcitol (capsule) in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Paricalcitol (capsule) in the drug label.

Pharmacology

There is limited information regarding Paricalcitol (capsule) Pharmacology in the drug label.

Mechanism of Action

Structure

File:Paricalcitol (capsule)01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Paricalcitol (capsule) in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Paricalcitol (capsule) in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Paricalcitol (capsule) in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Paricalcitol (capsule) in the drug label.

How Supplied

Storage

There is limited information regarding Paricalcitol (capsule) Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

{{#ask: Label Page::Paricalcitol (capsule) |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Paricalcitol (capsule) in the drug label.

Precautions with Alcohol

  • Alcohol-Paricalcitol (capsule) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Look-Alike Drug Names

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

  1. ↑ Empty citation (help)
  2. ↑ "http://www.ismp.org". External link in |title= (help)

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