Paricalcitol

Paricalcitol is a synthetic, biologically active vitamin D 2 analog of calcitriol. Preclinical and in vitro studies have demonstrated that paricalcitol's biological actions are mediated through binding of the VDR, which results in the selective activation of vitamin D responsive pathways.

• & USAGE 1.1 Chronic Kidney Disease Stages 3 and 4 Paricalcitol Capsules are indicated in adults for the prevention and treatment of secondary hyperparathyroidism associated with Chronic Kidney Disease (CKD) Stages 3 and 4. Pediatric use information for patients 10 to 16 years of age is approved for AbbVie Inc.’s Zemplar (Paricalcitol) capsules.ICD-10: N18.9

• Paricalcitol Capsules should not be given to patients with evidence of hypercalcemia or vitamin D toxicity [see Warnings and Precautions (5.1)]. Evidence of hypercalcemia (4).contraindicated

DOSAGE & 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 Capsules 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 Capsules 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 or decreased 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% or iPTH 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.

Excessive administration of vitamin D compounds. including Paricalcitol Capsules, can cause over suppression of PTH, hypercalcemia, hypercalciuria, hyperphosphatemia, and adynamic bone disease. 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 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. 5.2 Digitalis Toxicity Digitalis toxicity is potentiated by hypercalcemia of any cause. Use caution when Paricalcitol Capsules are prescribed concomitantly with digitalis compounds.

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. 6.1 Clinical Trials Experience CKD Stages 3 and 4 Adults 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 in: Table 3. Table 3.

Lactation: Breastfeeding not recommended (8.2). 8.1 Pregnancy Risk Summary Limited data with Paricalcitol capsules in pregnant women are insufficient to inform a drug- associated risk for major birth defects and miscarriage. There are risks to the mother and fetus associated with chronic kidney disease in pregnancy [see Clinical Considerations] . In animal reproduction studies, slightly increased embryofetal loss was observed in pregnant rats and rabbits administered paricalcitol intravenously during the period of organogenesis at doses 2 and 0.5 times, respectively, the maximum recommended human dose (MRHD). Adverse reproductive outcomes were observed at doses that caused maternal toxicity [see Data] . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Chronic kidney disease in pregnancy increases the maternal risk for hypertension, spontaneous abortion, preterm labor, and preeclampsia.

Metabolism

Absorption The mean absolute bioavailability of Paricalcitol Capsules under low-fat fed condition ranged from 72% to 86% in healthy adult volunteers, CKD Stage 5 patients on HD, and CKD Stage 5 patients on PD. A food effect study in healthy adult volunteers indicated that the C max and AUC 0-∞, were unchanged when paricalcitol was administered with a high fat meal compared to fasting.

Excessive administration of Paricalcitol Capsules can cause hypercalcemia, hypercalciuria, and hyperphosphatemia, and over suppression of PTH [ see Warnings and Precautions (5.1) ]. Treatment of Overdosage The treatment of acute overdosage of Paricalcitol Capsules should consist of general supportive measures. If drug ingestion is discovered within a relatively short time, induction of emesis or gastric lavage may be of benefit in preventing further absorption. If the drug has passed through the stomach, the administration of mineral oil may promote its fecal elimination. Serial serum electrolyte determinations (especially calcium), rate of urinary calcium excretion, and assessment of electrocardiographic abnormalities due to hypercalcemia should be obtained. Such monitoring is critical in patients receiving digitalis. Discontinuation of supplemental calcium and institution of a low-calcium diet are also indicated in accidental overdosage. Due to the relatively short duration of the pharmacological action of paricalcitol, further measures are probably unnecessary.

• Apr 17, 1998NDANDA020819Abbvie
• May 26, 2005NDANDA021606Abbvie
• Mar 27, 2014ANDAANDA202539Bionpharma
• Jun 24, 2014ANDAANDA091412Chartwell Rx
• Nov 18, 2014NDANDA205917Hikma Pharms
• Jan 13, 2016ANDAANDA204327Amneal Pharms
• Jan 14, 2016ANDAANDA207672Aurobindo Pharma Ltd
• Feb 4, 2016NDANDA207174Accord Hlthcare

Reference statistics from the openFDA drug-shortage dataset. For a live view, consult the FDA database directly. Not clinical guidance.

• Zemplar, Capsule, 1 ug (NDC 0074-9036-30)To be discontinued
  Sponsor: AbbVie Inc.
  Updated Oct 7, 2025
• Zemplar, Capsule, 2 ug (NDC 0074-9037-30)To be discontinued
  Sponsor: AbbVie Inc.
  Updated Oct 7, 2025

1. 1Death3,57025%
2. 2Cardiac Disorder6224.4%
3. 3Myocardial Infarction5844.2%
4. 4Sepsis4833.4%
5. 5Cardio-respiratory Arrest4763.4%
6. 6Dyspnoea3932.8%
7. 7Cardiac Failure3482.5%
8. 8Renal Failure3082.2%
9. 9Pneumonia3022.2%
10. 10Nausea3002.1%
11. 11Cerebrovascular Accident2852.0%
12. 12Asthenia2762.0%
13. 13Diarrhoea2742.0%
14. 14Vomiting2711.9%
15. 15Fatigue2681.9%

The 10 most recently updated of 119 ClinicalTrials.gov registrations naming Paricalcitol as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• PHL Treatment in Pancreatic Cancer
  Active not recruiting · Early phase 1 · Interventional · 20 enrolled · Fox Chase Cancer Center
  NCT05365893updated 2026-05-22
• Paclitaxel Protein Bound Plus Cisplatin Plus Gemcitabine and Paricalcitol for Pancreatic Adenocarcinoma (NABPLAGEMD)
  Completed · Phase 2 · Interventional · 34 enrolled · HonorHealth Research Institute
  NCT03415854updated 2026-05-12
• Pre-operative Treatment for Patients With Untreated Pancreatic Cancer
  Completed · Phase 2 · Interventional · 40 enrolled · HonorHealth Research Institute
  NCT03138720updated 2026-04-22
• Paricalcitol and Hydroxychloroquine in Combination With Gemcitabine and Nab-Paclitaxel for Advanced Pancreatic Cancer
  Completed · Phase 2 · Interventional · 10 enrolled · Emory University
  NCT04524702updated 2026-01-23
• A Study to Evaluate Safety, Efficacy and Pharmacokinetics of Paricalcitol For Treatment of Secondary Hyperparathyroidism (SHPT) in Pediatric Participants With Stage 5 Chronic Kidney Disease (CKD)
  Terminated · Phase 3 · Interventional · 2 enrolled · AbbVie
  NCT04064827updated 2025-12-04
• Paricalcitol Addition to Chemotherapy in Patients With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma
  Completed · Phase 2 · Interventional · 27 enrolled · Barts & The London NHS Trust
  NCT04054362updated 2025-11-21
• A PiLot ClinicaL TrIal of ParicAlcitol for ChroNiC PancrEatitis
  Recruiting · Early phase 1 · Interventional · 24 enrolled · Cedars-Sinai Medical Center
  NCT05664880updated 2025-11-14
• Combination Therapy for Patients With Untreated Metastatic Pancreatic Ductal Adenocarcinoma
  Completed · Phase 2 · Interventional · 35 enrolled · HonorHealth Research Institute
  NCT02754726updated 2025-08-27
• A Study of Neoadjuvant Paricalcitol to Target the Microenvironment in Resectable Pancreatic Cancer
  Completed · Phase 1 · Interventional · 15 enrolled · Abramson Cancer Center at Penn Medicine
  NCT02030860updated 2025-07-25
• Paricalcitol Plus Gemcitabine and Nab-paclitaxel in Metastatic Pancreatic Cancer
  Terminated · Phase 1 · Interventional · 36 enrolled · Dana-Farber Cancer Institute
  NCT03520790updated 2025-03-21

Frequently asked questions

How does Paricalcitol work?

Paricalcitol is a synthetic, biologically active vitamin D 2 analog of calcitriol. Preclinical and in vitro studies have demonstrated that paricalcitol's biological actions are mediated through binding of the VDR, which results in the selective activation of vitamin D responsive pathways.

What is Paricalcitol used for?

According to FDA labeling, Paricalcitol carries indications including: & USAGE 1.1 Chronic Kidney Disease Stages 3 and 4 Paricalcitol Capsules are indicated in adults for the prevention and treatment of secondary hyperparathyroidism associated with Chronic Kidney Disease (CKD) Stages 3 and 4. Pediatric use information for patients 10 to 16 years of age is approved for AbbVie Inc.’s Zemplar (Paricalcitol) capsules.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Paricalcitol?

Paricalcitol is classified as Other anti-parathyroid agents, Vitamin D Analog, Vitamin D2 Analog, Enzyme Interactions, Decreased PTH Secretion.

What are the brand names for Paricalcitol?

Paricalcitol is marketed under brand names including Zemplar.

What are the contraindications for Paricalcitol?

Paricalcitol labeling lists contraindications including: Paricalcitol Capsules should not be given to patients with evidence of hypercalcemia or vitamin D toxicity [see Warnings and Precautions (5.1)]. Evidence of hypercalcemia (4).. Always consult the full prescribing information and a clinician.