Paricalcitol 2 ug/mL Injection, 25 vials
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Vitamin D Analog class.
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🏭 Manufacturer & labeler
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🩺 Clinical
- Paricalcitol isn't repairing your kidneys directly — what it's doing is fixing a problem caused by kidney disease. When your kidneys are damaged, they can't activate vitamin D the...
- What exactly is paricalcitol doing for my kidneys?
- High calcium — called hypercalcemia — can sneak up on you, but there are signs to watch for: feeling unusually tired or weak, trouble thinking clearly, loss of appetite, nausea, vo...
- How will I know if my calcium gets too high while I'm on this medication?
Patient education
Supplement & herbal interactions
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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UNII 3K9958V90M
A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
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UNII 506T60A25R
Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
3 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
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| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
| Medicare Part B allowsASP · J2501 | $0.899 / J2501 unit | — |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Zemplar 2 ug/mL 00074-4637-01 | AbbVie | 25 vials | — | AP | FDA listed | — |
| Paricalcitol 2 ug/mLthis 00143-9625-25 | West-Ward | 25 vials | — | — | FDA listed | — |
| Paricalcitol 2 ug/mL 16729-0310-08 | Accord | 25 vials | — | AP | FDA listed | — |
| Paricalcitol 2 ug/mL 55150-0212-01 | Eugia | 25 vials | — | — | FDA listed | — |
| Paricalcitol 2 ug/mL 70121-1033-05 | Amneal | 25 vials | — | AP | FDA listed | — |
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⏳ Availability & generic status
The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.
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📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00143-9625-25 You're viewing this | 25 VIAL, SINGLE-DOSE in 1 CARTON (0143-9625-25) / 1 mL in 1 VIAL, SINGLE-DOSE (0143-9625-01) | 2014-11-18 | Active |
🧭 About this NDC listing & data coverage
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| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | ✓ Available |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Paricalcitol Injection is an active vitamin D 2 analogue indicated for the prevention and treatment of secondary hyperparathyroidism associated with chronic kidney disease (CKD) Stage 5. Paricalcitol Injection is an active vitamin D 2 analog indicated for the prevention and treatment of secondary hyperparathyroidism associated with chronic kidney disease Stage 5. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION For intravenous use through hemodialysis vascular access port only. The recommended starting dose of Paricalcitol Injection is 0.04 mcg/kg to 0.1 mcg/kg (2.8 – 7 mcg) administered through a hemodialysis vascular access port as a bolus dose at any time during dialysis. Dosing should not occur more frequently than every other day.
The drug product should not be injected directly into a vein. Dosage should be individualized. If a satisfactory parathyroid hormone (PTH) lowering response is not observed using the recommended starting dose, the dose may be increased by 2 to 4 mcg every 2 to 4 weeks based on PTH levels (refer to Table 1).
Table 1: Suggested Dosage Adjustment PTH Level at Follow-up Visit Dosage Adjustment Above target and PTH increased Increase Above target and PTH decreased by less than 30% Increase Above target and PTH decreased by 30 to 60% No Change Above target and PTH decreased by more than 60% Decrease At target and PTH stable No Change When initiating Paricalcitol Injection or adjusting Paricalcitol Injection dose, measure serum calcium and phosphorus frequently (e.g., twice weekly) and PTH every 2 to 4 weeks. Once a maintenance dose has been established, serum calcium and phosphorus should be measured at least monthly and plasma PTH every 3 months.
The recommended starting dose is 0.04 mcg/kg to 0.1 mcg/kg (2.8 – 7 mcg). Administer Paricalcitol Injection as a bolus through a hemodialysis vascular access port at any time during dialysis. Dosing should not occur more frequently than every other day.
Do not inject Paricalcitol Injection directly into a vein. Paricalcitol Injection dose should be individualized. If a satisfactory PTH lowering response is not observed with the initial dose, the dose may be increased by 2 to 4 mcg at 2- to 4- week intervals based on parathyroid hormone (PTH) levels.
( 2 ) Suggested Dosage Adjustment PTH Level at Follow-up Visit Dosage Adjustment Above target and PTH increased Increase Above target and PTH decreased by less than 30% Increase Above target and PTH decreased by 30 to 60% No Change Above target and PTH decreased by more than 60% Decrease At target and PTH stable No Change
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Paricalcitol Injection is available in the following presentations: 2 mcg per mL single dose vial 5 mcg per mL single dose vial 10 mcg per 2 mL (5 mcg per mL) multiple dose vial Paricalcitol Injection is available in the following presentations: 2 mcg per mL single dose vial, 5 mcg per mL single dose vial, 10 mcg per 2 mL (5 mcg per mL) multiple dose vial. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Paricalcitol Injection is contraindicated in patients with evidence of: Hypercalcemia [see Warnings and Precautions ( 5.1 ) ] Vitamin D toxicity [see Warnings and Precautions ( 5.1 ) ] or Hypersensitivity to paricalcitol or any inactive ingredient in this product [see Adverse Reactions ( 6.2 ) ] Evidence of hypercalcemia, vitamin D toxicity or hypersensitivity. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Hypercalcemia : The risk may be increased when Paricalcitol Injection is used concomitantly with high dose calcium preparations, thiazide diuretics, or metabolically inactive or active forms of vitamin D. Monitor serum calcium when using Paricalcitol Injection and adjust dose accordingly. ( 5.1 ) Digitalis Toxicity : Hypercalcemia increases the risk of digitalis toxicity.
In patients using Paricalcitol Injection concomitantly with digitalis compounds, monitor both serum calcium and patients for signs and symptoms of digitalis toxicity and increase frequency of monitoring when initiating or adjusting the dose of Paricalcitol Injection. ( 5.2 ) Risk of Increased Paricalcitol Levels With Concomitant Use of Strong CYP3A Inhibitors : Use of Paricalcitol Injection with strong CYP3A inhibitors increases the concentration of paricalcitol in the blood. In patients on Paricalcitol Injection who are initiating or discontinuing drugs known to be strong CYP3A inhibitors, monitor serum calcium and PTH more frequently and adjust Paricalcitol Injection dose as required.
( 5.3 ) Adynamic Bone Disease : May develop if PTH levels are suppressed to abnormally low levels. Monitor PTH levels and adjust Paricalcitol Injection accordingly. ( 5.4 )
5.1Hypercalcemia Hypercalcemia may occur during Paricalcitol Injection treatment and may be exacerbated by concomitant administration of high doses of calcium containing preparations, thiazide diuretics, or vitamin D (i.e., all forms). Acute hypercalcemia may exacerbate tendencies for cardiac arrhythmias and seizures and may potentiate the effect of digitalis on the heart. Chronic hypercalcemia can lead to generalized vascular calcification and other soft-tissue calcification.
Hypercalcemia may be so severe as to require emergency attention. High intake of calcium and phosphate concomitantly with vitamin D compounds may lead to hypercalcemia, hypercalciuria, and hyperphosphatemia. Prevention of such adverse reactions requires frequent serum calcium monitoring and careful Paricalcitol Injection dose adjustments.
Concomitant use with other active vitamin D analogues should be avoided during Paricalcitol Injection treatment to prevent hypercalcemia. 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.
5.2Digitalis Toxicity Hypercalcemia of any cause increases the risk of digitalis toxicity. In patients using Paricalcitol Injection concomitantly with digitalis compounds, monitor both serum calcium and patients for signs and symptoms of digitalis toxicity and increase frequency of monitoring when initiating or adjusting the dose of Paricalcitol Injection [see Dosage and Administration ( 2 ) ].
5.3Risk of Increased Paricalcitol Levels With Concomitant Use of Strong CYP3A Inhibitors Concomitant use of Paricalcitol Injection with strong CYP3A inhibitors will increase the levels of paricalcitol in the blood. In patients on Paricalcitol Injection who are initiating or discontinuing therapy with drugs known to be strong CYP3A inhibitors, monitor serum calcium and PTH more frequently and adjust Paricalcitol Injection dose as required [see Drug Interactions ( 7.1 ), Clinical Pharmacology ( 12.3 ) ].
5.4Adynamic Bone Disease Adynamic bone disease with subsequent increased risk of fractures may develop if PTH levels are suppressed to abnormally low levels. Monitor PTH levels and adjust Paricalcitol Injection dose [see Dosage and Administration ( 2 ) ].
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The most common adverse reactions (greater than 5% and more frequent than placebo) include nausea, vomiting and edema. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceutical Corp. at 1-877-233-2001 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1Clinical 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. Safety has been evaluated in clinical studies conducted with another paricalcitol injection product in 609 patients with CKD Stage 5. In four, placebo-controlled, double-blind, multicenter studies, discontinuation of therapy due to any adverse event occurred in 6.5% of 62 patients treated with paricalcitol injection (dosage titrated as tolerated, [see Clinical Studies ( 14 ) ]) and 2% of 51 patients treated with placebo for 1 to 3 months.
Adverse reactions occurring with greater frequency in the paricalcitol group and at a frequency of 2% or greater are presented in the following table: Table 2: Adverse Reactions Occurring at a Rate A patient who reported the same medical term more than once was counted only once for that medical term. of 2% or Greater in CKD Stage 5 Patients in Four Placebo-Controlled Studies Adverse Reaction Placebo (n=51) % Paricalcitol Injection (n=62) % Cardiac Disorders Palpitations 0.0
3.2Gastrointestinal Disorders Nausea 7.8
12.9Vomiting 5.9
8.1Gastrointestinal Hemorrhage 2.0
4.8Dry Mouth 2.0
3.2General Disorders and Administration Site Conditions Edema 0.0
6.5Chills 2.0
4.8Pyrexia 2.0
4.8Malaise 0.0
3.2Infections and Infestations Pneumonia 0.0
4.8Sepsis 2.0
4.8Influenza 3.9
4.8Musculoskeletal and Connective Tissue Disorders Arthralgia 3.9
4.8Specific laboratory parameters [i.e., changes in mean Calcium (Ca), Phosphorus (P), and Calcium Phosphorus product (Ca × P)] were followed in an open-label safety study conducted with another paricalcitol injection product for up to 13 months in duration in this patient population and results are shown below [see Clinical Studies ( 14 ) ]. Other Adverse Reactions Associated with Paricalcitol Injection Use The following adverse reactions occurred in less than 2% of the paricalcitol-treated patients in the above mentioned double-blind, placebo-controlled clinical trials and in additional double-blind, active-controlled and open-label studies: Blood and Lymphatic System Disorders: Anemia, lymphadenopathy Cardiac Disorders: Arrhythmia, atrial flutter, cardiac arrest Ear and Labyrinth Disorders: Ear discomfort Endocrine Disorders: Hypoparathyroidism Eye Disorders: Conjunctivitis, glaucoma, ocular hyperemia Gastrointestinal Disorders: Abdominal discomfort, constipation, diarrhea, dysphagia, gastritis, intestinal ischemia, rectal hemorrhage General Disorders and Administration Site Conditions: Asthenia, chest discomfort, chest pain, condition aggravated, edema peripheral, fatigue, feeling abnormal, gait disturbance, injection site extravasation, injection site pain, pain, swelling, thirst Infections and Infestations: Nasopharyngitis, upper respiratory tract infection, vaginal infection Laboratory Investigations and Vital Signs: Increased aspartate aminotransferase, prolonged bleeding time, irregular heart rate, decreased weight Metabolism and Nutrition Disorders: Decreased appetite, hypercalcemia, hyperkalemia, hyperphosphatemia, hypocalcemia Musculoskeletal and Connective Tissue Disorders: Joint stiffness, muscle twitching, myalgia Neoplasms Benign, Malignant and Unspecified : Breast cancer Nervous System Disorders: Cerebrovascular accident, dizziness, dysgeusia, headache, hypoesthesia, myoclonus, paresthesia, syncope, unresponsive to stimuli Psychiatric Disorders: Agitation, confusional state, delirium, insomnia, nervousness, restlessness Reproductive System and Breast Disord…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Co-administration with strong CYP3A inhibitors (e.g. ketoconazole) increases paricalcitol blood levels. See WARNINGS AND PRECAUTIONS. ( 5.3 , 7.1 )
7.1Strong CYP3A Inhibitors Paricalcitol is partially metabolized by CYP3A. Paricalcitol blood levels will be increased when paricalcitol is co-administered with strong CYP3A inhibitors. If a patient initiates or discontinues therapy with a strong CYP3A inhibitor, monitor both PTH and serum calcium more frequently and adjust Paricalcitol Injection dose as required [see Clinical Pharmacology ( 12.3 ) ].
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Pregnancy : Use during pregnancy only if the potential benefit justifies the potential risk. ( 8.1 ) Nursing Mothers : A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. ( 8.3 )
8.1Pregnancy Pregnancy Category C Paricalcitol has been shown to cause minimal decreases in fetal viability (5%) when administered daily to rabbits at a dose 0.5 times the 0.24 mcg/kg human dose (based on surface area, mg/m 2 ) and when administered to rats at a dose 2 times the 0.24 mcg/kg human dose (based on plasma levels of exposure). At the highest dose tested (20 mcg/kg 3 times per week in rats, 13 times the 0.24 mcg/kg human dose based on surface area), there was a significant increase of the mortality of newborn rats at doses that were maternally toxic (hypercalcemia).
No other effects on offspring development were observed. Paricalcitol was not teratogenic at the doses tested. There are no adequate and well-controlled studies in pregnant women.
Paricalcitol Injection should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus.
8.3Nursing Mothers Studies in rats have shown that paricalcitol is present in the milk. It is not known whether paricalcitol is excreted in human milk. In the nursing patient, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
8.4Pediatric Use The safety and effectiveness of paricalcitol injection were examined with another paricalcitol injection product in a 12-week randomized, double-blind, placebo-controlled study of 29 pediatric patients, aged 5-19 years, with end-stage renal disease on hemodialysis and nearly all had received some form of vitamin D prior to the study. Seventy-six percent of the patients were male, 52% were Caucasian and 45% were African-American. The initial dose of paricalcitol injection was 0.04 mcg/kg 3 times per week based on baseline iPTH level of less than 500 pg/mL, or 0.08 mcg/kg 3 times a week, based on baseline iPTH level of ≥ 500 pg/mL, respectively.
The dose of paricalcitol injection was adjusted in 0.04 mcg/kg increments based on the levels of serum iPTH, calcium and Ca x P. The mean baseline levels of iPTH were 841 pg/mL for the 15 paricalcitol injection-treated patients and 740 pg/mL for the 14 placebo-treated subjects. The mean dose of paricalcitol injection administered was 4.6 mcg (range: 0.8 mcg-9.6 mcg).
Ten of the 15 (67%) paricalcitol injection-treated patients and 2 of the 14 (14%) placebo-treated patients completed the trial. Ten of the placebo patients (71%) were discontinued due to excessive elevations in iPTH levels as defined by 2 consecutive iPTH levels > 700 pg/mL and greater than baseline after 4 weeks of treatment. In the primary efficacy analysis, 9 of 15 (60%) subjects in the paricalcitol injection group had 2 consecutive 30% decreases from baseline iPTH compared with 3 of 14 (21%) patients in the placebo group (95% CI for the difference between groups -1%, 63%).
Twenty-three percent of paricalcitol injection vs. 31% of placebo patients had at least one serum calcium level > 10.3 mg/dL and 40% vs. 14% of paricalcitol injection vs. placebo subjects had at least one Ca x P ion product > 72 (mg/dL) 2 .
The overall percentage of serum calcium measurements >10.3 mg/dL was 7% in the paricalcitol injection group and 7% in the placebo group; the overall percentage of patients with Ca x P product >72 (mg/dL) 2 was 8% in the paricalcitol injection group and 7% in the placebo group. No subjects in either the paricalcitol injection group or placebo group developed hypercalcemia (defined as at least one calcium value > 11.2 mg/dL) during the study.
8.5Geriatric Use Clinical studies of paricalcitol injection did not include sufficient numbers of subjects aged 65 and over to determine whether they resp…
🤰 Pregnancy ▾
8.1Pregnancy Pregnancy Category C Paricalcitol has been shown to cause minimal decreases in fetal viability (5%) when administered daily to rabbits at a dose 0.5 times the 0.24 mcg/kg human dose (based on surface area, mg/m 2 ) and when administered to rats at a dose 2 times the 0.24 mcg/kg human dose (based on plasma levels of exposure). At the highest dose tested (20 mcg/kg 3 times per week in rats, 13 times the 0.24 mcg/kg human dose based on surface area), there was a significant increase of the mortality of newborn rats at doses that were maternally toxic (hypercalcemia).
No other effects on offspring development were observed. Paricalcitol was not teratogenic at the doses tested. There are no adequate and well-controlled studies in pregnant women.
Paricalcitol Injection should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of paricalcitol injection were examined with another paricalcitol injection product in a 12-week randomized, double-blind, placebo-controlled study of 29 pediatric patients, aged 5-19 years, with end-stage renal disease on hemodialysis and nearly all had received some form of vitamin D prior to the study. Seventy-six percent of the patients were male, 52% were Caucasian and 45% were African-American. The initial dose of paricalcitol injection was 0.04 mcg/kg 3 times per week based on baseline iPTH level of less than 500 pg/mL, or 0.08 mcg/kg 3 times a week, based on baseline iPTH level of ≥ 500 pg/mL, respectively.
The dose of paricalcitol injection was adjusted in 0.04 mcg/kg increments based on the levels of serum iPTH, calcium and Ca x P. The mean baseline levels of iPTH were 841 pg/mL for the 15 paricalcitol injection-treated patients and 740 pg/mL for the 14 placebo-treated subjects. The mean dose of paricalcitol injection administered was 4.6 mcg (range: 0.8 mcg-9.6 mcg).
Ten of the 15 (67%) paricalcitol injection-treated patients and 2 of the 14 (14%) placebo-treated patients completed the trial. Ten of the placebo patients (71%) were discontinued due to excessive elevations in iPTH levels as defined by 2 consecutive iPTH levels > 700 pg/mL and greater than baseline after 4 weeks of treatment. In the primary efficacy analysis, 9 of 15 (60%) subjects in the paricalcitol injection group had 2 consecutive 30% decreases from baseline iPTH compared with 3 of 14 (21%) patients in the placebo group (95% CI for the difference between groups -1%, 63%).
Twenty-three percent of paricalcitol injection vs. 31% of placebo patients had at least one serum calcium level > 10.3 mg/dL and 40% vs. 14% of paricalcitol injection vs. placebo subjects had at least one Ca x P ion product > 72 (mg/dL) 2 .
The overall percentage of serum calcium measurements >10.3 mg/dL was 7% in the paricalcitol injection group and 7% in the placebo group; the overall percentage of patients with Ca x P product >72 (mg/dL) 2 was 8% in the paricalcitol injection group and 7% in the placebo group. No subjects in either the paricalcitol injection group or placebo group developed hypercalcemia (defined as at least one calcium value > 11.2 mg/dL) during the study.
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical studies of paricalcitol injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
🆘 Overdosage ▾
10 OVERDOSAGE Overdosage of Paricalcitol Injection may lead to hypercalcemia, hypercalciuria, hyperphosphatemia, and oversuppression of PTH resulting in adynamic bone disease. [see Warnings and Precautions ( 5 .1 , 5.4 ) ].
10.1Treatment of Overdosage and Hypercalcemia The treatment of acute overdosage should consist of supportive measures, discontinuation of drug administration and supplemental calcium, institution of a low calcium diet. Serum calcium levels should be measured until normocalcemia ensues. When serum calcium levels have returned to within normal limits, Paricalcitol Injection may be reinitiated at a lower dose.
Paricalcitol is not significantly removed by dialysis.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Preclinical and in vitro studies have demonstrated that paricalcitol's biological actions are mediated through binding of the vitamin D receptor (VDR), which results in the selective activation of vitamin D responsive pathways. Vitamin D and paricalcitol have been shown to reduce parathyroid hormone levels by inhibiting PTH synthesis and secretion.
12.3Pharmacokinetics Within two hours after administering paricalcitol intravenous doses ranging from 0.04 to 0.24 mcg/kg, concentrations of paricalcitol decreased rapidly; thereafter, concentrations of paricalcitol declined log-linearly. No accumulation of paricalcitol was observed with three times a week dosing. Distribution : Paricalcitol is extensively bound to plasma proteins (≥ 99.8%).
In healthy subjects, the steady state volume of distribution is approximately
23.8L. The mean apparent volume of distribution following a 0.24 mcg/kg dose of paricalcitol in CKD Stage 5 subjects requiring hemodialysis (HD) and peritoneal dialysis (PD) is between 31 and 35 L. Metabolism : After intravenous administration of a 0.48 mcg/kg dose of 3 H-paricalcitol, parent drug was extensively metabolized, with only about 2% of the dose eliminated unchanged in the feces and no parent drug found in the urine.
Several metabolites were detected in both the urine and feces. Most of the systemic exposure was from the parent drug. Two minor metabolites, relative to paricalcitol, were detected in human plasma.
One metabolite was identified as 24(R)-hydroxy paricalcitol, while the other metabolite was unidentified. The 24(R)-hydroxy paricalcitol is less active than paricalcitol in an in vivo rat model of PTH suppression. In vitro data suggest that paricalcitol is metabolized by multiple hepatic and non-hepatic enzymes, including mitochondrial CYP24, as well as CYP3A4 and UGT1A4.
The identified metabolites include the product of 24(R)-hydroxylation (present at low levels in plasma), as well as 24,26- and 24,28-dihydroxylation and direct glucuronidation. Elimination : Paricalcitol is excreted primarily by hepatobiliary excretion. Approximately 63% of a radioactive dose was recovered in the feces and 19% was recovered in the urine in healthy subjects.
In healthy subjects, the mean elimination half-life of paricalcitol is about five to seven hours over the studied dose range of 0.04 to 0.16 mcg/kg. The pharmacokinetics of paricalcitol has been studied in CKD Stage 5 subjects requiring hemodialysis (HD) and peritoneal dialysis (PD). The mean elimination half-life of paricalcitol after administration of 0.24 mcg/kg paricalcitol intravenous bolus dose in CKD Stage 5 HD and PD patients is 13.9 and 15.4 hours, respectively (Table 3).
Table 3: Mean ± SD Paricalcitol Pharmacokinetic Parameters in CKD Stage 5 Subjects Following Single 0.24 mcg/kg Intravenous Bolus Dose CKD Stage 5 HD n = 14 CKD Stage 5 PD n = 8 C max (ng/mL) 1.680 ± 0.511 1.832 ± 0.315 AUC 0-∞ (ng•h/mL) 14.51 ± 4.12 16.01 ± 5.98 β (1/h) 0.050 ± 0.023 0.045 ± 0.026 t 1/2 (h) harmonic mean ± pseudo standard deviation, HD: hemodialysis, PD: peritoneal dialysis. The degree of accumulation was consistent with the half-life and dosing frequency. 13.9 ± 7.3 15.4 ±
10.5CL (L/h) 1.49 ± 0.60 1.54 ±
0.95Vd β (L) 30.8 ± 7.5 34.9 ±
9.5Specific Populations Geriatric : The pharmacokinetics of paricalcitol has not been investigated in geriatric patients greater than 65 years. Pediatric : The pharmacokinetics of paricalcitol has not been investigated in patients less than 18 years of age. Gender : The pharmacokinetics of paricalcitol was gender independent.
Hepatic Impairment : The disposition of intravenous paricalcitol (0.24 mcg/kg) was compared in patients with mild (n=5) and moderate (n=5) hepatic impairment (as indicated by the Child-Pugh method) and subjects with normal hepatic function (n=10). The pharmacokinetics of unbound paricalcitol was similar across the range of hepatic function evaluated in this stud…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Preclinical and in vitro studies have demonstrated that paricalcitol's biological actions are mediated through binding of the vitamin D receptor (VDR), which results in the selective activation of vitamin D responsive pathways. Vitamin D and paricalcitol have been shown to reduce parathyroid hormone levels by inhibiting PTH synthesis and secretion.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Paricalcitol Injection is available in 2 mcg/mL single dose vials (NDC 0143-9625-25), 5 mcg/mL single dose vials (NDC 0143-9624-25) and 10 mcg/2 mL (5 mcg/mL) multiple dose vials (NDC 0143-9596-25) in cartons of 25 vials. NDC Number Volume/Container Concentration Total Content Vial Type 0143-9625-25 1 mL/Fliptop Vial 2 mcg/mL 2 mcg Single Dose 0143-9624-25 1 mL/Fliptop Vial 5 mcg/mL 5 mcg Single Dose 0143-9596-25 2 mL/Fliptop Vial 5 mcg/mL 10 mcg Multiple Dose Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Do not freeze. After initial vial use, the contents of the multiple dose vial remain stable up to seven days when stored at controlled room temperature. Discard unused portion of the single dose vial.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
📋 Description ▾
11 DESCRIPTION Paricalcitol, USP, the active ingredient in Paricalcitol Injection, is a synthetically manufactured active vitamin D 2 analog. It is a white powder chemically designated as 19-nor-1α,3β,25-trihydroxy-9,10-secoergosta-5(Z),7(E),22(E)-triene and has the following structural formula: Paricalcitol Injection is available as a sterile, clear, colorless, aqueous solution for intravenous injection. Each mL contains paricalcitol 2 mcg or 5 mcg and the following inactive ingredients: alcohol, 35% (v/v) and 70% sorbitol solution 7% (v/v) in water for injection. chemical structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Patients should be advised: of the most common adverse reactions with use of Paricalcitol Injection, which include nausea, vomiting and fluid retention. to adhere to instructions regarding diet and phosphorus restriction. to contact a health care provider if they develop symptoms of elevated calcium, (e.g. feeling tired, difficulty thinking clearly, loss of appetite, nausea, vomiting, constipation, increased thirst, increased urination and weight loss). to return to their dialysis clinic/health care provider’s office for routine monitoring.
More frequent monitoring is necessary during the initiation of therapy, following dose changes or when potentially interacting medications are started or discontinued. to inform their health care provider of all medications, including prescription and nonprescription drugs, supplements, and herbal preparations they are taking and any change to their medical condition. Patients should also be advised to inform their health care provider prescribing a new medication that they are taking Paricalcitol Injection. Manufactured by: Exela Pharma Sciences, LLC Lenoir, NC 28645 USA Distributed by: WEST-WARD PHARMACEUTICAL CORP.
Eatontown, NJ 07724 USA 9625-0415-00 April 2015