Substance / Medication

Voclosporin

Overview

Active Ingredient
voclosporin
RxNorm CUI
2475166

Indications

Clinical Studies 14 [see()] LUPKYNIS is indicated in combination with a background immunosuppressive therapy regimenfor the treatment of adult patients with active lupus nephritis (LN). Limitations of Use: Safety and efficacy of LUPKYNIS have not been established in combination with cyclophosphamide. Use of LUPKYNIS is not recommended in this situation.

Labeler: Aurinia Pharma U.S., Inc.Updated: 2025-10-08T00:00:00.000ZFull label on DailyMed

Boxed Warning

FDA Black Box Warning

Increased risk for developing malignancies and serious infections with LUPKYNIS or other immunosuppressants that may lead to hospitalization or death Warnings and Precautions 5.1 5.2 [see(,)].

Contraindications

When this intervention should not be used

LUPKYNIS is contraindicated in: Warnings and Precautions 5.3 Drug Interactions 7.1 Pharmacokinetics 12.3 [see(),(), and()] Patients concomitantly using strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin) because these medications can significantly increase exposure to LUPKYNI

Indications & Related Conditions

Conditions associated via SNOMED clinical relationships

Administration & Protocol

Dosing, route, and treatment protocol

Detailed dosage and administration information is available in the full FDA drug label.

View full prescribing information on DailyMed

Monitoring & Follow-Up

Biomarkers relevant to this intervention via related conditions

No monitoring biomarkers have been mapped yet. Biomarker-intervention linkages are derived through related conditions and will expand as the knowledge graph grows.

Clinical Trials

1 trials linked to this intervention

1
Total Trials
1
Recruiting
0
With Results

Research Evidence

Published studies and systematic reviews

Sort:
Effect of Long-Term Voclosporin Treatment on Renal Histology in Patients With Active Lupus Nephritis With Repeat Renal Biopsies.
Rovin Brad H, Cassol Clarissa, Parikh Samir V et al. · Arthritis Rheumatol · 2025
PMID: 40317902RCTFull text (PMC)
Efficacy of Voclosporin in Proliferative Lupus Nephritis with High Levels of Proteinuria.
Menn-Josephy Hanni, Hodge Lucy S, Birardi Vanessa et al. · Clin J Am Soc Nephrol · 2024
PMID: 38110196RCTFull text (PMC)
Update on the Efficacy and Safety Profile of Voclosporin: An Integrated Analysis of Clinical Trials in Lupus Nephritis.
Arriens Cristina, Teng Y K Onno, Ginzler Ellen M et al. · Arthritis Care Res (Hoboken) · 2023
PMID: 36039949RCT
Voclosporin food effect and single oral ascending dose pharmacokinetic and pharmacodynamic studies in healthy human subjects.
Mayo Patrick R, Huizinga Robert B, Ling Spencer Y et al. · J Clin Pharmacol · 2013
PMID: 23736966RCT
Clinical adverse events to voclosporin: a real-world drug safety study based on the FDA Adverse Event Reporting System.
Zhang Jiaqi, Wan Yanjun, Liu Liheng et al. · Clin Exp Rheumatol · 2026
PMID: 40737084Observational
Dried blood spot LC-MS/MS quantification of voclosporin in renal transplant recipients using volumetric dried blood spot sampling.
Metscher E, Meziyerh S, Arends E J et al. · J Pharm Biomed Anal · 2025
PMID: 39729691Observational
Calcineurin inhibitor effects on kidney electrolyte handling and blood pressure: tacrolimus versus voclosporin.
Wei Kuang-Yu, van Heugten Martijn H, van Megen Wouter H et al. · Nephrol Dial Transplant · 2024
PMID: 38777623ObservationalFull text (PMC)

Research data from MEDLINE/PubMed

Benefits & Expected Outcomes

Benefits, expected outcomes, efficacy data, and NNT (Number Needed to Treat) are pending physician authorship and evidence review.

Risks & Side Effects

Adverse reaction and safety data for this drug is sourced from the FDA-approved label.

View adverse reactions & drug interactions on DailyMed

Related Symptoms

Symptoms associated with conditions this intervention addresses

No related symptoms have been mapped yet. Symptom linkages are derived through associated conditions.

Alternatives & Comparisons

Alternative treatments, comparison data, and clinical decision support are pending physician authorship.

Medical Disclaimer

This information is for educational purposes only and does not constitute medical advice, diagnosis, or treatment. Always consult with a qualified healthcare provider regarding any medical condition or treatment plan.

Do not start, stop, or change any treatment without consulting your healthcare provider.

Quick Facts

Type
Substance / Medication
Fully Specified Name
Voclosporin (substance)
SNOMED CT
1149151008
UMLS CUI
C2607219
RxNorm CUI
2475166
Labeler
Aurinia Pharma U.S., Inc.

Clinical Data

This intervention maps to 1 entities in the Healos knowledge graph.

1
Conditions
0
Biomarkers
0
Specialists
0
Symptoms
1
Clinical Trials

Data is sourced from SNOMED CT, UMLS, and the Healos clinical knowledge graph. Content sections marked as pending require physician authorship. Consult a healthcare provider before starting any treatment.