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INDICATION
LUPKYNIS is indicated in combination with a background immunosuppressive therapy regimen for 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.

Updated 2024 ACR Guideline for the Screening, Treatment, and Management of LN
FULL ACR GUIDELINE

DEFENDHer FROM THE THREATS OF LUPUS NEPHRITIS (LN)

Help Protect Her Kidney Function for Tomorrow by Rapidly Reducing Her Proteinuria Today1,a

DISCOVER EFFICACY
A combination of real patients and actor portrayals.

aAURORA 1 was a 52-week, randomized, double-blind, placebo-controlled, phase 3 trial of 357 patients evaluating MMF + low-dose steroids with or without the addition of LUPKYNIS in adults with active lupus nephritis. Patients in the LUPKYNIS arm were more likely to achieve a complete renal response at 52 weeks (40.8% LUPKYNIS arm vs. 22.5% active control arm; OR: 2.7; 95% CI: 1.6-4.3, P<0.001), UPCR ≤0.5 mg/mg at 52 weeks (45.3% LUPKYNIS arm vs. 23.0% active control arm; OR: 3.1; 95% CI: 1.9-5.0), as well as complete renal response at 24 weeks (32.4% LUPKYNIS arm vs. 19.7% active control arm; OR: 2.2; 95% CI: 1.3-3.7). Time to UPCR of ≤0.5 mg/mg was shorter in the LUPKYNIS arm than the active control arm (median time of 169 days vs. 372 days, respectively; HR: 2.0; 95% CI: 1.5-2.7). Time to achieve a 50% reduction in UPCR was shorter in the LUPKYNIS arm than the active control arm (median time of 29 days vs. 63 days, respectively; HR: 2.1; 95% CI: 1.6-2.6).1,2

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Even Low Levels of Proteinuria May Be Associated With Significant Kidney Damage3

Did you know that nearly 90% of patients with proteinuria <0.5 g/day have been reported to have class III or IV (±V) LN?3 Learn more about risk factors, current treatment, and ACR Guideline recommendations for LN.

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ACR=American College of Rheumatology; CI=confidence interval; HR=hazard ratio; MMF=mycophenolate mofetil; OR=odds ratio; UPCR=urine protein-to-creatinine ratio.

References: 1. LUPKYNIS®. Prescribing information. Aurinia Pharma U.S., Inc.; 2025. 2. Rovin BH, Teng YKO, Ginzler EM, et al. Efficacy and safety of voclosporin versus placebo for lupus nephritis (AURORA 1): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial. Lancet. 2021;397(10289):2070-2080 3. De Rosa M, Rocha AS, De Rosa G, Dubinsky D, Almaani SJ, Rovin BH. Low-grade proteinuria does not exclude significant kidney injury in lupus nephritis. Kidney Int Rep. 2020;5(7):1066-1068.

IMPORTANT SAFETY INFORMATION

BOXED WARNING: MALIGNANCIES AND SERIOUS INFECTIONS

LUPKYNIS increases the risk of serious infections and malignancies that may result in hospitalization or death. See full Prescribing Information for complete BOXED WARNING.

CONTRAINDICATIONS

  • DO NOT use with strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin).
  • DO NOT use LUPKYNIS if a patient has a history of serious hypersensitivity reactions, including anaphylaxis, to LUPKYNIS or any of its components.

WARNINGS AND PRECAUTIONS

  • Nephrotoxicity may occur. Monitor eGFR and adjust dose as needed.
  • Hypertension is common. Monitor blood pressure. May require antihypertensive therapy; watch for possibility of drug interactions with some antihypertensives.
  • Neurotoxicity: Monitor for neurologic symptoms including risk of posterior reversible encephalopathy syndrome (PRES).
  • Hyperkalemia: Monitor potassium, especially with concomitant agents associated with hyperkalemia.
  • QT Prolongation: Monitor ECG and electrolytes in high-risk patients.
  • Hypersensitivity Reactions (Including Anaphylaxis and Angioedema): Monitor and discontinue if reaction occurs.
  • Pure Red Cell Aplasia: Monitor and consider discontinuation if diagnosed.
  • Immunizations: Avoid live vaccines.
  • Lymphomas and Other Cancers: Immunosuppressants increase the risk of lymphomas and other cancers, especially of the skin. Monitor for skin changes and advise sun protection and avoidance of artificial UV light.

ADVERSE REACTIONS

The most common adverse reactions (≥3% and ≥2% against placebo) include decreased GFR, hypertension, diarrhea, headache, anemia, cough, urinary tract infection, abdominal pain upper, dyspepsia, alopecia, renal impairment, abdominal pain, mouth ulceration, fatigue, tremor, acute kidney injury, and decreased appetite. Nausea and vomiting have been reported during post-approval use.

SPECIFIC POPULATIONS

Pregnancy: Inform female patients of the potential risk to a fetus and to avoid use of LUPKYNIS during pregnancy.

Indication

LUPKYNIS is indicated in combination with a background immunosuppressive therapy regimen for 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.

Please see full Prescribing Information, including BOXED WARNING, and Medication Guide for additional Important Safety Information about LUPKYNIS.

IMPORTANT SAFETY INFORMATION

BOXED WARNING: MALIGNANCIES AND SERIOUS INFECTIONS

LUPKYNIS increases the risk of serious infections and malignancies that may result in hospitalization or death. See full Prescribing Information for complete BOXED WARNING.

CONTRAINDICATIONS:

  • DO NOT use with strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin).
  • DO NOT use LUPKYNIS if a patient has a history of serious hypersensitivity reactions, including anaphylaxis, to LUPKYNIS or any of its components.

WARNINGS AND PRECAUTIONS

  • Nephrotoxicity may occur. Monitor eGFR and adjust dose as needed.
  • Hypertension is common. Monitor blood pressure. May require antihypertensive therapy; watch for possibility of drug interactions with some antihypertensives.
  • Neurotoxicity: Monitor for neurologic symptoms including risk of posterior reversible encephalopathy syndrome (PRES).
  • Hyperkalemia: Monitor potassium, especially with concomitant agents associated with hyperkalemia.
  • QT Prolongation: Monitor ECG and electrolytes in high-risk patients.
  • Hypersensitivity Reactions (Including Anaphylaxis and Angioedema): Monitor and discontinue if reaction occurs.
  • Pure Red Cell Aplasia: Monitor and consider discontinuation if diagnosed.
  • Immunizations: Avoid live vaccines.
  • Lymphomas and Other Cancers: Immunosuppressants increase the risk of lymphomas and other cancers, especially of the skin. Monitor for skin changes and advise sun protection and avoidance of artificial UV light.

ADVERSE REACTIONS

The most common adverse reactions (≥3% and ≥2% against placebo) include decreased GFR, hypertension, diarrhea, headache, anemia, cough, urinary tract infection, abdominal pain upper, dyspepsia, alopecia, renal impairment, abdominal pain, mouth ulceration, fatigue, tremor, acute kidney injury, and decreased appetite. Nausea and vomiting have been reported during post-approval use.

SPECIFIC POPULATIONS

Pregnancy: Inform female patients of the potential risk to a fetus and to avoid use of LUPKYNIS during pregnancy.

Indication

LUPKYNIS is indicated in combination with a background immunosuppressive therapy regimen for 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.

Please see full Prescribing Information, including BOXED WARNING, and Medication Guide for additional Important Safety Information about LUPKYNIS.