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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

How LUPKYNIS Works

LUPKYNIS Is a Novel, Structurally Modified Calcineurin Inhibitor (CNI)1

LUPKYNIS Demonstrated2-4:

  • No adverse impact on glucose or lipids in AURORA 1 or AURORA 2
  • Magnesium and potassium levels maintained within normal range over 3 yearsa
      Concomitant use of agents associated with hyperkalemia may increase the risk for hyperkalemia; monitor serum potassium levels periodically
  • Predictable pharmacokinetic profile
  • No drug monitoring required
  • No interference with MMF metabolism

IMPORTANT NOTE:

Voclosporin nonclinical data are not meant to imply clinical benefit. No data from AURORA 1 or AURORA 2 suggest that LUPKYNIS has a direct effect on serum glucose or lipids. LUPKYNIS is not indicated as a lipid-lowering agent.

Amino acid
modificationb
LUPKYNIS chemical structure

aPatients who completed AURORA 1, and who elected to continue, remained in the same blinded treatment group. Patients in AURORA 2 had up to an additional 24 months of total exposure. Analysis of AURORA 2 patients includes data from pretreatment baseline of AURORA 1, the 1-year treatment period in AURORA 1, and up to a 2-year treatment period in AURORA 2.2

bModification to cyclosporine A molecule.

Mean Glucose Level Remained Stable5,a,c

Effect on Lipid Parameters5,a,c

  • Over 3 years, for patients continuing in the study, mean magnesium levels remained within normal range5,a

cNo data from AURORA 1 or AURORA 2 suggest that LUPKYNIS has a direct effect on serum glucose or lipids. LUPKYNIS is not indicated as a lipid-lowering agent.

LUPKYNIS Targets Lupus Nephritis With a Dual Mechanism of Action4,d

Calcineurin inhibition

Podocyte Stability

Immunosuppression

LUPKYNIS reduces proteinuria levels

Podocyte stability

  • Promotes podocyte stability, reducing proteinuria4

Immunosuppression

  • Acts as an immunosuppressant through inhibition of T-cell activation and cytokine production4

dComplete mechanism of action is not fully established.4

MMF=mycophenolate mofetil.

References: 1. Kuglstatter A, Mueller F, Kusznir E, et al. Structural basis for the cyclophilin A binding affinity and immunosuppressive potency of E-ISA247 (voclosporin). Acta Crystallogr D Biol Crystallogr. 2011;67(pt 2):119-12. 2. Saxena A, Ginzler EM, Gibson K, et al. Safety and efficacy of long-term voclosporin treatment for lupus nephritis in the phase 3 AURORA 2 clinical trial. Arthritis Rheumatol. 2024;76(1):59-67. 3. 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. 4. LUPKYNIS®. Prescribing information. Aurinia Pharma U.S., Inc.; 2025. 5. Aurinia Pharma U.S. Inc. Data on file.

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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.