You are using an outdated browser. Please upgrade your browser to improve your experience and security.

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

LUPKYNIS Has Demonstrated More Than 3 Years of Safety

Well tolerated in AURORA 2, with adverse event
(AE) rates declining over 3 years1,2

Adverse Reactions in ≥3% of Patients Treated With LUPKYNIS 23.7 mg Twice a Day and ≥2% Higher Than Placebo in AURORA 1 and AURA-LV1,a
Adverse Reactions LUPKYNIS
23.7 mg BID +
MMF + LDS
(n=267)		 Placebo +
MMF + LDS
(n=266)
Glomerular filtration rate decreased 26% 9%
Hypertension 19% 9%
Diarrhea 19% 13%
Headache 15% 8%
Anemia 12% 6%
Cough 11% 2%
Urinary tract infection 10% 6%
Abdominal pain upper 7% 2%
Dyspepsia 6% 3%
Alopecia 6% 3%
Renal impairment 6% 3%
Abdominal pain 5% 2%
Mouth ulceration 4% 1%
Fatigue 4% 1%
Tremor 3% 1%
Acute kidney injury 3% 1%
Decreased appetite 3% 1%

aAURA-LV, a phase 2 clinical trial, and AURORA 1 were integrated to represent safety through 48/52 weeks for LUPKYNIS 23.7 mg twice a day (n=267), voclosporin 39.5 mg twice a day (n=88), and active control (n=266).1

BID=twice daily; LDS=low-dose steroids; MMF=mycophenolate mofetil.

BID=twice daily; LDS=low-dose steroids; MMF=mycophenolate mofetil.

Overview of AEs in AURORA 22
Primary Endpoint
LUPKYNIS
23.7 mg BID +
MMF + LDS
(n=116)		 Placebo +
MMF + LDS
(n=100)
Any AE 86.2% 80.0%
Treatment-related AE 24.1% 21.0%
Serious AE 18.1% 23.0%
Treatment-related serious AE 0.9% 2.0%
AEs leading to discontinuation 9.5% 17.0%
Deaths (n) 0 4

In AURORA 2, LUPKYNIS demonstrated safety comparable to that seen in AURORA 1 with no unexpected safety signals observed through 3 years.1,2,b,c

See Study Design for AURORA 1 and AURORA 2 criteria

bAE was defined as any untoward medical occurrence that occurred on or after entrance into AURORA 2 and up to 30 days after study treatment end.2

cThree deaths occurred during the study, and one death occurred during follow-up.2

The overall profile of AEs in the 2-year AURORA 2 treatment period was similar to the first year of treatment in AURORA 11,2

Infections were the most common AE reported in AURORA 1 and AURORA 2.2,3

References: 1. LUPKYNIS®. Prescribing information. Aurinia Pharma U.S., Inc.; 2025. 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.

Connect with an Aurinia representative.
Sign up for the latest news, updates, and materials for LUPKYNIS.

GET CONNECTED
View dosing instructions for 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.

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.