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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.

Efficacy

Use LUPKYNIS to Triple the Chance of a Complete Response

Patients Treated With LUPKYNIS Were 2.7x More Likely to Achieve a Complete Response Than With MMF + Low-dose Steroids Alone (OR: 2.7; 95% CI: 1.6-4.3)1a

LUPKYNIS to Triple the Chance of a Complete Response

51%

of newly diagnosed patients receiving LUPKYNIS achieved a complete renal response at 1 year (compared with 28% of patients receiving MMF + low-dose steroids; OR: 2.91)2b

Proven Efficacy Across Biopsy Classes and Racial and Ethnic Groups

Proven Efficacy Across Biopsy Classes

Adapted with permission from The Lancet. Rovin BH, et al. 2021;397(10289):2070-2080, with permission from Elsevier.

At-risk patients are more likely to achieve CR3f:

  • 4.8x Black patients
  • 3.5x Hispanic patients
  • 3.7x Asian patients

Adapted with permission from The Lancet. Rovin BH, et al. 2021;397(10289):2070-2080, with permission from Elsevier.

fRace and ethnicity were post hoc analyses and should be interpreted with caution. Results were not significant for White race; class V; and Europe and South Africa or North American region.3

More stringent CR criteria per current guideline recommendations1,6:

  • UPCR of ≤0.5 mg/mg
  • Maintained stable eGFR
  • Sustained low-dose steroids
  • No administration of rescue medication

The AURORA phase 3 trial: Patients with biopsy-proven active LN (class III, IV, or V [alone or in combination with class III or IV]), UPCR ≥1.5 mg/mg (class III or IV [alone or in combination with class V]) or ≥2 mg/mg (class V), and eGFR >45 mL/min/1.73 m2 were randomized to receive LUPKYNIS and MMF + low-dose steroids or MMF + low-dose steroids alone for 52 weeks. The primary efficacy endpoint of complete renal response was defined as a confirmed UPCR ≤0.5 mg/mg; eGFR ≥60 mL/min/1.73 m2 or no confirmed decrease from baseline in eGFR of >20% or no treatment- or disease-related eGFR-associated event at time of assessment; received low-dose steroids (≤10 mg prednisone from Weeks 44 to 52); and no administration of rescue medications. Proteinuria reduction was based on time to UPCR ≤0.5 mg/mg.1

aPatients with biopsy-proven active LN (class III, IV, or V [alone or in combination with class III or IV]), UPCR ≥1.5 mg/mg (class III or IV [alone or in combination with class V]) or ≥2 mg/mg (class V), and eGFR >45 mL/min/1.73 m2 were randomized to receive LUPKYNIS and MMF + low-dose steroids or MMF + low-dose steroids alone for 52 weeks. The primary efficacy endpoint of complete renal response was defined as a confirmed UPCR ≤0.5 mg/mg; eGFR ≥60 mL/min/1.73 m2 or no confirmed decrease from baseline in eGFR of >20% or no treatment- or disease-related eGFR-associated event at time of assessment; received low-dose steroids (≤10 mg prednisone from Weeks 44 to 52); and no administration of rescue medications. Proteinuria reduction was based on time to UPCR ≤0.5 mg/mg.1

bPost hoc analysis of patients with recent-onset LN—excluding class V—defined as LN diagnosis within ≤6 months based on reported year of diagnosis, study start date, and date of biopsy. Post hoc results should be viewed with caution.2

LUPKYNIS Reduces Proteinuria 2x Faster Than MMF + Low-dose Steroids Alone

50% UPCR Reduction in <1 Month3c
(HR: 2.1; 95% CI: 1.6-2.6)

LUPKYNIS 50% UPCR Reduction in less than 1 Month

UPCR ≤0.5 mg/mg in <6 Months1,3c
(HR: 2.0; 95% CI: 1.5-2.7)

Earlier reductions in proteinuria were achieved across all biopsy classes.4

  • Meaningful proteinuria reductions were maintained over 3 years5d
    • According to the Prescribing Information, the safety and efficacy of LUPKYNIS have not been established beyond 12 months1

cPrimary endpoint of complete renal response was assessed at week 52. All patients were followed for up to 4 weeks after the last visit at week 52.1,5

dIncludes data from pretreatment baseline of AURORA 1, 12 months in AURORA 1, and up to 24 months in AURORA 2.5

Rapid and Sustained Steroid Reductions to ≤2.5 mg/day1,3,5
(Per AURORA 1 Protocol)

  • Guidelines recommend tapering steroids to ≤7.5 mg/day by 3 to 6 months due to adverse effects from long-term use6
  • Per protocol, steroid doses were tapered faster and lower than guideline recommendations in both study groups1,6

Maintain Stable eGFR Over 3 Years With LUPKYNIS5

Mean eGFR Over Time5e

Slope of eGFR Change Over 2 Years7g

  • Slopes of the change in eGFR were –0.2 mL/min/1.73 m2 with LUPKYNIS and –5.4 mL/min/1.73 m2 with MMF + low-dose steroids over 2 years5,7a
  • Mean SCr levels remained within normal range over 3 years with LUPKYNIS5

aThis was a post hoc analysis and should be interpreted with caution.5

eKidney function assessed with corrected eGFR (Chronic Kidney Disease Epidemiology Collaboration equation) using a prespecified ceiling of 90 mL/min/1.73 m2. Analysis of AURORA 2 patients includes data from pretreatment baseline of AURORA 1, 12 months in AURORA 1, and up to 24 months in AURORA 2. The AURORA 2 continuation trial remained double blinded.5

CI=confidence interval; CR=complete response; eGFR=estimated glomerular filtration rate; HR=hazard ratio; LN=lupus nephritis; LS=least squares; MMF=mycophenolate mofetil; NC=non-calculable; OR=odds ratio; UPCR=urine protein-to-creatinine ratio.

References: 1. LUPKYNIS. Package insert. Aurinia Pharma U.S., Inc; 2024. 2. Mackay M, Truman M, England N, Birardi V, Mina-Osorio P. Efficacy of voclosporin in recent onset lupus nephritis. Abstract. Arthritis Rheumatol. 2021;73(suppl 10). 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. doi:10.1016/S0140-6736(21)00578-X 4. Askanase A, Hodge L, Birardi V, Leher H. Early reductions in proteinuria with voclosporin treatment across lupus nephritis biopsy classes: pooled data from the AURA-LV and AURORA 1 trials. Abstract FC056. Nephrol Dial Transplant. 2022;37(suppl 3):i820-i822. doi:10.1093/ndt/gfac108.004 5. Aurinia Pharma U.S., Inc. Data on file. 6. Fanouriakis A, Kostopoulou M, Cheema K, et al. 2019 update of the Joint European League Against Rheumatism and European Renal Association-European Dialysis and Transplant Association (EULAR/ERA-EDTA) recommendations for the management of lupus nephritis. Ann Rheum Dis. 2020;79(6):713-723. doi:10.1136/annrheumdis-2020-216924 7. Gibson K, Teng YKO, Hodge L, Collins C. Long-term efficacy and safety of voclosporin with MMF and low-dose steroids: data from the AURORA 2 continuation study. Presented at: 13th European Lupus Meeting; October 5-8, 2022.

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Find more information on the safety profile of LUPKYNIS

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.

Important Safety Information

BOXED WARNINGS: MALIGNANCIES AND SERIOUS INFECTIONS

Increased risk for developing malignancies and serious infections with LUPKYNIS or other immunosuppressants that may lead to hospitalization or death.

CONTRAINDICATIONS: LUPKYNIS is contraindicated in patients taking strong CYP3A4 inhibitors because of the increased risk of acute and/or chronic nephrotoxicity, and in patients who have had a serious/severe hypersensitivity reaction to LUPKYNIS or its excipients.

WARNINGS AND PRECAUTIONS

Lymphoma and Other Malignancies: Immunosuppressants, including LUPKYNIS, increase the risk of developing lymphomas and other malignancies, particularly of the skin. The risk appears to be related to increasing doses and duration of immunosuppression rather than to the use of any specific agent.

Serious Infections: Immunosuppressants, including LUPKYNIS, increase the risk of developing bacterial, viral, fungal, and protozoal infections, including opportunistic infections which lead to serious, including fatal outcomes.

Nephrotoxicity: LUPKYNIS, like other calcineurin inhibitors (CNIs), may cause acute and/or chronic nephrotoxicity. The risk is increased when CNIs are concomitantly administered with drugs associated with nephrotoxicity. Monitor eGFR regularly.

Hypertension: Hypertension is a common adverse reaction of LUPKYNIS therapy and may require antihypertensive therapy. Monitor blood pressure regularly.

Neurotoxicity: LUPKYNIS, like other CNIs, may cause a spectrum of neurotoxicities: severe include posterior reversible encephalopathy syndrome (PRES), delirium, seizure, and coma; others include tremor, paresthesia, headache, and changes in mental status and/or motor and sensory functions. Monitor for neurologic symptoms.

Hyperkalemia: Hyperkalemia, which may be serious and require treatment, has been reported with CNIs, including LUPKYNIS. Concomitant use of agents associated with hyperkalemia may increase the risk for hyperkalemia. Monitor serum potassium levels periodically.

QTc Prolongation: LUPKYNIS prolongs the QTc interval in a dose‑dependent manner when dosed higher than the recommended lupus nephritis therapeutic dose. The use of LUPKYNIS in combination with other drugs that are known to prolong QTc may result in clinically significant QT prolongation.

Immunizations: Avoid the use of live attenuated vaccines during treatment with LUPKYNIS. Inactivated vaccines noted to be safe for administration may not be sufficiently immunogenic during treatment with LUPKYNIS.

Pure Red Cell Aplasia: Cases of pure red cell aplasia (PRCA) have been reported in patients treated with another CNI immunosuppressant. If PRCA is diagnosed, consider discontinuation of LUPKYNIS.

Drug‑Drug Interactions: Avoid co‑administration of LUPKYNIS and strong CYP3A4 inhibitors or with strong or moderate CYP3A4 inducers. Co‑administration of LUPKYNIS with strong CYP3A4 inhibitors is contraindicated. Reduce LUPKYNIS dosage when co‑administered with moderate CYP3A4 inhibitors. Avoid use of LUPKYNIS with strong or moderate CYP3A4 inducers.

ADVERSE REACTIONS

The most common adverse reactions (≥3%) were glomerular filtration rate decreased, 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.

SPECIFIC POPULATIONS

Pregnancy: Avoid use of LUPKYNIS.

Lactation: Consider the mother’s clinical need of LUPKYNIS and any potential adverse effects to the breastfed infant when prescribing LUPKYNIS to a lactating woman.

Renal Impairment: LUPKYNIS is not recommended in patients with baseline eGFR ≤45 mL/min/1.73 m2 unless benefit exceeds risk. If used in this population, reduce LUPKYNIS dose.

Hepatic Impairment: For mild or moderate hepatic impairment, reduce LUPKYNIS dose. Avoid use with severe hepatic impairment.

Please see full Prescribing Information including Boxed Warning and Medication Guide for additional Important Safety Information about LUPKYNIS.

Important Safety Information

BOXED WARNINGS: MALIGNANCIES AND SERIOUS INFECTIONS

Increased risk for developing malignancies and serious infections with LUPKYNIS or other immunosuppressants that may lead to hospitalization or death.

CONTRAINDICATIONS: LUPKYNIS is contraindicated in patients taking strong CYP3A4 inhibitors because of the increased risk of acute and/or chronic nephrotoxicity, and in patients who have had a serious/severe hypersensitivity reaction to LUPKYNIS or its excipients.

WARNINGS AND PRECAUTIONS

Lymphoma and Other Malignancies: Immunosuppressants, including LUPKYNIS, increase the risk of developing lymphomas and other malignancies, particularly of the skin. The risk appears to be related to increasing doses and duration of immunosuppression rather than to the use of any specific agent.

Serious Infections: Immunosuppressants, including LUPKYNIS, increase the risk of developing bacterial, viral, fungal, and protozoal infections, including opportunistic infections which lead to serious, including fatal outcomes.

Nephrotoxicity: LUPKYNIS, like other calcineurin inhibitors (CNIs), may cause acute and/or chronic nephrotoxicity. The risk is increased when CNIs are concomitantly administered with drugs associated with nephrotoxicity. Monitor eGFR regularly.

Hypertension: Hypertension is a common adverse reaction of LUPKYNIS therapy and may require antihypertensive therapy. Monitor blood pressure regularly.

Neurotoxicity: LUPKYNIS, like other CNIs, may cause a spectrum of neurotoxicities: severe include posterior reversible encephalopathy syndrome (PRES), delirium, seizure, and coma; others include tremor, paresthesia, headache, and changes in mental status and/or motor and sensory functions. Monitor for neurologic symptoms.

Hyperkalemia: Hyperkalemia, which may be serious and require treatment, has been reported with CNIs, including LUPKYNIS. Concomitant use of agents associated with hyperkalemia may increase the risk for hyperkalemia. Monitor serum potassium levels periodically.

QTc Prolongation: LUPKYNIS prolongs the QTc interval in a dose‑dependent manner when dosed higher than the recommended lupus nephritis therapeutic dose. The use of LUPKYNIS in combination with other drugs that are known to prolong QTc may result in clinically significant QT prolongation.

Immunizations: Avoid the use of live attenuated vaccines during treatment with LUPKYNIS. Inactivated vaccines noted to be safe for administration may not be sufficiently immunogenic during treatment with LUPKYNIS.

Pure Red Cell Aplasia: Cases of pure red cell aplasia (PRCA) have been reported in patients treated with another CNI immunosuppressant. If PRCA is diagnosed, consider discontinuation of LUPKYNIS.

Drug‑Drug Interactions: Avoid co‑administration of LUPKYNIS and strong CYP3A4 inhibitors or with strong or moderate CYP3A4 inducers. Co‑administration of LUPKYNIS with strong CYP3A4 inhibitors is contraindicated. Reduce LUPKYNIS dosage when co‑administered with moderate CYP3A4 inhibitors. Avoid use of LUPKYNIS with strong or moderate CYP3A4 inducers.

ADVERSE REACTIONS

The most common adverse reactions (≥3%) were glomerular filtration rate decreased, 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.

SPECIFIC POPULATIONS

Pregnancy: Avoid use of LUPKYNIS.

Lactation: Consider the mother’s clinical need of LUPKYNIS and any potential adverse effects to the breastfed infant when prescribing LUPKYNIS to a lactating woman.

Renal Impairment: LUPKYNIS is not recommended in patients with baseline eGFR ≤45 mL/min/1.73 m2 unless benefit exceeds risk. If used in this population, reduce LUPKYNIS dose.

Hepatic Impairment: For mild or moderate hepatic impairment, reduce LUPKYNIS dose. Avoid use with severe hepatic impairment.

Please see full Prescribing Information including Boxed Warning and Medication Guide for additional Important Safety Information about LUPKYNIS.