- Jodi was diagnosed with lupus nephritis 3 months ago and put on a regimen of MMF + high-dose steroids
- At 3-month follow-up, her UPCR had modestly declined
Not achieving EULAR/ERA–EDTA guideline recommendation for reduction in UPCR of at least 25% by 3 months1
- Her physician is considering adding treatment to help achieve a better renal response and decrease proteinuria levels
Lupus nephritis diagnosed 3 months ago
Biopsy findings at baseline
- ISN Class III + V
- Focal proliferative lupus nephritis affecting 40% of glomeruli
- Subendothelial, subepithelial, and mesangial immune deposition
- Basement membrane thickening
SLE history
- Diagnosed with SLE 1.5 years prior
Current medications
- MMF (2.5 g/day)
- Prednisone (20 mg/day)
- Hydroxychloroquine (200 mg BID)
- ACE inhibitor
- Hormonal IUD
| Baseline | 6 weeks | 3 months | |
|---|---|---|---|
| UPCR (mg/mg) | 2.2 | 1.9 | 2.1 |
| Urine microscopy | 5-10 RBC/HPF w/ dysmorphia and cellular casts | 5-10 RBC/HPF | 5-10 RBC/HPF |
| eGFR (mL/min/1.73 m2) | 85 | 87 | 85 |
| Serum creatinine (mg/dL) | 1.0 | 0.9 | 1.0 |
| C3 (mg/dL) | 60 | 78 | 80 |
| C4 (mg/dL) | 8 | 11 | 12 |
| Anti-dsDNA (IU/mL) | 130 | 84 | 80 |
| BP (mmHg) | 125/80 | 122/76 | 124/79 |
| Weight (lbs) | 155 | 162 | 166 |
Can more be done to help her achieve treatment goals?
Lupkynis Efficacy Download Profile- Julia was diagnosed with lupus nephritis 2 years ago and achieved a partial renal response after 12 months of treatment with MMF + steroids
- At her most recent follow-up, lab results showed significantly elevated UPCR relative to her previous visit
- Her physician wants to help ensure that the current flare of lupus nephritis is controlled as quickly as possible
Diagnosed with lupus nephritis 2 years ago
- UPCR 2.3 mg/mg at diagnosis
- Treated with MMF (2.5 g/day) and steroids for 12 months, achieved a partial response (50% reduction in UPCR)
Current biopsy findings
- ISN Class IV
- Diffuse proliferative lupus nephritis affecting 70% of glomeruli
- Subendothelial and mesangial immune deposition
SLE history
- Diagnosed with SLE 3.5 years prior
Current medications
- Hydroxychloroquine (200 mg BID)
- Prednisone (5 mg/day)
- MMF (1.5 g/day)
- Oral birth control
- Angiotensin II receptor blocker
| At lupus nephritis diagnosis (2 years prior) |
6 months prior | Present day | |
|---|---|---|---|
| UPCR (mg/mg) | 2.3 | 1.0 | 3.6 |
| Serum albumin (g/dL) | 3.0 | 3.6 | 2.8 |
| Urine microscopy | 5 RBC/HPF | No active sediment | 8 RBC/HPF |
| eGFR (mL/min/1.73 m2) | 88 | 90 | 80 |
| Serum creatinine (mg/dL) | 0.9 | 0.9 | 0.9 |
| C3 (mg/dL) | 60 | 90 | 55 |
| C4 (mg/dL) | 10 | 20 | 6 |
| Anti-dsDNA (IU/mL) | 100 | 70 | 125 |
| BP (mmHg) | 118/78 | 120/80 | 119/79 |
| Weight (lbs) | 148 | 150 | 155 |
How important is it to get her flaring signs and symptoms under control?
Lupkynis Efficacy Download Profile- Jenna was diagnosed with SLE 6 months ago
- Recent urinalysis was suggestive of lupus nephritis
Kidney biopsy confirmed diagnosis
- Her lab values and other clinical risk factors put her at high risk for poor long-term outcomes
Recent lupus nephritis diagnosis
Biopsy findings at baseline
- ISN Class IV + V
- Diffuse proliferative lupus nephritis affecting 60% of glomeruli
- Diffuse thickening of glomerular capillary wall
- Subendothelial, subepithelial, and mesangial immune deposition
SLE history
- Diagnosed 6 months prior after presenting with arthritis, malar rash, and positive serologies, along with hypertension and hyperlipidemia
Current medications
- Hydroxychloroquine (200 mg BID)
- Prednisone (5 mg/day)
- Statin
- Angiotensin II receptor blocker
| 6 months prior | Present day | |
|---|---|---|
| UPCR (mg/mg) | 0.1 | 4.1 |
| Serum albumin (g/dL) | 3.4 | 2.5 |
| Urine microscopy | No active sediment | 6 RBC/HPF w/ dysmorphia and cellular casts |
| eGFR (mL/min/1.73 m2) | 90 | 80 |
| Serum creatinine (mg/dL) | 0.9 | 1.0 |
| C3 (mg/dL) | 100 | 60 |
| C4 (mg/dL) | 20 | 8 |
| Anti-dsDNA (IU/mL) | 90 | 120 |
| BP (mmHg) | 130/80 | 120/76 |
| Weight (lbs) | 165 | 172 |
Do her risk factors require a strong start with treatment?
Lupkynis Efficacy Download Profile- Natalie was diagnosed with lupus nephritis 1 year ago and treated with MMF + steroids
- Follow-up appointments showed improvement; however, she was not reaching EULAR/ERA–EDTA-recommended treatment goals1
UPCR remains above recommendation of ≤0.5-0.7 mg/mgSteroid use remains above recommendation of ≤7.5 mg/day
- Her physician is concerned that she may be at risk for poor outcomes and is considering adding treatment
Lupus nephritis diagnosed 1 year ago
Biopsy findings at baseline
- ISN Class III
- Focal proliferative lupus nephritis affecting 40% of glomeruli
- Subendothelial and mesangial immune deposition
SLE history
- Diagnosed with SLE 2 years prior
Current medications
- MMF (3 g/day)
- Prednisone (10 mg/day)
- Hydroxychloroquine (200 mg BID)
- Hormonal IUD
- ACE inhibitor
| Baseline (12 months prior) | 6 months prior | Present day | |
|---|---|---|---|
| UPCR (mg/mg) | 1.8 | 1.2 | 1.2 |
| Serum albumin (g/dL) | 3.0 | 3.2 | 3.2 |
| Urine microscopy | 5 RBC/HPF | 2 RBC/HPF | No active sediment |
| eGFR (mL/min/1.73 m2) | 90 | 90 | 90 |
| Serum creatinine (mg/dL) | 0.8 | 0.8 | 0.8 |
| C3 (mg/dL) | 70 | 80 | 78 |
| C4 (mg/dL) | 10 | 12 | 9 |
| Anti-dsDNA (IU/mL) | 115 | 70 | 75 |
| BP (mmHg) | 120/80 | 119/79 | 118/78 |
| Weight (lbs) | 150 | 155 | 168 |
What more can be done for patients who aren't reaching treatment goals?
Lupkynis Efficacy Download Profile- April recently presented to her primary care physician with peripheral edema and hypertension; she was referred to a nephrologist after she was found to have nephrotic-range proteinuria
- Following a kidney biopsy, April was diagnosed with class V lupus nephritis and SLE
- Knowing that class V patients may be more difficult to treat, her physician wants to ensure she gets a strong treatment regimen from the start
Recent diagnosis of lupus nephritis
Biopsy findings at baseline
- ISN Class V
- Diffuse thickening of glomerular capillary wall
- Global subepithelial immune deposition
SLE history
- Diagnosed concurrently with lupus nephritis
Current medications
- ACE inhibitor
- Hormonal IUD
| Present day | |
|---|---|
| UPCR (mg/mg) | 4.2 |
| Serum albumin (g/dL) | 2.2 |
| Urine microscopy | No active sediment |
| eGFR (mL/min/1.73 m2) | 95 |
| Serum creatinine (mg/dL) | 0.8 |
| C3 (mg/dL) | 85 |
| C4 (mg/dL) | 15 |
| Anti-dsDNA (IU/mL) | 28 |
| BP (mmHg) | 135/82 |
| Weight (lbs) | 145 |
What more can be done to help difficult-to-treat patients?
Lupkynis Efficacy Download ProfileThese are hypothetical case studies. This resource is intended to help you determine the types of patients who may be appropriate for treatment with LUPKYNIS. These representations were not designed to assess efficacy for individual patient subgroups.
ACE=angiotensin-converting enzyme; BID=twice daily; BP=blood pressure; eGFR=estimated glomerular filtration rate; ERA–EDTA=European Renal Association–European Dialysis and Transplant Association; EULAR=European League Against Rheumatism; HPF=high-power field; IUD=intrauterine device; MMF=mycophenolate mofetil; RBC=red blood cell; SLE=systemic lupus erythematosus; UPCR=urine protein-to-creatinine ratio.
Reference: 1. 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
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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.
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.
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.
