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Indications: 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.

Patient Profiles

The patient profiles below describe specific, hypothetical patient types who may be appropriate for treatment with LUPKYNIS. Review medical backgrounds and current lab values to see how adding LUPKYNIS to a treatment regimen can help improve outcomes for these patients.

  • 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
Laboratory findings and vitals
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
Laboratory findings and vitals
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
Laboratory findings and vitals
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/mg
      Steroid 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
Laboratory findings and vitals
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
Laboratory findings and vitals
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 Profile

These 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.

BID=twice daily; BP=blood pressure; eGFR=estimated glomerular filtration rate; EULAR/ERA–EDTA=European League Against Rheumatism and European Renal Association–European Dialysis and Transplant Association; MMF=mycophenolate mofetil; SLE=systemic lupus erythematosus; UPCR=urine protein/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.

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Indications

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 may 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.

Hypertension: Hypertension is a common adverse reaction of LUPKYNIS therapy and may require antihypertensive therapy.

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.

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.

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. Reduce LUPKYNIS dosage when co-administered with moderate CYP3A4 inhibitors. Reduce dosage of certain P-gp substrates with narrow therapeutic windows when co-administered.

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/Lactation: May cause fetal harm. Advise not to breastfeed.

Renal Impairment: 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 Prescribing Information including Boxed Warning and Medication Guide for 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.