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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.

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Improve Clinical Outcomes in Lupus Nephritis With...


A MORE
COMPLETE
RESPONSE

Use LUPKYNIS with MMF and low-dose steroids to triple the chance of a complete
renal response (OR: 2.7)1a,b:

UPCR reduced to ≤0.5 mg/mg
Maintained stable eGFR
Sustained low-dose steroids

Malisha,
On LUPKYNIS® (voclosporin)

aComplete renal response at week 52 was achieved in 40.8% of patients receiving
LUPKYNIS and 22.5% receiving MMF + low-dose steroids (OR: 2.7; 95% CI: 1.6-4.3;
P<0.001).1 Complete renal response is defined here.

beGFR ≥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 the time of
assessment.1

CI=confidence interval; eGFR=estimated glomerular filtration rate;
MMF=mycophenolate mofetil; OR=odds ratio; UPCR=urine protein-to-creatinine
ratio.

Reference: 1. LUPKYNIS. Package insert. Aurinia Pharma U.S., Inc; 2021.


STARTING PATIENTS

Find out more about the educational materials, financial assistance, and
treatment support available through Aurinia Alliance®.

PRESCRIBE NOW


CONNECT WITH
AN EXPERT

Hear from expert rheumatologists and nephrologists to learn more about managing
and treating lupus nephritis.

Learn More


REQUEST A REP

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

Get connected



PATIENT PROFILES

Could your patient with lupus nephritis benefit from treatment with LUPKYNIS?
Explore our patient profiles to learn about appropriate patient types.

Read More


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.

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