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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.

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 * For US healthcare professionals only.
 * Important Safety Information
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 * Treating
   with Lupkynis
 * Efficacy
 * Safety
 * Dosing
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   Profiles
 * Starting
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RESOURCES

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Prescribing Information

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LUPKYNIS Outcomes
Introduction Flashcard

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LUPKYNIS Outcomes
Reminder Flashcard

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LUPKYNIS Dosing
Flashcard

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Access to
LUPKYNIS Flashcard

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Treatment Goals Flashcard

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PATIENT PROFILES

Jodi W., 33-year-old patient with lupus nephritis who is not adequately
responding to treatment

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Julia T., 29-year-old patient with newly flaring lupus nephritis

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Jenna R., 39-year-old patient newly diagnosed with lupus nephritis

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Natalie S., 36-year-old patient with lupus nephritis who remains stable on MMF +
steroids but has not reached treatment goals

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April J., 31-year-old patient with class V lupus nephritis

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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.

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.


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LUPKYNIS and Aurinia Alliance are trademarks of Aurinia Pharmaceuticals Inc.

©2021 Aurinia Pharma U.S., Inc. All Rights Reserved.   
US-LUP-2100268   11/21


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