Voclosporin

What Voclosporin is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

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. …

— FDA label: Lupkynis, Aurinia Pharma U.S., Inc., effective August 25, 2026. Read the full label on DailyMed →

Label quoted: the one for the most common form (capsule, oral), Lupkynis, Aurinia Pharma U.S., Inc.; it covers 1 product in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

This label has a boxed warning. Its heading: WARNING: MALIGNANCIES AND SERIOUS INFECTIONS. Read it on the full label →

Voclosporin boxed warning: what the label says

Quoted from the boxed warning of the FDA-approved label.

WARNING: MALIGNANCIES AND SERIOUS INFECTIONS Increased risk for developing malignancies and serious infections with LUPKYNIS or other immunosuppressants that may lead to hospitalization or death [see Warnings and Precautions (5.1, 5.2)]. WARNING: MALIGNANCIES AND SERIOUS INFECTIONS See full prescribing information for complete boxed warning.

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Increased risk for developing serious infections and malignancies with LUPKYNIS or other immunosuppressants that may lead to hospitalization or death. (5.1, 5.2)

— FDA label: Lupkynis, Aurinia Pharma U.S., Inc., effective August 25, 2026. Read the full label on DailyMed →

Voclosporin side effects

Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.

The following clinically significant adverse reactions are described elsewhere in the labeling: Lymphoma and Other Malignancies [see Warnings and Precautions (5.1)] Serious Infections [see Warnings and Precautions (5.2)] Nephrotoxicity due to LUPKYNIS and Drug Interactions [see Warnings and Precautions (5.3)] Hypertension [see Warnings and Precautions (5.4)] Neurotoxicity [see Warnings and Precautions (5.5)] Hyperkalemia [see Warnings and Precautions (5.6)] QTc Prolongation …

— FDA label: Lupkynis, Aurinia Pharma U.S., Inc., effective August 25, 2026. This is part of the section. Read the full label on DailyMed →

Voclosporin drug interactions

Quoted from the “Drug Interactions” section of the FDA-approved label. Tell your pharmacist about every medicine, vitamin and herbal product you take.

Moderate CYP3A4 inhibitors: Reduce LUPKYNIS daily dosage to 15.8 mg in the morning and 7.9 mg in the evening. (2.5, 7.1, 12.3) Strong and moderate CYP3A4 inducers: Avoid co-administration. (7.1, 12.3) Certain P-gp substrates: Reduce dosage of certain P-gp substrates with a narrow therapeutic window when co-administered with LUPKYNIS. (7.2, 12.3) 7.1 Effect of Other Drugs on LUPKYNIS Strong and Moderate CYP3A4 Inhibitors Voclosporin is a sensitive CYP3A4 substrate.

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Co-administration with strong or moderate CYP3A4 inhibitors increases voclosporin exposure [see Clinical Pharmacology (12.3)], which may increase the risk of LUPKYNIS adverse reactions. Co-administration of LUPKYNIS with strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin) is contraindicated [see Contraindications (4)]. Reduce LUPKYNIS dosage when co-administered with moderate CYP3A4 inhibitors (e.g., verapamil, fluconazole, diltiazem) [see Dosage and Administration (2.5]. Avoid food or drink containing grapefruit when taking LUPKYNIS. Strong and Moderate CYP3A4 Inducers Voclosporin is a sensitive CYP3A4 substrate. Co-administration with strong or moderate CYP3A4 inducers decreases voclosporin exposure [see Clinical Pharmacology (12.3)], which may decrease the efficacy of LUPKYNIS. Avoid co-administration of LUPKYNIS with strong or moderate CYP3A4 inducers. 7.2 Effect of LUPKYNIS on Other Drugs Certain P-gp Substrates Voclosporin is a P-gp inhibitor. Co-administration of voclosporin increases exposure of P-gp substrates [see Clinical Pharmacology (12.3)], which may increase the risk of adverse reactions of these substrates. For certain P-gp substrates with a narrow therapeutic window, reduce the dosage of the substrate as recommended in its prescribing information, if needed. OATP1B1 Substrates Voclosporin is an inhibitor of OATP1B1 and OATP1B3 transporters. In one clinical study the concomitant administration of a single 40 mg dose of simvastatin with 23.7 mg BID voclosporin increased C max and AUC of the active metabolite simvastatin acid (an OATP1B1 substrate) by 3.1-fold and 1.8-fold, respectively [see Clinical Pharmacology (12.3)]. Monitor for adverse reactions such as myopathy and rhabdomyolysis when OATP1B1/OATP1B3 substrates (e.g., simvastatin, atorvastatin, pravastatin, rosuvastatin, pitavastatin, fluvastatin) are used concomitantly with LUPKYNIS and reduce the dosage of these substrates as recommended in their prescribing information. For example, when taking LUPKYNIS with simvastatin, limit the simvastatin dosage to 20 mg daily, or 40 mg daily for patients who have previously tolerated simvastatin 80 mg daily for at least one year without evidence of muscle toxicity.

— FDA label: Lupkynis, Aurinia Pharma U.S., Inc., effective August 25, 2026. Read the full label on DailyMed →

Voclosporin dosage

Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.

Administration: LUPKYNIS must be swallowed whole on an empty stomach. (2.1) Administer consistently as close to a 12-hour schedule as possible, and with at least 8 hours between doses. (2.1) If a dose is missed, instruct the patient to take it as soon as possible within 4 hours after missing the dose. Beyond the 4-hour time frame, instruct the patient to wait until the usual scheduled time to take the next regular dose. Instruct the patient not to double the next dose.

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(2.1) Instruct patients to avoid eating grapefruit or drinking grapefruit juice while taking LUPKYNIS. (2.1, 7.1) Dosage Recommendations: Before initiating LUPKYNIS, establish an accurate baseline estimated glomerular filtration rate (eGFR) and check blood pressure (BP). Use of LUPKYNIS is not recommended in patients with a baseline eGFR ≤45 mL/min/1.73 m 2 unless the benefit exceeds the risk; these patients may be at increased risk for acute and/or chronic nephrotoxicity. (2.2, 5.3) Do not initiate LUPKYNIS in patients with baseline BP >165/105 mmHg or with hypertensive emergency. (2.2, 5.4) Recommended starting dose: 23.7 mg orally, twice a day. (2.3) Use LUPKYNIS in combination with mycophenolate mofetil (MMF) and corticosteroids. (2.3) Modify the LUPKYNIS dose based on eGFR (2.3, 5.3): Assess eGFR every two weeks for the first month, every four weeks through the first year, and quarterly thereafter. If eGFR <60 mL/min/1.73 m 2 and reduced from baseline by >20% and <30%, reduce the dose by 7.9 mg twice a day. Re-assess eGFR within two weeks; if eGFR is still reduced from baseline by >20%, reduce the dose again by 7.9 mg twice a day. If eGFR <60 mL/min/1.73 m 2 and reduced from baseline by ≥30%, discontinue LUPKYNIS. Re-assess eGFR within two weeks; consider re-initiating LUPKYNIS at a lower dose (7.9 mg twice a day) only if eGFR has returned to ≥80% of baseline. For patients that had a decrease in dose due to eGFR, consider increasing the dose by 7.9 mg twice a day for each eGFR measurement that is ≥80% of baseline; do not exceed the starting dose. Monitor blood pressure every two weeks for the first month after initiating LUPKYNIS, and as clinically indicated thereafter. For patients with BP >165/105 mmHg or with hypertensive emergency, discontinue LUPKYNIS and initiate antihypertensive therapy. (2.3, 5.4) If the patient has not experienced therapeutic benefit by 24 weeks, consider discontinuation of LUPKYNIS. (2.3) Dosage Adjustments: Patients with severe renal impairment: the recommended dose is 15.8 mg twice daily. (2.4, 8.6) Patients with mild and moderate hepatic impairment: the recommended dose is 15.8 mg twice daily. (2.4, 8.7) 2.1 Important Administration Instructions LUPKYNIS capsules must be swallowed whole and must not be opened, crushed, or divided. LUPKYNIS should be taken on an empty stomach consistently as close to a 12-hour schedule as possible, and with a minimum of 8 hours between doses. If a dose is missed, instruct the patient to take it as soon as possible within 4 hours after missing the dose. Beyond the 4-hour time frame, instruct the patient to wait until the usual scheduled time to take the next regular dose. Instruct the patient not to double the next dose.

— FDA label: Lupkynis, Aurinia Pharma U.S., Inc., effective August 25, 2026. This is part of the section. Read the full label on DailyMed →

Voclosporin in pregnancy

Quoted from the pregnancy part of the FDA-approved label. Ask your doctor before you take any medicine while pregnant or planning a pregnancy.

Risk Summary Avoid use of LUPKYNIS in pregnant women due to the alcohol content of the drug formulation. The available data on the use of LUPKYNIS in pregnant patients are insufficient to determine whether there is a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes. There are risks to the mother and fetus associated with systemic lupus erythematosus (SLE) (see Clinical Considerations).

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LUPKYNIS may be used in combination with a background immunosuppressive therapy regimen that includes MMF. MMF used in pregnant women and men whose female partners are pregnant can cause fetal harm (major birth defects and miscarriage). Refer to the MMF prescribing information for more information on its use during pregnancy. In animal reproductive studies, oral administration of either voclosporin or a 50:50 mixture of voclosporin and its cis-isomer was embryocidal and fetocidal in rats and rabbits at doses 15- and 1-times, respectively, the maximum recommended human dose (MRHD) of 23.7 mg twice a day, based on drug exposure AUC. There were no treatment-related fetal malformations or variations. Additional findings of reduced placental and fetal body weights occurred in rabbits at 0.1 to 0.3-times the MRHD and in rats at higher drug exposures. Voclosporin was transferred across the placenta in pregnant rats. For rats, but not all doses in rabbits, these effects were associated with maternal toxicity consisting of reductions in body weight gain. Dystocia was evident in a pre- and postnatal study in rats, but there were no effects of voclosporin on postnatal growth and development (see Data). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Pregnant women with SLE are at increased risk of adverse pregnancy outcomes, including worsening of the underlying disease, premature birth, miscarriage, and intrauterine growth restriction. Maternal LN increases the risk of hypertension and preeclampsia/eclampsia. Passage of maternal autoantibodies across the placenta may result in adverse neonatal outcomes, including neonatal lupus and congenital heart block. Fetal/Neonatal adverse reactions The formulation of LUPKYNIS contains alcohol (21.6 mg of dehydrated ethanol per capsule for a total daily dose of 129.4 mg/day). Published studies have demonstrated that alcohol is associated with fetal harm including central nervous system abnormalities, behavioral disorders and impaired intellectual development. There is no safe level of alcohol exposure in pregnancy; therefore, avoid use of LUPKYNIS in pregnant women. Data Animal Data Voclosporin (90 to 95% trans-isomer) is the active ingredient in LUPKYNIS. Animal reproductive studies were primarily conducted with an approximate 50:50 mixture of voclosporin and its cis-isomer.

— FDA label: Lupkynis, Aurinia Pharma U.S., Inc., effective August 25, 2026. This is part of the section. Read the full label on DailyMed →

When Voclosporin should not be used

Quoted from the “Contraindications” section of the FDA-approved label.

LUPKYNIS is contraindicated in: Patients concomitantly using strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin) because these medications can significantly increase exposure to LUPKYNIS which may increase the risk of acute and/or chronic nephrotoxicity [see Warnings and Precautions (5.3), Drug Interactions (7.1), and Pharmacokinetics (12.3)].

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Patients with a history of serious or severe hypersensitivity reaction, including anaphylaxis, to LUPKYNIS or any of its excipients [see Warnings and Precautions (5.8)]. Patients concomitantly using strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin). (4) History of serious or severe hypersensitivity reaction, including anaphylaxis, to LUPKYNIS or any of its excipients. (4)

— FDA label: Lupkynis, Aurinia Pharma U.S., Inc., effective August 25, 2026. Read the full label on DailyMed →

Voclosporin overdose

Quoted from the “Overdosage” section of the FDA-approved label. If someone may have taken too much, call Poison Help at 1-800-222-1222 (or 911 in an emergency).

Cases of accidental overdose have been reported with LUPKYNIS; symptoms may include tremor, headache, nausea and vomiting, infections, tachycardia, urticaria, lethargy, and increases in blood urea nitrogen, serum creatinine, and alanine aminotransferase levels. No specific antidote to LUPKYNIS therapy is available.

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If overdose occurs, general supportive measures and symptomatic treatment should be conducted, including stopping treatment with LUPKYNIS and assessing blood urea nitrogen, serum creatinine, eGFR and alanine aminotransferase levels. Consider contacting a poison center (1-800-222-1222) or medical toxicologist for advice and review of overdosage management recommendations.

— FDA label: Lupkynis, Aurinia Pharma U.S., Inc., effective August 25, 2026. Read the full label on DailyMed →

Forms and how it is given

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

• Aurinia Pharma U.S., Inc.1 product

FDA approval history

• NDA: New Drug Application: how a new (usually brand-name) medicine is approved.

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.

Official identifiers

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Sources

1. FDA-approved label on DailyMed (National Library of Medicine) — Lupkynis, Aurinia Pharma U.S., Inc., effective August 25, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

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