Voclosporin
Pronunciation: vok-loh-SPOR-in.
- Generic name
- voclosporin
- Drug class
- Calcineurin-inhibitor immunosuppressant
- Form
- Soft capsule, 7.9 mg
- Route
- Oral
- Legal status
- Prescription-only, specialist (rheumatology/nephrology)-initiated
Availability and supply rules vary by country
Trade names by country: United Kingdom
Australia: · Full directory
Boxed warning: Malignancies and serious infections
Voclosporin carries a boxed warning (the US FDA's strongest safety warning) for an increased risk of developing malignancies and serious infections with voclosporin or other immunosuppressants, which may lead to hospitalization or death. This is the standard, shared risk of the calcineurin-inhibitor/immunosuppressant drug class to which voclosporin belongs. It is separate from -- and does not replace -- voclosporin's other genuine, serious warnings that are not boxed-warning level: kidney injury (nephrotoxicity), high blood pressure, nervous-system effects (including a rare but serious brain-swelling condition called posterior reversible encephalopathy syndrome, PRES), and dose-dependent effects on the heart's electrical rhythm (QT prolongation). (1)
What voclosporin is and how it works
Voclosporin is a prescription calcineurin-inhibitor immunosuppressant taken by mouth, used together with another immune-suppressing medicine (mycophenolate mofetil) to treat active lupus nephritis -- kidney inflammation caused by systemic lupus erythematosus (SLE). (1) (2)
Because it suppresses the immune system, voclosporin carries a genuine, serious boxed warning for an increased risk of infections and certain cancers, shared with other immunosuppressant medicines. It also needs regular blood pressure and kidney-function (eGFR) monitoring, since it can affect both. Never adjust your own dose -- dose changes are guided by your clinician based on your blood pressure and kidney-function results.
Mechanism of action: how voclosporin works
Voclosporin is a calcineurin inhibitor. By inhibiting calcineurin, it blocks T-lymphocyte activation, cytokine production, and expression of T-cell activation surface antigens, producing an immunosuppressive effect used to control the immune-mediated kidney inflammation of lupus nephritis. (1) (2)
What voclosporin is used for
Active lupus nephritis
Used in combination with a background immunosuppressive regimen (mycophenolate mofetil, per the UK/EU label) to treat adults with active class III, IV, or V (including mixed class III/V and IV/V) lupus nephritis, a serious kidney complication of systemic lupus erythematosus. Not established or recommended in combination with cyclophosphamide. (1) (2)
Before taking voclosporin
Do not take / not appropriate for
- Do not take voclosporin if you have a history of a serious or severe allergic reaction (including anaphylaxis) to it. (all countries) (1)
- Do not take voclosporin together with strong CYP3A4 inhibitor medicines (such as ketoconazole, itraconazole, or clarithromycin) -- this combination is contraindicated. (all countries) (1) (2)
Tell your clinician about
- Any history of kidney problems, high blood pressure, or heart rhythm problems (including a prolonged QT interval).
- Any history of seizures, or previous neurological symptoms.
- Any history of serious or recurrent infections, or a weakened immune system.
- Any personal or family history of skin cancer or other malignancies.
- All other medicines you take, especially anything affecting liver enzymes (CYP3A4), statins, or medicines like digoxin.
- Whether you are pregnant, plan to become pregnant, or are breastfeeding.
- Your vaccination history -- live vaccines are generally avoided during treatment.
How to take voclosporin
- Swallow capsules whole, on an empty stomach, as close to a 12-hour schedule as possible, with a minimum of 8 hours between doses.
- Take voclosporin together with your other prescribed background immunosuppressive medicine (such as mycophenolate mofetil), exactly as directed.
- Do not change your dose or stop taking voclosporin without your clinician's guidance -- dose changes depend on regular blood pressure and kidney-function (eGFR) results.
- Avoid grapefruit and grapefruit juice, which can raise voclosporin levels in your body.
Procedures and treatment changes
Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (4) (5)
Missed dose
Contact your prescriber or care team for guidance if you miss a dose. do not take an extra dose or adjust your next dose on your own.
Overdose
Seek urgent medical attention if you think you have taken too much voclosporin, or if you develop severe dizziness, a very fast or irregular heartbeat, sudden weakness, seizures, or other new neurological symptoms. (1)
Side effects
Side effects and their urgency vary; report severe, persistent, or concerning symptoms.
Decreased kidney function (lower eGFR)
What to notice: Kidney function is monitored during treatment.
What to do: Your prescriber checks kidney function regularly and adjusts the dose as needed. (1) (2)
High blood pressure
What to notice: Blood pressure is monitored during treatment.
What to do: Contact your prescriber if you notice symptoms of high blood pressure such as severe headache. (1) (2)
Diarrhoea and headache
What to notice: Common gastrointestinal and neurological effects.
What to do: Contact your prescriber if severe or persistent. (1)
Low red blood cell count (anaemia)
What to notice: Blood counts are monitored during treatment.
What to do: Contact your prescriber if you notice unusual tiredness or pale skin. (1) (2)
Upper respiratory tract or urinary tract infections, cough
What to notice: Immunosuppression can increase infection risk.
What to do: Contact your prescriber for signs of infection such as fever or persistent cough. (1) (2)
Tremor, mouth ulcers, decreased appetite, and fatigue
What to notice: Reported side effects.
What to do: Contact your prescriber if any of these are bothersome or persistent. (1)
Serious warnings
Signs of a serious infection — boxed_warning
Symptoms: Fever, chills, persistent cough, unusual tiredness, or any infection that does not improve.
Action: Contact your clinician promptly -- voclosporin carries a boxed warning for an increased risk of serious infections that may lead to hospitalization or death, shared with other immunosuppressant medicines. (1)
Signs that could suggest a malignancy (including skin cancer) — boxed_warning
Symptoms: A new or changing skin lesion or mole, unexplained lumps, unexplained weight loss, or persistent swollen glands.
Action: Have any new or unusual symptoms assessed promptly -- voclosporin carries a boxed warning for an increased risk of malignancies, including lymphoma and skin cancers, shared with other immunosuppressant medicines. Routine skin checks and sun protection are recommended. (1) (2)
Signs of kidney injury (nephrotoxicity) — high caution
Symptoms: A significant drop in urine output, swelling, or unexpectedly abnormal kidney blood test (eGFR) results.
Action: Report to your clinician promptly -- voclosporin can cause acute or chronic kidney injury, which is why regular eGFR monitoring and dose adjustment are required throughout treatment. (1) (2)
High blood pressure — high caution
Symptoms: Severe headache, visual disturbance, or a very high blood pressure reading.
Action: Contact your clinician -- voclosporin can cause or worsen high blood pressure; regular monitoring is required, and treatment may need to be stopped if blood pressure becomes severely elevated with symptoms. (2)
Neurological symptoms, including signs of posterior reversible encephalopathy syndrome (PRES) — high caution
Symptoms: Sudden severe headache, seizures, confusion, vision changes, or tremor.
Action: Seek prompt medical attention -- voclosporin can cause a spectrum of nervous-system effects, including a rare but serious brain condition (PRES), seizures, and tremor. (1)
Heart rhythm changes (QT prolongation) — high caution
Symptoms: Palpitations, dizziness, or fainting.
Action: Contact your clinician promptly -- voclosporin prolongs the QT interval in a dose-dependent manner; caution is needed if you take other medicines that also affect heart rhythm. (1)
Interactions
| Medicine or test | Effect | Action |
|---|---|---|
| Strong CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, clarithromycin) | Contraindicated with voclosporin — exposure can rise dramatically (up to around 18.6-fold in the sources reviewed). | Do not combine; discuss alternatives with your prescriber. (1) (2) |
| Moderate CYP3A4 inhibitors | Increase voclosporin exposure substantially (around 2.71-fold). | Requires a reduced, individualised dose set by your prescriber. (2) |
| Strong or moderate CYP3A4 inducers | Can reduce voclosporin’s effectiveness. | Should generally be avoided; ask your prescriber before starting one. (1) |
| Grapefruit and grapefruit juice | Increase voclosporin levels. | Avoid grapefruit and grapefruit juice while taking voclosporin. (1) |
| Statins and other OATP1B1/OATP1B3-transported medicines (e.g. simvastatin, atorvastatin) | May need dose reduction or closer monitoring. | Tell your prescriber about any statin you take. (1) (2) |
| P-glycoprotein substrate medicines (e.g. digoxin, dabigatran) | May need closer monitoring when combined with voclosporin. | Tell your prescriber about all medicines you take. (2) |
| Live attenuated vaccines | Should generally be avoided during treatment. | Discuss any planned vaccination with your prescriber first. (2) |
Pregnancy, breastfeeding, kidney/liver function, age
Pregnancy
Avoid in pregnancy -- voclosporin may cause fetal harm, and it is used together with mycophenolate mofetil, which carries its own significant, well-established risk of fetal harm and pregnancy loss. Discuss family planning and contraception with your clinician before starting. (1) (2) (3) (4) (5)
Breastfeeding
Small amounts of voclosporin have been detected in breast milk (estimated infant dose around 1.4% of the maternal weight-adjusted dose in the sources reviewed); breastfeeding requires an individual benefit-risk discussion with your clinician. (1) (2) (3) (4) (5)
Children
Not established for use in children in the sources reviewed for this dossier. (1) (2) (3) (4) (5)
Elderly
No specific dose adjustment based on age alone is described in the sources reviewed, but kidney function and blood pressure should be monitored closely regardless of age. (1) (2) (3) (4) (5)
Hepatic Impairment
A reduced starting dose (15.8 mg twice daily) is used for mild-to-moderate hepatic impairment; use in severe hepatic impairment is avoided in the sources reviewed. (1) (2) (3) (4) (5)
Renal Impairment
A reduced starting dose (15.8 mg twice daily) is used if baseline eGFR is 45 mL/min/1.73 m2 or below; further dose adjustments during treatment are guided by eGFR changes, following a structured monitoring and titration schedule. (1) (2) (3) (4) (5)
Monitoring
Before starting
- Baseline eGFR (kidney function)
- Baseline blood pressure
- Review of other medicines for CYP3A4 interactions
- Screening for active or chronic infections
During treatment
- eGFR: at baseline, every 2 weeks for the first month, then every 4 weeks thereafter (UK/EU schedule) -- with dose adjusted or treatment paused based on the size of any eGFR decline.
- Blood pressure: every 2 weeks initially, then as clinically indicated; treatment reconsidered if blood pressure rises above 165/105 mmHg with symptoms.
- Serum potassium levels.
- Ongoing assessment for signs of infection, unusual bleeding or bruising, new skin lesions, and neurological symptoms.
Storage
Store capsules in their original packaging at room temperature, protected from light and moisture, out of reach of children.
Professional information
Clinician-facing context only, sourced from the current US FDA/DailyMed prescribing information and the UK EMC Summary of Product Characteristics; verify against the current full label before prescribing.
United States, United Kingdom, European Union
Indication: Active lupus nephritis (in combination with mycophenolate mofetil / background immunosuppressive regimen)
Dose summary: 23.7 mg twice daily starting dose (~12 hours apart, minimum 8 hours between doses); reduced to 15.8 mg twice daily for baseline eGFR <=45 mL/min/1.73 m2 or mild/moderate hepatic impairment; further titrated per a structured eGFR-decline rule (>=30% decline: stop, restart at 7.9 mg twice daily on recovery; 20-30% decline: reduce by 7.9 mg twice daily; <=20% decline: maintain).
Renal context: Baseline eGFR determines starting dose; ongoing eGFR changes drive a structured titration/interruption rule throughout treatment (every 2 weeks for month 1, then every 4 weeks). (1) (2)
Hepatic guidance
Reduced starting dose (15.8 mg twice daily) for mild/moderate hepatic impairment; avoid in severe hepatic impairment.
Overdose note
No specific antidote identified in the sources reviewed; manage with supportive care and close monitoring of blood pressure, kidney function, and cardiac rhythm. (1) (2)
Frequently asked questions
Does voclosporin carry a boxed warning?
Yes. Voclosporin's current FDA label carries a boxed warning titled 'WARNING: MALIGNANCIES AND SERIOUS INFECTIONS', reflecting an increased risk of developing malignancies and serious infections with voclosporin or other immunosuppressants, which may lead to hospitalization or death. This is the standard, shared risk of the calcineurin-inhibitor/immunosuppressant class it belongs to. Separately, but not at boxed-warning level, voclosporin also carries genuine warnings for kidney injury, high blood pressure, nervous-system effects, and heart-rhythm changes. (1)
Is voclosporin used on its own?
No. Voclosporin is used together with a background immunosuppressive regimen -- specifically mycophenolate mofetil, per the UK/EU label -- for active lupus nephritis. It has not been established, and is not recommended, in combination with cyclophosphamide. (1) (2)
Is voclosporin (Lupkynis) available in the US, UK, Europe, Canada, Australia, and New Zealand?
It is confirmed authorised in the United States, United Kingdom, and European Union (via a genuine EU-wide centralised marketing authorisation). Direct checks of the official Canadian and Australian drug registries found no record of voclosporin or Lupkynis in either country -- it is genuinely not authorised there. New Zealand's Medsafe status could not be located after direct search and is disclosed honestly as unable to verify, not assumed. (1) (2) (3) (4) (5)
Why do I need frequent kidney function and blood pressure checks on voclosporin?
Voclosporin can cause acute or chronic kidney injury and can cause or worsen high blood pressure. Regular eGFR (kidney function) and blood pressure checks -- especially frequent in the first month -- let your clinician adjust your dose, pause treatment, or manage blood pressure before these effects become serious. (2)
What is the mechanism of action of voclosporin?
Voclosporin is a calcineurin inhibitor. By inhibiting calcineurin, it blocks T-lymphocyte activation, cytokine production, and expression of T-cell activation surface antigens, producing an immunosuppressive effect used to control the immune-mediated kidney inflammation of lupus nephritis. (1) (2)
References
- LUPKYNIS (voclosporin) capsules, for oral use -- full prescribing informationU.S. Food and Drug Administration / DailyMed (NIH), full prescribing information, Aurinia Pharmaceuticals Inc. · United States · accessed 2026-07-31 · source 1
- Lupkynis 7.9 mg soft capsules -- Summary of Product Characteristicselectronic medicines compendium (emc), United Kingdom -- Otsuka Pharmaceuticals (UK) Ltd · United Kingdom · accessed 2026-07-31 · source 2
- Lupkynis (voclosporin) -- EPAR medicine overviewEuropean Medicines Agency (EMA) -- centralised marketing authorisation / EPAR · European Union · accessed 2026-07-31 · source 3
- Health Canada Drug Product Database -- query for brand name "lupkynis" and active ingredient "voclosporin"Health Canada -- Drug Product Database (DPD), official public API · Canada · accessed 2026-07-31 · source 4
- TGA eBS PICMI repository search -- "voclosporin"Therapeutic Goods Administration (TGA), Australia -- eBS PICMI (Product and Consumer Medicine Information) repository · Australia · accessed 2026-07-31 · source 5
Brand names by country
Single-ingredient voclosporin names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.
Priority countries
United Kingdom
- Lupkynis 7.9 mg soft capsules7.9 mg · Otsuka Pharmaceuticals (UK) Ltd