Voclosporin
Voclosporin is a calcineurin-inhibitor immune-suppressing medicine used with other medicines to treat active lupus nephritis (lupus-related kidney inflammation) in adults.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Voclosporin (Lupkynis) is a newer specialist immune-suppressing drug, on the U.S. market since about 2021, that blocks an enzyme, calcineurin, to quiet the immune cells (T-cells) attacking the kidney in adults with active lupus nephritis (kidney inflammation caused by lupus). It is always added to other immune-suppressing medicines. Many people tolerate it reasonably well, and diarrhea, headache and cough are the side effects most often noticed. Its boxed warning covers serious infections and cancers that can lead to hospitalization or death, so report fever, new skin changes or swollen glands right away, and expect regular checks of kidney function, blood pressure and potassium.
Clinical pearls
- Take it on an empty stomach, about 12 hours apart, and swallow the capsules whole without opening, crushing or dividing them.
- Skip grapefruit, and have any new prescription checked first, since clarithromycin, ketoconazole or itraconazole must not be combined with it.
- Wear SPF 30 or higher sunscreen and avoid tanning beds, since it raises the risk of skin cancer.
- Avoid pregnancy on it, since it may harm the baby and mycophenolate, often taken alongside, can cause birth defects.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Lupkynis can raise your risk of serious infections and cancers, which may lead to hospitalization or death.
This is because it suppresses the immune system, as other similar medicines do. Watch for fever, signs of infection, new skin changes, or swollen glands, and tell your doctor right away.
Patient information guide A plain-language walkthrough of Voclosporin, written from its FDA label.
What Voclosporin is used for
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Voclosporin is used for one condition, as the capsule Lupkynis:
- Active lupus nephritis in adults, used together with a background immunosuppressive regimen
- Lupkynis is not recommended in combination with cyclophosphamide, because safety and effectiveness have not been established
How Voclosporin works
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Voclosporin is a calcineurin inhibitor. It blocks calcineurin, an enzyme that helps activate T-cells, a type of immune cell. This reduces T-cell growth and the release of inflammatory signals, which calms the immune attack on the kidneys.
Animal studies also suggest it helps stabilize podocytes, the kidney’s filtering cells. The exact mechanism has not been fully established.
Voclosporin dosage
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Lupkynis is a capsule taken by mouth twice a day on an empty stomach, as close to 12 hours apart as possible. Your doctor sets and adjusts the dose based on your kidney function and blood pressure, so follow your prescription.
- Swallow the capsule whole. Do not open, crush or divide it.
- Keep at least 8 hours between doses.
- Missed dose: take it within 4 hours. After that, skip it and take the next dose at the usual time. Never double up.
- Avoid grapefruit and grapefruit juice.
- If you do not benefit by 24 weeks, your doctor may consider stopping it.
Dosing details from the FDA-approved label
From the Voclosporin prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Recommended starting dose (used in combination with mycophenolate mofetil and corticosteroids)
- 23.7 mg twice a day
- Swallow whole on an empty stomach, as close to a 12-hour schedule as possible and at least 8 hours between doses; modify dose based on eGFR; if no therapeutic benefit by 24 weeks, consider discontinuation
- Patients with severe renal impairment
- 15.8 mg twice a day (recommended starting dose)
- Not recommended in patients with baseline eGFR ≤45 mL/min/1.73 m2 unless the benefit exceeds the risk
- Patients with mild and moderate hepatic impairment (Child-Pugh A and Child-Pugh B)
- 15.8 mg twice daily
- Not recommended in severe hepatic impairment (Child-Pugh C)
- Patients co-administered moderate CYP3A4 inhibitors (e.g., verapamil, fluconazole, diltiazem)
- 15.8 mg in the morning and 7.9 mg in the evening
- No dose adjustment with mild CYP3A4 inhibitors
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION 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. ( 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.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Voclosporin side effects
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The most common side effects in clinical studies were:
Common side effects
- Decreased kidney filtering (lower eGFR)
- High blood pressure
- Diarrhea
- Headache
- Anemia (low red blood cells)
- Cough
- Urinary tract infection
- Upper stomach pain, indigestion, or hair loss
- Mouth ulcers, tiredness, tremor, decreased appetite
When to get medical help
- Signs of infection such as fever, chills, painful rash, or urinary symptoms
- New or changing skin lesions, or other signs of cancer such as swollen lymph nodes
- Seizure, confusion, severe headache, or vision or other nervous system changes
- Signs of kidney problems, such as a drop in kidney function found on blood tests
- Very high blood pressure
- Fast or irregular heartbeat, fainting, or dizziness
- Swelling of the face, lips or throat, trouble breathing, or other allergic reaction signs
Voclosporin warnings and precautions
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- Serious infections and cancers: This is the boxed warning. Skin cancer and lymphoma are the main cancer concerns, so protect your skin from the sun.
- Kidney damage: Kidney function is checked often, and the dose may be lowered or stopped.
- High blood pressure: It may need treatment.
- Nervous system problems: These include tremor, headache, seizures, and PRES (a brain swelling condition).
- High potassium: Levels are checked periodically.
- QT prolongation: This can affect heart rhythm, especially with a slow heartbeat, low potassium or magnesium, or other QT-prolonging drugs.
- Allergic reactions: Stop the medicine and get treatment.
- Vaccines: Avoid live vaccines. Other vaccines may work less well.
- Pure red cell aplasia: Reported with another drug of this class. Your doctor may consider stopping Lupkynis if it is diagnosed.
Voclosporin interactions
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Many interactions involve CYP3A4, the enzyme that breaks down voclosporin.
- Strong CYP3A4 inhibitors (ketoconazole, itraconazole, clarithromycin): Contraindicated, because they raise voclosporin levels and kidney risk.
- Moderate CYP3A4 inhibitors (verapamil, fluconazole, diltiazem): The dose must be reduced.
- CYP3A4 inducers (strong or moderate): Avoid, since they lower levels and may reduce effectiveness.
- Grapefruit: Avoid it.
- Statins: Voclosporin raises statin levels, so doses may need to be lowered and muscle problems watched for.
- Certain P-gp substrate drugs with a narrow safety margin: These may need lower doses.
- Potassium-raising drugs and kidney-harming drugs: These add to the risk of high potassium and kidney damage.
- QT-prolonging drugs: These may add to the risk of QT prolongation.
Interactions listed in the FDA-approved label
From the Voclosporin prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin): Co-administration increases voclosporin exposure, which may increase the risk of LUPKYNIS adverse reactions. Co-administration is contraindicated.
- Moderate CYP3A4 inhibitors (e.g., verapamil, fluconazole, diltiazem): Co-administration increases voclosporin exposure, which may increase the risk of LUPKYNIS adverse reactions. Reduce LUPKYNIS daily dosage to 15.8 mg in the morning and 7.9 mg in the evening.
- Mild CYP3A4 inhibitors: No dose adjustment of LUPKYNIS is recommended.
- Grapefruit (food or juice): Food or drink containing grapefruit is to be avoided when taking LUPKYNIS. Avoid eating grapefruit or drinking grapefruit juice while taking LUPKYNIS.
- Strong and moderate CYP3A4 inducers: Co-administration decreases voclosporin exposure, which may decrease the efficacy of LUPKYNIS. Avoid co-administration.
- Certain P-gp substrates with a narrow therapeutic window: Voclosporin is a P-gp inhibitor and increases exposure of P-gp substrates, which may increase the risk of their adverse reactions. Reduce the dosage of the substrate as recommended in its prescribing information, if needed.
- OATP1B1/OATP1B3 substrates (e.g., simvastatin, atorvastatin, pravastatin, rosuvastatin, pitavastatin, fluvastatin): Voclosporin inhibits OATP1B1 and OATP1B3; with 40 mg simvastatin and 23.7 mg BID voclosporin, simvastatin acid Cmax and AUC increased 3.1-fold and 1.8-fold, respectively. Monitor for adverse reactions such as myopathy and rhabdomyolysis and reduce the substrate dosage as recommended in its prescribing information; with simvastatin, limit 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.
Read the label’s full interactions text
7 DRUG INTERACTIONS 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. 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.
Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Voclosporin
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- Do not take it if you use strong CYP3A4 inhibitors or have had a severe allergic reaction to it.
- Kidney function and blood pressure are checked before starting. It is not recommended with an eGFR of 45 or lower unless the benefit outweighs the risk, or with very high blood pressure.
- Mild or moderate liver impairment needs a lower dose. Avoid it in severe liver impairment.
- Pregnancy: avoid it, partly because the capsules contain alcohol. Mycophenolate, often used with it, can also cause birth defects.
- Breastfeeding: small amounts pass into milk. Discuss the risks and benefits with your doctor.
- Children: safety and effectiveness have not been established.
- Older adults: dosing should be cautious.
Voclosporin overdose
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Accidental overdoses have caused tremor, headache, nausea, vomiting, infections, fast heartbeat, hives, lethargy, and abnormal kidney and liver blood tests. There is no specific antidote. Treatment means stopping the drug and giving supportive care with monitoring. Contact a poison center at 1-800-222-1222 or seek medical help.
What Voclosporin does in the body
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Voclosporin blocks calcineurin in proportion to its concentration in the blood, with little delay between peak level and peak effect. In a single-dose study at doses above the therapeutic range, it lengthened the QT interval in a dose-dependent way. A separate multiple-dose study at lower doses showed no large increases.
How your body processes Voclosporin
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Voclosporin reaches peak blood levels in about 1.5 hours on an empty stomach. Food lowers how much is absorbed, which is why it is taken on an empty stomach. It is broken down mainly by CYP3A4 and leaves the body mostly in the feces. The half-life is about 30 hours, and steady levels build up after about 6 days of twice-daily dosing.
How to store Voclosporin
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Store at controlled room temperature 20ºC to 25ºC (68ºF to 77ºF); excursions permitted to 15ºC to 30ºC (59ºF to 86ºF) .
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Voclosporin
152 supplements and herbal products have documented interactions with Voclosporin in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 10
- Moderate · 101
- Minor · 41
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Voclosporin: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Voclosporin — the kind of thing our pharmacy team would talk through with you at the counter.
What is Lupkynis for?
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How should I take it?
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What side effects should I expect?
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Can I take other medicines with it?
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Is it safe during pregnancy or breastfeeding?
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Why am I protected from the sun and told about infections?
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Is Voclosporin available over the counter?
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When was Voclosporin first available?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Voclosporin on HelloPharmacist
Voclosporin forms and strengths (how it comes)
Voclosporin is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Voclosporin inactive ingredients by manufacturer.
Capsule
How this form is used
- Lupkynis is used with a background immunosuppressive regimen to treat active lupus nephritis in adults.
- Lupkynis capsules are swallowed whole on an empty stomach and must not be opened, crushed, or divided.
- Lupkynis is taken about every 12 hours, at least 8 hours apart.
- If a Lupkynis dose is missed, take it within 4 hours. Otherwise wait for the next scheduled dose and do not double up.
- Avoid grapefruit and grapefruit juice while taking Lupkynis.
Voclosporin on the U.S. market: products, makers and brands
How Voclosporin appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
1 company lists 1 Voclosporin product record with the FDA, mostly as capsule; the earliest marketing or approval year on record is 2021. Brand names on the directory include Lupkynis; the rest are generics.
Also listed with the FDA, not a patient dose form: Powder (6) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
How widely Voclosporin is used (Medicaid data)
A general measure of how commonly Voclosporin is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Voclosporin is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Voclosporin prescribed? Of the 1,601 medications we measure, Voclosporin ranks #1,178 by Medicaid prescriptions — more than 26% of them.
Utilization by Voclosporin product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
voclosporin 7.9 MG Oral Capsule
Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2475400
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Voclosporin, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 4 listed Voclosporin NDCs with Medicaid activity.
Compare Voclosporin products
A representative set of FDA-listed product records for Voclosporin — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Capsule | ||||
| 7.9 mg | Oral | Aurinia Pharma U.S., Inc. | NDA | View NDC → |
Showing 1 of 1 products — FDA National Drug Code Directory. See every product, package size and price: browse all 1 Voclosporin NDCs →
Voclosporin side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Voclosporin — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Voclosporin in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Voclosporin FDA approval history
How Voclosporin went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Voclosporin recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Voclosporin recalls since July 2021.
✅No Voclosporin recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 2475166 1 dose form · 1 strength
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Dose form (SCDF) Oral Capsule RxCUI 2475399In current FDA listingsClinical drug / strength (SCD) 7.9 MGRxCUI 2475400
Look up RxCUI 2475166 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Voclosporin supply and shortage status
Whether Voclosporin is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Voclosporin brand names
Voclosporin is sold under one brand name in the FDA directory — Lupkynis. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Voclosporin: manufacturers and labelers
One company lists Voclosporin products with the FDA. By number of product records, the largest are Aurinia Pharma U.S., Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Voclosporin drug class (RxNorm)
Voclosporin belongs to the Calcineurin Inhibitor Immunosuppressant class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Voclosporin page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Aurinia Pharma U.S., Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →