Prescription medicine
Voclosporin Brand names: Lupkynis
Voclosporin (Lupkynis) is a prescription medicine with an FDA approval on record since 2021. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the voclosporin FDA label on DailyMed (effective August 25, 2026, Aurinia Pharma U.S., Inc.); the NDA 213716 record on Drugs@FDA; every voclosporin label on DailyMed.
Highlights of the record
FDA label of August 25, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
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. Increased risk for developing serious infections and malignancies with LUPKYNIS or other immunosuppressants that may lead to hospitalization or death.
Used for
From the label: indications and usageLUPKYNIS is indicated in combination with a background immunosuppressive therapy regimen [see Clinical Studies ( 14 )] for the treatment of adult patients with active lupus nephritis (LN).
Forms and strengths
- 7.9 mg
Capsule.
On the market
- Earliest approval on file
- January 22, 2021 Lupkynis, Aurinia; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- December 7, 2037 Lupkynis capsules; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 8,634 through July 30, 2026
What is voclosporin used for?
From the label: indications and usageLUPKYNIS is indicated in combination with a background immunosuppressive therapy regimen [see Clinical Studies ( 14 )] 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. LUPKYNIS is a calcineurin-inhibitor immunosuppressant indicated in combination with a background immunosuppressive therapy regimen for the treatment of adult patients with active lupus nephritis (LN). ( 1 , 14 ) Limitations of Use: Safety and efficacy of LUPKYNIS have not been established in combination with cyclophosphamide. […]
FDA pharmacologic class: Calcineurin Inhibitor Immunosuppressant.
Source: FDA drug label (LUPKYNIS), Aurinia Pharma U.S., Inc., effective August 25, 2026 (SPL set 9f489295-1156-52c7-5fd0-5c4c52f9b813), via openFDA; the full label on DailyMed
What does the patient leaflet for voclosporin say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about LUPKYNIS?LUPKYNIS can cause serious side effects, including: Increased risk of cancer. People who take LUPKYNIS have an increased risk of getting certain kinds of cancer, including skin cancer and cancer of the lymph glands (lymphoma). Increased risk of infection. LUPKYNIS is a medicine that affects your immune system. LUPKYNIS can lower the ability of your immune system to fight infections. Serious infections can happen in people receiving LUPKYNIS that can lead to hospitalizations and can cause death. Call your healthcare provider right away if you have symptoms of an infection such as: fever cough or flu-like symptoms warm, red, or painful areas on your skin sweats or chills muscle aches See “What are the possible side effects of LUPKYNIS? ” for more information about side effects.
From the patient leaflet: What should I avoid while taking LUPKYNIS?Live vaccines such as flu vaccine through your nose, measles, mumps, rubella, polio by mouth, BCG (TB vaccine), yellow fever, chicken pox (varicella), or typhoid. Exposure to sunlight and UV light such as tanning machines. Wear protective clothing and use a sunscreen. You should not eat grapefruit or drink grapefruit juice while taking LUPKYNIS.
From the patient leaflet: How should I store LUPKYNIS?Store LUPKYNIS at room temperature between 68⁰F to 77⁰F (20⁰C to 25⁰C). Do not put LUPKYNIS in another container. Keep capsules in their original package until you are ready to take them. Keep LUPKYNIS and all medicines out of the reach of children.
Source: FDA drug label (LUPKYNIS), Aurinia Pharma U.S., Inc., effective August 25, 2026 (SPL set 9f489295-1156-52c7-5fd0-5c4c52f9b813), via openFDA; the full label on DailyMed
Is there a generic for voclosporin (Lupkynis)?
No generic voclosporin is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 3 patents for Lupkynis capsules: the compound patent runs to October 17, 2027, and the last listed entry to December 7, 2037. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2021 earliest approval on file
- 2037 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the voclosporin label say about other medicines?
The voclosporin label names 12 other medicines in its interaction, contraindication or warning sections. The labels of 4 other medicines name voclosporin. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Atorvastatin | drug interactions | 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. |
| Clarithromycin | contraindications | CONTRAINDICATIONS 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 … |
| Diltiazem | drug interactions | Reduce LUPKYNIS dosage when co-administered with moderate CYP3A4 inhibitors (e.g., verapamil, fluconazole, diltiazem) [see Dosage and Administration ( 2.5 ]. |
| Fluconazole | drug interactions | Reduce LUPKYNIS dosage when co-administered with moderate CYP3A4 inhibitors (e.g., verapamil, fluconazole, diltiazem) [see Dosage and Administration ( 2.5 ]. |
| Fluvastatin | drug interactions | 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. |
| Itraconazole | contraindications | CONTRAINDICATIONS 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 … |
| Ketoconazole | contraindications | CONTRAINDICATIONS 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 … |
| Pitavastatin | drug interactions | 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. |
| Pravastatin | drug interactions | 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. |
| Rosuvastatin | drug interactions | 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. |
| Simvastatin | drug interactions | 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 )]. |
| Verapamil | drug interactions | Reduce LUPKYNIS dosage when co-administered with moderate CYP3A4 inhibitors (e.g., verapamil, fluconazole, diltiazem) [see Dosage and Administration ( 2.5 ]. |
Other labels that name voclosporin
Source: FDA drug label (LUPKYNIS), Aurinia Pharma U.S., Inc., effective August 25, 2026 (SPL set 9f489295-1156-52c7-5fd0-5c4c52f9b813), via openFDA; the full label on DailyMed
What do FAERS reports show for voclosporin?
The FDA Adverse Event Reporting System holds 8,634 reports that list voclosporin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 49 are coded as a death and 786 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2025 (2,316, against a median of 1 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other calcineurin inhibitor immunosuppressants
- the pharmacologic class, with prices and generics
- Voclosporin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other