Human medicines European public assessment report (EPAR): Lupkynis, voclosporin, Date of authorisation: 15/09/2022, Revision: 7, Status: Authorised

Overview

Lupkynis is a medicine used to treat lupus nephritis, a manifestation of a disease called systemic lupus erythematosus. In lupus nephritis, the immune system (the body's natural defences) attacks the kidneys, causing inflammation and kidney damage. Lupkynis is used together with another medicine called mycophenolate mofetil in adults with active class III, IV or V lupus nephritis, which are severe forms of the condition. Lupkynis contains the active substance voclosporin. Expand section Collapse section How is Lupkynis used? The medicine can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in diagnosing and treating lupus nephritis. Lupkynis is available as a 7.9 mg capsule to be taken by mouth. The recommended dose is 23.7 mg (equivalent to three soft capsules) twice a day, with a minimum of 8 hours between each dose. The doctor should evaluate treatment effectiveness after about 24 weeks and weigh it against the risks to decide whether to continue treatment. For more information about using Lupkynis, see the package leaflet or contact your doctor or pharmacist. How does Lupkynis work? The active substance in Lupkynis, voclosporin, is an immunosuppressant (a medicine that reduces the activity of the immune system) known as a calcineurin inhibitor. This means that it blocks the action of calcineurin, an enzyme involved in activating T-lymphocytes (white blood cells that are part of the immune system and play a role in inflammation). By blocking the action of calcineurin, voclosporin reduces inflammation and other symptoms of lupus nephritis. What benefits of Lupkynis have been shown in studies? Lupkynis was shown to be more effective than placebo (a dummy treatment) in achieving stable kidney function in adults with active lupus nephritis. A main study involving 357 adults found that after 52 weeks, 41% (73 out of 179) of patients taking Lupkynis had acceptable measures of both kidney function and protein in the urine (a sign of kidney damage) compared with 23% (40 out of 178) of patients receiving placebo. All patients received mycophenolate mofetil (another immunosuppressant medicine) in addition to Lupkynis or placebo. What are the risks associated with Lupkynis? The most common side effects with Lupkynis (which may affect more than 1 in 10 people) are decreased glomerular filtration rate (a sign of kidney damage) and hypertension (high blood pressure). The most common serious side effects with Lupkynis are infections, acute kidney injury and high blood pressure. Lupkynis must not be used together with certain medicines called 'strong CYP3A4 inhibitors', including the antifungal medicines ketoconazole and itraconazole and the antibiotic medicine clarithromycin, as these may affect the levels of voclosporin in the blood. For the full list of side effects and restrictions with Lupkynis, see the package leaflet. Why is Lupkynis authorised in the EU? When used in combination with mycophenolate mofetil, Lupkynis has been shown to be effective in achieving stable kidney function in adults with active lupus nephritis. The medicine's side effect profile is serious and requires extensive monitoring of kidney function; adequate information on the risks and recommendations for monitoring is included in the product information. The European Medicines Agency therefore decided that Lupkynis's benefits are greater than its risks and it can be authorised for use in the EU. What measures are being taken to ensure the safe and effective use of Lupkynis? The company will carry out a study to provide more information on the long-term safety of Lupkynis. Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lupkynis have also been included in the summary of product characteristics and the package leaflet. As for all medicines, data on the use of Lupkynis are continuously monitored. Suspected side effects reported with Lupkynis are carefully evaluated and any necessary action taken to protect patients. Other information about Lupkynis Lupkynis received a marketing authorisation valid throughout the EU on 15 September 2022. Lupkynis : EPAR - Medicine overview Adopted Reference Number: EMEA/H/C/005256 English (EN) (118.99 KB - PDF) First published: 20/09/2022 View Other languages (22) български (BG) (135.58 KB - PDF) First published: 20/09/2022 View español (ES) (110.41 KB - PDF) First published: 20/09/2022 View čeština (CS) (130.83 KB - PDF) First published: 20/09/2022 View dansk (DA) (108.54 KB - PDF) First published: 20/09/2022 View Deutsch (DE) (113.42 KB - PDF) First published: 20/09/2022 View eesti (ET) (98.73 KB - PDF) First published: 20/09/2022 View ελληνικά (EL) (134.91 KB - PDF) First published: 20/09/2022 View français (FR) (111.56 KB - PDF) First published: 20/09/2022 View hrvatski (HR) (130.16 KB - PDF) First published: 20/09/2022 View italiano (IT) (109.45 KB - PDF) First published: 20/09/2022 View latviešu (LV) (148.44 KB - PDF) First published: 20/09/2022 View lietuvių (LT) (131.38 KB - PDF) First published: 20/09/2022 View magyar (HU) (130.24 KB - PDF) First published: 20/09/2022 View Malti (MT) (133.31 KB - PDF) First published: 20/09/2022 View Nederlands (NL) (109.73 KB - PDF) First published: 20/09/2022 View polski (PL) (134.59 KB - PDF) First published: 20/09/2022 View português (PT) (110.9 KB - PDF) First published: 20/09/2022 View română (RO) (129.67 KB - PDF) First published: 20/09/2022 View slovenčina (SK) (130.41 KB - PDF) First published: 20/09/2022 View slovenščina (SL) (127.75 KB - PDF) First published: 20/09/2022 View suomi (FI) (107.93 KB - PDF) First published: 20/09/2022 View svenska (SV) (108.37 KB - PDF) First published: 20/09/2022 View Lupkynis : EPAR - Risk management plan English (EN) (4.06 MB - PDF) First published: 20/09/2022 Last updated: 25/07/2024 View

Product information

Lupkynis : EPAR - Product Information English (EN) (575.4 KB - PDF) First published: 20/09/2022 Last updated: 13/08/2026 View Other languages (24) български (BG) (632.94 KB - PDF) First published: 20/09/2022 Last updated: 13/08/2026 View español (ES) (565.75 KB - PDF) First published: 20/09/2022 Last updated: 13/08/2026 View čeština (CS) (567.36 KB - PDF) First published: 20/09/2022 Last updated: 13/08/2026 View dansk (DA) (564.06 KB - PDF) First published: 20/09/2022 Last updated: 13/08/2026 View Deutsch (DE) (571.01 KB - PDF) First published: 20/09/2022 Last updated: 13/08/2026 View eesti (ET) (577.02 KB - PDF) First published: 20/09/2022 Last updated: 13/08/2026 View ελληνικά (EL) (630.43 KB - PDF) First published: 20/09/2022 Last updated: 13/08/2026 View français (FR) (590.88 KB - PDF) First published: 20/09/2022 Last updated: 13/08/2026 View hrvatski (HR) (591.5 KB - PDF) First published: 20/09/2022 Last updated: 13/08/2026 View italiano (IT) (559.73 KB - PDF) First published: 20/09/2022 Last updated: 13/08/2026 View latviešu (LV) (601 KB - PDF) First published: 20/09/2022 Last updated: 13/08/2026 View lietuvių (LT) (610.37 KB - PDF) First published: 20/09/2022 Last updated: 13/08/2026 View magyar (HU) (628.19 KB - PDF) First published: 20/09/2022 Last updated: 13/08/2026 View Malti (MT) (621.36 KB - PDF) First published: 20/09/2022 Last updated: 13/08/2026 View Nederlands (NL) (559.58 KB - PDF) First published: 20/09/2022 Last updated: 13/08/2026 View polski (PL) (644 KB - PDF) First published: 20/09/2022 Last updated: 13/08/2026 View português (PT) (558.51 KB - PDF) First published: 20/09/2022 Last updated: 13/08/2026 View română (RO) (596.31 KB - PDF) First published: 20/09/2022 Last updated: 13/08/2026 View slovenčina (SK) (609.08 KB - PDF) First published: 20/09/2022 Last updated: 13/08/2026 View slovenščina (SL) (607.82 KB - PDF) First published: 20/09/2022 Last updated: 13/08/2026 View suomi (FI) (569.05 KB - PDF) First published: 20/09/2022 Last updated: 13/08/2026 View svenska (SV) (574.19 KB - PDF) First published: 20/09/2022 Last updated: 13/08/2026 View Íslenska (IS) (544.3 KB - PDF) First published: 20/09/2022 Last updated: 13/08/2026 View norsk (NO) (564.53 KB - PDF) First published: 20/09/2022 Last updated: 13/08/2026 View Latest procedure affecting product information: VR/0000363060 11/08/2026 This medicine's product information is available in all official EU languages . Select 'available languages' to access the language you need. Product information documents contain: summary of product characteristics (annex I); manufacturing authorisation holder responsible for batch release (annex IIA); conditions of the marketing authorisation (annex IIB); labelling (annex IIIA); package leaflet (annex IIIB). Lupkynis : EPAR - All authorised presentations English (EN) (12.99 KB - PDF) First published: 20/09/2022 Last updated: 07/02/2023 View Other languages (24) български (BG) (35.07 KB - PDF) First published: 20/09/2022 Last updated: 07/02/2023 View español (ES) (13.15 KB - PDF) First published: 20/09/2022 Last updated: 07/02/2023 View čeština (CS) (34.38 KB - PDF) First published: 20/09/2022 Last updated: 07/02/2023 View dansk (DA) (10.97 KB - PDF) First published: 20/09/2022 Last updated: 07/02/2023 View Deutsch (DE) (11.03 KB - PDF) First published: 20/09/2022 Last updated: 07/02/2023 View eesti (ET) (11.04 KB - PDF) First published: 20/09/2022 Last updated: 07/02/2023 View ελληνικά (EL) (34.44 KB - PDF) First published: 20/09/2022 Last updated: 07/02/2023 View français (FR) (10.99 KB - PDF) First published: 20/09/2022 Last updated: 07/02/2023 View hrvatski (HR) (121.58 KB - PDF) First published: 20/09/2022 Last updated: 07/02/2023 View italiano (IT) (11.42 KB - PDF) First published: 20/09/2022 Last updated: 07/02/2023 View latviešu (LV) (35.67 KB - PDF) First published: 20/09/2022 Last updated: 07/02/2023 View lietuvių (LT) (34.43 KB - PDF) First published: 20/09/2022 Last updated: 07/02/2023 View magyar (HU) (30.81 KB - PDF) First published: 20/09/2022 Last updated: 07/02/2023 View Malti (MT) (31.15 KB - PDF) First published: 20/09/2022 Last updated: 07/02/2023 View Nederlands (NL) (10.98 KB - PDF) First published: 20/09/2022 Last updated: 07/02/2023 View polski (PL) (30.68 KB - PDF) First published: 20/09/2022 Last updated: 07/02/2023 View português (PT) (11.12 KB - PDF) First published: 20/09/2022 Last updated: 07/02/2023 View română (RO) (34.47 KB - PDF) First published: 20/09/2022 Last updated: 07/02/2023 View slovenčina (SK) (33.18 KB - PDF) First published: 20/09/2022 Last updated: 07/02/2023 View slovenščina (SL) (19.51 KB - PDF) First published: 20/09/2022 Last updated: 07/02/2023 View suomi (FI) (11.32 KB - PDF) First published: 20/09/2022 Last updated: 07/02/2023 View svenska (SV) (11.04 KB - PDF) First published: 20/09/2022 Last updated: 07/02/2023 View Íslenska (IS) (10.92 KB - PDF) First published: 20/09/2022 Last updated: 07/02/2023 View norsk (NO) (10.98 KB - PDF) First published: 20/09/2022 Last updated: 07/02/2023 View

Product details

Name of medicine Lupkynis Active substance voclosporin International non-proprietary name (INN) or common name voclosporin Therapeutic area (MeSH) Lupus Nephritis Anatomical therapeutic chemical (ATC) code L04AD03 Pharmacotherapeutic group Immunosuppressants Therapeutic indication Lupkynis is indicated in combination with mycophenolate mofetil for the treatment of adult patients with active class III, IV or V (including mixed class III/V and IV/V) lupus nephritis (LN).

Authorisation details

EMA product number EMEA/H/C/005256 Additional monitoring This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring . Marketing authorisation holder Otsuka Pharmaceutical Netherlands B.V. Herikerbergweg 292 1101 CT Amsterdam Netherlands Opinion adopted 21/07/2022 Marketing authorisation issued 15/09/2022 Revision 7

Assessment history

Expand section Collapse section Changes since initial authorisation of medicine Lupkynis : EPAR - Procedural steps taken and scientific information after authorisation English (EN) (158.88 KB - PDF) First published: 19/06/2025 Last updated: 13/08/2026 View Lupkynis : EPAR - Procedural steps taken and scientific information after authorisation (archive) English (EN) (104.7 KB - PDF) First published: 07/02/2023 Last updated: 19/06/2025 View Lupkynis-PSUSA-00011020-202501 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation Reference Number: EMADOC-1700519818-2639887 English (EN) (162.24 KB - PDF) First published: 24/11/2025 View Lupkynis-H-C-PSUSA-00011020-202401 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation Reference Number: EMA/552100/2024 English (EN) (93.5 KB - PDF) First published: 27/11/2024 View Initial marketing authorisation documents Lupkynis : EPAR - Public Assessment report Adopted Reference Number: EMA/681286/2022 English (EN) (3.73 MB - PDF) First published: 20/09/2022 View CHMP summary of positive opinion for Lupkynis Adopted Reference Number: EMA/CHMP/623061/2022 English (EN) (116.26 KB - PDF) First published: 22/07/2022 View

More information on Lupkynis

EMA/PE/0000228081 - paediatric investigation plan An observational post-authorisation safety study (PASS) in Europe to further characterise and quantify long-term safety profile with respect to neurotoxicity, chronic nephrotoxicity, and malignancy with use of voclosporin - post-authorisation study