Cyclosporine
Cequa®, Neoimmun, Sandimmun, Vanquoral · ATC code L04AD01
Also known as: Ciclosporin, siklosporin · Brand names: Cequa®, Neoimmun, Sandimmun, Vanquoral, Cequa, Cicloral, Ciqorin, Deximune, Immunosporin, Cylorin, Drosporin, Lymunir, Panosporin, Sigmasporin Microral, Gengraf …
- Key facts
- Active substance
- Cyclosporine
- Drug class
- Calcineurin inhibitor
- ATC code
- L04AD01
- Authorisation
- authorised nationally; no central EU authorisation
- Information as of
- 2026-10-27
Boxed warning
WARNING
Only physicians experienced in management of systemic immunosuppressive therapy for the indicated disease should prescribe cyclosporine capsules (modified). At doses used in solid organ transplantation, only physicians experienced in immunosuppressive therapy and management of organ transplant recipients should prescribe cyclosporine capsules (modified). Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient.
Cyclosporine capsules (modified), a systemic immunosuppressant, may increase the susceptibility to infection and the development of neoplasia. In kidney, liver, and heart transplant patients cyclosporine capsules (modified) may be administered with other immunosuppressive agents. Increased susceptibility to infection and the possible development of lymphoma and other neoplasms may result from the increase in the degree of immunosuppression in transplant patients.
Cyclosporine capsules (modified) have increased bioavailability in comparison to Sandimmune® Soft Gelatin Capsules (cyclosporine capsules, USP) [NON-MODIFIED]. Cyclosporine capsules (modified) and Sandimmune ® are not bioequivalent and cannot be used interchangeably without physician supervision. For a given trough concentration, cyclosporine exposure will be greater with cyclosporine capsules (modified) than with Sandimmune ® . If a patient who is receiving exceptionally high doses of Sandimmune ® is converted to cyclosporine capsules (modified), particular caution should be exercised. Cyclosporine blood concentrations should be monitored in transplant and rheumatoid arthritis patients taking cyclosporine capsules (modified) to avoid toxicity due to high concentrations. Dose adjustments should be made in transplant patients to minimize possible organ rejection due to low concentrations. Comparison of blood concentrations in the published literature with blood concentrations obtained using current assays must be done with detailed knowledge of the assay methods employed (see DOSAGE AND ADMINISTRATION ).
Key facts
Cyclosporine is a systemic immunosuppressant (calcineurin inhibitor). The modified capsules are used to prevent rejection after kidney, liver and heart transplantation and to treat severe rheumatoid arthritis and severe psoriasis.
What it is used for
- Prophylaxis of organ rejection in kidney, liver and heart allogeneic transplants
- Severe active rheumatoid arthritis not adequately responding to methotrexate (alone or with methotrexate)
- Severe recalcitrant plaque psoriasis in adult non-immunocompromised patients who failed at least one systemic therapy
Dosing
- The daily dose is always given in two divided doses, on a consistent schedule relative to time of day and meals
- Transplantation: initial dose depends on the organ and the other immunosuppressants; details in the full text
- Rheumatoid arthritis: initial dose 2.5 mg/kg/day; may be increased up to a maximum of 4 mg/kg/day
- Psoriasis: initial dose 2.5 mg/kg/day for at least 4 weeks; increases up to a maximum of 4 mg/kg/day
- Not bioequivalent with Sandimmune; not interchangeable without physician supervision
- Severe hepatic impairment: dose reduction may be necessary; RA/psoriasis with impaired renal function: should not receive cyclosporine
Contraindications
- Hypersensitivity to cyclosporine or any ingredient
- RA and psoriasis: abnormal renal function, uncontrolled hypertension or malignancies
- Psoriasis: no concomitant PUVA or UVB therapy, methotrexate, other immunosuppressants, coal tar or radiation therapy
Important warnings
- Boxed warning: only physicians experienced in systemic immunosuppression should prescribe; increased susceptibility to infection and possible lymphoma and other neoplasms
- Nephrotoxicity and hepatotoxicity, increasing with dose; serum creatinine must be monitored frequently
- Hypertension, particularly after transplantation
- Grapefruit and grapefruit juice increase blood concentrations and should be avoided
Side effects
- Principal reactions in transplantation: renal dysfunction, tremor, hirsutism, hypertension, gum hyperplasia
- Glomerular capillary thrombosis that may progress to graft failure
- Hypomagnesaemia, reported in some patients with convulsions
Interactions
- Cyclosporine is metabolised by CYP3A4 and is a P-glycoprotein substrate; inhibitors and inducers change its concentrations
- Care with nephrotoxic drugs
- Avoid orlistat (reduced absorption); repaglinide exposure may increase
Pregnancy and breastfeeding
- A pregnancy exposure registry (Transplant Pregnancy Registry International) monitors outcomes
- Cyclosporine is present in human milk; adverse effects on breastfed infants have not been reported
Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
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For patients
Patient information (US)
This product has no separate US patient information.
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
Austria
- Cequa®Sun Pharmaceutical Industries Europe B.V. · 1 register entry
- NeoimmunTeva B.V · 1 register entry
- SandimmunNovartis Pharma Gmbh · 2 register entries
- VanquoralTeva B.V · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Germany
- CequaSun Pharmaceutical Industries Europe B.V. · 1 register entry
- CicloralHexal Ag · 1 register entry
- Ciclosporin1 A Pharma Gmbh, Teva Gmbh, Hexal Ag, Viatris Germany Gmbh · 4 register entries
- CiqorinTeva Gmbh · 1 register entry
- DeximuneDexcel Pharma Gmbh · 1 register entry
- ImmunosporinNovartis Pharma Gmbh · 1 register entry
- SandimmunNovartis Pharma Gmbh · 3 register entries
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Turkey
- CylorinWORLD MEDICINE İLAÇ SAN. VE TİC. A.Ş. · 3 register entries
- DrosporinDROGSAN İLAÇLARI SAN. VE TİC. A.Ş. · 3 register entries
- LymunirDEVA HOLDİNG A.Ş. · 3 register entries
- PanosporinBİEM İLAÇ SAN. VE TİC. A.Ş. · 3 register entries
- SandimmunNOVARTİS SAĞLIK GIDA VE TARIM ÜRÜNLERİ SAN. VE TİC. A.Ş. · 4 register entries
- Sigmasporin MicroralKOÇAK FARMA İLAÇ VE KİMYA SAN. A.Ş. · 4 register entries
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
USA
- CequaSun Pharmaceutical Industries, Inc. · 1 register entry
- GengrafAbbVie Inc. · 1 register entry
- NeoralNovartis Pharmaceuticals Corporation · 1 register entry
- RestasisAllergan, Inc. · 2 register entries
- Restasis MultiDoseAllergan, Inc. · 1 register entry
- SandimmuneNovartis Pharmaceuticals Corporation · 1 register entry
- VerkaziaHarrow Eye, LLC, Santen Incorporated · 2 register entries
- VevyeHarrow Eye, LLC · 1 register entry
Source: U.S. FDA – Drug labels (openFDA/DailyMed), as of 2026-10-28
Brand names in 28 more European countries
- Belgium
- Neoral-Sandimmun, Sandimmun
- Bulgaria
- Сандимун Неорал
- Croatia
- Ciklosporin Alkaloid, Equoral, Sandimmun
- Cyprus
- Sandimmun Neoral
- Czechia
- Ciclosporin Viatris, Equoral, Sandimmun
- Denmark
- Ciqorin, Menelri, Sandimmun, Sekua
- Estonia
- Equoral, Sandimmun Neoral
- Finland
- Cequa, Ciqorin, Sandimmun
- France
- Cequa, Ciclograft, Neoral, Sandimmun
- Greece
- Imunofar, Sandimmun, Sporilen
- Hungary
- Sandimmun
- Iceland
- Ciqorin, Ikervis, Sandimmun, Verkazia, Vevizye
- Ireland
- Deximune, Neoral, Sandimmun
- Italy
- Cequa, Ciqorin, Sandimmun
- Latvia
- Sandimmun Neoral
- Liechtenstein
- Ikervis, Verkazia, Vevizye
- Lithuania
- Equoral, Sandimmun Neoral
- Luxembourg
- Neoral-Sandimmun, Sandimmun
- Malta
- Deximune, Sandimmun Neoral
- Netherlands
- Cequa, Ciclosporin Teva, Ciclosporine Teva, Cyclosporin Aurobindo, Neoral, Sandimmune
- Norway
- Cequa, Ikervis, Sandimmun, Verkazia, Vevizye
- Poland
- Cyclaid, Equoral, Sandimmun
- Portugal
- Ciclosporina Flica Germed Farmacêutica, Ciclosporina Generis, Ciclosporina Teva, Sandimmun
- Romania
- Cequa, Sandimmun Neoral
- Slovakia
- Ciclosporin Viatris, Equoral, Sandimmun
- Slovenia
- Sandimmun
- Spain
- Cequa, Ciqorin, Sandimmun
- Sweden
- Cequa, Ciklosporin Ivax, Ciqorin, Sandimmun
EMA – Article 57 product data (EU/EEA), 2026-10-28
Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.
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Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.
Sources
- U.S. Food and Drug Administration. CycloSPORINE, Modfied (Apotex Corp.) – Prescribing Information, 2026-09-10. DailyMed (NLM), 2026-10-27. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=5baaf78c-90f6-abcf-52c8-814490f3cf9f
- EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
- U.S. FDA – Drug labels (openFDA/DailyMed), 2026-10-28. https://dailymed.nlm.nih.gov/dailymed/
- Wikidata (CC0): ATC L04AD.
Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error
Source: U.S. Food and Drug Administration (FDA), prescribing information, via DailyMed (NLM); public domain. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.