Last reviewed 2026-06-01 · How we verify

Sandimmune (Ciclosporin)

Sandimmune (generic name: Ciclosporin) is a Calcineurin Inhibitor Immunosuppressant [EPC] Small molecule drug developed by Novartis. It is currently FDA-approved (first approved 1983) for Kawasaki's disease, Keratoconjunctivitis sicca, Prevention of Cardiac Transplant Rejection. Also known as: CsA, Cyclosporin, Sandimmun Neoral, Cyclosporine.

Sandimmune (Ciclosporin) is a calcineurin inhibitor immunosuppressant, a small molecule developed by NOVARTIS and currently owned by the same company. It targets the serine/threonine-protein phosphatase 2B catalytic subunit alpha isoform, and is used to treat various conditions including prevention of transplant rejection, rheumatoid arthritis, and severe psoriasis. Sandimmune was FDA approved in 1983 and has a half-life of 7.3 hours with 30% bioavailability. The commercial status of Sandimmune is patented, and it is used to prevent the body's immune system from rejecting transplanted organs or to treat autoimmune diseases. Key safety considerations include monitoring of kidney function and blood pressure.

At a glance

Approved indications

• Kawasaki's disease
• Keratoconjunctivitis sicca
• Prevention of Cardiac Transplant Rejection
• Prevention of Kidney Transplant Rejection
• Prevention of Liver Transplant Rejection
• Rheumatoid arthritis
• Severe Recalcitrant Psoriasis
• Tear film insufficiency

Boxed warnings

• WARNING: RECOMMENDATIONS FOR USE, USE WITH CORTICOSTERIODS, RISKS WITH INAPPROPRIATE SWITCHING, and MONITORING CYCLOSPORINE BLOOD LEVELS Recommendations for Use Only physicians experienced in immunosuppressive therapy and management of organ transplant patients should prescribe Sandimmune. Patients receiving Sandimmune 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. Use with Corticosteroids Sandimmune should be administered with adrenal corticosteroids but not with other immunosuppressive agents. Increased susceptibility to infection and the possible development of lymphoma may result from immunosuppression. Risks with Inappropriate Switching Between Neoral Capsules (MODIFIED) and Sandimmune Capsules Do not switch between Sandimmune capsules, 25 mg to Neoral capsules, MODIFIED, 25 mg (or between Sandimmune capsules, 100 mg to Neoral capsules, MODIFIED 100 mg) on a mg-to-mg basis to achieve the same total daily cyclosporine dosage. Inappropriate switching may lead to increased cyclosporine exposure which may increase the risk of cyclosporine-associated adverse reactions or decreased cyclosporine exposure which may decrease the efficacy of cyclosporine. Monitoring Cyclosporine Blood Levels The absorption of cyclosporine during chronic administration of Sandimmune capsules was found to be erratic. It is recommended that patients taking the Sandimmune capsules over a period of time be monitored at repeated intervals for cyclosporine blood concentrations and subsequent dosage adjustments be made in order to avoid toxicity due to high concentrations and possible organ rejection due to low absorption of cyclosporine. This is of special importance in liver transplants. Numerous assays are being developed to measure blood concentrations of cyclosporine. Comparison of concentrations in published literature to patient concentrations using current assays must be done with detailed knowledge of the assay methods employed (see DOSAGE AND ADMINISTRATION, Blood Concentration Monitoring) .

Common side effects

• Renal Dysfunction
• Hypertension
• Hirsutism
• Tremor
• Gum Hyperplasia
• Leukopenia
• Hypomagnesemia
• Convulsions
• Headache
• Diarrhea
• Nausea/Vomiting
• Hepatotoxicity

Drug interactions

• P-glycoprotein Substrates
• ambrisentan
• amobarbital
• aprobarbital
• barbital
• butalbital
• danazol
• darunavir
• diclofenac
• diltiazem
• ergotamine
• erythromycin

Key clinical trials

• Radiation- and Alkylator-free Bone Marrow Transplantation Regimen for Patients With Dyskeratosis Congenita (PHASE2)
• Campath/Fludarabine/Melphalan Transplant Conditioning for Non-Malignant Diseases (PHASE1,PHASE2)
• Rituximab Plus Cyclosporine in Idiopathic Membranous Nephropathy (PHASE2)
• Letermovir Prophylaxis in Children With EBV-Positive T/NK-Cell Lymphoproliferative Disease and Refractory/Relapsed EBV-Associated Hemophagocytic Lymphohistiocytosis (NA)
• A Study to Evaluate Axatilimab Versus Best Available Therapy in Participants With Chronic Graft Versus Host Disease After at Least 2 Prior Lines of Systemic Therapy (PHASE3)
• A Study to Evaluate Axatilimab Versus Best Available Therapy in Pediatric Participants With Chronic Graft-Versus-Host Disease After at Least 2 Prior Lines of Systemic Therapy (AGAVE-256) (PHASE2)
• Study on the Efficacy and Safety of the TmBU Conditioning Regimen in High-risk or Relapsed/Refractory Acute Leukemia (PHASE2)
• Effect of Anti-Psoriatic Biologics on Risk of Anogenital Warts (CONDYPSO)

Patents

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Sandimmune CI brief — competitive landscape report
• Sandimmune updates RSS · CI watch RSS
• Novartis portfolio CI

Frequently asked questions about Sandimmune

Related

• Drug class: All Calcineurin Inhibitor Immunosuppressant [EPC] drugs
• Target: All drugs targeting Serine/threonine-protein phosphatase 2B catalytic subunit alpha isoform
• Manufacturer: Novartis — full pipeline
• Therapeutic area: All drugs in Oncology
• Indication: Drugs for Kawasaki's disease
• Indication: Drugs for Keratoconjunctivitis sicca
• Indication: Drugs for Prevention of Cardiac Transplant Rejection
• Also known as: CsA, Cyclosporin, Sandimmun Neoral, Cyclosporine, Cyclosporine A

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing