Molecule
Cyclosporine is a calcineurin inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. It is available as capsules, ophthalmic emulsion and eye drops for oral and topical use. MedsAcross supplies Cyclosporine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
Sandimmune capsules and Sandimmune injection, in combination with adrenal corticosteroids, are indicated for the: Prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. Treatment of chronic rejection in patients previously treated with other immunosuppressive agents. Because of the risk of anaphylaxis, Sandimmune injection should be reserved for patients who are unable to take the Sandimmune capsules.
Source: US FDA prescribing information
Cyclosporine is a potent immunosuppressive agent, which in animals prolongs survival of allogeneic transplants involving skin, heart, kidney, pancreas, bone marrow, small intestine, and lung. Cyclosporine has been demonstrated to suppress some humoral immunity and to a greater extent, cell-mediated reactions, such as allograft rejection, delayed hypersensitivity, experimental allergic encephalomyelitis, Freund’s adjuvant arthritis, and graft vs. host disease in many animal species for a variety of organs. Successful kidney, liver, and heart allogeneic transplants have been performed in man using cyclosporine. The exact mechanism of action of cyclosporine is not known. Experimental evidence suggests that the effectiveness of cyclosporine is due to specific and reversible inhibition of immunocompetent lymphocytes in the G 0 - or G 1 -phase of the cell cycle.
Source: US FDA prescribing information
Recommended Dosage for Sandimmune Capsules Sandimmune (cyclosporine capsules) 25 mg and 100 mg and Neoral (cyclosporine capsules), MODIFIED 25 mg and 100 mg are not mutually substitutable on a mg-to-mg basis due to differences in pharmacokinetic profiles. If it is appropriate to switch from Neoral capsules, MODIFIED, to Sandimmune capsules, increase the frequency of cyclosporine monitoring (the cyclosporine dosage may need to be increased to reach the desired cyclosporine exposure and reduce the risk of insufficient efficacy). If it is appropriate to switch from Sandimmune capsules to Neoral capsules, increase the frequency of cyclosporine monitoring (the cyclosporine dosage may need to be decreased to reach the desired cyclosporine exposure and reduce the risk of cyclosporine-related adverse reactions).
Source: US FDA prescribing information
Sandimmune capsules and Sandimmune injection are contraindicated in patients with a hypersensitivity reaction to cyclosporine. Sandimmune injection is also contraindicated in patients with a history of a hypersensitivity reaction to Cremophor ® EL (polyoxyethylated castor oil).
Source: US FDA prescribing information
Boxed warning: 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. Kidney, Liver, and Heart Transplant Sandimmune, when used in high dosages, can cause hepatotoxicity and nephrotoxicity. Nephrotoxicity It is not unusual for serum creatinine and Blood Urea Nitrogen (BUN) levels to be elevated during Sandimmune therapy. These elevations in renal transplant patients do not necessarily indicate rejection, and each patient must be fully evaluated before dosage adjustment is initiated.
Source: US FDA prescribing information
The principal adverse reactions of Sandimmune therapy are renal dysfunction, tremor, hirsutism, hypertension, and gum hyperplasia. Hypertension Hypertension, which is usually mild to moderate, may occur in approximately 50% of patients following renal transplantation and in most cardiac transplant patients. Glomerular Capillary Thrombosis Glomerular capillary thrombosis has been found in patients treated with cyclosporine and may progress to graft failure. The pathologic changes resemble those seen in the hemolytic-uremic syndrome and include thrombosis of the renal microvasculature, with platelet-fibrin thrombi occluding glomerular capillaries and afferent arterioles, microangiopathic hemolytic anemia, thrombocytopenia, and decreased renal function. Similar findings have been observed when other immunosuppressives have been employed post transplantation.
Source: US FDA prescribing information
A. Effect of Drugs and Other Agents on Cyclosporine Pharmacokinetics and/or Safety All of the individual drugs cited below are well substantiated to interact with cyclosporine. In addition, concomitant use of nonsteroidal anti-inflammatory drugs (NSAIDs) with cyclosporine, particularly in the setting of dehydration, may potentiate renal dysfunction. Caution should be exercised when using other drugs which are known to impair renal function.
Source: US FDA prescribing information
Store and Dispense: Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F). Supplied as a 5 mL sterile ampul containing 50 mg of cyclosporine per mL, in boxes of 10 ampuls………………………………………………………………….NDC 0078-0109-01 Store and Dispense: At temperatures below 30°C (86°F). Protect from light. *Cremophor ® is the registered trademark of BASF Aktiengesellschaft.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
25 presentations of Cyclosporine, sorted by availability.
10 brand names across 1 markets.
Indian manufacturers are highlighted.
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Conditions linked to Cyclosporine in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 25 presentations of Cyclosporine and sources them for licensed hospitals, importers and physicians against valid import documents. Indian manufacturers include Sun Pharmaceutical Industries.
The catalogue lists 10 brand names for Cyclosporine, including Cequa, Cyclosporine Modified, CycloSPORINE, Modfied, Gengraf, Neoral, Restasis, Restasis MultiDose, Sandimmune.
Yes. The US FDA first approved Cyclosporine on 14 November 1983, according to Drugs@FDA.
Yes. Cyclosporine has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Cyclosporine is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Cyclosporine is classified under ATC code L04AD01 (Cyclosporine).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.