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a cyclic peptide from an extract of soil fungi, an inhibitor of t cell function; used as an immunosuppressant to prevent and treat rejection in organ transplant recipients and to treat severe psoriasis and as a disease-modifying antirheumatic drug.
Miller-Keane Encyclopedia and Dictionary of Medicine, Nursing, and Allied Health, Seventh Edition. © 2003 by Saunders, an imprint of Elsevier, Inc. All rights reserved.


Apo-Cyclosporine (CA), Gengraf, Neoral, Sandimmune, Sandoz Cyclosporine

cyclosporine ophthalmic emulsion

Restasis, Sandimmun (UK)

Pharmacologic class: Polypeptide antibiotic

Therapeutic class: Immunosuppressant

Pregnancy risk category C

Respiratory: cough, dyspnea, Pneumocystis jiroveci pneumonia, bronchospasm

FDA Box Warning

• Drug should be prescribed only by physicians experienced in managing systemic immunosuppressive therapy for indicated disease. At doses used for solid-organ transplantation, it should be prescribed only by physicians experienced in immunosuppressive therapy and management of organ transplant recipients. Patient should be managed in facility with adequate laboratory and medical resources. Physician responsible for maintenance therapy should have complete information needed for patient follow-up.

• Neoral may increase susceptibility to infection and neoplasia. In kidney, liver, and heart transplant patients, drug may be given with other immunosuppressants.

• Sandimmune should be given with adrenal corticosteroids but not other immunosuppressants. In transplant patients, increased susceptibility to infection and development of lymphoma and other neoplasms may result from increased immunosuppression.

• Sandimmune and Neoral aren't bioequivalent. Don't use interchangeably without physician supervision.

• In patients receiving Sandimmune soft-gelatin capsules and oral solution, monitor at repeated intervals (due to erratic absorption).


Unclear. Thought to act by specific, reversible inhibition of immunocompetent lymphocytes in G0-G1 phase of cell cycle. Preferentially inhibits T lymphocytes; also inhibits lymphokine production. Ophthalmic action is unknown.


Capsules: 25 mg, 100 mg

Injection: 50 mg/ml

Oral solution: 100 mg/ml

Solution (ophthalmic): 0.05% (0.4 ml in 0.9 ml single-use vial)

Indications and dosages


Adults: Neoral only-1.25 mg/kg P.O. b.i.d. for 4 weeks. Based on patient response, may increase by 0.5 mg/kg/day once q 2 weeks, to a maximum dosage of 4 mg/kg/day.

Severe active rheumatoid arthritis

Adults: Neoral only-1.25 mg/kg P.O. b.i.d. May adjust dosage by 0.5 to 0.75 mg/kg/day after 8 weeks and again after 12 weeks, to a maximum dosage of 4 mg/kg/day. If no response occurs after 16 weeks, discontinue therapy. Gengraf only-2.5 mg/kg P.O. daily given in two divided doses; after 8 weeks, may increase to a maximum dosage of 4 mg/kg/day.

To prevent organ rejection in kidney, liver, or heart transplantation

Adults and children: Sandimmune only-Initially, 15 mg/kg P.O. 4 to 12 hours before transplantation, then daily for 1 to 2 weeks postoperatively. Reduce dosage by 5% weekly to a maintenance level of 5 to 10 mg/kg/day. Or 5 to 6 mg/kg I.V. as a continuous infusion 4 to 12 hours before transplantation.

To increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca

Adults: 1 drop in each eye b.i.d. given 12 hours apart

Off-label uses

• Aplastic anemia

• Atopic dermatitis


• Hypersensitivity to drug and any ophthalmic components

• Rheumatoid arthritis, psoriasis in patients with abnormal renal function, uncontrolled hypertension, cancer (Gengraf, Neoral)

• Active ocular infections (ophthalmic use)


Use cautiously in:

• hepatic impairment, renal dysfunction, active infection, hypertension

• herpes keratitis (ophthalmic use)

• pregnant or breastfeeding patients

• children younger than age 16 (safety and efficacy not established for ophthalmic use).


• For I.V. infusion, dilute as ordered with dextrose 5% in water or 0.9% normal saline solution. Administer over 2 to 6 hours.

• Mix Neoral solution with orange juice or apple juice to improve its taste.

• Dilute Sandimmune oral solution with milk, chocolate milk, or orange juice. Be aware that grapefruit and grapefruit juice affect drug metabolism.

• In postoperative patients, switch to P.O. dosage as tolerance allows.

• Be aware that Sandimmune and Neoral aren't bioequivalent. Don't use interchangeably.

• Before administering eyedrops, invert unit-dose vial a few times to obtain a uniform, white, opaque emulsion.

• Know that eyedrops can be used concomitantly with artificial tears, allowing a 15-minute interval between products.

Adverse reactions

CNS: tremor, headache, confusion, paresthesia, insomnia, anxiety, depression, lethargy, weakness

CV: hypertension, chest pain, myocardial infarction

EENT: visual disturbances, hearing loss, tinnitus, rhinitis; (with ophthalmic use) ocular burning, conjunctival hyperemia, discharge, epiphora, eye pain, foreign body sensation, itching, stinging, blurring

GI: nausea, vomiting, diarrhea, constipation, abdominal discomfort, gastritis, peptic ulcer, mouth sores, difficulty swallowing, anorexia, upper GI bleeding, pancreatitis

GU: gynecomastia, hematuria, nephrotoxicity, renal dysfunction, glomerular capillary thrombosis Hematologic: anemia, leukopenia, thrombocytopenia

Metabolic: hyperglycemia, hypomagnesemia, hyperuricemia, hyperkalemia, metabolic acidosis

Musculoskeletal: muscle and joint pain

Respiratory: cough, dyspnea, Pneumocystis jiroveci pneumonia, bronchospasm

Skin: acne, hirsutism, brittle fingernails, hair breakage, night sweats

Other: gum hyperplasia, flulike symptoms, edema, fever, weight loss, hiccups, anaphylaxis


The following interactions pertain to oral and I.V. routes only.

Drug-drug. Acyclovir, aminoglycosides, amphotericin B, cimetidine, diclofenac, gentamicin, ketoconazole, melphalan, naproxen, ranitidine, sulindac, sulfamethoxazole, tacrolimus, tobramycin, trimethoprim, vancomycin: increased risk of nephrotoxicity

Allopurinol, amiodarone, bromocriptine, clarithromycin, colchicine, danazol, diltiazem, erythromycin, fluconazole, imipenem and cilastatin, itraconazole, ketoconazole, methylprednisolone, nicardipine, prednisolone, quinupristin/dalfopristin, verapamil: increased cyclosporine blood level

Azathioprine, corticosteroids, cyclophosphamide: increased immunosuppression Carbamazepine, isoniazid, nafcillin, octreotide, orlistat, phenobarbital, phenytoin, rifabutin, rifampin, ticlopidine: decreased cyclosporine blood level

Digoxin: decreased digoxin clearance

Live-virus vaccines: decreased antibody response to vaccine

Lovastatin: decreased lovastatin clearance, increased risk of myopathy and rhabdomyolysis

Potassium-sparing diuretics: increased risk of hyperkalemia

Drug-diagnostic tests. Alanine aminotransferase, aspartate aminotransferase, bilirubin, blood urea nitrogen, creatinine, glucose, low-density lipoproteins: increased levels

Hemoglobin, platelets, white blood cells: decreased values

Drug-food. Grapefruit, grapefruit juice: decreased cyclosporine metabolism, increased cyclosporine blood level

High-fat diet: decreased drug absorption (Neoral)

Drug-herbs. Alfalfa sprouts, astragalus, echinacea, licorice: interference with immunosuppressant action St. John's wort: reduced cyclosporine blood level, possibly leading to organ rejection

Patient monitoring

• Observe patient for first 30 to 60 minutes of infusion. Monitor frequently thereafter.

• Monitor cyclosporine blood level, electrolyte levels, and liver and kidney function test results.

• Assess for signs and symptoms of hyperkalemia in patients receiving concurrent potassium-sparing diuretic.

Patient teaching

• Advise patient to dilute Neoral oral solution with orange or apple juice (preferably at room temperature) to improve its flavor.

• Instruct patient to use glass container when taking oral solution. Tell him not to let solution stand before drinking, to stir solution well and then drink all at once, and to rinse glass with same liquid and then drink again to ensure that he takes entire dose.

• Tell patient taking Neoral to avoid high-fat meals, grapefruit, and grapefruit juice.

• Advise patient to dilute Sandimmune oral solution with milk, chocolate milk, or orange juice to improve its flavor.

• Instruct patient to invert vial a few times to obtain a uniform, white, opaque emulsion before using eyedrops and to discard vial immediately after use.

• Inform patient that eyedrops can be used with artificial tears but to allow 15-minute interval between products.

• Caution patient not to wear contact lenses because of decreased tear production; however, if contact lenses are used, advise patient to remove them before administering eyedrops and to reinsert 15 minutes after administration.

• Inform patient that he's at increased risk for infection. Caution him to avoid crowds and exposure to illness.

• Instruct patient not to take potassium supplements, herbal products, or dietary supplements without consulting prescriber.

• Tell patient he'll need to undergo repeated laboratory testing during therapy.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, foods, and herbs mentioned above.

McGraw-Hill Nurse's Drug Handbook, 7th Ed. Copyright © 2013 by The McGraw-Hill Companies, Inc. All rights reserved


A cyclic oligopeptide immunosuppressant produced by the fungus Tolypocladium inflatum Gams; used to inhibit organ transplant rejection.
Farlex Partner Medical Dictionary © Farlex 2012


(sī′klə-spôr′ēn, -ĭn) also


An immunosuppressive drug obtained from certain soil fungi, used mainly to prevent the rejection of transplanted organs.
The American Heritage® Medical Dictionary Copyright © 2007, 2004 by Houghton Mifflin Company. Published by Houghton Mifflin Company. All rights reserved.


Immunology A cyclic undecapeptide, which induces potent T-cell immunosuppression; cyclosporine mitigates GVHD, allograft rejection, ulcerative colitis, autoimmune disease, schistosomiasis; it may be of use in aplastic anemia, in combination with antilymphocyte globulin and methylprednisone for psoriasis Adverse effects Nephrotoxicity, HTN, neurotoxicity–eg, tremor, seizures, encephalopathy, headache, coma, hyperlipidemia, hyperkalemia, hypomagnesemia, HTN, anemia, anaphylaxis, nausea, paresthesias, ↑ EBV, lymphoma, pseudolymphoma, fluid retention, thromboses, hirsutism, liver toxicity Lab ↑ Creatinine, ↑ uric acid, ↑ BR, ↑ cholesterol. Cf Tacrolimus.
McGraw-Hill Concise Dictionary of Modern Medicine. © 2002 by The McGraw-Hill Companies, Inc.


A cyclic oligopeptide immunosuppressant produced by the fungus Tolypocladium inflatum Gams; used to inhibit organ transplant rejection.
Medical Dictionary for the Health Professions and Nursing © Farlex 2012

ciclosporin (cyclosporine) 

An immunosuppressant used in the treatment of the ocular manifestation of autoimmune diseases, uveitis, scleritis, keratoconjunctivitis sicca, ligneous conjunctivitis, and to prevent rejection of corneal grafts, etc. It is believed to exert its immunosuppressive effect by inhibiting the activation of cytotoxic T-lymphocytes. See immunosuppressants.
Millodot: Dictionary of Optometry and Visual Science, 7th edition. © 2009 Butterworth-Heinemann


A cyclic oligopeptide immunosuppressant used to inhibit organ transplant rejection.
Medical Dictionary for the Dental Professions © Farlex 2012
References in periodicals archive ?
"We are very pleased that the Court's decision allows us to continue to market and sell Gengraf."
SangStat Medical Corporation, Fremont, CA, the exclusive distributor of Gengraf in the US said in a statement that it will continue to market and sell Gengraf.
"We are very pleased that the Court's decision allows us to continue to market and sell Gengraf," said Richard Murdock, SangStat chairman, president and CEO.
The United States District Court for the District of Delaware jury found that Abbott Laboratories's Gengraf capsules infringed 1 of the 2 Novartis patents asserted in the lawsuit and awarded damages of $5 million to Novartis.
SangStat Medical Corporation, Fremont, CA, the exclusive distributor of Gengraf in the US was not named as a defendant in the lawsuit.
Novartis said in a press release that if Abbott is ordered to withdraw Gengraf, the company will implement a Neoral Assurance Program offering confidential blood level monitoring at no charge for patients who are being switched off Gengraf to any other AB-rated cyclosporine.
The SangStat Medical Corporation, Fremont, CA, announced it will undergo major structuring after reporting a wider-than-expected loss on slower sales of its generic cyclosporine Gengraf. The company said it plans to reduce its costs immediately by selling The Transplant Pharmacy, its mail-order pharmacy; possible job cuts and reductions in expenditures marketing Gengraf.
The recall of SangCya, the liquid generic form of Neoral, does not affect patients taking Gengraf, the company's capsule form of Neoral, which was approved for marketing in May.
Abbott Laboratories, Inc, Abbott Park, IL, and SangStat Medical Corporation, Menlo Park, CA, announced May 15 that the US Food and Drug Administration (FDA) has approved Abbott's Gengraf capsules (cyclosporine capsules, USP [MODIFIED], for the prevention of organ rejection in kidney, liver and heart transplants.
The companies say that in addition, Gengraf was granted an AB rating by the FDA.