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Cyclosporine

Generic Name
Cyclosporine
Brand Names
Cequa, Gengraf, Neoral, Restasis, Sandimmune, Verkazia, Vevye, Ikervis
Drug Type
Small Molecule
Chemical Formula
C62H111N11O12
CAS Number
59865-13-3
Unique Ingredient Identifier
83HN0GTJ6D

Overview

Cyclosporine is a calcineurin inhibitor known for its immunomodulatory properties that prevent organ transplant rejection and treat various inflammatory and autoimmune conditions. It is isolated from the fungus Beauveria nivea. Initially manufactured by Sandoz and approved for use by the FDA in 1983, cyclosporine is now available in various products by Novartis (previously known as Sandoz).

Background

Cyclosporine is a calcineurin inhibitor known for its immunomodulatory properties that prevent organ transplant rejection and treat various inflammatory and autoimmune conditions. It is isolated from the fungus Beauveria nivea. Initially manufactured by Sandoz and approved for use by the FDA in 1983, cyclosporine is now available in various products by Novartis (previously known as Sandoz).

Indication

Cyclosporine is approved for a variety of conditions. Firstly, it is approved for the prophylaxis of organ rejection in allogeneic kidney, liver, and heart transplants. It is also used to prevent bone marrow transplant rejection. For the above indications, cyclosporine can be used in conjunction with azathioprine and corticosteroids. Finally, cyclosporine can be used in patients who have chronic transplant rejection and have received previous immunosuppressive therapy and to prevent or treat graft-versus-host disease (GVHD). Secondly, cyclosporine is used for the treatment of patients with severe active rheumatoid arthritis (RA) when they no longer respond to methotrexate alone. It can be used for the treatment of adult non-immunocompromised patients with severe, recalcitrant, plaque psoriasis that have failed to respond to at least one systemic therapy or when systemic therapies are not tolerated or contraindicated. The ophthalmic solution of cyclosporine is indicated to increase tear production in patients suffering from keratoconjunctivitis sicca. In addition, cyclosporine is approved for the treatment of steroid dependent and steroid-resistant nephrotic syndrome due to glomerular diseases which may include minimal change nephropathy, focal and segmental glomerulosclerosis or membranous glomerulonephritis. A cyclosporine ophthalmic emulsion is indicated in the treatment of vernal keratoconjunctivitis in adults and children. Off-label, cyclosporine is commonly used for the treatment of various autoimmune and inflammatory conditions such as atopic dermatitis, blistering disorders, ulcerative colitis, juvenile rheumatoid arthritis, uveitis, connective tissue diseases, as well as idiopathic thrombocytopenic purpura.

Associated Conditions

  • Atopic Dermatitis
  • Bone Marrow Transplant Rejection
  • Chronic transplant rejection
  • Connective Tissue Disorders
  • Dry Eyes
  • Graft-versus-host Disease (GVHD)
  • Heart Transplant Rejection
  • Immune Thrombocytopenia (ITP)
  • Interstitial Cystitis
  • Juvenile Idiopathic Arthritis (JIA)
  • Kidney Transplant Rejection
  • Liver Transplant Rejection
  • Lupus Nephritis
  • Nephrotic Syndrome
  • Ocular Rosacea
  • Rheumatoid Arthritis
  • Severe Ulcerative Colitis
  • Steroid Dependent Nephrotic Syndrome
  • Steroid Resistant Nephrotic Syndrome
  • Uveitis
  • Vernal Keratoconjunctivitis
  • Blistering disorder
  • Refractory Ulcerative colitis
  • Severe Psoriasis
  • Severe, active Rheumatoid arthritis
  • Severe, recalcitrant Plaque psoriasis
  • Suppressed tear production

FDA Approved Products

CEQUA
Manufacturer:Sun Pharmaceutical Industries, Inc.
Route:OPHTHALMIC, TOPICAL
Strength:0.0009 mg in 1 mL
Approved: 2021/12/06
NDC:47335-507
Cyclosporine
Manufacturer:American Health Packaging
Route:ORAL
Strength:100 mg in 1 1
Approved: 2022/10/04
NDC:68084-921
Gengraf
Manufacturer:AbbVie Inc.
Route:ORAL
Strength:25 mg in 1 1
Approved: 2024/02/28
NDC:0074-3108
Cyclosporine/Chondroitin Sulfate PF
Manufacturer:ImprimisRx NJ
Route:OPHTHALMIC
Strength:1 mg in 1 mL
Approved: 2018/02/26
NDC:70261-514
RESTASIS
Manufacturer:Physicians Total Care, Inc.
Route:OPHTHALMIC
Strength:0.5 mg in 1 mL
Approved: 2011/05/18
NDC:54868-4793

Singapore Approved Products

No Singapore products found for this drug

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