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Cyclosporine

Generic Name
Cyclosporine
Brand Names
Cequa, Gengraf, Neoral, Restasis, Sandimmune, Verkazia, Vevye, Ikervis, Vevizye
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

Sandimmune
Manufacturer:Novartis Pharmaceuticals Corporation
Route:ORAL
Strength:100 mg in 1 1
Approved: 2016/12/23
NDC:0078-0241
Sandimmune
Manufacturer:Novartis Pharmaceuticals Corporation
Route:ORAL
Strength:100 mg in 1 mL
Approved: 2016/12/23
NDC:0078-0110
Gengraf
Manufacturer:AbbVie Inc.
Route:ORAL
Strength:50 mg in 1 1
Approved: 2024/02/28
NDC:0074-0541
Cyclosporine
Manufacturer:Mylan Pharmaceuticals Inc.
Route:OPHTHALMIC
Strength:0.5 mg in 1 mL
Approved: 2022/01/20
NDC:0378-8760
Cyclosporine
Manufacturer:Bryant Ranch Prepack
Route:INTRAVENOUS
Strength:50 mg in 1 mL
Approved: 2023/07/17
NDC:63629-8640

Singapore Approved Products

SANDIMMUN NEORAL CAPSULE 10 mg
Manufacturer:Catalent Germany Eberbach GmbH, Lek Pharmaceuticals d.d. (Primary and Secondary Packager)
Form:CAPSULE, LIQUID FILLED
Strength:10.0mg
Online:Yes
Approved: 1998/07/02
Approval:SIN09871P
SANDIMMUN NEORAL CAPSULE 100 mg
Manufacturer:Catalent Germany Eberbach GmbH, Lek Pharmaceuticals d.d. (Primary and Secondary Packager)
Form:CAPSULE, LIQUID FILLED
Strength:100.0mg
Online:Yes
Approved: 1995/04/27
Approval:SIN08177P
DEXIMUNE CAPSULES 100MG
Manufacturer:SWISS CAPS AG, DEXCEL LTD. (Primary and Secondary Packager)
Form:CAPSULE, LIQUID FILLED
Strength:100.00MG
Online:Yes
Approved: 2011/11/09
Approval:SIN14049P
IKERVIS EYE DROPS, EMULSION 1MG/ML
Manufacturer:EXCELVISION
Form:EMULSION
Strength:1mg/ml
Online:Yes
Approved: 2017/04/20
Approval:SIN15216P
SANDIMMUN NEORAL DRINK SOLUTION 100 mg/ml
Manufacturer:Delpharm Huningue S.A.S.
Form:SOLUTION
Strength:100.0mg/ml
Online:Yes
Approved: 1995/04/27
Approval:SIN08176P

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