CYCLOSPORINE
Details
- Status
- Prescription
- First Approved
- 1999-10-29
- Routes
- OPHTHALMIC, ORAL, INJECTION
- Dosage Forms
- EMULSION, CAPSULE, SOLUTION, INJECTABLE
Companies
CYCLOSPORINE Approval History
What CYCLOSPORINE Treats
3 indicationsCYCLOSPORINE is approved for 3 conditions since its original approval in 1999. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Organ Rejection
- Rheumatoid Arthritis
- Psoriasis
CYCLOSPORINE Boxed Warning
WARNING Only physicians experienced in management of systemic immunosuppressive therapy for the indicated disease should prescribe cyclosporine capsules, (modified). At doses used in solid organ transplantation, only physicians experienced in immunosuppressive therapy and management of organ transplant recipients should prescribe cyclosporine capsules, (modified). Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical reso...
WARNING Only physicians experienced in management of systemic immunosuppressive therapy for the indicated disease should prescribe cyclosporine capsules, (modified). At doses used in solid organ transplantation, only physicians experienced in immunosuppressive therapy and management of organ transplant recipients should prescribe cyclosporine capsules, (modified). Patients receiving the drug 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. Cyclosporine capsules, (modified), a systemic immunosuppressant, may increase the susceptibility to infection and the development of neoplasia. In kidney, liver, and heart transplant patients cyclosporine capsules, (modified) may be administered with other immunosuppressive agents. Increased susceptibility to infection and the possible development of lymphoma and other neoplasms may result from the increase in the degree of immunosuppression in transplant patients. Cyclosporine capsules, (modified) have increased bioavailability in comparison to Sandimmune ® Soft Gelatin Capsules (cyclosporine capsules, USP) [NON-MODIFIED]. Cyclosporine capsules, (modified) and Sandimmune ® are not bioequivalent and cannot be used interchangeably without physician supervision. For a given trough concentration, cyclosporine exposure will be greater with cyclosporine capsules, (modified) than with Sandimmune ® . If a patient who is receiving exceptionally high doses of Sandimmune ® is converted to cyclosporine capsules, (modified), particular caution should be exercised. Cyclosporine blood concentrations should be monitored in transplant and rheumatoid arthritis patients taking cyclosporine capsules, (modified) to avoid toxicity due to high concentrations. Dose adjustments should be made in transplant patients to minimize possible organ rejection due to low conce
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Active Pipeline
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Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
CYCLOSPORINE FDA Label Details
ProIndications & Usage
FDA Label (PDF)Kidney, Liver, and Heart Transplantation Cyclosporine capsules (modified) is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. Cyclosporine capsules (modified) has been used in combination with azathioprine and corticosteroids. Rheumatoid Arthritis Cyclosporine capsules (modified) is indicated for the treatment of patients with severe active, rheumatoid arthritis where the disease has not adequately responded to methotrexate. Cyclosporine capsules (modified) can be used in combination with methotrexate in rheumatoid arthritis patients who do n...
WARNING Only physicians experienced in management of systemic immunosuppressive therapy for the indicated disease should prescribe cyclosporine capsules, (modified). At doses used in solid organ transplantation, only physicians experienced in immunosuppressive therapy and management of organ transpl...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.