GENGRAF
Details
- Status
- Prescription
- First Approved
- 2000-05-12
- Routes
- ORAL
- Dosage Forms
- CAPSULE
GENGRAF Approval History
What GENGRAF Treats
6 indicationsGENGRAF is approved for 6 conditions since its original approval in 2000. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Kidney Transplantation
- Liver Transplantation
- Heart Transplantation
- Organ Rejection
- Rheumatoid Arthritis
- Psoriasis
GENGRAF Boxed Warning
WARNING Only physicians experienced in management of systemic immunosuppressive therapy for the indicated disease should prescribe Gengraf ® Capsules (cyclosporine capsules, USP [MODIFIED]). At doses used in solid organ transplantation, only physicians experienced in immunosuppressive therapy and management of organ transplant recipients should prescribe Gengraf ® . Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical re...
WARNING Only physicians experienced in management of systemic immunosuppressive therapy for the indicated disease should prescribe Gengraf ® Capsules (cyclosporine capsules, USP [MODIFIED]). At doses used in solid organ transplantation, only physicians experienced in immunosuppressive therapy and management of organ transplant recipients should prescribe Gengraf ® . 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. Gengraf ® , a systemic immunosuppressant, may increase the susceptibility to infection and the development of neoplasia. In kidney, liver, and heart transplant patients Gengraf ® 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. Gengraf ® Capsules (cyclosporine capsules, USP [MODIFIED]) has increased bioavailability in comparison to Sandimmune ® Soft Gelatin Capsules (cyclosporine capsules, USP). Gengraf ® and Sandimmune ® are not bioequivalent and cannot be used interchangeably without physician supervision. For a given trough concentration, cyclosporine exposure will be greater with Gengraf ® than with Sandimmune ® . If a patient who is receiving exceptionally high doses of Sandimmune ® is converted to Gengraf ® , particular caution should be exercised. Cyclosporine blood concentrations should be monitored in transplant and rheumatoid arthritis patients taking Gengraf ® to avoid toxicity due to high concentrations. Dose adjustments should be made in transplant patients to minimize possible organ rejection due to low concentrations. Comparison of blood concentrations in the published literature with blood concentrations obtained using current assays m
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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.
GENGRAF FDA Label Details
ProIndications & Usage
Kidney, Liver, and Heart Transplantation Gengraf ® Capsules (cyclosporine capsules, USP [ MODIFIED ]) is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. Cyclosporine ( MODIFIED ) has been used in combination with azathioprine and corticosteroids. Rheumatoid Arthritis Gengraf ® Capsules (cyclosporine capsules, USP [ MODIFIED ]) is indicated for the treatment of patients with severe active, rheumatoid arthritis where the disease has not adequately responded to methotrexate. Gengraf ® can be used in combination with methotrexate in rheumatoid a...
WARNING Only physicians experienced in management of systemic immunosuppressive therapy for the indicated disease should prescribe Gengraf ® Capsules (cyclosporine capsules, USP [MODIFIED]). At doses used in solid organ transplantation, only physicians experienced in immunosuppressive therapy and ma...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.