IFEX
Details
- Status
- Prescription
- First Approved
- 1987-08-14
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
IFEX Approval History
What IFEX Treats
1 indicationsIFEX is approved for 1 conditions since its original approval in 1987. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Testicular Cancer
IFEX Boxed Warning
MYELOSUPPRESSION, ENCEPHALOPATHY, NEPHROTOXICITY and UROTOXICITY • Myelosuppression can be severe and lead to fatal infections. Monitor blood counts prior to and at intervals after each treatment cycle [see Warnings and Precautions (5.1) ] . • Encephalopathy can be severe and may result in death. Monitor for CNS toxicity and discontinue treatment for encephalopathy [see Warnings and Precautions (5.2) ] . • Nephrotoxicity can be severe and result in renal failure. Hemorrhagic cystitis can be seve...
WARNING: MYELOSUPPRESSION, ENCEPHALOPATHY, NEPHROTOXICITY and UROTOXICITY • Myelosuppression can be severe and lead to fatal infections. Monitor blood counts prior to and at intervals after each treatment cycle [see Warnings and Precautions (5.1) ] . • Encephalopathy can be severe and may result in death. Monitor for CNS toxicity and discontinue treatment for encephalopathy [see Warnings and Precautions (5.2) ] . • Nephrotoxicity can be severe and result in renal failure. Hemorrhagic cystitis can be severe and can be reduced by the prophylactic use of mesna [see Warnings and Precautions (5.3) ] . WARNING: MYELOSUPPRESSION, ENCEPHALOPATHY, NEPHROTOXICITY and UROTOXICITY See full prescribing information for complete boxed warning . • Myelosuppression can be severe and lead to fatal infections ( 5.1 ) • Encephalopathy can be severe and may result in death ( 5.2 ) • Nephrotoxicity can be severe and result in renal failure. Hemorrhagic cystitis can be severe. ( 5.3 )
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Key Completed Trials
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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.
IFEX FDA Label Details
ProIndications & Usage
FDA Label (PDF)IFEX is indicated for use in adults in combination with certain other approved antineoplastic agents for third-line chemotherapy of germ cell testicular cancer. IFEX is an alkylating drug indicated for use in adults in combination with certain other approved antineoplastic agents for third-line chemotherapy of germ cell testicular cancer.
WARNING: MYELOSUPPRESSION, ENCEPHALOPATHY, NEPHROTOXICITY and UROTOXICITY • Myelosuppression can be severe and lead to fatal infections. Monitor blood counts prior to and at intervals after each treatment cycle [see Warnings and Precautions (5.1) ] . • Encephalopathy can be severe and may result in ...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.