IFOSFAMIDE
Details
- Status
- Prescription
- First Approved
- 2002-05-28
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
IFOSFAMIDE Approval History
What IFOSFAMIDE Treats
1 indicationsIFOSFAMIDE is approved for 1 conditions since its original approval in 2002. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Testicular Cancer
IFOSFAMIDE Boxed Warning
MYELOSUPPRESSION, NEUROTOXICITY, and UROTOXICITY Myelosuppression can be severe and lead to fatal infections. Monitor blood counts prior to and at intervals after each treatment cycle. CNS toxicities can be severe and result in encephalopathy and death. Monitor for CNS toxicity and discontinue treatment for encephalopathy. 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...
WARNING: MYELOSUPPRESSION, NEUROTOXICITY, and UROTOXICITY Myelosuppression can be severe and lead to fatal infections. Monitor blood counts prior to and at intervals after each treatment cycle. CNS toxicities can be severe and result in encephalopathy and death. Monitor for CNS toxicity and discontinue treatment for encephalopathy. 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 ( 5.1 - 5.3 )] WARNING: MYELOSUPPRESSION, NEUROTOXICITY, and UROTOXICITY See full prescribing information for complete boxed warning. Myelosuppression can be severe and lead to fatal infections ( 5.1 ) CNS toxicities can be severe and result in encephalopathy and 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
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.
IFOSFAMIDE FDA Label Details
ProIndications & Usage
FDA Label (PDF)Ifosfamide for Injection is indicated for use in combination with certain other approved antineoplastic agents for third-line chemotherapy of germ cell testicular cancer. It should be used in combination with mesna for prophylaxis of hemorrhagic cystitis. Ifosfamide for Injection is an alkylating drug indicated for use in combination with certain other approved antineoplastic agents for third-line chemotherapy of germ cell testicular cancer. It should be used in combination with mesna for prophylaxis of hemorrhagic cystitis.
WARNING: MYELOSUPPRESSION, NEUROTOXICITY, and UROTOXICITY Myelosuppression can be severe and lead to fatal infections. Monitor blood counts prior to and at intervals after each treatment cycle. CNS toxicities can be severe and result in encephalopathy and death. Monitor for CNS toxicity and disconti...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.