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Ifex (IFOSFAMIDE)
Ifosfamide is activated by liver enzymes to form cytotoxic compounds that cause DNA crosslinks, leading to cell death.
Ifosfamide (Ifex), marketed by Baxter, is a third-line chemotherapy agent for germ cell testicular cancer, positioned in a competitive landscape of alkylating agents. Its key strength lies in its unique mechanism of action, where it forms cytotoxic compounds that cause DNA crosslinks, leading to cell death, distinguishing it from other same-class drugs. The primary risk is the key composition patent expiry in 2028, which could lead to increased competition from generics.
At a glance
| Generic name | IFOSFAMIDE |
|---|---|
| Sponsor | Baxter |
| Drug class | Alkylating Drug [EPC] |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 1988 |
Mechanism of action
Ifosfamide is a prodrug that needs to be metabolically activated by liver enzymes. Once activated, it forms compounds that can damage DNA by creating crosslinks, which ultimately leads to cell death.
Approved indications
- Third-line chemotherapy for germ cell testicular cancer
Boxed warnings
- 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 )
Common side effects
- Alopecia
- Nausea/Vomiting
- Diarrhea
- Stomatitis
- Hematuria - without mesna
- Macrohematuria - without mesna
- Leukopenia <1 x 10^3 /µL
- Anemia
- Thrombocytopenia, 50 x 10^3 /µL
- Central nervous system toxicity
- Peripheral neuropathy
- Infection
Drug interactions
- CYP3A4 Inducers
- CYP3A4 Inhibitors
Key clinical trials
- Combination Chemotherapy With or Without Ganitumab in Treating Patients With Newly Diagnosed Metastatic Ewing Sarcoma (PHASE3)
- Radiation Therapy With or Without Combination Chemotherapy or Pazopanib Before Surgery in Treating Patients With Newly Diagnosed Non-rhabdomyosarcoma Soft Tissue Sarcomas That Can Be Removed by Surgery (PHASE2,PHASE3)
- CCCG-ALCL-2020 for Chinese Children and Adolescents With Newly Diagnosed High-risk ALCL (PHASE3)
- Capizzi Escalating Methotrexate Versus High Dose Methotrexate in Children With Newly Diagnosed T-cell Lymphoblastic Lymphoma (T-LBL) (PHASE3)
- Ascorbic Acid and Chemotherapy for the Treatment of Relapsed or Refractory Lymphoma, CCUS, and Chronic Myelomonocytic Leukemia (PHASE2)
- LBL-2016 for Children or Adolescents in China (PHASE3)
- Surgery With or Without Neoadjuvant Chemotherapy in High Risk RetroPeritoneal Sarcoma (PHASE3)
- Neoadjuvant ADI-PEG 20 + Ifosfamide + Radiotherapy in Soft Tissue Sarcoma (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |