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Eulexin (flutamide)
Eulexin (flutamide) is a small molecule androgen receptor inhibitor originally developed by Schering and currently owned by the same company. It was FDA approved in 1989 for the treatment of neoplasms of the prostate. As an off-patent medication, Eulexin is available as a generic from multiple manufacturers. Key safety considerations include its potential to cause liver damage and changes in liver function tests. Eulexin is a competitive inhibitor of the androgen receptor, which plays a crucial role in the growth and development of prostate cancer cells.
At a glance
| Generic name | flutamide |
|---|---|
| Sponsor | Pfizer Inc. |
| Drug class | Androgen Receptor Inhibitor [EPC] |
| Target | Androgen receptor |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 1989 |
Approved indications
- Neoplasm of prostate
Boxed warnings
- WARNINGS Hepatic Injury There have been postmarketing reports of hospitalization and rarely death due to liver failure in patients taking Eulexin ® . Evidence of hepatic injury included elevated serum transaminase levels, jaundice, hepatic encephalopathy and death related to acute hepatic failure. The hepatic injury was reversible after discontinuation of therapy in some patients. Approximately half of the reported cases occurred within the initial 3 months of treatment with Eulexin ® . Serum transaminase levels should be measured prior to starting treatment with Eulexin ® . Eulexin ® is not recommended in patients whose ALT values exceed twice the upper limit of normal. Serum transaminase levels should then be measured monthly for the first 4 months of therapy, and periodically thereafter. Liver function tests also should be obtained at the first signs and symptoms suggestive of liver dysfunction, e.g., nausea, vomiting, abdominal pain, fatigue, anorexia, "flu-like" symptoms, hyperbilirubinuria, jaundice or right upper quadrant tenderness. If at any time, a patient has jaundice, or their ALT rises above 2 times the upper limit of normal, Eulexin ® should be immediately discontinued with close follow-up of liver function tests until resolution.
Common side effects
- Hot Flashes
- Loss of Libido
- Impotence
- Diarrhea
- Nausea/Vomiting
- Gynecomastia
- Other GI
- Anorexia
- Edema
- Leukopenia
- Skin Irritation
- Rash
Key clinical trials
- Radiation Therapy With or Without Androgen-Deprivation Therapy in Treating Patients With Prostate Cancer (PHASE3)
- Hormone Therapy, Radiation Therapy, and Steroid 17alpha-monooxygenase TAK-700 in Treating Patients With High-Risk Prostate Cancer (PHASE3)
- Contributions to Hypertension With Androgen Deprivation Therapy (PHASE4)
- Finite Androgen Ablation With or Without Abiraterone Acetate and Prednisone in Treating Patients With Recurrent Prostate Cancer (PHASE2)
- Antiandrogen Therapy and Radiation Therapy With or Without Docetaxel in Treating Patients With Prostate Cancer That Has Been Removed by Surgery (PHASE2,PHASE3)
- Two Studies for Patients With Unfavorable Intermediate Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a Higher Gene Risk Score, The Guidance Trial (PHASE3)
- Two Studies for Patients With High Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a High Gene Risk Score, The PREDICT-RT Trial (PHASE3)
- Impact of Radical Prostatectomy as Primary Treatment in Patients With Prostate Cancer With Limited Bone Metastases (NA)
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 |