There have been postmarketing reports of hospitalization and rarely death due to liver failure in patients taking flutamide. 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 flutamide.
Serum transaminase levels should be measured prior to starting treatment with flutamide. Flutamide 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, eg, 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, flutamide should be immediately discontinued with close follow-up of liver function tests until resolution.
Media Articles Related to Eulexin (Flutamide)
Are Too Many Prostate Cancer Patients Receiving Treatment?
Source: MedicineNet Cancer Specialty [2015.02.20]
Title: Are Too Many Prostate Cancer Patients Receiving Treatment?
Category: Health News
Created: 2/19/2015 12:00:00 AM
Last Editorial Review: 2/20/2015 12:00:00 AM
Study: Surveillance Is for Middle-Risk Prostate Cancer Too
Source: Medscape Hematology-Oncology Headlines [2015.02.19]
Active surveillance might be useful in 'favorable' intermediate-risk disease, American researchers say about their study of more than 5000 men.
Medscape Medical News
Alternative to Overall Survival in Prostate Cancer Trials?
Source: Medscape Hematology-Oncology Headlines [2015.02.19]
Radiographic progression-free survival correlates with overall survival in patients with metastatic castration-resistant prostate cancer.
Medscape Medical News
New study reveals how to improve chemotherapy use in prostate cancer
Source: Endocrinology News From Medical News Today [2015.02.19]
Next generation chemotherapy for prostate cancer has unique properties that could make it more effective earlier in treatment if confirmed in clinical trialsProstate cancer is the second leading...
Two major studies strengthen case for prostate cancer drug before chemotherapy
Source: Prostate / Prostate Cancer News From Medical News Today [2015.02.06]
Pioneering prostate cancer drug abiraterone significantly extends the lives of men with advanced prostate cancer if given before chemotherapy, the results of a major phase III clinical trial have...
Published Studies Related to Eulexin (Flutamide)
A randomized phase IIb presurgical study of finasteride vs. low-dose flutamide
vs. placebo in men with prostate cancer. Efficacy monitored by karyometry. 
preventive agents in patients with CaP... CONCLUSION: This exploratory study establishes that karyometric monitoring can
Divergent effects of ethinylestradiol-drospirenone and flutamide-metformin on follistatin in adolescents and women with hyperinsulinemic androgen excess. [2011.03]
Randomized studies have disclosed that ethinylestradiol-drospirenone and flutamide-metformin have divergent effects on the body adiposity and adipokines of adolescents and young women with hyperinsulinemic androgen excess. We have now tested in 41 patients from those original studies whether the divergent effects on body adiposity could be mediated by divergent levels of follistatin, an adipokine that promotes subcutaneous adipogenesis...
Low-dose pioglitazone, flutamide, metformin plus an estro-progestagen for non-obese young women with polycystic ovary syndrome: increasing efficacy and persistent safety over 30 months. [2010.12]
CONTEXT: Therapy of androgen excess should not only confer cosmetic benefit, but also improve long-term markers of endocrine-metabolic and cardiovascular health. Here we report on our pilot experience with a low-dose polytherapy for 30 months... CONCLUSION: Low-dose polytherapy (24/28 day) with pioglitazone, flutamide, metformin and estro-progestagen was found to improve, without changing weight, a spectrum of long-term health markers in young women with hyperinsulinemic androgen excess.
Low-dose pioglitazone and low-dose flutamide added to metformin and oestro-progestagens for hyperinsulinaemic women with androgen excess: add-on benefits disclosed by a randomized double-placebo study over 24 months. [2009.09]
CONTEXT AND AIM: Metformin plus oestro-progestagen is a combination treatment for non-obese women with hyperinsulinaemic androgen excess. We explored whether low-dose pioglitazone (Pio) and flutamide (Flu) has readily detectable add-on effects... CONCLUSION: Low-dose Pio and Flu further improve long-term markers - such as IMT, lean mass and visceral fat - when jointly added to a treatment of metformin plus an oestro-progestagen in non-obese women with hyperinsulinaemic androgen excess.
Comparison of the clinical efficacy of flutamide and spironolactone plus ethinyloestradiol/cyproterone acetate in the treatment of hirsutism: a randomised controlled study. [2008.04]
INTRODUCTION: Hirsutism is commonly a consequence of ovarian androgen over-production. Polycystic ovary syndrome (PCOS) or peripheral hypersensitivity to normal androgen circulating levels (idiopathic hirsutism) can be the underlying cause. Several drugs with anti-androgenic properties, such as cyproterone acetate (CPA), spironolactone and flutamide have been used to treat hirsutism, but the efficacy of these drugs has yet to be fully elucidated. The objective of this study was to compare the effectiveness of flutamide, and spironolactone plus a combination tablet of 2 mg CPA/35 microg ethinyloestradiol (EE) in the treatment of hirsutism... CONCLUSION: Flutamide and spironolactone plus CPA/EE are effective drugs in the treatment of hirsutism.
Clinical Trials Related to Eulexin (Flutamide)
Vaccine Therapy With PROSTVAC/TRICOM and Flutamide Versus Flutamide Alone to Treat Prostate Cancer [Recruiting]
- Flutamide is an approved drug for prostate cancer that blocks the effects of
testosterone on prostate cancer cells and may slow the progression of the disease.
- The vaccine in this study consists of a priming vaccine called PROSTVAC-V/TRICOM,
made from vaccinia virus, and a boosting vaccine called PROSTVAC-F/TRICOM, made from
fowlpox virus. DNA is inserted into the priming and boosting vaccine viruses to cause
production of proteins that enhance immune activity and also to produce prostate
specific antigen (PSA) - a protein that is normally produced by the patient's tumor
- GM-CSF, given along with the vaccine, is a chemical that boosts the immune system. It
is used in this study to try to increase the usefulness of the vaccine by increasing
the number of immune cells at the vaccination site.
- To determine if treatment with a prostate cancer vaccine plus flutamide is more effective
than flutamide alone in delaying disease progression in patients with prostate cancer.
- Patients 18 years of age and older with androgen-insensitive prostate cancer that has
not spread beyond the prostate gland.
- Patients with a rising PSA who have already been treated with anti-iandrogen therapy
(either bicalutamide or nilutamide).
- There are two treatment groups in this study. Group A receives only flutamide; group B
receive flutamide plus vaccine.
- Patients in both groups receive flutamide by mouth three times a day.
- Patients in group B receive PROSTVAC-V/TRICOM on day 1 and PROSTVAC-F/TRICOM on day 29
and again every 4 weeks. All vaccines are given as injections under the skin.
- Patients have blood tests for PSA levels every month and scans every 3 months until the
- After 3 months of therapy, patients receiving in group A (flutamide alone) may cross
over to receive vaccine if they develop a rising PSA and scans show no sign of disease
spread. Patients in group B (flutamide plus vaccine) stop flutamide and may continue
vaccine therapy. At this point patients may continue to receive treatment until the
disease progresses or PSA levels rise....
Effect of Flutamide on Biomarkers in Blood and Tissue Samples From Patients at High Risk of Ovarian Cancer [Recruiting]
RATIONALE: Studying samples of blood and tissue in the laboratory from patients with a high
risk of developing ovarian cancer may help doctors identify and learn more about biomarkers
related to cancer. It may also help doctors learn more about the effects of flutamide on
PURPOSE: This phase II trial is studying the effect of flutamide on biomarkers in blood and
tissue samples from patients at high risk of ovarian cancer.
Effectiveness of Flutamide in Treating Women With Premenstrual Dysphoric Disorder [Recruiting]
This study will evaluate the effectiveness of flutamide in reducing symptoms of premenstrual
Metabolic Syndrome in PCOS: Precursors and Interventions [Recruiting]
The purpose of this study is to determine whether lowering insulin levels using a medication
called metformin, and blocking the action of male hormones with the medication flutamide wil
decrease central body fat, improve cholesterol levels or affect sugar handling in women with
PCOS (Polycystic ovary syndrome) The effects of these medications will be compared to the
effects of the oral contraceptive pill (OCP), Yasmin.
Flutamide, Suramin, and Hydrocortisone in Treating Patients With Prostate Cancer [Completed]
RATIONALE: Hormone therapy may be an effective treatment for prostate cancer.
PURPOSE: Randomized phase III trial to evaluate the effectiveness of treatment with flutamide
and suramin with or without hydrocortisone in men who have metastatic or recurrent prostate