DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Eulexin (Flutamide) - Summary



Hepatic Injury

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.



brand of flutamide
Capsules, USP

EULEXIN Capsules contain flutamide, an acetanilid, nonsteroidal, orally active antiandrogen having the chemical name, 2-methyl- N -[4-nitro-3-(trifluoromethyl)phenyl]propanamide. Each capsule contains 125 mg flutamide, USP.

EULEXIN Capsules are indicated for use in combination with LHRH agonists for the management of locally confined Stage B2-C and Stage D2 metastatic carcinoma of the prostate.

Stage B2-C Prostatic Carcinoma

Treatment with EULEXIN Capsules and the goserelin acetate implant should start 8 weeks prior to initiating radiation therapy and continue during radiation therapy.

Stage D2 Metastatic Carcinoma

To achieve benefit from treatment, EULEXIN Capsules should be initiated with the LHRH-agonist and continued until progression.

See all Eulexin indications & dosage >>


Media Articles Related to Eulexin (Flutamide)

International agreement on MRI-scans 'likely to change how we detect prostate cancer'
Source: MRI / PET / Ultrasound News From Medical News Today [2015.10.02]
International radiological bodies* have agreed on a standard for how doctors evaluate MRI to confirm a diagnosis of prostate cancer.

New prostate cancer treatments could target metabolism
Source: Clinical Trials / Drug Trials News From Medical News Today [2015.09.30]
Prostate cancer is the most commonly diagnosed malignancy and second leading cause of cancer-related deaths among men in the U.S.

Risk factors for prostate cancer
Source: Prostate / Prostate Cancer News From Medical News Today [2015.09.30]
New research suggests that age, race and family history are the biggest risk factors for a man to develop prostate cancer, although high blood pressure, high cholesterol, vitamin D deficiency...

Fewer, larger radiotherapy doses prove effective for prostate cancer patients
Source: Prostate / Prostate Cancer News From Medical News Today [2015.09.28]
Giving fewer but higher doses of radiotherapy, is as effective at treating prostate cancer as giving lower doses for a longer period, according to new research* presented at the 2015 European...

Study raises questions about androgen deprivation therapy for certain prostate cancer cases
Source: Cardiovascular / Cardiology News From Medical News Today [2015.09.23]
Among men with unfavorable-risk prostate cancer and moderate or severe co-existing illness, long-term follow-up finds that radiation therapy alone vs radiation therapy and androgen deprivation...

more news >>

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. [2013]
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.

more studies >>

Clinical Trials Related to Eulexin (Flutamide)

Flutamide In the Prevention of Prostate Cancer in Patients With Neoplasia of the Prostate [Completed]
RATIONALE: Chemoprevention therapy is the use of certain drugs such as flutamide to try to prevent the development of cancer. Flutamide may be effective in the prevention of prostate cancer. PURPOSE: Randomized clinical trial to study the effectiveness of flutamide in preventing prostate cancer in patients who have neoplasia of the prostate.

Effectiveness of Flutamide in Treating Women With Premenstrual Dysphoric Disorder [Completed]
This study will evaluate the effectiveness of flutamide in reducing symptoms of premenstrual dysphoric disorder.

Androgen Excess as a Mechanism for Adipogenic Dysfunction in PCOS Women [Recruiting]
The purpose of this research study is to collect specimen samples and study medical information from women with Polycystic Ovary Syndrome (PCOS) and women without PCOS. The goal is to learn more about the changes that take place in the body that result in PCOS. We anticipate that 59 women will take part in this study (15 without PCOS and 44 with PCOS). All patients will undergo a physical exam, blood tests, and ultrasound of their ovaries. If they meet the criteria for this study, they will then undergo additional blood tests, removal of a small amount of subcutaneous abdominal fat, measurement of regional body fat (i. e., MRI, DXA scan), a modified frequently-sampled intravenous glucose tolerance test (FSIGTT), and determination of ovarian function (via a follicle stimulating hormone [FSH] test). The women without PCOS will be complete the study at this point. The women with PCOS will be randomized to receive the drug flutamide 125 mg/day or placebo. They will take the drug every day for six 28-day cycles. They will be asked to collect and store a urine sample once a week. They will also be asked to complete a pill diary and menstrual diary. Once a month while they are taking the flutamide/placebo, they will return to the clinic and bring their frozen urine samples. At that time they will undergo a physical exam, toxicity assessment, and blood draw. Quality of Life assessments will be done at the beginning of the study for all participants. Women with PCOS who are taking the flutamide or placebo will be asked to repeat the Quality of Life assessments during the study and at the end of the study. Six months following the completion of protocol procedures, participants who received flutamide/placebo will be contacted by phone to check on the status of their health. They will be asked if they have experienced any health problems or have become pregnant since they completed the study procedures. After the six 28-day cycles are completed they will then undergo additional blood tests, removal of a small amount of subcutaneous abdominal fat, measurement of regional body fat (i. e., MRI, DXA scan), a modified frequently-sampled intravenous glucose tolerance test (FSIGTT), and determination of ovarian function (via a FSH test).

Effect of Flutamide on Biomarkers in Blood and Tissue Samples From Patients at High Risk of Ovarian Cancer [Completed]
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 biomarkers. 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.

Vaccine Therapy With PROSTVAC/TRICOM and Flutamide Versus Flutamide Alone to Treat Prostate Cancer [Active, not 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 cells.

- 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. Objectives:

- 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. Eligibility:

- 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). Design:

- 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

disease worsens.

- 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....

more trials >>


Based on a total of 1 ratings/reviews, Eulexin has an overall score of 10. The effectiveness score is 10 and the side effect score is 10. The scores are on ten point scale: 10 - best, 1 - worst.

Eulexin review by 38 year old female patient

Overall rating:  
Effectiveness:   Highly Effective
Side effects:   No Side Effects
Treatment Info
Condition / reason:   Acne
Dosage & duration:   125 mg taken twice daily for the period of ongoing; took 1 month to take effect
Other conditions:   None
Other drugs taken:   None
Reported Results
Benefits:   Completely cleared resistant adult cystic acne that had not responded to any topical meds or to Accutane.
Side effects:   None. I had regular blood tests to check liver function, but had no negative reactions of any type.
Comments:   Fifteen years of dermatologists, peels, topicals, Accutane, and nothing had cleared my cystic acne and constant breakouts, though a few treatments lessened the severity. Flutamide 125mg b.i.d. took one month to take effect, and within 6 weeks completely cleared ongoing resistant acne that had lasted more than 20 years and was worsening in my late 30s. AFter one year, we tried weaning off the drug. The results lasted for about 5 months, before the acne gradually returned. Went back on flutamide, and a month later the acne had left. We are now trying to see if a lesser maintenance dose is possible.

See all Eulexin reviews / ratings >>

Page last updated: 2015-10-02

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2015