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Eulexin (Flutamide) - Summary

 
 



WARNINGS

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.

 

EULEXIN SUMMARY

EULEXIN®
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 >>

NEWS HIGHLIGHTS

Media Articles Related to Eulexin (Flutamide)

Study extols anti-prostate cancer effects of walnuts
Source: Cancer / Oncology News From Medical News Today [2014.11.14]
A new mouse study suggests it is a component of walnuts themselves - not their omega-3 fatty acid content - that confers health benefits of slowing prostate cancer growth.

Improved detection of prostate cancer offered by novel molecular imaging drug
Source: Prostate / Prostate Cancer News From Medical News Today [2014.11.13]
A novel study demonstrates the potential of a novel molecular imaging drug to detect and visualize early prostate cancer in soft tissue, lymph nodes and bone.

Prostate cancer spread may be halted by molecular breakthrough
Source: Eye Health / Blindness News From Medical News Today [2014.11.12]
Scientists believe a new treatment, shown to be effective in mice, could halt the growth of tumours in patients with prostate cancer.

Promising treatment option and improved survival rates for patients with ovarian, breast, pancreatic, and prostate cancers
Source: Breast Cancer News From Medical News Today [2014.11.11]
Olaparib, an experimental twice-daily oral cancer drug, produces an overall tumor response rate of 26 percent in several advanced cancers associated with BRCA1 and BRCA2 mutations, according to new...

BRCA-targeting drugs could treat prostate cancer, leading expert says
Source: Prostate / Prostate Cancer News From Medical News Today [2014.11.06]
A pioneering cancer drug set to become the first to be approved specifically for inherited cancers could also be used much more widely to treat prostate cancer, a world-leading expert has said.

more news >>

Published Studies Related to Eulexin (Flutamide)

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.

Flutamide metformin for post-menarcheal girls with preclinical ovarian androgen excess: evidence for differential response by androgen receptor genotype. [2007.11]
OBJECTIVE: Addition of androgen receptor (AR) blockade (flutamide) to insulin-sensitising therapy (metformin) may confer synergistic benefits in girls with hyperinsulinaemic androgen excess. We hypothesised that girls with shorter AR gene CAG repeat alleles, and thus greater receptor sensitivity, might benefit more from the addition of low-dose flutamide. DESIGN: Open randomised crossover study... CONCLUSIONS: In young post-menarcheal girls with preclinical androgen excess, low-dose flutamide-metformin improved body composition and key endocrine-metabolic abnormalities. However, only those girls with genetic markers of greater AR sensitivity may benefit from the addition of flutamide above metformin alone.

more studies >>

Clinical Trials Related to Eulexin (Flutamide)

Vaccine Therapy With PROSTVAC/TRICOM and Flutamide Versus Flutamide Alone to Treat Prostate Cancer [Recruiting]
Background:

- 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....

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 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.

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

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.

Effect of High Testosterone on Sleep-associated Slowing of Follicular Luteinizing Hormone (LH) Frequency in Polycystic Ovary Syndrome [Recruiting]
The purpose of this study is to determine whether a testosterone receptor blocker (flutamide) will normalize sleep-wake luteinizing hormone pulse frequency relationships in women with polycystic ovary syndrome.

more trials >>


PATIENT REVIEWS / RATINGS / COMMENTS

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

  Rating
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: 2014-11-14

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