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.
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NEWS HIGHLIGHTSMedia Articles Related to Eulexin (Flutamide)
Among Patients Carrying BRCA Mutations, PARP Inhibitor Shows Activity In Pancreatic, Prostate Cancers
Source: Health News from Medical News Today [2013.05.18]
In the largest clinical trial to date to examine the efficacy of PARP inhibitor therapy in BRCA 1/2 carriers with diseases other than breast and ovarian cancer, the oral drug olaparib was found to be effective against advanced pancreatic and prostate cancers. Results of the study, led by researchers from the Perelman School of Medicine at the University of Pennsylvania and Sheba Medical Center in Tel Hashomer, Israel, will be presented during the American Society of Clinical Oncology's annual meeting in Chicago in early June (Abstract #11024)...
Advanced Prostate Cancer Drug Xofigo Approved By FDA
Source: Health News from Medical News Today [2013.05.17]
Xofigo (radium Ra 223 dichloride) has been approved by the US FDA for symptomatic late-stage (metastatic) castration-resistant prostate cancer that has reached bones but not other organs, i.e. with no known visceral metastatic disease. The Food and Drug Administration (FDA) approved Xifogo under the priority review program, three months ahead of schedule. According to an online FDA communiqué published this week, Xofigo is aimed at male patients whose prostate cancer metastasized despite receiving medical or surgical interventions to reduce testosterone levels...
Xofigo Approved for Prostate Cancer
Source: MedicineNet Prostate Cancer Specialty [2013.05.17]
Title: Xofigo Approved for Prostate Cancer
Category: Health News
Created: 5/16/2013 4:36:00 PM
Last Editorial Review: 5/17/2013 12:00:00 AM
Androgen Deprivation Therapy For Prostate Cancer Can Cause Osteoporosis
Source: Bones / Orthopedics News From Medical News Today [2013.05.16]
Androgen deprivation therapy is a common and effective treatment for advanced prostate cancer. However, among other side-effects, it can cause significant bone thinning in men on long-term treatment...
FDA Approves New Drug to Fight Advanced Prostate Cancer
Source: MedicineNet Prostate Cancer Specialty [2013.05.16]
Title: FDA Approves New Drug to Fight Advanced Prostate Cancer
Category: Health News
Created: 5/15/2013 12:36:00 PM
Last Editorial Review: 5/16/2013 12:00:00 AM
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.
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.
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