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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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.
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NEWS HIGHLIGHTSMedia Articles Related to Eulexin (Flutamide)
Tulane Cancer Center To Begin Novel Clinical Trial For Late-Stage Prostate Cancer Drug
Source: Prostate / Prostate Cancer News From Medical News Today [2009.11.18]
International prostate cancer expert Dr. Oliver Sartor of Tulane Cancer Center is the first oncologist in the United States to offer patients an experimental new treatment for late-stage prostate cancer through a multi-center clinical trial that is currently recruiting patients at 100 sites across 20 countries worldwide.
Hollis-Eden Presents New Interim Data From Prostate Cancer Phase I/II Clinical Studies Of Apoptone (HE3235) At AACR Molecular Targets Conference
Source: Conferences News From Medical News Today [2009.11.17]
Hollis-Eden Pharmaceuticals, Inc. (Nasdaq: HEPH), reported preliminary results of its ongoing Phase I/II clinical trial with Apoptone® (HE3235) for hormone-resistant prostate cancer (also called castrate-resistant prostate cancer or CRPC).
Anxiety And Distress During Active Surveillance For Early Prostate Cancer
Source: Prostate / Prostate Cancer News From Medical News Today [2009.11.16]
UroToday.com - The present study found that the majority of men with early prostate cancer (PC) included in a protocol-based program for active surveillance (AS) show favorable anxiety and distress scores when compared to reference values and to groups of patients with PC who underwent other treatments.
Percentage Of Positive Biopsy Cores At The Onset Of Hormone Therapy For Prostate Cancer: Prognostic Significance
Source: Prostate / Prostate Cancer News From Medical News Today [2009.11.16]
UroToday.com - Accurate prediction of outcome after hormonal treatment for localized prostate cancer is important for patient counselling, follow-up, treatment planning and research protocol design. Few prognostic tools incorporating pre-therapeutic parameters are available to increase disease relapse predictions and survival.
Degarelix: A New Approach For The Treatment Of Prostate Cancer
Source: Prostate / Prostate Cancer News From Medical News Today [2009.11.16]
UroToday.com - Gonadotrophin-releasing hormone (GnRH) agonists are currently the 'standard of care' for androgen deprivation therapy (ADT) in prostate cancer. Improvements in ADT would have a great value for many patients. The agonists are associated with an initial testosterone surge, which delays castration and may stimulate tumor growth and induce 'clinical flare' in patients with symptomatic advanced disease.
Published Studies Related to Eulexin (Flutamide)
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.
Long-term efficacy and tolerability of flutamide combined with oral contraception in moderate to severe hirsutism: a 12-month, double-blind, parallel clinical trial. [2007.09]
OBJECTIVE: Our objective was to test the efficacy and tolerability of three doses of flutamide (125, 250, and 375 mg) combined with a triphasic oral contraceptive (ethynylestradiol/levonorgestrel) during 12 months to treat moderate to severe hirsutism in patients with polycystic ovary syndrome or idiopathic hirsutism. DESIGN: We conducted a randomized, double-blind, placebo-controlled, parallel clinical trial. PATIENTS: A total of 131 premenopausal women, suffering from moderate to severe hirsutism, were randomized to placebo or 125, 250, or 375 mg flutamide daily associated with a triphasic oral contraceptive pill. Hirsutism (Ferriman-Gallwey), acne and seborrhea (Cremoncini), and hormone serum levels were monitored at baseline and at 3 (except hormone serum levels), 6, and 12 months. Side effects and biochemical, hematological, and hepatic parameters were assessed... CONCLUSIONS: Flutamide at 125 mg daily during 12 months was the minimum effective dose to diminish hirsutism in patients with polycystic ovary syndrome or with idiopathic hirsutism.
Long-term efficacy and tolerability of flutamide combined with oral contraception in moderate to severe hirsutism. A 12-month, double-blind, parallel clinical trial. [2007.06.12]
Objective: Efficacy and tolerability of three doses of flutamide (125, 250, 375 mg) combined with a triphasic oral contraceptive (ethynylestradiol / levonorgestrel) during 12 months to treat moderate to severe hirsutism in patients with polycystic ovary syndrome (PCOS) or idiopathic hirsutism... Conclusions: Flutamide 125 mg daily during 12 months was the minimum effective dose to diminish hirsutism in patients with polycystic ovary syndrome or with idiopathic hirsutism.
Clinical Trials Related to Eulexin (Flutamide)
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 randomized phase II trial is studying the effect of flutamide on biomarkers in
blood and tissue samples from patients at high risk of ovarian cancer.
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
cancer.
Flutamide With or Without Vaccine Therapy in Treating Patients With Nonmetastatic Prostate Cancer [Recruiting]
RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy,
such as flutamide, may lessen the amount of androgens made by the body. Vaccines made from a
gene-modified virus may help the body build an effective immune response to kill tumor
cells. Giving flutamide together with vaccine therapy may kill more tumor cells.
PURPOSE: This randomized phase II trial is studying flutamide and vaccine therapy to see how
well they work compared with flutamide alone in treating patients with nonmetastatic
prostate cancer.
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 [Recruiting]
This study will evaluate the effectiveness of flutamide in reducing symptoms of premenstrual
dysphoric disorder.
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PATIENT REVIEWS / RATINGS / COMMENTSBased 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. |
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Page last updated: 2009-11-18
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