pharmacopeia
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Boxed warning

Hepatic Injury There have been postmarketing reports of hospitalization and rarely death due to liver failure in patients taking Eulexin ® . 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 Eulexin ® . Serum transaminase levels should be measured prior to starting treatment with Eulexin ® . Eulexin ® 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, e.g., 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, Eulexin ® should be immediately discontinued with close follow-up of liver function tests until resolution.

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Androgen Receptor Antagonists.

Androgen Receptor

Indications

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  • Eulexin ® capsules are indicated for use in combination with LHRH-agonists for the management of locally confined Stage B 2 -C and Stage D 2 metastatic carcinoma of the prostate. Stage B 2 -C Prostatic Carcinoma Treatment with Eulexin ® capsules and the goserelin acetate implant should start eight weeks prior to initiating radiation therapy and continue during radiation therapy.

Contraindications

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  • Eulexin ® capsules are contraindicated in patients who are hypersensitive to Eulexin ® or any component of this preparation. Eulexin ® capsules are contraindicated in patients with severe hepatic impairment (baseline hepatic enzymes should be evaluated prior to treatment).contraindicated

Dosage & administration

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The recommended dosage is 2 capsules 3 times a day at 8 hour intervals for a total daily dose of 750 mg.

Warnings & precautions

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Hepatic Injury SEE BOXED WARNINGS Use in Women Eulexin ® capsules are for use only in men. This product has no indication for women and should not be used in this population, particularly for nonserious or nonlife-threatening conditions. Fetal toxicity Eulexin ® may cause fetal harm when administered to a pregnant woman (see Pregnancy ). Aniline toxicity One metabolite of Eulexin ® is 4-nitro-3-fluoro-methylaniline. Several toxicities consistent with aniline exposure, including methemoglobinemia, hemolytic anemia and cholestatic jaundice have been observed in both animals and humans after Eulexin ® administration. In patients susceptible to aniline toxicity (e.g. persons with glucose-6-phosphate dehydrogenase deficiency, hemoglobin M disease and smokers), monitoring of methemoglobin levels should be considered.

Adverse reactions

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Stage B 2 -C Prostatic Carcinoma Treatment with Eulexin ® capsules and the goserelin acetate implant did not add substantially to the toxicity of radiation treatment alone. The following adverse experiences were reported during a multicenter clinical trial comparing Eulexin ® + goserelin acetate implant + radiation versus radiation alone. The most frequently reported (greater than 5%) adverse experiences are listed below: Adverse Events During Acute Radiation Therapy (within first 90 days of radiation therapy) (n=231) Goserelin Acetate Implant + Eulexin ® + Radiation (n=235) Radiation Only % All % All Rectum/Large Bowel 80 76 Bladder 58 60 Skin 37 37 Adverse Events During Late Radiation Phase (after 90 days of radiation therapy) (n=231) Goserelin Acetate Implant + Eulexin ® + Radiation (n=235) Radiation Only % All % All Diarrhea 36 40 Cystitis 16 16 Rectal Bleeding 14 20 Proctitis 8 8 Hematuria 7 12 Additional adverse event data were collected for the combination therapy with radiation group over both the hormonal treatment and hormonal treatment plus radiation phases of the study. Adverse experiences occurring in more than 5% of patients in this group, over both parts of the study, were hot flashes (46%), diarrhea (40%), nausea (9%), and skin rash (8%). Stage D 2 Metastatic Carcinoma The following adverse experiences were reported during a multicenter clinical trial comparing Eulexin ® + LHRH agonist versus placebo + LHRH agonist.

Use in specific populations

Sourced from openFDA

Pregnancy Pregnancy Category D There was decreased 24 hour survival in the offspring of pregnant rats treated with Eulexin ® at doses of 30, 100 or 200 mg/kg/day (approximately 3, 9 and 19 times the human dose). A slight increase in minor variations in the development of the sternebrae and vertebrae was seen in fetuses of rats treated with two higher doses. Feminization of the male rats also occurred at the two higher dose levels. There was a decreased survival rate in the offspring of rabbits receiving the highest dose (15 mg/kg/day, equal to 1.4 times the human dose).

Pharmacokinetics

Sourced from openFDA
Metabolism
Absorption Analysis of plasma, urine, and feces following a single oral 200 mg dose of tritium-labeled Eulexin ® to human volunteers showed that the drug is rapidly and completely absorbed. Following a single 250 mg oral dose to normal adult volunteers, the biologically active alpha-hydroxylated metabolite reaches maximum plasma concentrations in about 2 hours, indicating that it is rapidly formed from flutamide.

Overdosage

Sourced from openFDA

In animal studies with Eulexin ® alone, signs of overdose included hypoactivity, piloerection, slow respiration, ataxia, and/or lacrimation, anorexia, tranquilization, emesis, and methemoglobinemia. Clinical trials have been conducted with Eulexin ® in doses up to 1500 mg per day for periods up to 36 weeks with no serious adverse effects reported. Those adverse reactions reported included gynecomastia, breast tenderness, and some increases in SGOT. The single dose of Eulexin ® ordinarily associated with symptoms of overdose or considered to be life-threatening has not been established. Eulexin ® is highly protein bound, and is not cleared by hemodialysis. As in the management of overdosage with any drug, it should be borne in mind that multiple agents may have been taken. If vomiting does not occur spontaneously, it should be induced if the patient is alert. General supportive care, including frequent monitoring of the vital signs and close observation of the patient, is indicated.

Approval history

Sourced from openFDA
  • Sep 18, 2001ANDAANDA075298Waylis Therap

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
983 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Prostate Cancer707.1%
  2. 2Anaemia656.6%
  3. 3Fatigue636.4%
  4. 4Prostatic Specific Antigen Increased606.1%
  5. 5Asthenia464.7%
  6. 6Death454.6%
  7. 7Diarrhoea414.2%
  8. 8Nausea373.8%
  9. 9Metastases To Bone363.7%
  10. 10Pain353.6%
  11. 11Malaise333.4%
  12. 12Malignant Neoplasm Progression333.4%
  13. 13Back Pain323.3%
  14. 14Drug Ineffective323.3%
  15. 15Rash313.2%

Literature

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Recent PubMed references pinned to Flutamide as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 78 ClinicalTrials.gov registrations naming Flutamide as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Flutamide work?
Mechanism-of-action class: Androgen Receptor Antagonists.
What is Flutamide used for?
According to FDA labeling, Flutamide carries indications including: Eulexin ® capsules are indicated for use in combination with LHRH-agonists for the management of locally confined Stage B 2 -C and Stage D 2 metastatic carcinoma of the prostate. Stage B 2 -C Prostatic Carcinoma Treatment with Eulexin ® capsules and the goserelin acetate implant should start eight weeks prior to initiating radiation therapy and continue during radiation therapy.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Flutamide?
Flutamide is classified as Anti-androgens, Androgen Receptor Inhibitor, Androgen Receptor Antagonists, Testicular Endocrine Activity Alteration.
What are the brand names for Flutamide?
Flutamide is marketed under brand names including Eulexin.
What are the contraindications for Flutamide?
Flutamide labeling lists contraindications including: Eulexin ® capsules are contraindicated in patients who are hypersensitive to Eulexin ® or any component of this preparation. Eulexin ® capsules are contraindicated in patients with severe hepatic impairment (baseline hepatic enzymes should be evaluated prior to treatment).. Always consult the full prescribing information and a clinician.
Note. Data for flutamide is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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