Eulexin

Eulexin is an FDA-registered drug product whose active ingredient is FLUTAMIDE. It is labelled by Waylis Therapeutics LLC taken by oral and marketed as a human prescription drug product. Identifiers on file: NDC 80725-600, application ANDA075298, label effective 20220113. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing FLUTAMIDE are most often described in connection with: eulexin capsules, stage metastatic, radiation therapy, management locally, prostatic carcinoma, goserelin acetate, start eight, weeks prior. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

INDICATIONS AND USAGE 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. Stage D 2 Metastatic Carcinoma To achieve benefit from treatment, Eulexin™ capsules should be initiated with the LHRH-agonist and continued until progression.

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

CONTRAINDICATIONS 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).

WARNINGS 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 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. The most frequently reported (greater than 5%) adverse experiences during treatment with Eulexin™ capsules in combination with an LHRH agonist are listed in the table below. For comparison, adverse experiences seen with an LHRH agonist and placebo are also listed in the following table. (n=294) Eulexin™ + LHRH agonist (n=28) Placebo + LHRH agonist % All % All Hot Flashes 61 57 Loss of Libido 36 31 Impotence 33 29 Diarrhea 12 4 Nausea/Vomiting 11 10 Gynecomastia 9 11 Other 7 9 Other GI 6 4 As shown in the table, for both treatment groups, the most frequently occurring adverse experiences (hot flashes, impotence, loss of libido) were those known to be associated with low serum androgen levels and known to occur with LHRH agonists alone. The only notable difference was the higher incidence of diarrhea in the Eulexin™ + LHRH agonist group (12%), which was severe in 5% as opposed to the placebo + LHRH agonist (4%), which was severe in less than 1%. In addition, the following adverse reactions were reported during treatment with Eulexin™ + LHRH agonist. Cardiovascular System: hypertension in 1% of patients. Central Nervous System : CNS (drowsiness/confusion/depression/anxiety/nervousness) reactions occurred in 1% of patients. Gastrointestinal System : anorexia 4%, and other GI disorders occurred in 6% of patients. Hematopoietic System : anemia occurred in 6%, leukopenia in 3%, and thrombocytopenia in 1% of patients. Liver and Biliary System : hepatitis and jaundice in less than 1% of patients. Skin : irritation at the injection site and rash occurred in 3% of patients. Other: edema occurred in 4%, genitourinary and neuromuscular symptoms in 2%, and pulmonary symptoms in less than 1% of patients. In addition, the following spontaneous adverse experiences have been reported during the marketing of Eulexin™: hemolytic anemia,macrocytic anemia,methemoglobinemia, sulfhemoglobinemia, photosensitivity reactions (including erythema, ulceration, bullous eruptions, and epidermal necrolysis) and urine discoloration. The urine was noted to change to an amber or yellow-green appearance which can be attributed to the Eulexin™ and/or its metabolites. Also reported were cholestatic jaundice, hepatic encephalopathy, and hepatic necrosis. The hepatic conditions were often reversible after discontinuing therapy; however, there have been reports of death following severe hepatic injury associated with use of Eulexin™. Malignant breast neoplasms have occurred rarely in male patients being treated with Eulexin™ capsules. Abnormal Laboratory Test Values Laboratory abnormalities including elevated SGOT, SGPT, bilirubin values, SGGT, BUN, and serum creatinine have been reported.

What is Eulexin used for?
INDICATIONS AND USAGE 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 …

Who makes Eulexin?
Waylis Therapeutics LLC is the labeler of record for Eulexin.

What form does Eulexin come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Eulexin prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Has Eulexin been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.