Eulexin

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

EULEXIN Capsules contain flutamide, an acetanilid, nonsteroidal, orally active anti-androgen having the chemical name, 2-methyl-N-[4-nitro-3 (trifluoromethyl) phenyl] propanamide.

Each capsule contains 125 mg flutamide. The compound is a buff to yellow powder with a molecular weight of 276.2 and the following structual formula:

The inactive ingredients for EULEXIN (flutamide) Capsules include: corn starch, lactose, magnesium stearate, povidone, and sodium lauryl sulfate. Gelatin capsule shells may contain methylparaben, propylparaben, butylparaben, and the following dye systems: FD&C Blue 1, FD&C Yellow 6, and either FD&C Red 3 or FD&C Red 40 plus D&C Yellow 10, with titanium dioxide and other inactive ingredients.

EULEXIN (flutamide) 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 (flutamide) Capsules and the LHRH agonist should start 8 weeks prior to initiating radiation therapy and continue during radiation therapy.

Stage D2 Metastatic Carcinoma

To achieve benefit from treatment, EULEXIN (flutamide) Capsules should be initiated with the LHRH agonist and continued until progression.

In rare cases, flutamide has caused severe liver damage resulting in death or hospitalization. Notify your doctor immediately if you develop nausea, vomiting, abdominal pain, unusual fatigue, loss of appetite, "flu-like" symptoms, yellow skin or eyes, itching, clay-colored stools, or dark urine. These symptoms may be early signs of liver damage.

Your doctor will need to monitor your liver function with blood tests before starting treatment with flutamide, every month for the first 4 months of treatment, and periodically thereafter.

Do not stop taking this medication without first talking to your doctor.

Flutamide is an antiandrogen. It works in the body to prevent the actions of androgens (male hormones).

Flutamide is used together with another hormone to treat prostate cancer.

Flutamide may also be used for purposes not listed in this medication guide.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Call your doctor for instructions if you miss an appointment for your LHRH injection.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Prostate Cancer

First-line therapy in combination with a luteinizing hormone-releasing hormone (LHRH) analog (e.g., goserelin, leuprolide acetate, triptorelin) for prostate cancer.1 3 5 6 7 20 22 23

Treatment of locally confined (stage B2 or C)1 20 22 23 and metastatic (stage D2) prostate cancer;1 3 5 6 7 20 should be used in conjunction with an LHRH analog.1 3 5 6 7 20 22 23

Contraindications

• Known hypersensitivity to flutamide or any ingredient in the formulation.1

• Severe hepatic impairment.1

Warnings/Precautions

Warnings

For warnings regarding hepatotoxicity, see Boxed Warning.

Not intended for use in women, particularly for nonserious or nonlife-threatening conditions.1

May cause fetal harm if used in pregnant women.1

Metabolized in part to 4-nitro-3-fluoro-methylaniline; toxicities associated with aniline exposure (i.e., methemoglobinemia, hemolytic anemia, cholestatic jaundice) reported.1

Monitor methemoglobin concentrations periodically in susceptible patients (e.g., those with glucose-6-phosphate dehydrogenase deficiency, hemoglobin M disease, smokers).1

Sensitivity Reactions

Photosensitivity reactions (i.e., erythema, ulceration, bullous eruptions, epidermal necrolysis) reported.1

General Precautions

Possible gynecomastia.1 27

Regularly monitor serum PSA to assess response; if PSA increases, evaluate possible disease progression.1

For patients with objective progression of disease and elevated serum PSA, consider temporarily withdrawing flutamide while continuing LHRH analog.1

Specific Populations

Category D.1 (See Fetal/Neonatal Morbidity and Mortality under Warnings.)

Not intended for use in women.1

Not studied in pediatric patients.1

Contraindicated in patients with severe hepatic impairment. (See Boxed Warning.)1

Not intended for use in women, particularly for nonserious or nonlife-threatening conditions.1

Common Adverse Effects

Combined therapy with LHRH analog: hot flashes, loss of libido, impotence, diarrhea, nausea, vomiting, gynecomastia.1

Cystitis, rectal bleeding, proctitis, skin rash, hematuria also frequent when flutamide combined with LHRH analog and radiation therapy.1

Storage

Oral

2–30°C.1 Protect unit dose packages from excessive moisture.1

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

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.

PRODUCT
INFORMATION

Applies to flutamide: oral capsule, oral tablet

Along with its needed effects, flutamide (the active ingredient contained in Eulexin) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking flutamide:

• Black, tarry stools
• bloody or cloudy urine
• continuing diarrhea
• continuing stomach pain
• difficult, burning, or painful urination
• frequent urge to urinate
• pale skin
• troubled breathing with exertion
• unusual bleeding or bruising
• unusual tiredness or weakness

• Blurred vision
• chest pain
• chills
• cough
• difficulty with breathing
• dizziness
• drowsiness
• fever
• headache
• nervousness
• pounding in the ears
• shortness of breath
• slow or fast heartbeat
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• swelling
• swollen glands

• Abdominal or stomach pain
• clay-colored stools
• dark urine
• general tiredness and weakness
• itching
• light-colored stools
• loss of appetite
• nausea and vomiting
• rash
• tumor
• unpleasant breath odor
• upper right abdominal pain
• vomiting of blood
• yellow eyes and skin

• Back, leg, or stomach pains
• bleeding gums
• blistering, peeling, or loosening of the skin
• bluish-colored lips, fingernails, or palms
• discoloration of the urine
• dizziness or lightheadedness
• flushing or redness of the skin
• general body swelling
• headache
• itching
• joint or muscle pain
• nosebleeds
• rapid heart rate
• red irritated eyes
• red skin lesions, often with a purple center
• unusually warm skin

Get emergency help immediately if any of the following symptoms of overdose occur while taking flutamide:

• Goosebumps
• shakiness and unsteady walk
• tearing of the eyes
• unsteadiness, trembling, or other problems with muscle control or coordination
• weight loss

Some side effects of flutamide may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Decreased interest in sexual intercourse
• diarrhea
• feeling of warmth
• inability to have or keep an erection
• indigestion
• loss in sexual ability, desire, drive, or performance
• passing of gas
• redness of the face, neck, arms and occasionally, upper chest
• stomach pain, fullness, or discomfort
• sudden sweating
• swelling of the breasts or breast soreness in both females and males

• Depression
• drowsiness
• fear or nervousness
• mood or mental changes

There are no data on the excretion of flutamide into human milk.