Uses for Eulexin

Flutamide is used together with a luteinizing hormone-releasing hormone (LHRH) agonist to treat metastatic (cancer that has spread) prostate cancer in men. Flutamide belongs to the group of medicines called antiandrogens. It works by blocking the effects of androgen (a male hormone), to stop the growth and spread of cancer cells.

This medicine is available only with your doctor's prescription.

Before using Eulexin

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

No information is available on the relationship of age to the effects of flutamide in the pediatric population. Safety and efficacy have not been established.

Geriatric

No information is available on the relationship of age to the effects of flutamide in geriatric patients.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Methotrexate
• Pexidartinib

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Glucose-6-phosphate dehydrogenase (G6PD) deficiency or
• Hemoglobin M disease (blood disorder) or
• Tobacco smoking—This medicine contains aniline, which may cause problems in patients with these conditions.

• Liver disease, severe—Should not be used in patients with this condition.

Proper use of Eulexin

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

Flutamide should be taken together with other medicines used for surgery. Do not stop taking these medicines without checking with your doctor first.

This medicine comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  • For prostate cancer:
    • Adults—Two 125-milligram (mg) capsules three times a day every eight hours for a total daily dose of 750 mg.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Liver problems may occur while you are using this medicine. Stop using this medicine and check with your doctor right away if you are having more than one of these symptoms: clay-colored stools; dark urine; fever; headache; loss of appetite; nausea and vomiting; pain or tenderness in the upper right side of the stomach; unusual tiredness or weakness; or yellow eyes or skin.

This medicine may cause gynecomastia (swelling of the breasts and breast soreness) in some patients. If you have questions on this, ask your doctor.

Do not take other medicines unless they have been discussed with your doctor. Your doctor may adjust the doses of your medications or monitor you carefully for side effects.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

Flutamide should be taken together with other medicines used for surgery. Do not stop taking these medicines without checking with your doctor first.

This medicine comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  • For prostate cancer:
    • Adults—Two 125-milligram (mg) capsules three times a day every eight hours for a total daily dose of 750 mg.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

No information is available on the relationship of age to the effects of flutamide in the pediatric population. Safety and efficacy have not been established.

Geriatric

No information is available on the relationship of age to the effects of flutamide in geriatric patients.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Methotrexate
• Pexidartinib

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Glucose-6-phosphate dehydrogenase (G6PD) deficiency or
• Hemoglobin M disease (blood disorder) or
• Tobacco smoking—This medicine contains aniline, which may cause problems in patients with these conditions.

• Liver disease, severe—Should not be used in patients with this condition.

Along with its needed effects, a medicine 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:

More common

• 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

Less common

• 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

Rare

• 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

Incidence not known

• 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:

Symptoms of overdose

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

Some side effects 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:

More common

• 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

Less common

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

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.