Flutamide

Flutamide is a prescription medication used together with another medication (called an LHRH-agonist) to treat certain types of prostate cancer. Flutamide belongs to a group of drugs called nonsteroidal antiandrogens. These work by blocking the effects of certain hormones to prevent growth or spread of cancer cells. 

This medication comes as a capsule to take by mouth and is usually taken 3 times a day (every 8 hours), with or without food. 

Common side effects of flutamide include diarrhea, hot flashes, decreased sexual desire, and the inability to get or maintain an erection.

Flutamide is a prescription medication used together with another medication (called an LHRH-agonist) to treat certain types of prostate cancer.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Flutamide may be found in some form under the following brand names:

• Eulexin

Common side effects of flutamide include the following:

• diarrhea
• nausea
• vomiting
• loss of appetite
• hot flashes
• decrease in sexual ability or desire
• breast enlargement in men
• drowsiness
• confusion
• depression
• anxiety
• swelling of the hands, feet, ankles, or lower legs
• blue-green or orange-colored urine

This is not a complete list of flutamide side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take: 

• Anticoagulants such as warfarin
• Theophylline

This is not a complete list of flutamide drug interactions. Ask your doctor or pharmacist for more information. 

Serious side effects have been reported with flutamide. 

Some men taking flutamide had liver injury and needed to be hospitalized. In rare cases, men died because of liver failure while they were taking flutamide. In about half of these cases, the liver failure occurred in the first 3 months that they were taking flutamide. Because the flutamide product may cause liver failure, it is very important that you have all blood tests recommended by your doctor. These tests help identify whether you are having liver problems. A recommended schedule for these blood tests is:

• before starting flutamide treatment
• every month for the first 4 months of therapy
• periodically after the first 4 months

In addition, you should call your doctor right away if you have any of the following signs or symptoms: (These may be signs of liver failure.)

• loss of appetite
• nausea and vomiting
• stomach or abdominal pain
• fatigue (feeling extremely tired)
• flu-like symptoms (muscle aches, soreness)
• brown urine
• jaundice (yellowing of the skin or whites of the eyes)

If you experience moderate diarrhea due to flutamide capsules, the following advice may help:

• drink plenty of fluids
• reduce your intake of dairy products (for example, milk, cheese, yogurt)
• increase your intake of whole grains, fruits, and vegetables
• stop laxative use
• take non-prescription anti-diarrheal medicines

If your diarrhea continues or it becomes severe, contact your doctor right away.

Periodic liver function tests and sperm count determinations must be performed in patients on long-term treatment with flutamide.

Since flutamide tends to elevate plasma testosterone and estradiol levels, fluid retention may occur. Accordingly, flutamide should be used with caution in those patients with cardiac disease.

Flutamide is not to be used by women. It is only indicated for men. 

Flutamide can cause harm to your unborn baby if given to a pregnant woman. 

Flutamide has a metabolite that can cause methemoglobinemia, hemolytic anemia and cholestatic jaundice. If you have glucose-6-phosphate dehydrogenase deficiency, have hemoglobin M disease and/or smoke, you are at increased risk for toxicity from the metabolite. In these cases, your doctor may monitor methemoglobin levels. 

Do not take flutamide if you:

• are allergic to flutamide or any of its ingredients
• have severe liver impairment (patients whose liver does not really work)
• are a woman

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of flutamide, there are no specific foods that you must exclude from your diet when receiving this medication. 

Before taking flutamide, tell your doctor about all of your medical conditions. Especially tell your doctor if you: 

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Flutamide falls into category D. It has been shown that use of flutamide in pregnant women caused some babies to be born with problems. However, in some serious situations, the benefit of using this medication may be greater than the risk of harm to the baby.

According to the manufacturer, this product is not indicated for use in women. Information related to the use in nursing women has not been located.

Take flutamide exactly as prescribed. 

If you miss a dose of flutamide, simply continue therapy with your next scheduled dose. Do not try to make up for it by taking extra capsules.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

Your doctor will determine whether flutamide therapy is right for you based on many different factors. These include how large your tumor is, how far it has spread and your physical condition. In addition to flutamide, you may be getting other treatments, including regular injections of LH-RH agonist or radiation therapy. Do not stop or interrupt any treatment without consulting your healthcare professional.

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

If you take too much flutamide, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away. 

• Store at 20° to 25°C (68° to 77°F). 
• Keep this and all medicines out of the reach of children.

Liver 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, 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, flutamide should be immediately discontinued with close follow-up of liver function tests until resolution.