There have been post-marketing 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 .
Liver failure has been reported in patients taking flutamide. Evidence of hepatic injury included elevated serum transaminase levels, jaundice, hepatic encephalopathy, and death related to acute hepatic failure. Serum transaminase levels should be measured prior to starting treatment, monthly for the first 4 months of therapy, and periodically thereafter. Flutamide is not recommended in patients whose ALT values exceed twice the upper limit of normal and should be discontinued if the ALT rises above 2 times the upper limit of normal or jaundice occurs during therapy .
Commonly used brand name(s):
In the U.S.
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Therapeutic Class: Antiandrogen
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.
flutamide is available only with your doctor's prescription.
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 flutamide, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to flutamide 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.
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.
No information is available on the relationship of age to the effects of flutamide in geriatric patients.
|All Trimesters||D||Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.|
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.
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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
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.
The presence of other medical problems may affect the use of flutamide. Make sure you tell your doctor if you have any other medical problems, especially:
Take flutamide 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.
flutamide comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.
The dose of flutamide 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 flutamide. 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.
If you miss a dose of flutamide, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
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 flutamide is working properly. Blood tests may be needed to check for unwanted effects.
Liver problems may occur while you are using flutamide. Stop using flutamide 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.
flutamide 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.
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
Get emergency help immediately if any of the following symptoms of overdose occur:Symptoms of overdose
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
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.
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