Drug Notebook

FDA Alerts

    Hepatotoxicity
  • Severe liver injury (i.e., increased serum transaminase concentrations, jaundice, hepatic encephalopathy, acute hepatic failure) reported, sometimes resulting in hospitalization and/or rarely death; manifestations generally occurred within first 3 months and in some patients, were reversible after discontinuance.
  • Measure serum transaminase concentrations prior to initiation of therapy, monthly during first 4 months, and periodically thereafter.
  • Immediately measure serum transaminase (especially ALT) concentrations if manifestations suggestive of liver dysfunction (e.g., nausea, vomiting, abdominal pain, fatigue, anorexia, flu-like symptoms, hyperbilirubinuria, jaundice, right upper quadrant tenderness) occur.
  • Immediately discontinue if jaundice develops or serum ALT concentration is >2 times ULN; monitor liver function closely until resolves.

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flutamide
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(FLEW ta mide)

What is the most important information I should know about flutamide?

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.

What is flutamide?

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

Flutamide is used in the treatment of prostate cancer.

Flutamide may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before taking flutamide?

Before taking flutamide, tell your doctor if you

You may not be able to take flutamide, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Flutamide is not indicated for use by women. Flutamide is in the FDA pregnancy category D. This means that it is known to harm an unborn baby. Do not take flutamide if you are pregnant. Flutamide is not indicated for use by women. It is not known whether flutamide passes into breast milk. Do not take flutamide without first talking to your doctor if you are breast-feeding.

How should I take flutamide?

Take flutamide exactly as directed by your doctor. If you do not understand these directions, ask your doctor, nurse, or pharmacist to explain them to you.

Take each dose with a full glass of water.

Flutamide is usually taken three times a day (every 8 hours). Follow your doctor's instructions.

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.

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.

Do not stop taking this medication without first talking to your doctor. Store flutamide at room temperature away from moisture and heat.
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