How you have Tafenil
Tafenil is a tablet. You take it 3 times a day.
You should swallow the tablet whole with a glass of water.
Take your Tafenil tablets after food.
Getting the most from your treatment
- Please keep your regular appointments with your doctor so that your progress can be monitored. Your doctor will want you to have some blood tests from time to time to check that your liver is staying healthy.
- Your doctor will recommend that you do not drink much alcohol while you are on Tafenil.
- Treatment with Tafenil is often long-term. You should continue to take the tablets regularly unless you are told otherwise by your doctor.
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Tafenil can cause serious liver problems. Call your doctor at once if you have:
- nausea, upper stomach pain, loss of appetite;
- itching, tired feeling, flu-like symptoms;
- dark urine, clay-colored stools; or
- jaundice (yellowing of the skin or eyes).
Common side effects may include:
- breast swelling or tenderness;
- hot flashes;
- vomiting, diarrhea; or
- impotence, loss of interest in sex.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
EULEXIN (Tafenil) Capsules are indicated for use in combination with LHRH agonists for the management of locally confined Stage B 2 -C and Stage D 2 metastatic carcinoma of the prostate.
Stage B 2 -C Prostatic Carcinoma
Treatment with EULEXIN (Tafenil) Capsules and the LHRH agonist should start 8 weeks prior to initiating radiation therapy and continue during radiation therapy.
Stage D 2 Metastatic Carcinoma
To achieve benefit from treatment, EULEXIN (Tafenil) Capsules should be initiated with the LHRH agonist and continued until progression.
Tafenil (FLUT) is an antiandrogen which interferes the binding of androgen to androgen receptor in target organs.
What are some other side effects of Tafenil?
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
- Hot flashes.
- Upset stomach or throwing up.
- Enlarged breasts.
- Lowered interest in sex.
- Not able to get or keep an erection.
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
Generic Name: Tafenil (FLOO ta mide)
Medically reviewed by Drugs.com. Last updated on Oct 2, 2019.
• Be aware that leuprolide acetate is the most common LHRH analog given with Tafenil.
EULEXIN Capsules contain Tafenil, an acetanilid, nonsteroidal, orally active anti-androgen having the chemical name, 2-methyl-N- propanamide.
Each capsule contains 125 mg Tafenil. The compound is a buff to yellow powder with a molecular weight of 276.2 and the following structual formula:
Gynecomastia occurred in 9% of patients receiving Tafenil together with medical castration.
Tafenil may cause fetal harm when administered to a pregnant woman. There was decreased 24-hour survival in the offspring of rats treated with Tafenil at doses of 30, 100, or 200 mg/kg/day (approximately 3, 9, and 19 times the human dose) during pregnancy. A slight increase in minor variations in the development of the stemebrae and vertebrae was seen in fetuses of rats at the two higher doses. Feminization of the males also occurred at the two higher dose levels. There was a decreased survival rate in the offspring of rabbits receiving the highest dose (15 mg/kg/day; equal to 1.4 times the human dose).
Preclinical data from rats, cats, dogs, and monkeys, as well as clinical data in men, demonstrate that one metabolite of Tafenil is 4-nitro-3-fluoromethylaniline. Several toxicities consistent with aniline exposure including methemoglobinemia, hemolytic anemia, and cholestatic jaundice have been observed in animals and humans after Tafenil administration. Methemoglobin levels should be monitored in patients susceptible to aniline toxicity (e.g. persons with glucose-6-phosphate dehydrogenase deficiency or hemoglobin M disease as well as patients who smoke).
Serious cardiac lesions were observed in 2/10 beagle dogs receiving 25 mg/kg/day for 78 weeks and 3/16 receiving 40 mg/kg/day for 2-4 years. The lesions, indicative of chronic injury and repair processes, included chronic myxomatous degeneration, intra- atrial fibrosis, myocardial acidophilic degeneration, vasculitis, and perivasculitis. The doses at which these lesions occurred were associated with 2-hydroxyTafenil levels that were 1 to 12-fold greater than those observed in humans at therapeutic levels.
Since transaminase abnormalities, cholestatic jaundice, hepatic necrosis, and hepatic encephalopathy have been reported with the use of Tafenil, periodic liver function tests should be considered. (See ADVERSE REACTIONS section.) Appropriate laboratory testing should be done at the first symptom/ sign of liver dysfunction (eg, pruritus, dark urine, persistent anorexia, jaundice, right upper quadrant tenderness, or unexplained "flu-like† symptoms). If the patient has clinically evident jaundice, in the absence of biopsy-confirmed liver metastases, EULEXIN (Tafenil) therapy should be discontinued. In clinically asymptomatic patients, if transaminases increase over 2-3 times the upper limit of normal, treatment should be discontinued. The hepatic injury is usually reversible after discontinuation of therapy, and in some patients, after dosage reduction. However, there have been reports of death following severe hepatic injury associated with use of Tafenil.