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Indication & Safety Information for EULEXIN™
EULEXIN™ should be used only in men. It it not known whether EULEXIN™ is safe for women to take, and may be toxic to the fetus in pregnant women.
Warfarin: Patients receiving long-term warfarin therapy may need to have their doctor closely monitor their prothrombin time, as adjustments to their warfarin dosage may be necessary when EULEXIN™ and Warfarin therapies are undergone at the same time.
Warning: Liver Damage
There have been reports of patients needing to be hospitalized and rarely death due to liver failure in patients taking EULEXIN™ (flutamide). Evidence of liver damage from flutamide included high levels of a family of enzymes called transaminases, yellowing of the skin or eyes (jaundice), a nervous system disorder brought on by severe liver disease, and death related to sudden liver failure. The liver damage was able to be reversed after stopping flutamide therapy in some patients. About half of the reported cases occurred within the first 3 months of treatment with flutamide.
Before starting flutamide therapy, have your doctor check your serum transaminase levels. Serum transaminase levels should then be measured each for the first 4 months of therapy, and regularly after that. Patients should also receive liver function tests at the first signs and symptoms of the liver not functioning properly. These symptoms include feeling sick, vomiting, belly pain (especially in the upper right section of the belly), extreme tiredness, lack or loss of appetite, "flu-like" symptoms, or yellowing of the skin or eyes. If at any time, you experience yellowing of the skin or eyes, call your doctor immediately.
INDICATIONS AND USAGE
EULEXIN™ (flutamide) Capsules are an orally active testosterone blocker used to treat certain prostate cancers.
CONTRAINDICATIONS
EULEXIN™ is contraindicated in patients who are hypersensitive to Flutamide or any component of this preparation.
EULEXIN™ is contraindicated in patients with severe liver impairment (baseline hepatic enzymes should be evaluated prior to treatment).
EULEXIN™ should not be given to pregnant women as flutamide may cause fetal harm when administered to a pregnant woman.
SIDE EFFECTS
- During Early-Stage (Stage I-III) Prostate Cancer Radiation Therapy:
- During Actual Acute Radiation Therapy, patients experienced pain in the following areas: Rectum/Large Bowel (80%), Bladder (58%), and Skin (37%).
- During Later Rounds of Radiation Therapy, the most often reported side effects were: diarrhea (36%), urinary tract infection or UTI (16%), rectal bleeding (14%), anal pain (8%), and blood in urine (7%).
- Over both parts of treatment, the most commonly reported side effects were hot flashes (46%), diarrhea (40%), nausea (9%), and skin rash (8%).
- During Late-Stage (Stage IV) Prostate Cancer Radiation Therapy:
- The most commonly reported (greater than 5%) side effects were: hot flashes (61%), loss of sexual function and desire (36%), inability to achieve erection (33%), diarrhea (12%), nausea/vomiting (11%), and growth of breast tissue (9%).
- Clinically significant adverse experiences occurring in greater than >2%of patients were lowered levels of iron in blood (6%), lack or loss of appetite (4%), and reduced white blood cell count (3%).
ADVERSE REACTIONS
To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.