Eulexin Side Effects
Generic Name: Flutamide
Please note - some side effects for Eulexin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
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Eulexin
Stage B2-C Prostatic Carcinoma
Treatment with Eulexin Capsules and the goserelin acetate implant did not add substantially to the toxicity of radiation treatment alone. The following adverse experiences were reported during a multicenter clinical trial comparing flutamide + goserelin acetate implant + radiation versus radiation alone. The most frequently reported (greater than 5%) adverse experiences are listed below.
| Adverse Events During Acute Radiation Therapy (within first 90 days of radiation therapy) |
Adverse Events During Late Radiation Phase (after 90 days of radiation therapy) |
||||
|---|---|---|---|---|---|
| (n=231) | (n=235) | (n=231) | (n=235) | ||
| Goserelin acetate implant + Eulexin + Radiation | Radiation Only | Goserelin acetate implant + Eulexin + Radiation | Radiation Only | ||
| % All | % All | % All | % All | ||
| Rectum/ Large Bowel |
80 | 76 | Diarrhea | 36 | 40 |
| Cystitis | 16 | 16 | |||
| Bladder | 58 | 60 | Rectal Bleeding | 14 | 20 |
| Skin | 37 | 37 | Proctitis | 8 | 8 |
| Hematuria | 7 | 12 | |||
Additional adverse event data were collected for the combination therapy with radiation group over both the hormonal treatment and hormonal treatment plus radiation phases of the study. Adverse experiences occurring in more than 5% of patients in this group, over both parts of the study, were hot flashes (46%), diarrhea (40%), nausea (9%), and skin rash (8%).
Stage D2 Metastatic Carcinoma
The following adverse experiences were reported during a multicenter clinical trial comparing flutamide + LHRH agonist versus placebo + LHRH agonist.
The most frequently reported (greater than 5%) adverse experiences during treatment with Eulexin Capsules in combination with an LHRH agonist are listed in the table below. For comparison, adverse experiences seen with an LHRH agonist and placebo are also listed in the following table.
| (n=294) | (n=285) | |
|---|---|---|
| Flutamide + LHRH agonist | Placebo + LHRH agonist | |
| % All | % All | |
| Hot Flashes | 61 | 57 |
| Loss of Libido | 36 | 31 |
| Impotence | 33 | 29 |
| Diarrhea | 12 | 4 |
| Nausea/Vomiting | 11 | 10 |
| Gynecomastia | 9 | 11 |
| Other | 7 | 9 |
| Other GI | 6 | 4 |
As shown in the table, for both treatment groups, the most frequently occurring adverse experiences (hot flashes, impotence, loss of libido) were those known to be associated with low serum androgen levels and known to occur with LHRH agonists alone.
The only notable difference was the higher incidence of diarrhea in the flutamide + LHRH agonist group (12%), which was severe in 5% as opposed to the placebo + LHRH agonist (4%), which was severe in less than 1%.
In addition, the following adverse reactions were reported during treatment with flutamide + LHRH agonist.
Cardiovascular System: hypertension in 1% of patients.
Central Nervous System: CNS (drowsiness/confusion/depression/anxiety/nervousness) reactions occurred in 1% of patients.
Gastrointestinal System: anorexia 4%, and other GI disorders occurred in 6% of patients.
Hematopoietic System: anemia occurred in 6%, leukopenia in 3%, and thrombocytopenia in 1% of patients.
Liver and Biliary System: hepatitis and jaundice in less than 1% of patients.
Skin: irritation at the injection site and rash occurred in 3% of patients.
Other: edema occurred in 4%, genitourinary and neuromuscular symptoms in 2%, and pulmonary symptoms in less than 1% of patients.
In addition, the following spontaneous adverse experiences have been reported during the marketing of flutamide: hemolytic anemia, macrocytic anemia, methemoglobinemia, sulfhemoglobinemia, photosensitivity reactions (including erythema, ulceration, bullous eruptions, and epidermal necrolysis), and urine discoloration. The urine was noted to change to an amber or yellow-green appearance which can be attributed to the flutamide and/or its metabolites. Also reported were cholestatic jaundice, hepatic encephalopathy, and hepatic necrosis. The hepatic conditions were often reversible after discontinuing therapy; however, there have been reports of death following severe hepatic injury associated with use of flutamide.
Malignant breast neoplasms have occurred rarely in male patients being treated with Eulexin Capsules.
Abnormal Laboratory Test ValuesLaboratory abnormalities including elevated SGOT, SGPT, bilirubin values, SGGT, BUN, and serum creatinine have been reported.
TopMore resources:
Eulexin - Includes detailed dosage instructions.
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