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Eulexin

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Eulexin

Eulexin

SIDE EFFECTS

Stage B2-C Prostatic Carcinoma

Treatment with EULEXIN (flutamide) Capsules and the LHRH agonist did not add substantially to the toxicity of radiation treatment alone. The following adverse experiences were reported during a multicenter clinical trial comparing EULEXIN (flutamide) Capsules + LHRH-A +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)

 

(n= 231)
LHRH -A +
EULEXIN (flutamide) Capsules +
Radiation
% All

(n= 235)
Radiation
Only
 
% All

Rectum/Large Bowel

80

76

Bladder

58

60

Skin

37

37

Adverse Events During Late Radiation Phase
(after 90 days of radiation therapy)

 

(n= 231)
LHRH-A +
EULEXlN Capsules +
Radiation
%All

(n= 235)
Radiation
Only
 
%All

Diarrhea

36

40

Cystitis

16

16

Rectal Bleeding

14

20

Proctitis

8

8

Hematuria

7

12


Additional adverse event data was 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 multi-center clinical trial comparing EULEXIN (flutamide) Capsules + LHRH agonist versus placebo + LHRH agonist.

The most frequently reported (greater than 5%) adverse experiences during treatment with EULEXIN (flutamide) 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)
Flutamide +
LHRH
agonist
%All

(n= 285)
Placebo +
LHRA
agonist
%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 than1%.

In addition, the following adverse reactions were reported during treatment with flutamide + LHRH agonist. No causal relatedness of these reactions to drug treatment has been made, and some of the adverse experiences reported are those that commonly occur in elderly patients.

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, 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 usually reversible after discontinuing therapy; however, there have been reports of death following severe hepatic injury associated with use of flutamide.

Malignant breast neoplasms have occured in male patients being treated with EULEXIN (flutamide) Capsules.

Abnormal Laboratory Test Values: Laboratory abnormalities including elevated SGOT, SGPT, bilirubin values, SGGT, BUN, and serum creatinine have been reported.

Read the Eulexin (flutamide) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Increases in prothrombin time have been noted in patients receiving long- term warfarin therapy after flutamide was initiated. Therefore, close monitoring of prothrombin time is recommended and adjustment of the anticoagulant dose may be necessary when EULEXIN (flutamide) Capsules are administered concomitantly with warfarin.

Read the Eulexin Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 12/28/2004
This monograph has been modified to include the generic and brand name in many instances.

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