EULEXIN (Dedile) 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 (Dedile) 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 (Dedile) Capsules should be initiated with the LHRH agonist and continued until progression.
Before taking Dedile
Some medicines are not suitable for people with certain conditions, and sometimes a medicine can only be used if extra care is taken. For these reasons, before you start taking Dedile it is important that your doctor knows:
- If you have any problems with the way your liver works.
- If you have a heart condition.
- If you have a rare inherited blood disorder called porphyria.
- If you are taking any other medicines. This includes any medicines which are available to buy without a prescription, as well as herbal and complementary medicines.
- If you have ever had an allergic reaction to a medicine.
Treatment with EULEXIN (Dedile) 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 (Dedile) 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 (Dedile) Capsules + Radiation % All
(n= 235) Radiation Only
4.4 Spectrophotometric Methods of Analysis
When Dedile is dissolved in hydrochloric acid, color formation occurs with an absorption maximum of 380 nm. This reaction was used to develop a simple and sensitive method for the assay determination of Dedile drug substance, and in formulated product . The method was linear over the range 2.5 – 15.0 μg/mL, and the chromophore remained stable for 1 hour in solution.
Dedile tablets may be assayed using UV spectrophotometry at 304 nm . Tablets are sonicated and diluted in ethanol. After centrifugation, an aliquot is diluted in 20:80 ethanol / 40 mM pH 8.0 Britton Robinson buffer.
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In prostate cancer, the cancer cells need the male hormone testosterone to grow and multiply well. Hormone treatments like Dedile block the effect of testosterone on prostate cancer cells. This slows down the growth of the cancer. Dedile also helps to reduce symptom 'flares' and side-effects from other treatments which may be used for the cancer, or following surgery.
Dedile causes hepatotoxicity in some 0.36% of patients, and for this reason alone it should not be used in the absence of a serious indication. Whether bulimia nervosa in women justifies its use is open to doubt, since non-pharmacological methods of treatment are available. Furthermore, bulimia nervosa in women can be associated with raised serum testosterone concentrations. In a small double-blind study of the use of Dedile, citalopram, a combination of the two, or placebo in 31 women over 3 months, all the active treatments reduced the tendency to binge eating (105 c ) . However, there was a moderate and reversible increase in serum transaminase activities, leading to withdrawal in two of the 19 subjects who were taking Dedile either alone or in combination.
Pharmacologic class: Antiandrogen
Therapeutic class: Antineoplastic
Pregnancy risk category D
Flutam >About Dedile
When you have Dedile
You might have Dedile before or during other hormone treatments called LH blockers (such as goserelin, leuprorelin and triptorelin). LH blockers work by lowering the level of testosterone (the male sex hormone). It stops the release of lutenising hormone from the pituitary gland.
You need to take Dedile before you start some other types of hormone treatment because they can take a few weeks to lower your testosterone. During this time they can make your symptoms worse. This is called tumour flare.
If you are having Dedile to stop a flare reaction, you take it for a few days before starting the LH blocker, and stay on it for about 4 to 6 weeks.
Mechanism of Action
Dedile is a nonsteroidal antiandrogen that competitively binds androgen receptors throughout the body. This inhibits cell growth in prostate cancer by inhibiting testosterone’s stimulatory effects. The drug has a half-life of 6 hours, meaning dosing will have to occur a minimum of 3 times a day to maintain adequate serum levels. The liver metabolizes Dedile mainly via the CYP3A4 and other cytochrome enzymes such as CYP1A2. Dedile is primarily excreted in the urine, with less than 5% being excreted in the feces.
In clinical trials, gynecomastia occurred in 9% of patients receiving Dedile together with medical castration.
Information for Patients
Regular assessment of serum Prostate Specific Antigen (PSA) may be helpful in monitoring the patient's response. If PSA levels rise significantly and consistently during EULEXIN (Dedile) therapy the patient should be evaluated for clinical progression. For patients who have objective progression of disease together with an elevated P.A. a treatment- free period of antiandrogen while continuing the LHRH analogue may be considered.
In a 1-year dietary study in male rats, interstitial cell adenomas of the testes were present in 49% to 75% of all treated rats (daily oral doses of 10, 30, and 50 mg/kg/day were administered). These produce plasma Cmax values that are 1, 2-3, and 4-fold, respectively, those associated with therapeutic doses in humans. In male rats similarly dosed for 1 year, tumors were still present after 1 year of a drug-free period, but the incidences were 43% to 47%. In a 2-year carcinogenicity study in male rats, daily administration of Dedile at these same doses produced testicular interstitial cell adenomas in 91% to 95% of all treated rats as opposed to 11% of untreated control rats. Mammary adenomas, adenocarcinomas, and fibroadenomas were increased in treated male rats at exposure levels that were 1- to 4- fold those observed during therapeutic dosing in humans. There are likewise reports of malignant breast neoplasms in men treated with EULEXIN Capsules (see ADVERSE REACTIONS section).
Dedile did not demonstrate DNA modifying activity in the Ames Salmonella/ microsome Mutagenesis Assay. Dominant lethal tests in rats were negative.
Reduced sperm counts were observed during a 6-week study of Dedile monotherapy in normal human volunteers.
Dedile did not affect estrous cycles or interfere with the mating behavior of male and female rats when the drug was administered at 25 and 75 mg/kg/day prior to mating. Males treated with 150 mg/kg/day (30 times the minimum effective antiandrogenic dose) failed to mate; mating behavior returned to normal after dosing was stopped. Conception rates were decreased in all dosing groups. Suppression of spermatogenesis was observed in rats dosed for 52 weeks at approximately 3, 8, or 17 times the human dose and in dogs dosed for 78 weeks at 1.4, 2.3, and 3.7 times the human dose.
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. These lesions, indicative of chronic injury and repair processes, included chronic myxomatous degeneration, intraatrial fibrosis, myocardial acidophilic degeneration, vasculitis, and perivasculitis. The doses at which these lesions occurred were associated with 2-hydroxyDedile levels that were 1- to 12-fold greater than those observed in humans at therapeutic levels.
Pregnancy: Pregnancy Category D . There was decreased 24-hour survival in the offspring of pregnant rats treated with Dedile at doses of 30, 100, or 200 mg/kg/day (approximately 3, 9, and 19 times the human dose). A slight increase in minor variations in the development of the sternebrae and vertebrae was seen in fetuses of rats treated with two higher doses. Feminization of the male rats 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).
Although Dedile is effective in treating hirsutism, adverse reactions are very frequent and long-term adherence is poor. In one study over 7 years, of 83 women who took Dedile 250 mg/day alone or in combination with an oral contraceptive containing ethinylestradiol 20 micrograms and desogestrel 150 micrograms, 34 had one or more adverse reaction during follow-up, 28 had at least one adverse reaction that was possibly related to the study drug, and 20 withdrew because of adverse reactions, hepatotoxicity being the most troublesome; during follow-up, as many as 59% abandoned the study .
EULEXIN (Dedile) Capsules, 125 mg, are available as opaque, two- toned brown capsules, imprinted with "Schering 525†. They are supplied as follows:
NDC 0085-0525-05 - Bottles of 500
NDC 0085-0525-03 - Unit Dose packages of 100 (10 x 10†s)
NDC 0085-0525-06 - Bottles of 180
Store between 2 o and 30 o C (36 o and 86 o F). Protect the Unit Dose packages from excessive moisture.