Casodex is an anti-androgenic non-steroidal agent with antitumor activity.
Release form and composition
Casodex dosage form - film-coated tablets (14 each in blisters, 2 blisters in a carton box).
The active ingredient of the drug is bicalutamide, in 1 tablet it may contain 50 or 150 mg.
Auxiliary components: povidone, sodium carboxymethyl starch, lactose monohydrate, magnesium stearate, purified water.
The composition of the shell: purified water, titanium dioxide, macrogol 300 and hypromellose.
Indications for use
Casodex 50 mg is used in combination with a gonadotropin-releasing hormone analogue (GnRH) or surgical castration to treat advanced prostate cancer.
Casodex 150 mg is prescribed:
- As an adjuvant (adjuvant) therapy or immediate monotherapy in combination with radiation therapy or prostatectomy for locally advanced prostate cancer;
- As monotherapy for locally advanced non-metastatic prostate cancer, when other methods are inapplicable or unacceptable.
- The need for simultaneous use of terfenadine, astemizole and / or cisapride;
- Hypersensitivity to the drug.
Casodex is not intended to treat children and women.
Patients with an impaired liver function should be under especially careful observation during the treatment period.
Dosing and Administration
Tablets should be taken orally:
- Casodex 50 mg - 1 tablet 1 time per day simultaneously with GnRH analogue or surgical castration;
- Casodex 150 mg - 1 tablet 1 time per day for at least 2 years. In case of signs of progression of the disease, the drug is canceled.
When taking Casodex as a monodrug, the following side effects are noted:
- Very often (more than in 10% of patients): flushing of the face, tenderness of the mammary glands and gynecomastia, which can persist even after discontinuation of the drug (especially in the case of long-term prima);
- Often (more than 1% but less than 10% of patients): diarrhea, nausea, cholestasis and jaundice, a transient increase in liver transaminase activity (changes in liver function as serious are rarely evaluated, are mostly transient in nature and completely disappear or decrease with continuation of therapy or after cessation of treatment), asthenia, itching; when taking pills 150 mg - weight gain, restoration of hair growth or alopecia, sexual dysfunction, decreased sexual desire;
- Rarely (more than 0.1%, but less than 1% of patients): hypersensitivity reactions, incl. urticaria, interstitial lung disease, angioedema; while taking pills 150 mg - dyspepsia, abdominal pain, hematuria, depression;
- Very rarely (more than 0.01%, but less than 0.1% of patients): dry skin (however, dryness is often observed when taking tablets at a dose of 150 mg), vomiting, as well as liver failure, a causal link which with the use of the drug is not reliably established.
When taking Casodex in combination with GnRH analogues, in addition, the side effects listed below are sometimes noted, however, their connection with bicalutamide has not been precisely proven:
- Cardiovascular system: heart failure;
- Nervous system: headache, increased drowsiness or insomnia, dizziness;
- Digestive system: dry mouth, flatulence, constipation, dyspepsia, anorexia;
- Genitourinary system: nocturia, sexual dysfunction;
- Respiratory system: shortness of breath;
- Hematopoietic system: anemia;
- Skin and its appendages: excessive sweating, rash, alopecia, hirsutism;
- Others: pain in the chest, abdomen and pelvic region, increase or decrease in body weight, hyperglycemia, chills, diabetes mellitus.
Cases of overdose are not described. The specific antidote bikalutamida does not exist. Dialysis is ineffective. In the case of taking too high a dose of the drug, general supportive therapy is shown with monitoring of vital body functions.
Patients with impaired liver function need to control the state of this organ. In case of marked changes, the drug should be discontinued.
Patients receiving anticoagulants coumarin, it is necessary to periodically monitor the indicators of prothrombin time.
Patients with lactose intolerance should take into account that each Casodex 50 mg tablet contains 61 mg of lactose monohydrate, and a 150 mg tablet contains 183 mg.
There are cases of decreased glucose tolerance in patients taking GnRH agonists, which led to the development of diabetes mellitus and a decrease in glucose tolerance in patients with diabetes mellitus. For this reason, patients receiving Casodex and GnRH agonists need to monitor their blood glucose levels.
Casodex, as a rule, does not have a negative effect on the speed of psychophysical reactions and the ability to concentrate. However, the likelihood of such side effects as dizziness and drowsiness cannot be ruled out; therefore, at the initial stage of treatment, care should be taken when driving and performing potentially dangerous types of work.
It is forbidden to use Casodex in combination with terfenadine, astemizole and cisapride.
Caution should be exercised when using bicalutamide with slow calcium channel blockers or cyclosporine. Sometimes it is necessary to reduce the dose of these drugs, especially in the case of development or increase in the severity of adverse reactions. After the initiation and withdrawal of Casodex, it is recommended to carefully monitor the patient's clinical condition and monitor the concentration of cyclosporine in the blood plasma.
Care should be taken with Casodex in combination with drugs that inhibit microsomal liver enzymes (for example, cimetidine and ketoconazole). Such combinations can lead to an increase in plasma bicalutamide concentration and, presumably, to an increase in the incidence of side effects.
Also, caution is needed in the simultaneous appointment of Casodex with drugs that are metabolized mainly with the participation of the isoenzyme CYP3A4.
Bicalutamide enhances the effect of indirect coumarin anticoagulants (including warfarin).
Terms and conditions of storage
Store at a temperature not higher than 30 ºС in a place with limited access to children.
Shelf life - 4 years.