Касодекс

Касодекс – the anti-androgenic nonsteroid drug used for treatment of a widespread prostate cancer.

Form of release and structure

Касодекс release in the form of tablets, film coated: biconvex, round, white color, on one of the parties – a logo engraving in the form of the rounded-off arrow, on another – "50" and "Cdx" (tablets on 50 mg) or "Casodex 150" (tablets on 150 mg), in blisters on 14 pieces, on 2 blisters in a cardboard pack.

Is a part of 1 tablet:

• Active agent: бикалутамид – 50 or 150 mg;
• Auxiliary components (50/150 mg respectively): monohydrate of lactose – 61/183 mg, sodium carboxymethylstarch – 7,5/22,5 mg, povidone – 5/15 mg, magnesium stearate – 1,5/4,5 mg.

Structure of a cover (50/150 mg respectively): a gipromelloza – 2,5/7,5 mg, a macrogoal 300 – 0,5/1,5 mg, titanium dioxide (E171) – 0,77/2,3 mg.

Indications to use

Касодекс appoint at treatment of a widespread prostate cancer (in a combination with surgical castration or an analog of gonadotrophin-rileasing-hormone).

Contraindications

• Simultaneous use with astemizoly, terfenadiny, tsizapridy;
• Hypersensitivity to drug components.

To women and children of Kasodeks do not appoint.

Drug should be used with care the patient with functional disturbances of a liver, and also at deficit of lactase, a lactose intolerance and a sprue of galactose/glucose.

Route of administration and dosage

Касодекс accept inside.

Drug is appointed to adult men, including patients of advanced age, 50 mg a day in a combination with an analog of gonadotrophin-rileasing-hormone (GNRG) or with performing surgical castration (treatment should be begun at the same time).

Patients with easy abnormal liver functions and functional disturbances of kidneys should not adjust a dose.

At patients with heavy and moderate functional disturbances of a liver Kasodeks's cumulation can increase.

Side effects

During Kasodeks's use the disturbances from some systems of an organism which are shown with various frequency can be observed:

• Very often (≥10%): skin rash, a gynecomastia (can remain even after the treatment termination, especially at long administration of drug), an adynamy, morbidity of chest glands;
• Often (from ≥1% to <10%): drowsiness, dizziness, depression, anorexia, heat inflows, abdominal pain, itch, lock, nausea, dyspepsia, increase in body weight, loss of appetite, xeroderma, meteorism, growth recovery of hair or alopecia, hirsutism, hamaturia, decrease in sexual desire, erectile dysfunction, hypostases, stethalgia, anemia, jaundice, increase in activity of hepatic transaminases, hepatotoxic;
• Infrequently (from ≥ 0,1% to <1%): a Quincke's disease, a small tortoiseshell, hypersensitivity reactions, intersticial pulmonary diseases (there are data on cases with a fatal outcome);
• Seldom (from ≥ 0,01% to <0,1%): a liver failure (there are data on cases with a fatal outcome).

Jaundice, cholestasia and increase in activity of hepatic transaminases were seldom estimated as serious. These disturbances had tranzitorny character and decreased or completely took place at continuation of treatment or after Kasodeks's cancellation. Very seldom during administration of drug the liver failure developed, however relationship of cause and effect is authentically not established.

Special instructions

At patients with functional disturbances of a liver during therapy it is reasonable to estimate function of a liver periodically. In most cases changes of function of a liver are observed within the first 6 months of therapy. At development of the expressed disturbances treatment should be interrupted.

When progressing a disease against the background of increase in level of the prostates specific antigens (PSA) therapy cancellation can be required.

It is necessary to show care at simultaneous use of Kasodeks with the medicines which are preferential metabolized with participation of CYP3A4.

At simultaneous use with anticoagulants of a coumarinic row regular control of a prothrombin time is recommended.

Patients with a lactose intolerance should consider that 61/183 mg of monohydrate of lactose are a part of each tablet 50/150 of mg.

During Kasodeks's use dizziness and drowsiness because of what it is necessary to be careful at control of motor transport or other moving mechanisms can be observed.

Medicinal interaction

At simultaneous use of Kasodeks with some medicines there can be undesirable effects:

• Blockers of slow calcium channels, cyclosporine: potentiation or development of undesirable reactions (decrease in a dose can be required, it is recommended to carry out careful monitoring of a clinical condition of the patient and concentration of cyclosporine in a blood plasma);
• The medicines inhibiting microsomal enzymes of a liver (for example, кетоконазол, Cimetidinum): increase in concentration of a bikalutamid in plasma and, perhaps, increase in frequency of emergence of side effects (at simultaneous use it is necessary to be careful);
• Indirect anticoagulants of a coumarinic row (including warfarin): strengthening of their action (it is recommended to carry out regular control of a prothrombin time).

Simultaneous use of Kasodeks with terfenadiny, tsizapridy and astemizoly is contraindicated.

Terms and storage conditions

To store in the place, unavailable to children, at a temperature up to 30 °C.

Period of validity: Касодекс on 50 mg – 5 years, on 150 mg – 4 years.