Non-steroidal anti-androgenic agent. By binding to receptors having an affinity for the androgen inhibits androgen resulting observed prostate tumor regression. It does not have other types of endocrine activity.
After ingestion well absorbed from the gastrointestinal tract. Eating does not affect the bioavailability.
Plasma protein binding is 96%. It is extensively metabolized in the liver by oxidation and formation of glucuronide conjugates.
It is displayed in the form of metabolites in the urine and bile in approximately equal proportions.
Possible accumulation of bicalutamide in the body.
For adults on prescription
50 mg of bicalutamide.
corn starch 35 mg
croscarmellose sodium 6.5 mg,
Lactose monohydrate 44.3 mg
povidone 3.2 mg,
Sodium stearyl fumarate 1 mg.
The composition of the coating film:
Opadry II White 4 mg.
Prostate cancer – as part of combination therapy with GnRH analogue or surgical castration.
- Simultaneous treatment with terfenadine, astemizole, cisapride;
- children’s age;
- Hypersensitivity to bicalutamide;
- does not prescribe female patients.
From endocrine system: hot flashes, breast tenderness and gynecomastia, decreased libido.
From the digestive system: abdominal pain, diarrhea, nausea, vomiting, increased levels of transaminases, jaundice, cholestasis.
CNS: possible asthenia, depression.
Dermatological reactions: alopecia, hair growth reduction, itching, dry skin.
How to accept, acceptance rate and dosage
Individual, depending on indications and treatment regimens.
In a dry place, protected from light at a temperature not higher than 25 ° C
In applying bicalutamide for 28 days in patients receiving midazolam, midazolam AUC increased by 80%.
With simultaneous application of bicalutamide with cyclosporin or calcium channel blockers may potentiation or development of adverse reactions.
Theoretically bicalutamide may increase the concentration in plasma when it is applied simultaneously with inhibitors of hepatic microsomal enzymes which may be accompanied by an increase in the incidence of adverse reactions.
In vitro studies have shown that bicalutamide can displace the coumarin anticoagulant warfarin a number of binding sites to plasma proteins.
With caution in patients with moderate and severe hepatic impairment, as possible accumulation of bicalutamide in the body.
During treatment requires regular monitoring of liver function. In case of severe changes, you must stop taking bicalutamide.
Pregnancy and lactation
Do not appoint female patients.
Cases of overdose have not been described in humans. There is no specific antidote.
Treatment is symptomatic. Dialysis is not efficient since bicalutamide binds strongly with proteins and excreted by the kidneys in unchanged form.
Shows a general supportive treatment and monitoring of vital body functions.