Manufacturer of Casodex
"Corden Pharma GmbH", Germany.
"AstraZeneca GmbH Plankstadt" for "AstraZeneca UK Limited", Germany / United Kingdom.
Active ingredient of Casodex
Tablet contains bicalutamide
Form of Casodex
Tablets coated with 50 mg No. 28, 150 mg No. 28.
To whom Casodex
is indicated The common prostate cancer( late stages) is used together with the analogue LHRH( releasing hormoneluteinizing hormone) or surgical castration.
How to use Casodex
Adult men, including the elderly, take one 50 mg tablet once a day. Treatment with Casodex should start simultaneously with treatment with an analogue of LHRH or surgical castration. The duration of treatment is determined by the doctor.
Renal failure: dose adjustment for patients with renal insufficiency is not required.
Hepatic failure: dose adjustments for patients with mild hepatic insufficiency are not required.
Increased accumulation may occur in patients with moderate to severe hepatic insuf
Use during pregnancy or lactation. The use of Casodex is contraindicated in women during pregnancy and lactation.
Children. Casodex is contraindicated in children.
Application features. Because Kasodex is extensively metabolized by the liver, its inference can be slow in patients with severe hepatic insufficiency and this in turn can lead to Casodex cumulation. Therefore, Kasodeks such patients should be administered with caution.
In the treatment with Casodex, liver function testing should be performed periodically. Most of these changes are expected in the first 6 months of treatment with Casodex.
If severe liver damage occurs, treatment with Casodex should be discontinued.
Casodex depresses cytochrome P450( CYP 3A4), so caution should be exercised when administering Casodex with drugs that are metabolized by CYP 3A4.
The ability to influence the reaction rate when driving or working with machinery. It is unlikely that the Casodex influenced the ability of patients to drive a car or other mechanisms. However, it should be noted that somnolence may sometimes occur. Patients who take this drug should be careful.
Side effects of Casodex
Casodex is well tolerated by most patients, and only in rare cases did side effects require discontinuation of its administration.
|Frequency||organs and systems Adverse events|
|Very often( ≥ 10%)|| |
Blood and lymphatic system disorders
Nervous system disorders
Disturbancesfrom the side of the kidneys and urinary system
Disorders from the reproductive system and mammary glands
General disorders and the condition of the injection site
Pain in the liveconstipation, nausea
Gynaecomastia, tenderness of dairy hallb
Asthenia, chest pain, edema
|Often( ≥ 1% - & lt; 10%)|| |
Metabolic and nutritional disorders
Nervous system disorders
Disorders from the digestive tract
Disorders from the hepatobiliary system
Skin and subcutaneous tissue disorders
Reproductive system and breast disorders
General disorders and site of injection
Decreased libido, depression
Dyspepsia, flatulence, diarrhea
Changes in liver function( increased level of transaminases, jaundice) / hepatobiliary disordersc.
Alopecia, hirsutism / excess hair growth, rash, dry skin, itching
|Rarely( ≥0.1% - & lt; 1%)|| |
Immune system disorders
Respiratory, thoracic andmediastinal disorders
Hypersensitivity reactions( including angioedema and urticaria) Interstitial pulmonary diseases. Fatal cases are known.
|Very rarely( ≥0.01% - & lt; 0.1%)|| Disorders from the hepatobiliary system |
Side effects of the SCT
| Hepatic failuref. |
There are known fatal cases.
A Most patients who received 150 mg of Casodex as monotherapy had gynecomastia and / or tenderness of the mammary glands. During the study, these symptoms were severe in about 5% of patients.
Gynecomastia does not always disappear on its own after the cessation of treatment, especially after long-term treatment.
B May decrease with concomitant castration.
C Changes in the liver are most often transient and completely disappear or decrease with continued therapy or after its termination.
D Adverse reaction "dry skin" was coded under the term "rash".Therefore, for Casodex, 150 mg does not have a separate frequency descriptor. It is assumed that the frequency for this dose is the same as for 50 mg.
E Reported as a side reaction in the analysis of post-marketing data. The frequency was determined based on reports of cases of interstitial pneumonia during the randomization of emf studies in which a dose of 150 mg was used.
F Reported as a side reaction in the analysis of post-marketing data. The frequency was determined based on reports of cases of hepatic insufficiency during open EMF studies in which a dose of 150 mg was used.
In addition, at the time of clinical trials with the simultaneous use of Casodex and the analogue of LH-RG, there was a reaction such as heart failure( with a frequency of> 1%, which is regarded as a possible side effect).There is no reliable causal relationship with the treatment.
In addition, during clinical trials with the simultaneous use of Casodex and the LHRH analog, there were observed undesirable events with a frequency of ≥1%, which, according to the researchers, were regarded as possible side effects:
- central nervous system: insomnia;
- respiratory system: dyspnea;
- genitourinary system: nocturia;
- metabolic disorders: diabetes, hyperglycemia, weight loss;
- general disorders: headache, fever.
However, it was not possible to establish a reliable causal relationship between these effects and therapy, in addition, some of these effects are of a general nature and often occur in elderly patients.
To whom is contraindicated Casodex
Casodex is not used in patients with established hypersensitivity.
Casodex should not be administered together with terfenadine, astemizole and cisapride.
Interaction of Casodex
There is no information on the drug interaction between Casodex and analogues of LHRH.
In vitro studies have shown that R-bicalutamide depresses CYP 3A4, to a lesser extent inhibits CYP 2C 9, 2C 19 and 2D6.
Although clinical studies with an antipyrine, a marker of P450 activity( CYP), did not confirm the possibility of interaction with Casodex, the use of Casodex within 28 days against the medication of midazolam led to an increase in the area of the midazolam concentration-time curve( AUC) by 80%.Such an increase may be important for drugs with a narrow therapeutic index. Therefore, the use of Casodex along with terfenadine, astemizole and cisapride is contraindicated. Caution should be exercised with simultaneous administration of Casodex with cyclosporine or calcium channel blockers. Perhaps, it is necessary to reduce the doses of these drugs, especially in case of suspicion or occurrence of undesirable reactions. Patients who take cyclosporine should be carefully monitored, especially at the beginning of treatment with Casodex and when it is withdrawn.
Caution should be exercised when administering Casodex with drugs that inhibit the metabolism of drugs( cimetidine, ketoconazole).Theoretically, this appointment can lead to an increase in the concentration of Casodex, which can lead to an increase in the incidence of undesirable phenomena.
In vitro studies have shown that Casodex can displace the coumarin anticoagulant warfarin from its binding sites to proteins. Therefore, with the appointment of Casodex to those patients who receive anticoagulants of the coumarin series, it is recommended to monitor prothrombin time on a regular basis.
Overdose of Casodex
No data on overdose in humans. Specific antidote does not exist, the patient should be prescribed symptomatic treatment. Dialysis is not indicated, since Casodex has a high ability to bind to proteins and it is not present in the urine in unchanged form. General supportive therapy and monitoring of vital functions are shown.