Medicinal Products

BICALUTAMIDE ALTER 50 mg

Generic drug of Casodex
Therapeutic class: Oncology and hematology
Active ingredients: Bicalutamide
laboratory: Alter

Coated tablet
Box of 30
All forms

Indication

- Metastasized prostate cancer:
Metastasized prostate cancer, in combination with medical or surgical castration.
- Locally advanced prostate cancer:
BICALUTAMIDE ALTER is indicated in patients with locally advanced prostate cancer at high risk of disease progression, either as treatment alone or as adjunctive therapy to radical prostatectomy or radiotherapy (see section 5.1).

Dosage BICALUTAMIDE ALTER 50 mg Film-coated tablet Box of 30

- Metastasized prostate cancer:
In the adult man, including the elderly, a 50 mg tablet a day, starting with medical or surgical castration.
- Locally advanced prostate cancer:
In the adult man, including the elderly, three tablets of 50 mg per day.
It is currently recommended to treat 5 years.
- In patients with renal impairment or mild hepatic impairment, no dose adjustment is necessary. In patients with moderate to severe hepatic impairment, accumulation may be observed (see sections contraindications and warnings and precautions for use).

Against indications

- Women.
- Children.
- Patients who have shown a hypersensitivity reaction to BICALUTAMIDE ALTER.
- History of liver injury related to bicalutamide intake.
- Severe hepatic insufficiency.
- Due to the presence of lactose, this drug is contraindicated in case of congenital galactosemia, glucose-galactose malabsorption syndrome or lactase deficiency.

Side effects Bicalutamide Alter

EFFECTS OBSERVED IN THE TREATMENT OF NON-METASTASIS PROSTATE CANCER IN THE LOCALLY ADVANCED STAGE, BY ADDING TO RADICAL PROSTATECTOMY OR RADIOTHERAPY.
The pharmacological properties of bicalutamide are responsible for some observed adverse effects. Among these :
- Very frequently (> 10%) :
Gynecomastia and breast tenderness: The majority of patients who received BICALUTAMIDE ALTER (150 mg / day) were affected by this problem. Clinical experience shows that these effects were considered severe in 5% of patients. Gynecomastia may be discontinued in some patients, particularly after prolonged treatment.
- Frequently (> 1%) :
Hot flashes, pruritus, asthenia, alopecia, hair regrowth, dry skin, low libido, impotence and weight gain.
OTHER EFFECTS:
- Frequently (> 1%) :
Nausea.
- Not very often (<1%) :
Abdominal pain, depression, dyspepsia and hematuria.
EFFECTS OBSERVED IN THE TREATMENT OF PROSTATE METASTASE CANCER:
- In relation to the pharmacological properties:
. flushing, pruritus,
. breast tenderness and gynecomastia which can be reduced by associated castration,
. asthenia, diarrhea, nausea and vomiting.
- During treatment with BICALUTAMIDE ALTER - an analogue of LHRH, the following effects have been observed in clinical studies (in more than 1% of cases) without a cause-and-effect relationship being established knowing that some of these effects are usually seen in the elderly:
. digestive tract (anorexia, dry mouth, dyspepsia, flatulence, constipation),
. central nervous system (insomnia, drowsiness, dizziness, decreased libido),
. respiratory system (dyspnea),
. urogenital system (impotence, nocturia),
. cutaneous (alopecia, rash, sweating),
. nutritional and metabolic (hyperglycemia, peripheral edema, gain or loss of weight),
. Other : abdominal, thoracic, pelvic pain and headache.
- Increases in transaminases have been reported very rarely. Nevertheless, some cases of jaundice and severe hepatitis have been reported (see section on warnings and precautions for use).

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