Medicinal Products

BICALUTAMIDE SANDOZ 50 mg

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

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 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 SANDOZ 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 adult men, including the elderly, three 50 mg tablets per day.

It is currently recommended to treat 5 years.

In patients with renal impairment or mild hepatic impairment, no dose adjustment is required. 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 had a hypersensitivity reaction to bicalutamide.

· History of hepatic impairment related to bicalutamide intake.

· Severe hepatic insufficiency.

Side effects Bicalutamide Sandoz

Effects observed during treatment 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.

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 (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.

· Few Frequently (<1%)

Abdominal pain, depression, dyspepsia and hematuria.

Effects observed during treatment of metastasized prostate cancer

· In relation to the pharmacological properties:

o hot flashes, pruritus,

o breast tenderness and gynecomastia that can be reduced by associated castration,

asthenia, diarrhea, nausea and vomiting.

· During treatment with the bicalutamide-LHRH analogue combination, the following effects have been observed in clinical studies (in more than 1% of cases) without a cause-and-effect relationship being established. some of these effects are usually seen in the elderly:

o digestive tract (anorexia, dry mouth, dyspepsia, flatulence, constipation),

central nervous system (insomnia, drowsiness, dizziness, decreased libido),

o respiratory system (dyspnea),

o uro-genital apparatus (impotence, nocturia),

o cutaneous (alopecia, rash, sweating),

o nutritional and metabolic (hyperglycemia, peripheral edema, gain or loss of weight),

o Other: pains including abdominal, thoracic, pelvic and cephalal.

· Increases in transaminases have been reported very rarely. Nevertheless, some cases of jaundice and severe hepatitis have been reported (see Warnings and Precautions ).

Popular Posts

Category Medicinal Products, Next Article