Advanced hormone-dependent prostate cancer

Active Ingredient: Degarelix

Indication for Degarelix

Population group: men, only adults (18 years old or older)

Degarelix is a gonadotrophin releasing hormone (GnRH) antagonist indicated for treatment of adult male patients with advanced hormone-dependent prostate cancer.

For this indication, competent medicine agencies globally authorize below treatments:

80-240 mg in 1-2 divided doses daily

Route of admnistration


Defined daily dose

80 - 240 mg

Dosage regimen

From 80 To 240 mg once every 30 day(s)

Loading dose

240 mg

Maintenance dose

80 mg

Detailed description

Starting dose: 240 mg administered as two consecutive subcutaneous injections of 120 mg each.

Maintenance dose – monthly administration: 80 mg administered as one subcutaneous injection.

The first maintenance dose should be given one month after the starting dose.

The therapeutic effect of degarelix should be monitored by clinical parameters and prostate specific antigen (PSA) serum levels. Clinical studies have shown that testosterone (T) suppression occurs immediately after administration of the starting dose with 96% of the patients having serum testosterone levels corresponding to medical castration (T≤0.5 ng/ml) after three days and 100% after one month. Long term treatment with the maintenance dose up to 1 year shows that 97% of the patients have sustained suppressed testosterone levels (T≤0.5 ng/ml).

In case the patient’s clinical response appears to be sub-optimal, it should be confirmed that serum testosterone levels are remaining sufficiently suppressed. Since degarelix does not induce a testosterone surge it is not necessary to add an anti-androgen as surge protection at initiation of therapy.

Dosage considerations

Degarelix is administered as a subcutaneous injection in the abdominal region. The injection site should vary periodically. Injections should be given in areas where the patient will not be exposed to pressure e.g. not close to waistband or belt and not close to the ribs.

Active ingredient


Degarelix is a selective gonadotrophin releasing-hormone (GnRH) antagonist that competitively and reversibly binds to the pituitary GnRH receptors, thereby rapidly reducing the release of the gonadotrophins, luteinizing hormone (LH) and follicle stimulating hormone (FSH), and thereby reducing the secretion of testosterone (T) by the testes.

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