Advanced hormone-dependent prostate cancer

Active Ingredient: Degarelix

Indication for Degarelix

Population group: men, only adults (18 years old or older)
Therapeutic intent: Curative procedure

Degarelix is a gonadotrophin releasing hormone (GnRH) antagonist indicated:

  • for treatment of adult male patients with advanced hormone-dependent prostate cancer.
  • for treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy.

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

240 mg as starting dose given for 1 month and thereafter 80 mg once a month

For:

Dosage regimens

Subcutaneous, 240 milligrams degarelix, one dose, over the duration of 1 month. Afterwards, subcutaneous, 80 milligrams degarelix, once monthly.

Detailed description

Starting dose Maintenance dose – monthly
administration
240 mg80 mg

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 for subcutaneous use ONLY, not to be administered intravenously. Intramuscular administration is not recommended as it has not been studied.

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

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.

Read more about Degarelix

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