Degarelix 120mg Injection

Degarelix 120mg Injection contains degarelix acetate, a selective gonadotrophin-releasing hormone (GnRH) antagonist used as part of androgen-deprivation therapy for adult men with hormone-dependent prostate cancer. Current UK electronic Medicines Compendium (eMC) information lists FIRMAGON 120mg powder and solvent for solution for injection and DEGARELIX FERRING 120mg powder and solvent for solution for injection under degarelix acetate products manufactured by Ferring Pharmaceuticals Ltd.

The 120mg presentation is used as part of the initial 240mg degarelix regimen, which consists of two consecutive 120mg subcutaneous injections. The UK SmPC specifies that subsequent monthly maintenance treatment uses an 80mg injection.

Product Information

Generic Name

Degarelix

Active Ingredient

Degarelix acetate

Strength

120mg

Drug Class

Gonadotrophin-Releasing Hormone (GnRH) Antagonist

Therapeutic Class

Androgen-Deprivation Therapy / Hormonal Anticancer Medicine

Brand Reference

FIRMAGON®

UK Product

Degarelix Ferring 120mg

Manufacturer / Marketing Authorisation Holder

Ferring Pharmaceuticals Ltd

Dosage Form

Powder and solvent for solution for injection

Route

Subcutaneous injection

UK Legal Category

Prescription Only Medicine (POM)

ATC Code

L02BX02

Degarelix 120mg vs Degarelix 80mg

The two strengths have different roles in the UK product regimen.

Degarelix 120mg is supplied as the two individual 120mg injections that together make up the 240mg starting dose.

Degarelix 80mg is used as the subsequent monthly maintenance injection according to the UK SmPC.

This distinction is important when creating product pages for individual strengths because the 120mg presentation should not be described as the standard monthly maintenance dose.

Degarelix 120mg and Firmagon 120mg

Degarelix is the active pharmaceutical ingredient, while FIRMAGON® is a branded degarelix product.

The current UK eMC record specifically names both:

• FIRMAGON 120mg powder and solvent for solution for injection
• DEGARELIX FERRING 120mg powder and solvent for solution for injection

Therefore, “Degarelix 120mg” and “Firmagon 120mg” can be used as related search entities, but an individual product should only be described as an authorised generic equivalent of Firmagon when that specific product's regulatory status supports that statement.

Degarelix 120mg Injection Formulation

The UK 120mg presentation contains 120mg degarelix as acetate per vial. After reconstitution, the resulting solution contains 40mg degarelix per mL. The dosage form is a white to off-white powder with a clear, colourless solvent.

The UK patient information describes the pack as containing vials of degarelix powder together with pre-filled syringes containing solvent and the associated preparation components.

Degarelix 120mg Injection and Prostate Cancer

Degarelix is used in prostate cancer because many prostate tumours depend on androgen signalling. By suppressing testosterone production, androgen-deprivation therapy reduces the hormonal stimulation supporting androgen-sensitive prostate cancer.

NICE's technology appraisal describes degarelix as a treatment option for advanced hormone-dependent prostate cancer and specifically addresses its use in patients with spinal metastases under the applicable NHS recommendation and commercial arrangement.

Degarelix 120mg Injection Availability in the UK

The UK eMC currently lists FIRMAGON 120mg Injection and DEGARELIX FERRING 120mg Powder and solvent for solution for injection as prescription-only medicines from Ferring Pharmaceuticals Ltd.

The availability of a particular manufacturer, pack presentation or supplier can change. UK supply should therefore be checked against the current product information and applicable pharmacy or healthcare requirements.

International Availability

Search demand for Degarelix 120mg extends beyond the UK, including Australia, Thailand, UAE/Dubai, Russia, South Korea and the USA. Regulatory approval, product names, reimbursement, prescription requirements and supply arrangements can differ substantially between these markets.

International product pages should therefore use country-specific availability language rather than assuming that a UK authorisation automatically applies to another jurisdiction.

How it works

Degarelix selectively and reversibly binds to GnRH receptors in the pituitary gland. This reduces release of luteinising hormone (LH) and follicle-stimulating hormone (FSH), which in turn reduces testosterone secretion by the testes.

Unlike GnRH agonists, degarelix does not cause the initial LH and testosterone surge associated with agonist treatment. The UK SmPC reports rapid testosterone suppression following the starting regimen.

The UK SmPC states that degarelix is indicated for:

• treatment of adult male patients with advanced hormone-dependent prostate cancer;
• treatment of high-risk localised and locally advanced hormone-dependent prostate cancer in combination with radiotherapy; and
• neoadjuvant treatment before radiotherapy in specified high-risk localised or locally advanced hormone-dependent prostate cancer.

Degarelix is therefore a form of androgen-deprivation therapy (ADT) designed to reduce testosterone stimulation of androgen-sensitive prostate cancer.

NICE describes degarelix as a selective GnRH antagonist and notes that, unlike GnRH agonists, it does not produce an initial hormone surge that can cause testosterone elevation at treatment initiation.

Degarelix treatment requires medical supervision.

The UK SmPC identifies hot flushes, weight increase and injection-site reactions among the most commonly observed adverse reactions. Injection-site reactions can include pain, erythema, swelling, induration and nodules.

Long-term androgen-deprivation therapy may be associated with QT interval prolongation, and appropriate assessment is advised in patients with relevant cardiac risk factors or concomitant medicines that may prolong QT.

Other clinically relevant considerations include possible effects on glucose tolerance, bone density and cardiovascular risk. Liver-function monitoring is advised in patients with known or suspected hepatic disorders, while caution is recommended in severe renal impairment.

Degarelix may also inhibit male fertility while testosterone remains suppressed.

Degarelix 120mg Injection Interactions

The UK SmPC states that no formal drug-drug interaction studies have been performed. Because androgen-deprivation treatment may prolong QTc, concomitant medicines known to prolong QTc or increase the risk of torsades de pointes require careful clinical evaluation.

Healthcare professionals should review a patient's complete medication profile before treatment.