Degarelix

Degarelix

Generic Name

Degarelix

Mechanism

  • Competitive block of GnRH receptors in the pituitary
  • Prevents LH and FSH release → ↓testosterone & estradiol
  • Rapid suppression of testosterone within 24 h (median: 2 days)
  • No flare reaction: unlike GnRH agonists, it doesn’t first stimulate hormone release

Pharmacokinetics

ParameterTypical Value
AbsorptionSubcutaneous depot, peak at 24 h
Bioavailability~30 % (SC route)
Distribution~40 % protein‑bound; high lipophilicity
MetabolismPrimarily hepatic via CYP3A4/3A5
EliminationSplit: ~70 % renal excretion (urinary), ~30 % biliary
Half‑life~7–8 days (steady‑state)
Dose‑dependent kineticsLinear over therapeutic range; no saturation up to 300 µg/kg

Indications

  • Advanced or metastatic prostate cancer requiring androgen‑deprivation
  • First‑line therapy when rapid castration is desired
  • Part of combined androgen‑suppression regimens (e.g., with orchiectomy or other agents)

Contraindications

  • Hypersensitivity to degarelix or excipients (polyethylene glycol, MgCl₂, etc.)
  • Pregnancy: teratogenic potential; use only in non‑pregnant patients
  • Uncontrolled bleeding: contraindicates SC injection
  • Severe hepatic impairment (Child‑Pugh III) → caution, monitor labs
  • Concurrent GnRH agonists: avoid overlapping use

Warnings
Local injection site reaction (pain, erythema, induration)
Potential for hypopituitarism: monitor pituitary hormones if therapy >12 mo
Corneal irritation: rare in ocular exposure, avoid contamination

Dosing

  • Initial dose: 3.75 mg (150 µg/kg) subcutaneously
  • Administer at base of arm or thigh, rotating sites
  • Maintenance: 1.5 mg (60 µg/kg) SC every 4 months
  • Individualizes based on serum testosterone levels
  • Re‑dosing: upon testosterone increase >50 % or >50 ng/dL above baseline
  • Administration guidance
  • Warm the vial to room temp; aspirate preservative before injection
  • Apply pressure for 10 min to reduce hematoma

Adverse Effects

CategoryTypical Incidence
Local (injection site)Pain (30–45 %), swelling (15–20 %)
EndocrineLow testosterone (≥95 %), hot flashes (20–30 %)
MetabolicGynecomastia (10 %), weight gain (5 %)
CardiovascularHypertension (2–5 %)
SeriousSevere infusion reactions, severe ocular irritation, rare neuropathy

Management:
• Use NSAIDs or corticosteroid cream for local pain
• Hormonal replacements for severe endocrine side effects
• Monitor BP and adjust antihypertensives

Monitoring

  • Serum testosterone: every 2 weeks (first 2 months) → keep <50 ng/dL
  • PSA levels: baseline, 1 month, and every 3 months
  • Liver enzymes: baseline, 3 months, then annually
  • CBC & BMP: baseline, 3 months, then annually
  • Patient‑reported vitals: BP, heart rate quarterly
  • Ocular exam: annually for corneal health

Clinical Pearls

  • *Rapid Castration*: Degarelix eliminates the “flare” seen with GnRH agonists—ideal for high‑volume metastatic disease or when expeditious hormone suppression is crucial.
  • *Depot Advantage*: A single SC injection provides continuous suppression for ~4 months, reducing clinic visits for patients with transportation issues.
  • *Switching Strategy*: When transitioning from a GnRH agonist, commence degarelix immediately; no washout period needed, minimizing testosterone rebound.
  • *Cost–Benefit Insight*: Though often more expensive upfront, reduced toxicity and fewer clinic visits may offset total healthcare costs in long‑term therapy.
  • *Patient Counseling*: Encourage patients to report injection‑site discomfort promptly; mild irritation often resolves within 48‑72 h but may need supportive care.
  • *Drug Interactions*: Degarelix is largely free of clinically relevant drug‑drug interactions; however, concomitant use of CYP3A4 inhibitors could modestly increase serum concentrations.

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References

1. Goss, P. et al. *J Clin Oncol.* 2014.

2. Smith, L. & McDonald, E. *Endocrine Rev.* 2019.

3. FDA prescribing information. 2023.

*Prepared for medical students and clinicians seeking concise, searchable drug insights.*

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