Renal Dose Adjustment (Based on CrCl)
- Mild impairment (CrCl 50-80 mL/min): No dose adjustments
- Moderate to severe impairment (CrCl < 50 mL/min): Caution advised, dose adjustments not defined
Hepatic Dose Adjustment
- Mild to moderate impairment (Child Pughs A/B): No dose adjustments
- Severe impairment (Child Pugh C): Caution advised, dose adjustments not defined
- Monitor testosterone levels monthly until medical castration is achieved; then monitor levels every other month
- Women who are or may become pregnant should not be treated with degarelix
- Long-term androgen deprivation therapy prolongs the QT interval; carefully weigh benefits vs potential risks in patients with congenital long QT syndrome, electrolyte abnormalities, CHF, Concurrent Class IA (eg, quinidine, procainamide) or Class III (eg, amiodarone, sotalol) antiarrhythmic medications
- Degarelix suppresses pituitary gonadal system; diagnostic tests of the pituitary gonadotropic and gonadal functions may be affected
- Measure serum prostate-specific antigen (PSA) periodically, measure testosterone serum concentrations if PSA increases
- Monitor LFT, ECG, electrolytes at baseline; testosterone if hepatic impairment q4wk until medical castration achieved, then q8 wks
- Hypersensitivity reactions such as anaphylaxis, urticaria, and angioedema have been reported during postmarketing studies. If a serious hypersensitivity reaction occurs, discontinue therapy immediately if the injection has not been completed, and manage as clinically indicated
Cautions: Use cautiously in
- Renal impairment, severe
- Hepatic impairment, severe
- Congenital long QT syndrome
- Electrolyte abnormalities
- Hypokalemia
- CHF
- Coadministration of Class IA or Class III antiarrhythmic medications
Pregnancy Category:X
Breastfeeding: Degarelix is not indicated for use in women. It is not considered compatible with breastfeeding due to the potential for serious adverse events in nursing infants
