ERLEADA FILM-COATED TABLET 60MG

JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD

JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD

Therapeutic

Prescription Only

TABLET, FILM COATED

**Dosage and Administration** **Dosage** The recommended dose of ERLEADA® is 240 mg (four 60 mg tablets) administered orally once daily. Medical castration with gonadotropin releasing hormone analogue (GnRHa) should be continued during treatment in patients not surgically castrated. **Alternative Method of Administration** For patients who have difficulty swallowing tablets whole, the recommended dose of ERLEADA® tablets may be mixed with 4 ounces (120 mL) of applesauce. Do not crush the tablets. Stir applesauce upon introduction of whole tablets as well as at 15 minutes and 30 minutes afterwards until tablets are dispersed (well mixed with no chunks remaining). Using a spoon, swallow the mixture right away. Rinse the mixture container with 2 ounces of water and immediately drink the contents. Repeat the rinse with 2 ounces of water one more time to ensure the whole dose is taken. The mixture should be consumed within one hour of preparation (see _Pharmacological Properties – Pharmacokinetic Properties_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Dose modification** If a patient experiences a ≥ Grade 3 toxicity or an intolerable side effect, hold dosing until symptoms improve to ≤ Grade 1 or original grade, then resume at the same dose or a reduced dose (180 mg or 120 mg), if warranted. **Missed dose(s)** If the patient misses a dose, it should be taken as soon as possible on the same day with a return to the normal schedule on the following day. The patient should not take extra tablets to make up the missed dose. **Special populations** **_Pediatrics (17 years of age and younger)_** The safety and effectiveness of ERLEADA® in children have not been evaluated. There is no relevant use of ERLEADA® in pediatric patients aged 17 years and younger. **_Elderly (65 years of age and older)_** No dose adjustment is necessary for elderly patients (see _Clinical studies and Pharmacokinetic Properties_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **_Renal impairment_** No dosage adjustment is necessary for patients with mild to moderate renal impairment. No data are available in patients with severe renal impairment or end-stage renal disease (eGFR ≤ 29 mL/min/1.73m2) (see _Pharmacokinetic Properties_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **_Hepatic impairment_** No dosage adjustment is necessary for patients with baseline mild or moderate hepatic impairment. No data are available in patients with severe hepatic impairment (Child-Pugh Class C) (see _Pharmacokinetic Properties_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Administration** ERLEADA® should be administered orally once daily, with or without food. Swallow the tablets whole.