ERLEADA FILM-COATED TABLET 60MG [SIN15698P]

Product Info

ERLEADA FILM-COATED TABLET 60MG

[SIN15698P]

Indications
ERLEADA® is indicated for the treatment of patients with

• metastatic castration-sensitive prostate cancer (mCSPC)

• non-metastatic, castration-resistant prostate cancer (nm-CRPC) who are at high risk of developing metastatic disease (see Clinical studies – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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.

Contraindications
ERLEADA® is contraindicated in women who are or may become pregnant (see Pregnancy, Breast-feeding and Fertility – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).