Negara: Indonesia
Bahasa: Bahasa Indonesia
Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
APALUTAMIDE
SOHO INDUSTRI PHARMASI - Indonesia
APALUTAMIDE
60.0 MG
TABLET SALUT SELAPUT
DUS, 1 BOTOL PLASTIK @ 120 TABLET SALUT SELAPUT
JANSSEN ORTHO LLC - United States of America
2019-12-31
PI ERLEADA (apalutamide) tablet 60mg (CCDS 3May19 v.03 + TD BPOM 11Jul19) 1 PRODUCT NAME ERLEADA™ (apalutamide) tablets. DOSAGE FORMS AND STRENGTHS ERLEADA 60 mg tablets contain 60 mg of apalutamide. Slightly yellowish to greyish green, oblong-shaped, film-coated (FC) tablets, debossed with “AR 60” on one side. For excipients, see _PHARMACEUTICAL INFORMATION - List of Excipient._ CLINICAL INFORMATION INDICATIONS ERLEADA is indicated in adult men for the treatment of non-distant metastatic castration resistant prostate cancer (nm-CRPC) who are at high risk of developing metastatic disease. DOSAGE AND ADMINISTRATION ERLEADA should only be administered to patients who: • Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features, with high risk for development of metastases, defined as PSADT ≤ 10 months. PSADT is calculated using at least 3 PSA values obtained during continuous ADT; • Castration-resistant prostate cancer demonstrated during continuous ADT, defined as 3 PSA rises at least 1 week apart, with the last PSA > 2 ng/mL; • Surgically or medically castrated, with testosterone levels of < 50 ng/dL. If the patient is medically castrated, dosing with a GnRH analogue; • Are absence of DISTANT METASTASES, including central nervous system (CNS) and vertebral or meningeal involvement, or history of distant metastases (with exception: pelvic lymph nodes < 2 cm in short axis (N1) located below the iliac bifurcation are included). DOSAGE The recommended dose of ERLEADA is 240 mg (four 60 mg tablets) administered orally once daily. Swallow the tablets whole. ERLEADA can be taken with or without food. Patients should also receive a gonadotropin-releasing hormone (GnHR) analog concurrently or should have had bilateral archiectomy. 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 red Baca dokumen lengkapnya