ERLEADA

Country: Indonesia

Language: Indonesian

Source: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Active ingredient:

APALUTAMIDE

Available from:

SOHO INDUSTRI PHARMASI - Indonesia

INN (International Name):

APALUTAMIDE

Dosage:

60.0 MG

Pharmaceutical form:

TABLET SALUT SELAPUT

Units in package:

DUS, 1 BOTOL PLASTIK @ 120 TABLET SALUT SELAPUT

Manufactured by:

JANSSEN ORTHO LLC - United States of America

Authorization date:

2019-12-31

Summary of Product characteristics

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