ERLEADA

Valsts: Indonēzija

Valoda: indonēziešu

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

Aktīvā sastāvdaļa:

APALUTAMIDE

Pieejams no:

SOHO INDUSTRI PHARMASI - Indonesia

SNN (starptautisko nepatentēto nosaukumu):

APALUTAMIDE

Deva:

60.0 MG

Zāļu forma:

TABLET SALUT SELAPUT

Vienības iepakojumā:

DUS, 1 BOTOL PLASTIK @ 120 TABLET SALUT SELAPUT

Ražojis:

JANSSEN ORTHO LLC - United States of America

Autorizācija datums:

2019-12-31

Produkta apraksts

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