ERLEADA

מדינה: אינדונזיה

שפה: אינדונזית

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

יחידות באריזה:

DUS, 1 BOTOL PLASTIK @ 120 TABLET SALUT SELAPUT

תאריך אישור:

2022-12-16

מאפייני מוצר

PI ERLEADA (apalutamide) tablet 60mg
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.
ERLEADA is indicated for the treatment of patients with metastatic
castration-sensitive prostate cancer (mCSPC)
in combination with androgen deprivation therapy (ADT).
DOSAGE AND ADMINISTRATION
For nm-CRPC, 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 orchidectomy.
DOSE MODIFICATION
If a patient experiences a ≥ Grade 3 t