XALKORI

Negara: Indonesia

Bahasa: Bahasa Indonesia

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

Bahan aktif:

CRIZOTINIB

Tersedia dari:

PFIZER INDONESIA - Indonesia

INN (Nama Internasional):

CRIZOTINIB

Dosis:

200 MG

Bentuk farmasi:

KAPSUL

Unit dalam paket:

DUS, 1 BLISTER @ 10 KAPSUL

Diproduksi oleh:

PFIZER MANUFACTURING DEUTSCHLAND Gmbh - Germany

Tanggal Otorisasi:

2018-08-01

Karakteristik produk

PT. PFIZER INDONESIA
LOCAL PRODUCT DOCUMENT
Generic Name: Crizotinib
Trade Name: XALKORI
CDS Effective Date: May 22, 2018
Supersedes: June 24, 2016
0 B
NAME OF THE MEDICINAL PRODUCT
XALKORI 250 mg; XALKORI 200 mg
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains either 250 mg or 200 mg of crizotinib.
Excipients: see Section
LIST OF EXCIPIENTS
for a full list of excipients.
Cl
Cl
F
O
N
NH
2
N
N
NH
CH
3
(_R_)
Crizotinib is a white to pale yellow powder with a pKa of 9.4
(piperidinium cation) and 5.6
(pyridinium cation).
PHARMACEUTICAL FORM
Hard gelatin capsules
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Crizotinib is indicated for the treatment of adults with anaplastic
lymphoma kinase (ALK)-
positive advanced non-small cell lung cancer (NSCLC).
Crizotinib is indicated for the treatment of adults with previously
treated anaplastic
lymphoma kinase (ALK)-positive advanced non-small cell lung cancer
(NSCLC).
DISETUJUI OLEH BPOM: 18/08/2020
ID: 216241229, 216241231, 216241232,
218241064, 218241065
Crizotinib should be prescribed by a qualified healthcare professional
who is experienced
in the use of anti-neoplastic therapy.
POSOLOGY AND METHOD OF ADMINISTRATION
ALK TESTING
Detection of ALK-positive NSCLC is necessary for selection of patients
for treatment with
crizotinib because these are the only patients for whom benefit has
been shown.
Assessment for
ALK-positive NSCLC
should be
performed by
laboratories with
demonstrated proficiency in
the specific technology being utilized. Improper assay
performance can lead to unreliable test results.
RECOMMENDED DOSING
The recommended dose schedule of crizotinib is 250 mg taken orally
twice daily. Continue
treatment as long as the patient is deriving clinical benefit from
therapy. Crizotinib may be
taken with or without food (see Section
PHARMACOKINETIC PROPERTIES
). Capsules should
be swallowed whole. If a dose of crizotinib is missed, then it should
be taken as soon as
the patient remembers unless it is less than 6 hours until the next
dose, in which case the