XALKORI

Nchi: Indonesia

Lugha: Kiindonesia

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

Viambatanisho vya kazi:

CRIZOTINIB

Inapatikana kutoka:

PFIZER INDONESIA - Indonesia

INN (Jina la Kimataifa):

CRIZOTINIB

Kipimo:

200 MG

Dawa fomu:

KAPSUL

Vitengo katika mfuko:

DUS, 1 BLISTER @ 10 KAPSUL

Viwandani na:

PFIZER MANUFACTURING DEUTSCHLAND Gmbh - Germany

Idhini ya tarehe:

2018-08-01

Tabia za bidhaa

Generic Name: Crizotinib
Trade Name: XALKORI
CDS Effective Date: July 3, 2019
Supersedes: June 24, 2016
Approved by BPOM:
2017-0027378; 2017-0028629; 2018-0037001
Page 1 of 29
PT. PFIZER INDONESIA
LOCAL PRODUCT DOCUMENT
Generic Name: Crizotinib
Trade Name: XALKORI
CDS Effective Date: July 3, 2019
Supersedes: June 24, 2016
0 B
NAME OF THE MEDICINAL PRODUCT
XALKORI 200 mg; XALKORI 250 mg
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains either 200 mg or 250 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).
Crizotinib is indicated for the treatment of ROS1-positive advanced
NSCLC.
DISETUJUI OLEH BPOM: 08/09/2021
EREG10024111900186, EREG10024112000078,
EREG10024111900185, EREG10024112000079,
EREG10024111900187, EREG10024112000080,
Generic Name: Crizotinib
Trade Name: XALKORI
CDS Effective Date: July 3, 2019
Supersedes: June 24, 2016
Approved by BPOM:
2017-0027378; 2017-0028629; 2018-0037001
Page 2 of 29
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 AND ROS1 TESTING
Detection of either ALK-positive or ROS1 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 either ALK-positive or ROS1 positive NSCLC should be
performed by
laboratories
with
demonstrated
proficiency
in
the
specific
technology
bein