XALKORI crizotinib 200 mg capsule bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

crizotinib

Available from:

Pfizer Australia Pty Ltd

INN (International Name):

Crizotinib

Authorization status:

Registered

Summary of Product characteristics

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AUSTRALIAN PRODUCT INFORMATION
XALKORI
® (CRIZOTINIB)
1. NAME OF THE MEDICINE
Australian Approved Name (AAN): Crizotinib
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
XALKORI is supplied as hard gelatin capsules containing 200 mg or 250
mg of crizotinib.
For the full list of excipients, see Section 6.1 List of excipients.
3. PHARMACEUTICAL FORM
The capsules are differentiated by size, colour and printing.
200 mg strength: Hard gelatin capsule with white opaque body and pink
opaque cap containing
a white to pale yellow powder, printed with black ink “Pfizer” on
the cap and “CRZ 200” on the
body.
250 mg strength: Hard gelatin capsule with pink opaque cap and body
containing a white to pale
yellow powder, printed with black ink “Pfizer” on the cap and
“CRZ 250” on the body.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
XALKORI is indicated for the treatment of patients with anaplastic
lymphoma kinase (ALK)-
positive advanced non-small cell lung cancer (NSCLC).
XALKORI is indicated for the treatment of patients with ROS1-positive
advanced non-small
cell lung cancer (NSCLC).
4.2 DOSE AND METHOD OF ADMINISTRATION
ALK AND ROS1 TESTING
An accurate and validated assay for either ALK or ROS1 is necessary
for the selection of patients
for treatment with XALKORI. Either ALK-positive or ROS1-positive NSCLC
status needs to
be established to select patients for treatment with crizotinib
because these are the only patients
for whom benefit has been shown (see Section 5.1 Pharmacodynamic
properties - Clinical
Trials).
Assessment
for
either
ALK-positive
or
ROS1-positive
NSCLC
should
be
performed
by
laboratories with demonstrated proficiency in the specific technology
being utilised. Improper
assay performance can lead to unreliable test results.
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Supersedes: pfpxalkc10419
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DOSAGE AND METHOD OF ADMINISTRATION
The recommended dose schedule of XALKORI is 250 mg taken orally twice
daily. Continue
treatment as long as th