Xalkori

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Crizotinib 250mg;  ;  

Available from:

Pfizer New Zealand Limited

INN (International Name):

Crizotinib 250 mg

Dosage:

250 mg

Pharmaceutical form:

Capsule

Composition:

Active: Crizotinib 250mg     Excipient: Calcium hydrogen phosphate Colloidal silicon dioxide Gelatin Iron oxide red Magnesium stearate Microcrystalline cellulose Sodium starch glycolate TekPrint black SW-9008 Titanium dioxide

Prescription type:

Prescription

Manufactured by:

Pfizer Ireland Pharmaceuticals

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).

Product summary:

Package - Contents - Shelf Life: Blister pack, Polyvinyl chloride (PVC) with aluminium backing - 60 capsules - 48 months from date of manufacture stored at or below 30°C

Authorization date:

2014-06-06

Patient Information leaflet

XALKORI®
1
XALKORI
®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I TAKING XALKORI?
XALKORI contains the active ingredient crizotinib. XALKORI is used to
treat rare types of lung cancer caused by defects in a gene
called anaplastic lymphoma kinase (ALK) or a gene called ROS1. For
more information, see Section 1. Why am I taking XALKORI?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I TAKE XALKORI?
Do not take XALKORI if you have ever had an allergic reaction to
crizotinib or any of the ingredients listed at the end of the CMI.
Tell your doctor if you have had any other lung problems, problems
with your heart, heart rate or heart rhythm, liver problems,
kidney problems, stomach or intestine problems, or cancer that has
spread to the stomach or intestines.
Also tell your doctor if you are pregnant, plan to become pregnant or
plan to father a child, are breastfeeding, or taking any other
medicines. For more information, see Section 2. What should I know
before I take XALKORI?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with XALKORI and affect how well it
works.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW DO I TAKE XALKORI?
The usual dose of XALKORI is one 250 mg capsule taken twice a day.
Swallow the capsule whole with a glass of water. Your doctor
may change your dose during treatment. More instructions can be found
in Section 4. How do I take XALKORI? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE TAKING XALKORI?
THINGS YOU
SHOULD DO
•
Follow your doctor's instructions. Keep all of your appointments,
including any blood tests.
•
Tell your doctor immediately if you or your partner become pregnant.
•
Use effective birth control while taking XALKORI and for at least 90
days after taking the last dose.
•
Tell any doctor, dentist or pharmacist you visit that you are taking
X

Summary of Product characteristics

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Page 1 of 33
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
XALKORI
®
(crizotinib 200 mg) Capsules
XALKORI
®
(crizotinib 250 mg) Capsules
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.
3.
PHARMACEUTICAL FORM
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
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
being utilised. Improper
assay performance can lead to unreliable test results.
RECOMMENDED DOSING
The recommended dose schedule of XALKORI is 250 mg taken orally twice
daily. Continue
treatment as long as the patient is deriving clinical benefit from
therapy.
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Page 2 of 33
XALKORI may be taken with or without food (see section 5.2).
Grapefruit or grapefruit juice
should be avoided since it may increase crizotinib plasma
concentration; St. John’s wort should
be avoided since it may decrease crizotinib p