XALKORI crizotinib 200 mg capsule blister pack

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Ingredientes ativos:

crizotinib, Quantity: 200 mg

Disponível em:

Pfizer Australia Pty Ltd

DCI (Denominação Comum Internacional):

Crizotinib

Forma farmacêutica:

Capsule, hard

Composição:

Excipient Ingredients: titanium dioxide; Gelatin; calcium hydrogen phosphate; colloidal anhydrous silica; microcrystalline cellulose; iron oxide red; magnesium stearate; sodium starch glycollate; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide

Via de administração:

Oral

Unidades em pacote:

60 capsules

Tipo de prescrição:

(S4) Prescription Only Medicine

Indicações terapêuticas:

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).

Resumo do produto:

Visual Identification: Hard gelatin capsule with white opaque body and pink opaque cap, printed with black ink Pfizer on the cap, CRZ 200 on the body.; Container Type: Blister Pack; Container Material: Al laminated with PVC/paper; Container Life Time: 48 Months; Container Temperature: Store below 30 degrees Celsius

Status de autorização:

Licence status A

Data de autorização:

2013-09-27

Folheto informativo - Bula

XALKORI
®
_crizotinib_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about XALKORI.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking XALKORI
against the benefits it is expected to
have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT XALKORI IS
USED FOR
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.
XALKORI may slow or stop the
growth of these types of lung cancer.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
XALKORI is only available with a
doctor's prescription.
It is not addictive.
_USE IN CHILDREN_
The safety and efficacy of
XALKORI in children have not been
established.
BEFORE YOU TAKE
XALKORI
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE XALKORI IF YOU HAVE
AN ALLERGY TO:
•
crizotinib (the active ingredient in
XALKORI)
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin
DO NOT TAKE XALKORI AFTER THE
EXPIRY DATE PRINTED ON THE PACK OR
IF THE PACKAGING IS TORN OR SHOWS
SIGNS OF TAMPERING.
If it has expired or is damaged, return
it to your pharmacist for disposal.
_BEFORE YOU START TO TAKE IT_
TELL YOUR DOCTOR IF YOU HAVE
ALLERGIES TO ANY OTHER MEDICINES,
FOODS, PRESERVATIVES OR DYES.
TELL YOUR DOCTOR IF YOU HAVE OR
HAVE EVER HAD ANY OF THE FOLLOWING
MEDICAL CONDITIONS:
•
any other lung problems
•
problems with your heart rate or
heart rhythm, including
prolonged Q

Características técnicas

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Page 1 of 35
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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DOSAGE AND METHOD OF ADMINISTRATION
The recommended dose schedule of XALKORI is 250 mg taken orally twice
daily. Continue
treatment as long as th