XALKORI 200 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

CRIZOTINIB

Available from:

PFIZER PHARMACEUTICALS ISRAEL LTD

ATC code:

L01XE16

Pharmaceutical form:

CAPSULES

Composition:

CRIZOTINIB 200 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

PFIZER MANUFACTURING DEUTSCHLAND GMBH, GERMANY

Therapeutic group:

CRIZOTINIB

Therapeutic area:

CRIZOTINIB

Therapeutic indications:

XALKORI is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK)-positive. Xalkori is indicated for the treatment of patients with metastatic NSCLC whose tumors are ROS1-positive.

Authorization date:

2017-01-31

Patient Information leaflet

Xalkori PIL CC 270722 ENG
2022-0076331, 2022-0077209
1
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
XALKORI
® 200MG, CAPSULES XALKORI
® 250MG, CAPSULES
Each capsule contains CRIZOTINIB 200 MG OR 250 MG
Inactive ingredients and allergens: see section 2 under "Important
information about some of this
medicine's ingredients" and section 6 "Further information".
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This
leaflet contains concise
information about this medicine. If you have any further questions,
consult your doctor or
pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may harm
them, even if it seems to you that their medical condition is similar
to yours.
1. WHAT IS THE MEDICINE INTENDED FOR?
The medicine is indicated for the treatment of patients with locally
advanced or metastatic non-
small cell lung cancer (NSCLC) positive for a mutation in a gene
called anaplastic lymphoma
kinase (ALK).
The medicine is indicated for the treatment of patients with
metastatic non-small cell lung cancer
(NSCLC) positive for a mutation in a gene called ROS1.
THERAPEUTIC GROUP: A medicine from the protein kinase inhibitors
group, antineoplastic.
2. BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
•
You are sensitive (allergic) to crizotinib or to any of the other
ingredients in this medicine (see
section 6).
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE
BEFORE TREATMENT WITH XALKORI, TELL YOUR DOCTOR IF:
•
You have a moderate or severe liver disease.
•
You have ever had any lung problems. Some lung problems may worsen
during treatment
with Xalkori, as Xalkori may cause inflammation of the lungs during
the treatment.
Symptoms may be similar to those of lung cancer. Contact your doctor
immediately if you
have any new or worsening symptoms including difficulty breathing,
shortness of breath, or
cough with or without mucus, or fever.
•
You have

Summary of Product characteristics

Xalkori LPD CC 270722
2022-0077209, 2022-0076331
Xalkori
®
200 mg
Xalkori
®
250 mg
1.
NAME OF THE MEDICINAL PRODUCT
XALKORI 200 mg, capsules
XALKORI 250 mg, capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
XALKORI 200 mg capsules
Each hard capsule contains 200 mg of crizotinib.
XALKORI 250 mg capsules
Each hard capsule contains 250 mg of crizotinib.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
capsule.
XALKORI 200 mg capsules
White opaque and pink opaque hard capsule, with “Pfizer” imprinted
on the cap and
“CRZ 200” on the body.
XALKORI 250 mg capsules
Pink opaque hard capsule, with “Pfizer” imprinted on the cap and
“CRZ 250” on the body.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ALK-POSITIVE METASTATIC NSCLC
XALKORI is indicated for the treatment of patients with locally
advanced or metastatic non-
small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase
(ALK)-positive.
ROS1-POSITIVE METASTATIC NSCLC
XALKORI is indicated for the treatment of patients with metastatic
NSCLC whose tumors
are ROS1-positive.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with XALKORI should be initiated and supervised by a
physician experienced in
the use of anticancer medicinal products.
PATIENT SELECTION
Select patients for the treatment of metastatic NSCLC with XALKORI
based on the
presence of ALK or ROS1 positivity in tumor specimens
RECOMMENDED DOSING
Xalkori LPD CC 270722
2022-0077209, 2022-0076331
The recommended dose of XALKORI is 250 mg orally, twice daily until
disease
progression or no longer tolerated by the patient.
The recommended dose of XALKORI in patients with severe renal
impairment
[creatinine clearance (CLcr) <30 mL/min] not requiring dialysis is 250
mg orally,
once daily
XALKORI may be taken with or without food. Swallow capsules whole. If
a dose of
XALKORI is missed, make up that dose unless the next dose is due
within 6 hours. If
vomiting occurs after taking a dose of XALKORI, take the next dose at
the regular
time.
DOSE MODIFICATION
Redu