Country: Awstralja
Lingwa: Ingliż
Sors: Department of Health (Therapeutic Goods Administration)
crizotinib, Quantity: 200 mg
Pfizer Australia Pty Ltd
Crizotinib
Capsule, hard
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
Oral
60 capsules
(S4) Prescription Only Medicine
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).
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
Licence status A
2013-09-27
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 Aqra d-dokument sħiħ
Version: pfpxalkc10920 Supersedes: pfpxalkc10419 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. Version: pfpxalkc10920 Supersedes: pfpxalkc10419 Page 2 of 35 DOSAGE AND METHOD OF ADMINISTRATION The recommended dose schedule of XALKORI is 250 mg taken orally twice daily. Continue treatment as long as th Aqra d-dokument sħiħ