Nchi: Malesia
Lugha: Kiingereza
Chanzo: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Ceritinib
NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.
Ceritinib
150 Capsules; 50 Capsules
NOVARTIS PHARMA STEIN A.G.
_Customer Medication Indication Leaflet (RiMUP) _ ZYKADIA® HARD CAPSULES Ceritinib (150mg) 1 WHAT IS IN THIS LEAFLET 1. WHAT ZYKADIA IS USED FOR 2. HOW ZYKADIA WORKS 3. BEFORE YOU USE ZYKADIA 4. HOW TO USE ZYKADIA 5. WHILE YOU ARE USING ZYKADIA 6. SIDE EFFECTS 7. STORAGE AND DISPOSAL OF ZYKADIA 8. PRODUCT DESCRIPTION 9. MANUFACTURER AND PRODUCT REGISTRATION HOLDER 10. DATE OF REVISION WHAT ZYKADIA IS USED FOR ZYKADIA is a cancer medicine that contains active substance ceritinib. It is used to treat adults with advanced stages of a form of lung cancer called non-small cell lung cancer (NSCLC). Zykadia is only given to patients whose disease is due to a defect in a gene called ALK (anaplastic lymphoma kinase). HOW ZYKADIA WORKS Zykadia belongs to a group of anti-tumour medicines which stop cancer from making new cells if the cancer is caused by a defect in a gene called ALK (i.e., “ALK- positive”). Zykadia slows down the growth and spread of NSCLC which is ALK-positive. If you have any questions about how Zykadia works or why this medicine has been prescribed for you, ask your doctor. BEFORE YOU USE ZYKADIA Follow all the doctor’s instructions carefully. They may differ from the general information contained in this leaflet. _When you must not use it _ - if you are pregnant or breast- feeding. If the above applies to you, tell your doctor who will then decide whether you should start treatment with Zykadia. _PREGNANCY AND BREAST-FEEDING _ Zykadia is not recommended during pregnancy unless the potential benefit outweighs the potential risk to the fetus. If you are pregnant, think you might be pregnant or plan to become pregnant, ask your doctor for advice. Your doctor will discuss with you the potential risks of taking Zykadia during pregnancy. Zykadia should not be used during breast feeding. You and your doctor will decide together whether you should breast-feed or take Zykadia. You should not do both. _Before you start to use it _ Before you take ZYKADIA, tell your healthcare provider about all of your med Soma hati kamili
Novartis Page 2 Malaysia Package Leaflet 5 Jan 2021 Zykadia® FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE Zykadia as monotherapy is indicated for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)- positive advanced non-small cell lung cancer (NSCLC). ZYKADIA as monotherapy is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)- positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib. 2 DOSAGE AND ADMINISTRATION 2.1 PATIENT SELECTION Select patients for treatment of metastatic NSCLC with ZYKADIA based on the presence of ALK positivity in tumor specimens _[see Clinical Studies (14.1)]_ . 2.2 RECOMMENDED DOSAGE The recommended dosage of ZYKADIA is 450 mg orally once daily with food until disease progression or unacceptable toxicity _[see Clinical Pharmacology (12.3)]_ . If a dose of ZYKADIA is missed, make up that dose unless the next dose is due within 12 hours. If vomiting occurs during the course of treatment, do not administer an additional dose and continue with the next scheduled dose of ZYKADIA. 2.3 DOSAGE MODIFICATIONS FOR ADVERSE REACTIONS TABLE 1: RECOMMENDED ZYKADIA DOSE REDUCTIONS DOSE REDUCTION RECOMMENDED DOSAGE First-dose reduction 300 mg taken orally once daily with food Second-dose reduction 150 mg taken orally once daily with food Discontinue ZYKADIA for patients unable to tolerate 150 mg taken orally once daily with food. Dosage modifications for selected adverse reactions of ZYKADIA are provided in Table 2. If dose reduction is required due to an adverse reaction not listed in Table 2, then reduce the daily dose of ZYKADIA by 150 mg. TABLE 2: RECOMMENDED ZYKADIA DOSAGE MODIFICATIONS FOR ADVERSE REACTIONS ADVERSE REACTION ZYKADIA DOSE MODIFICATION GASTROINTESTINAL ADVERSE REACTIONS _[see Warnings and Precautions (5.1)]_ Severe or intolerable nausea, vomiting, or diarrhea despite optimal antiemetic or anti-diarrheal therapy Withhold until improved, then resume ZYKADIA at the next lower dosage. HE Soma hati kamili