Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Capmatinib
NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.
Capmatinib
60 Tablets
NOVARTIS PHARMA PRODUKTIONS GMBH
_CUSTOMER MEDICATION INFORMATION LEAFLET (RIMUP) _ RAHIKA ® FILM-COATED TABLET Capmatinib dihydrochloride monohydrate (150mg, 200mg) 1 WHAT IS IN THIS LEAFLET 1. What Rahika is used for 2. How Rahika works 3. Before you use Rahika 4. How to use Rahika 5. While you are using Rahika 6. Side Effects 7. Storage and Disposal of Rahika 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT RAHIKA IS USED FOR Rahika is a prescription medicine used to treat adults with a kind of lung cancer called non-small cell lung cancer (NSCLC) that: • has spread to other parts of the body or cannot be removed by surgery (metastatic), and • whose tumors have an abnormal mesenchymal epithelial transition (MET) gene HOW RAHIKA WORKS Rahika helps to slow down or stop the growth and spread of your lung cancer if it is caused by a change (mutation) in a gene that makes an enzyme called MET. BEFORE YOU USE RAHIKA _-When you must not use it _ Do not take Rahika if you are allergic to Capmatinib or any of the ingredients in Rahika. _- Before you start to use it _ Before you take Rahika, tell your doctor about all of your medical conditions, including if you: • have or have had lung or breathing problems other than your lung cancer • have or have had liver problems • are pregnant or plan to become pregnant. Rahika can harm your unborn baby. • are breastfeeding or plan to breastfeed. _- Taking other medicines _ Tell your doctor about all the medicines you take or start taking, including prescription and over- the-counter medicines, vitamins, and herbal supplements. _- Females who are able to become _ _pregnant _ • Your doctor should do a pregnancy test before you start your treatment with Rahika. • You should use effective birth control during treatment and for 1 week after your last dose of Rahika. Talk to your doctor about birth control choices that might be right for you during this time. • Tell your doctor right away if you become pregnant or think you may be pregnant during trea Baca dokumen lengkap
FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE RAHIKA is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping. 2 DOSAGE AND ADMINISTRATION 2.1 PATIENT SELECTION Select patients for treatment with RAHIKA based on the presence of a mutation that leads to MET exon 14 skipping in tumor specimens _[see Clinical Studies (14)]_ . 2.2 RECOMMENDED DOSAGE The recommended dosage of RAHIKA is 400 mg orally twice daily with or without food. Swallow RAHIKA tablets whole. Do not break, crush or chew the tablets. If a patient misses or vomits a dose, instruct the patient not to make up the dose, but to take the next dose at its scheduled time. 2.3 DOSAGE MODIFICATIONS FOR ADVERSE REACTIONS The recommended dose reductions for the management of adverse reactions are listed in Table 1. TABLE 1: RECOMMENDED RAHIKA DOSE REDUCTIONS FOR ADVERSE REACTIONS DOSE REDUCTION DOSE AND SCHEDULE First 300 mg orally twice daily Second 200 mg orally twice daily Permanently discontinue RAHIKA in patients who are unable to tolerate 200 mg orally twice daily. The recommended dosage modifications of RAHIKA for adverse reactions are provided in Table 2. TABLE 2: RECOMMENDED RAHIKA DOSAGE MODIFICATIONS FOR ADVERSE REACTIONS ADVERSE REACTION SEVERITY DOSAGE MODIFICATION Interstitial Lung Disease (ILD)/Pneumonitis _[see Warnings and Precautions (5.1)]_ Any grade Permanently discontinue RAHIKA. Increased ALT and/or AST without increased total bilirubin _[see Warnings and Precautions (5.2)]_ Grade 3 Withhold RAHIKA until recovery to baseline ALT/AST. If recovered to baseline within 7 days, then resume RAHIKA at the same dose; otherwise resume RAHIKA at a reduced dose. Grade 4 Permanently discontinue RAHIKA. Increased ALT and/or AST with increased total bilirubin in the absence of cholestasis or hemolysis _[see Warnings and Precautions (5.2)]_ ALT and/or AST greater than 3 times ULN with total bilirubin greate Baca dokumen lengkap