Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Evolocumab
Amgen Biopharmaceuticals Malaysia Sdn Bhd
Evolocumab
1x1ml mL
Amgen manufactuirng ,Ltd
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ REPATHA ® SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE/AUTOINJECTOR Evolocumab 140 mg/mL 1 WHAT IS IN THIS LEAFLET? 1. What REPATHA is used for 2. How REPATHA works 3. Before you use REPATHA 4. How to use REPATHA 5. While you are using it 6. Side effects 7. Storage and Disposal of REPATHA 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT REPATHA IS USED FOR REPATHA is used: • along with diet and other cholesterol-lowering medicines to reduce the risk of heart attack, stroke and certain types of heart surgery in adults with cardiovascular disease. • to reduce low-density lipoprotein (LDL) or bad cholesterol in adults with high blood cholesterol levels called primary hyperlipidemia (including a type of high cholesterol called heterozygous familial hypercholesterolemia [HeFH]): - along with diet and a statin, with or without other cholesterol-lowering medicines, where additional lowering of LDL cholesterol is required, - along with diet, alone or together with other cholesterol- lowering medicines, when statins do not work well or cannot be used. • Along with diet and other LDL- cholesterol-lowering therapies in pediatric patients aged 10 years and older with HeFH to reduce LDL-C • along with diet and other LDL- lowering medicine in adults and pediatric patients aged 10 years and older with a type of high cholesterol called homozygous familial hypercholesterolemia (HoFH), who need additional lowering of LDL cholesterol. It is not known if REPATHA is safe and effective in children with HeFH or HoFH who are younger than 10 years of age or in children with other types of hyperlipidemia. HOW REPATHA WORKS REPATHA is a medicine that lowers levels of ‘bad’ cholesterol, a type of fat, in the blood. REPATHA contains the active substance evolocumab, a monoclonal antibody (a type of specialized protein designed to attach to a target substance in the body). Evolocumab is designed to attach to a substance called PCSK9 t Baca dokumen lengkap
1 REPATHA ® (EVOLOCUMAB) SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE/ PRE-FILLED AUTOINJECTOR 140 MG/ML FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE PREVENTION OF CARDIOVASCULAR EVENTS REPATHA ® is indicated as an adjunct to diet and standard of care therapy (including moderate- to high-intensity statin therapy alone or in combination with other lipid-lowering therapy), to reduce the risk of myocardial infarction, stroke, and coronary revascularization in adult patients with atherosclerotic cardiovascular disease. PRIMARY HYPERLIPIDEMIA (INCLUDING HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA) REPATHA is indicated for the reduction of elevated low-density lipoprotein cholesterol (LDL-C) in adult patients with primary hyperlipidemia (including heterozygous familial hypercholesterolemia [HeFH]): • as an adjunct to diet and statin therapy, with or without other lipid-lowering therapies, in patients who require additional lowering of LDL-C, • as an adjunct to diet, alone or in combination with non-statin lipid-lowering therapies, in patients for whom a statin is contraindicated. PEDIATRIC PATIENTS WITH HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA REPATHA is indicated as an adjunct to diet and other LDL-C-lowering therapies (e.g., statins, ezetimibe) in pediatric patients aged 10 years and older with HeFH who require additional lowering of LDL-C. HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA REPATHA is indicated as an adjunct to diet and other LDL-lowering therapies (e.g., statins, ezetimibe, LDL apheresis) in adult and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH) who require additional lowering of LDL-C. 2 DOSAGE AND ADMINISTRATION 2.1 RECOMMENDED DOSAGE The recommended subcutaneous dosage of REPATHA in adults with established cardiovascular disease or in adults with primary hyperlipidemia (including heterozygous familial hypercholesterolemia [HeFH]) is either 140 mg every 2 weeks OR 420 mg once monthly, based on patient preference for dosing frequency and injec Baca dokumen lengkap