Country: Malaysia
Language: English
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
MEPOLIZUMAB
GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.
MEPOLIZUMAB
1 Pre-filled pen (auto-injector) per carton Units
Glaxo Operations UK Ltd (Trading as Glaxo Wellcome Operations)
_ _ _ _ _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ NUCALA 100MG/ML SOLUTION FOR INJECTION IN PRE-FILLED PEN (AUTOINJECTOR)_ _ Mepolizumab 100mg/ml 1 WHAT IS IN THIS LEAFLET 1. What NUCALA is used for 2. How NUCALA works 3. Before you use NUCALA 4. How to use NUCALA 5. While you are using NUCALA 6. Side effects 7. Storage and disposal of NUCALA 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT NUCALA IS USED FOR NUCALA contains the active substance MEPOLIZUMAB , a _monoclonal antibody_ , a type of protein designed to recognize a specific target substance in the body. It is used to treat severe eosinophilic asthma in patients 12 years and older. HOW NUCALA WORKS Mepolizumab, the active substance in NUCALA, blocks a protein called _interleukin-5_ . By blocking the action of this protein, it limits the production of eosinophils from the bone marrow and lowers the number of eosinophils in the bloodstream and the lungs. SEVERE EOSINOPHILIC ASTHMA Some people with severe asthma have too many _eosinophils_ (a type of white blood cell) in the blood and lungs. This condition is called _eosinophilic_ _asthma_ – the type of asthma NUCALA can treat. NUCALA can reduce your number of asthma attacks, if you or your child are already using medicines such as high dose inhalers, but your asthma is not well controlled by these medicines. If you are taking medicines called _oral _ _corticosteroids_ , NUCALA can also help reduce the daily dose you need to control your asthma. _ _ BEFORE YOU USE NUCALA _When you must not use it _ _ _ If you are allergic to mepolizumab or any other ingredients of NUCALA _Before you start to use it _ _ _ Before you use NUCALA your doctor needs to know: • Medicines of this type (monoclonal antibodies) can cause severe allergic reactions when injected into the body. Check with your doctor if you think this may apply to you. • NUCALA may weaken your resistance to infections caused by parasites. If you have a parasitic infection, it should be treate Read the complete document
CONFIDENTIAL [GSK logo] NUCALA MEPOLIZUMAB QUALITATIVE AND QUANTITATIVE COMPOSITION A clear to opalescent, colourless to pale yellow to pale brown solution in a single-use, pre- filled pen or syringe. Each pre-filled pen (auto-injector) or pre-filled syringe (safety-syringe) delivers 100 mg mepolizumab in 1 mL (100 mg/mL). Mepolizumab is a humanised monoclonal antibody (IgG1, kappa), directed against human interleukin-5 (IL-5) produced in Chinese hamster ovary cells by recombinant DNA technology. PHARMACEUTICAL FORM: Solution for injection in a pre-filled pen (auto-injector) Solution for injection in a pre-filled syringe (safety syringe) CLINICAL PARTICULARS I NDICATIONS SEVERE EOSINOPHILIC ASTHMA _NUCALA_ is indicated as an add-on maintenance treatment for patients aged 12 years old and older with severe eosinophilic asthma who: • have at least two exacerbations in the preceding 12 months on current standard of care (high doses of inhaled corticosteroids plus additional maintenance treatment) and/or requirement for treatment with systemic corticosteroids, and • have a blood eosinophil count of ≥ 150 cells/µL (0.15 GI/L) at initiation of treatment with _NUCALA _ OR ≥ 300 cells/µL (0.3 GI/L) in the past 12 months. _NUCALA_ is not indicated for other eosinophilic conditions or for relief of acute bronchospasm or status asthmaticus ( _see Warnings and Precautions)_ . DOSAGE AND ADMINISTRATION _NUCALA_ should be prescribed by a specialist experienced in the diagnosis and treatment of severe eosinophilic asthma. CONFIDENTIAL _NUCALA_ should only be administered as a subcutaneous injection (see _Special precautions _ _for disposal and other handling _ and _ Instructions for Use_ ). _NUCALA_ may be self-administered by the patient or administered by a caregiver if their healthcare professional determines that it is appropriate and the patient or caregiver are trained in injection techniques. POSOLOGY SEVERE EOSINOPHILIC ASTHMA ADULTS AND ADOLESCENTS (12 YEARS AND OLDER) The recommended dose is 100 mg of _NUCAL Read the complete document