Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Mepolizumab, Quantity: 100 mg
GlaxoSmithKline Australia Pty Ltd
Mepolizumab
Injection, powder for
Excipient Ingredients: polysorbate 80; water for injections; dibasic sodium phosphate heptahydrate; sucrose
Subcutaneous
1
(S4) Prescription Only Medicine
Severe eosinophilic asthma,NUCALA is indicated as an add-on treatment for severe eosinophilic asthma in patients aged 12 years and over (see Section 5.1 PHARMACODYNAMIC PROPERTIES, Clinical Trials).,Chronic Rhinosinusitis with Nasal Polyps (CRSwNP),NUCALA is indicated as add-on treatment in adult patients (18 years and above) with severe chronic rhinosinusitis with nasal polyps (CRSwNP) with an inadequate response to intranasal corticosteroids (see Section 5.1 PHARMACODYNAMIC PROPERTIES, Clinical 2 Trials).,Relapsed or refractory EGPA,NUCALA is indicated as an add-on treatment for relapsing or refractory Eosinophilic Granulomatosis with Polyangiitis (EGPA) in adult patients aged 18 years and over (see section 5.1 PHARMACODYNAMIC PROPERTIES, Clinical Trials).
Visual Identification: Lyophilised powder in 10 mL type I glass vial with bromobutyl rubber (non-latex) stopper and a gray aluminium overseal with a plastic flip-cap.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 48 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2016-02-02
NUCALA _mepolizumab 100 mg powder for injection_ AUSTRALIAN CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start using NUCALA. This leaflet answers some common questions about NUCALA. 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 using NUCALA against the benefits he or she expects it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT NUCALA IS USED FOR NUCALA is a medicine which contains the active substance mepolizumab, a monoclonal antibody. This antibody blocks a specific protein called interleukin-5. By blocking the action of interleukin-5, NUCALA limits the production of more eosinophils (a type of white blood cell) from the bone marrow and lowers the number of eosinophils in the bloodstream and the lungs. NUCALA is used to treat severe eosinophilic asthma, chronic rhinosinusitis with nasal polyps and eosinophilic granulomatosis with polyangiitis (EGPA). _SEVERE EOSINOPHILIC ASTHMA_ Some people with severe asthma have too many eosinophils (a type of white blood cell) in the blood, lungs and tissues. Having too many eosinophils in your blood can damage the airways and can cause your asthma to get worse or can increase the number of your asthma flare ups. NUCALA is used to treat asthma by reducing the frequency of asthma flare ups in adolescents (over 12 years of age) and adults who are already receiving asthma medicines, but whose asthma flare ups are not well controlled by medicines such as high-dose corticosteroid inhalers or beta-agonist inhalers. NUCALA can also be used to help reduce the daily dose of oral corticosteroids in patients taking these medicines to control asthma symptoms and flare ups. NUCALA DOES NOT TREAT ACUTE ASTHMA SYMPTOMS, SUCH AS A SUDDEN ASTHMA ATTACK. THEREFO Read the complete document
1 AUSTRALIAN PRODUCT INFORMATION NUCALA (MEPOLIZUMAB) POWDER FOR INJECTION AND SOLUTION FOR INJECTION 1 NAME OF THE MEDICINE Mepolizumab 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Mepolizumab is a humanised monoclonal antibody (IgG1, kappa) directed against human interleukin-5 (IL-5). Mepolizumab is expressed as a soluble glycoprotein secreted from a recombinant Chinese hamster ovary cell line. Powder for injection Each vial contains mepolizumab 100 mg (100 mg/mL after reconstitution). Solution for injection in pre-filled pen (auto-injector) or pre-filled syringe (safety syringe) Each pre-filled pen (auto-injector) or pre-filled syringe (safety-syringe) delivers 100 mg mepolizumab in 1 mL (100 mg/mL). For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Powder for injection NUCALA is a sterile lyophilised white powder for injection in a single-use vial. It contains no preservative. Solution for injection in pre-filled pen (auto-injector) or pre-filled syringe (safety syringe) NUCALA is a clear to opalescent, colourless to pale yellow to pale brown solution in a single-use, pre-filled pen or syringe. It contains no preservative. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS SEVERE EOSINOPHILIC ASTHMA NUCALA is indicated as an add-on treatment for severe eosinophilic asthma in patients aged 12 years and over (see Section 5.1 PHARMACODYNAMIC PROPERTIES, Clinical Trials). CHRONIC RHINOSINUSITIS WITH NASAL POLYPS (CRSWNP) NUCALA is indicated as add-on treatment in adult patients (18 years and above) with severe chronic rhinosinusitis with nasal polyps (CRSwNP) with an inadequate response to intranasal corticosteroids (see Section 5.1 PHARMACODYNAMIC PROPERTIES, Clinical 2 Trials). RELAPSED OR REFRACTORY EGPA NUCALA is indicated as an add-on treatment for relapsing or refractory Eosinophilic Granulomatosis with Polyangiitis (EGPA) in adult patients aged 18 years and over (see section 5.1 PHARMACODYNAMIC PROPERTIES, Clinical Trials). 4.2 DOSE AND METHOD OF ADMINISTRATION NUCALA Read the complete document