100 mg solution for injection in a pre-filled pen mepolizumab<\/p>\n\n\n\n
Nucala contains the active substance\u00a0mepolizumab<\/strong>, a\u00a0monoclonal\u00a0antibody, a type of\u00a0protein\u00a0that is designed to recognize a specific target substance in the body.\u00a0It is used to treat\u00a0severe\u00a0asthma\u00a0and EGPA\u00a0(\u00a0eosinophilic\u00a0granulomatous\u00a0polyangiitis) in adults, adolescents, and children from 6 years of age.\u00a0It is also used to treat\u00a0chronic\u00a0rhinosinusitis\u00a0with nasal polyps<\/strong>\u00a0and\u00a0HES<\/strong>\u00a0(hypereosinophilic syndrome) in adults.<\/p>\n\n\n\n Mepolizumab, the active substance in Nucala, blocks a\u00a0protein\u00a0called\u00a0interleukin\u00a0\u20115<\/em>.\u00a0By blocking the effect of this\u00a0protein, the production of\u00a0eosinophils\u00a0(a type of\u00a0white blood cell\u00a0) in the\u00a0bone marrow\u00a0is limited and the number of\u00a0eosinophils\u00a0in the blood and lungs is reduced.<\/p>\n\n\n\n Severe eosinophilic asthma<\/u><\/strong><\/p>\n\n\n\n Some people with severe asthma have too many eosinophils (<\/em> a type of white blood cell ) in their blood and lungs. This disease is called eosinophilic asthma<\/em> – the type of asthma that Nucala can treat.<\/p>\n\n\n\n Nucala can reduce the number of asthma attacks if you or your child are already using high-dose\u00a0inhaled drugs but still do not have good control over your\u00a0asthma.<\/p>\n\n\n\n If you are taking medicines called\u00a0oral\u00a0corticosteroids<\/em>, Nucala\u00a0may also help reduce the daily\u00a0dose\u00a0you need to control your\u00a0asthma.<\/p>\n\n\n\n Chronic rhinosinusitis with nasal polyps<\/u><\/strong><\/p>\n\n\n\n Chronic\u00a0rhinosinusitis\u00a0with nasal polyps is a disease that means that you have too many\u00a0eosinophils\u00a0(<\/em>\u00a0a type of\u00a0white blood cell\u00a0) in the blood and the mucous membranes of the nose and sinuses.\u00a0It can lead to symptoms such as nasal congestion and lost sense of smell and the growth of\u00a0polyps\u00a0(soft tissue growths) inside the nose.<\/p>\n\n\n\n Nucala reduces the number of eosinophils in the blood and can reduce the size of the polyps, relieve nasal congestion and reduce the need to operate on the nasal polyps.<\/p>\n\n\n\n Nucala may also require you to take fewer oral\u00a0corticosteroids\u00a0to relieve your symptoms.<\/p>\n\n\n\n Eosinophilic\u00a0granulomatous\u00a0polyangiitis (EGPA)<\/u><\/strong><\/p>\n\n\n\n EGPA is a disease that means that you have too many\u00a0eosinophils\u00a0(<\/em>\u00a0a type of\u00a0white blood cell\u00a0) in the blood and\u00a0tissues\u00a0and that you also have a type of\u00a0vasculitis.\u00a0Vasculitis\u00a0means “inflammation of the blood vessels”.\u00a0The disease mainly affects the lungs and sinuses but often also other organs such as the skin, heart, and kidneys.<\/p>\n\n\n\n Nucala may control and delay the flare-up of EGPA symptoms. It can also help reduce the daily dose of oral corticosteroids you<\/em> need to control your symptoms.<\/p>\n\n\n\n Hypereosinophilic Syndrome (HES)<\/u><\/strong><\/p>\n\n\n\n Hypereosinophilic<\/em>\u00a0syndrome (HES) is a disease characterized by a high number of\u00a0eosinophils<\/em>\u00a0(a type of\u00a0white blood cell\u00a0) in the blood.\u00a0These cells can damage the body’s organs, especially the heart, lungs, nerves, and skin.<\/strong><\/p>\n\n\n\n Nucala can relieve symptoms and prevent\u00a0relapses.\u00a0If you are taking medicines called\u00a0oral\u00a0corticosteroids, Nucala\u00a0can also help reduce the daily\u00a0dose\u00a0you need to control your symptoms\/relapses in HES.<\/p>\n\n\n\n Talk to your doctor before using this medicine.<\/p>\n\n\n\n Deteriorating asthma<\/strong><\/p>\n\n\n\n Some people experience asthma-related side effects or their asthma may worsen during treatment with Nucala.<\/p>\n\n\n\n Allergic reactions and reactions at the injection site<\/strong><\/p>\n\n\n\n Drugs of this type ( monoclonal antibodies ) can cause<\/em> severe allergic reactions when injected into the body (see section 4, \u201cPossible side effects\u201d).<\/p>\n\n\n\n If you have had a similar reaction to any injection or medicine,<\/p>\n\n\n\n Parasite infections<\/strong><\/p>\n\n\n\n Nucala can weaken your resistance to infection caused by parasites. If you already have a parasite infection, it should be treated before starting treatment with Nucala. If you live in a region where such infections are common or if you travel to such a region:<\/p>\n\n\n\n Severe eosinophilic asthma<\/p>\n\n\n\n The pre-filled pen is not intended for use in\u00a0children under 12 years<\/strong>\u00a0of age for the treatment of severe\u00a0eosinophilic\u00a0asthma.<\/strong><\/p>\n\n\n\n For children between 6 and 11 years of age, contact a doctor who will prescribe a recommended dose that will be administered by a nurse or doctor.<\/p>\n\n\n\n Chronic rhinosinusitis with nasal polyps<\/p>\n\n\n\n This medicine is not intended for use in children or adolescents under 18 years<\/strong> of age for the treatment of chronic rhinosinusitis with nasal polyps.<\/p>\n\n\n\n EGPA (\u00a0eosinophilic\u00a0granulomatous\u00a0polyangiitis)<\/p>\n\n\n\n This medicine is not intended for use in children under 6 years<\/strong> of age for the treatment of EGPA.<\/p>\n\n\n\n HES (hypereosinophilic syndrome)<\/p>\n\n\n\n This medicine is not intended for use in adolescents and children under 18 years<\/strong> of age for the treatment of HES.<\/p>\n\n\n\n Tell your doctor<\/strong>\u00a0if you are taking, have recently taken, or might take any other medicines.<\/p>\n\n\n\n Other medicines for\u00a0asthma,\u00a0chronic\u00a0rhinosinusitis\u00a0with nasal polyps, EGPA or HES<\/strong><\/p>\n\n\n\n If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby,\u00a0ask your doctor<\/strong>\u00a0for advice before using this medicine.\u00a0<\/p>\n\n\n\n It is not known whether the ingredients in Nucala can pass into breast milk.\u00a0If you are breastfeeding, you must consult your doctor<\/strong>\u00a0before using Nucala.<\/p>\n\n\n\n Your ability to drive or use machines is unlikely to be affected by the side effects that Nucala may cause.<\/p>\n\n\n\n This medicine contains less than 1 mmol (23 mg)\u00a0sodium\u00a0per 100 mg\u00a0dose, ie it is essentially ‘sodium-free’.<\/p>\n\n\n\n Nucala is given as an\u00a0injection\u00a0just under the skin\u00a0(\u00a0subcutaneous\u00a0injection\u00a0)<\/em>.<\/p>\n\n\n\n Your doctor or nurse will decide if you or your carer can inject Nucala. If appropriate, your doctor or nurse will show you or your caregiver how to inject Nucala correctly.<\/p>\n\n\n\n Severe eosinophilic asthma<\/u><\/strong><\/p>\n\n\n\n The recommended dose<\/strong> for adults and adolescents from the age of 12 is 100 mg. You will receive 1 injection every four weeks.<\/p>\n\n\n\n Chronic rhinosinusitis with nasal polyps<\/u><\/strong><\/p>\n\n\n\n The recommended dose<\/strong> for adults is 100 mg. You will receive 1 injection every four weeks.<\/p>\n\n\n\n EGPA\u00a0(\u00a0eosinophilic\u00a0granulomatous\u00a0polyangiitis)<\/strong><\/p>\n\n\n\n The recommended dose<\/strong> for adults and adolescents from the age of 12 is 300 mg. You will receive 3 injections every four weeks.<\/p>\n\n\n\n Children 6 to 11 years<\/em><\/p>\n\n\n\n Children weighing 40 kg or more:<\/em><\/p>\n\n\n\n The recommended dose<\/strong> is 200 mg. You will receive 2 injections every four weeks.<\/p>\n\n\n\n Children weighing less than 40 kg:<\/em><\/p>\n\n\n\n The recommended dose<\/strong> is 100 mg. You will receive 1 injection every four weeks.<\/p>\n\n\n\n There should be at least 5 cm spacing between the injection sites.<\/p>\n\n\n\n HES (hypereosinophilic syndrome)<\/u><\/strong><\/p>\n\n\n\n The recommended dose<\/strong> for adults is 300 mg. You will receive 3 injections every four weeks.<\/p>\n\n\n\n There should be at least 5 cm spacing between the injection sites.<\/p>\n\n\n\n Instructions on how to dispense the pre-filled pen are provided on the other side of this leaflet.<\/p>\n\n\n\n If you think you have injected too much Nucala, talk to your doctor<\/strong> for advice.<\/p>\n\n\n\n You or your caregiver should inject the next\u00a0dose\u00a0as soon as you remember.\u00a0If you have not discovered that you have missed a\u00a0dose\u00a0until it is time to take the next\u00a0dose, inject the next\u00a0dose\u00a0as planned.\u00a0If you are not sure, ask your doctor, pharmacist, or nurse.<\/p>\n\n\n\n Do not stop injecting yourself with Nucala unless your doctor tells you to. If you stop or stop treatment with Nucala, your symptoms and seizures may return.<\/p>\n\n\n\n If your symptoms worsen while you are being injected with Nucala:<\/p>\n\n\n\n If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.<\/p>\n\n\n\n Like all medicines, this medicine can cause\u00a0side effects, although not everybody gets them.\u00a0The side effects of Nucala are usually mild to moderate but can sometimes be serious.<\/p>\n\n\n\n Allergic reactions<\/strong><\/p>\n\n\n\n Some people may have allergic or allergic reactions. Such reactions may be common (they may affect up to 1 in 10 people<\/strong> ). They usually occur within minutes to hours after injection one but the symptoms can sometimes come up to several days later.<\/p>\n\n\n\n The symptoms can be:<\/p>\n\n\n\n If you have had a similar reaction to any injection or medicine,<\/p>\n\n\n\n Other side effects include:<\/strong><\/p>\n\n\n\n Very common:<\/strong> Common:<\/strong> Rare; Keep this medicine out of the sight and reach of children.<\/p>\n\n\n\n Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiration date is the last day of the specified month.<\/p>\n\n\n\n Store in a refrigerator (2 \u00b0 C to 8 \u00b0 C).<\/p>\n\n\n\n Do not freeze.<\/p>\n\n\n\n Store in the original package. Sensitive to light.<\/p>\n\n\n\n Nucala pre-filled pen can be removed from the refrigerator and stored with unopened packaging at room temperature (up to 30 \u00b0 C) and protected from light for up to 7 days. Discard if it has been out of the refrigerator for more than 7 days.<\/p>\n\n\n\n The active substance is mepolizumab.<\/p>\n\n\n\n 1 ml pre-filled pen contains 100 mg mepolizumab,<\/p>\n\n\n\n The other ingredients are sucrose, dibasic sodium phosphate heptahydrate, citric acid monohydrate, polysorbate 80, disodium edetate, water for\u00a0injections.<\/p>\n\n\n\n Nucala is supplied as 1 ml clear to opalescent, colorless to pale yellow to pale brown solution in a disposable pre-filled\u00a0pen.<\/p>\n\n\n\n Nucala is available in packs containing 1 pre-filled pen or in a multi-pack of 3×1 pre-filled pens or 9 x 1 pre-filled pens.<\/p>\n\n\n\n GlaxoSmithKline Trading Services Limited<\/p>\n\n\n\n 12 Riverwalk<\/p>\n\n\n\n Citywest Business Campus<\/p>\n\n\n\n Dublin 24<\/p>\n\n\n\n Ireland<\/p>\n\n\n\n Manufacturer<\/strong><\/p>\n\n\n\n GlaxoSmithKline Manufacturing SPA<\/p>\n\n\n\n Strada Provinciale Atlanta, 90<\/p>\n\n\n\n 43056 San Polo di Torrile, Parma<\/p>\n\n\n\n Italy<\/p>\n\n\n\n Contact the representative of the marketing authorization holder to find out more about this medicine:<\/p>\n\n\n\n Nucala contains the active substance mepolizumab , a monoclonal antibody , a type of protein that is designed to recognize a specific target substance in the body. It is used to treat severe asthma and EGPA ( eosinophilic granulomatous polyangitis) in adults, adolescents and children from 6 years of age. It is also used to treat chronic rhinosinusitis with nasal polyps and HES (hypereosinophilic syndrome) in adults.<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"cybocfi_hide_featured_image":"","footnotes":""},"categories":[2200,15581],"tags":[19343,19334,19338,19337,19339,19342,19335,19340,19336,19341],"class_list":["post-19295","post","type-post","status-publish","format-standard","hentry","category-medicines","category-n","tag-benefits-of-nucala","tag-mepolizumab","tag-mepolizumab-dosage","tag-mepolizumab-side-effects","tag-nucala","tag-nucala-side-effects","tag-what-is-mepolizumab","tag-what-is-nucala","tag-what-mepolizumab-is-used-for","tag-what-nucala-is-used-for"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/19295","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/comments?post=19295"}],"version-history":[{"count":3,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/19295\/revisions"}],"predecessor-version":[{"id":19339,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/19295\/revisions\/19339"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=19295"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=19295"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=19295"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}What you need to know before using Nucala<\/h2>\n\n\n\n
Do not use Nucala:<\/h2>\n\n\n\n
Warnings and cautions<\/h2>\n\n\n\n
Children and young people<\/h2>\n\n\n\n
Other drugs and Nucala<\/h2>\n\n\n\n
Pregnancy and breastfeeding<\/h2>\n\n\n\n
Driving and using machines<\/h2>\n\n\n\n
Nucala contains sodium<\/h2>\n\n\n\n
How to use Nucala<\/h2>\n\n\n\n
If you take more Nucala than you should<\/h2>\n\n\n\n
If you miss a dose of Nucala<\/h2>\n\n\n\n
Discontinuation of treatment with Nucala<\/h2>\n\n\n\n
Possible side effects<\/h2>\n\n\n\n
may affect more than 1 in 10 people:<\/p>\n\n\n\n
may affect up to 1 in 10 people:<\/p>\n\n\n\n
<\/strong>can occur in up to 1 in 1,000 people:<\/p>\n\n\n\nHow to store Nucala<\/h2>\n\n\n\n
Contents of the package and other information<\/h2>\n\n\n\n
Content declaration<\/h2>\n\n\n\n
What the medicine looks like and contents of the pack<\/h2>\n\n\n\n
Marketing Authorisation Holder<\/h2>\n\n\n\n
Belgium \/ Belgique \/ Belgien<\/strong>GlaxoSmithKline Pharmaceuticals sa \/ nvTel: + 32 (0) 10 85 52 00<\/td> Lithuania<\/strong>UAB \u201cBERLIN-CHEMIE MENARINI BALTIC\u201dTel: + 370 52 691 947lt@berlin-chemie.com<\/td><\/tr> Bulgaria<\/strong>Berlin-Hemi \/ A. MenariniBULGARIA \u201dEODETel: + 359 2 454 0950bcsofia@berlin-chemie.com<\/td> Luxembourg \/ Luxemburg<\/strong>GlaxoSmithKline Pharmaceuticals sa \/ nvBelgium \/ BelgiumTel: + 32 (0) 10 85 52 00<\/td><\/tr> Czech Republic<\/strong>GlaxoSmithKline, sroTel: + 420 222 001 111cz.info@gsk.com<\/td> Hungary<\/strong>Berlin-Chemie \/ A. Menarini Kft.Tel .: + 36 23501301bc-hu@berlin-chemie.com<\/td><\/tr> Denmark<\/strong>GlaxoSmithKline Pharma A \/ STel: + 45 36 35 91 00dk-info@gsk.com<\/td> Malta<\/strong>GlaxoSmithKline Trading Services Ltd.Tel: + 356 80065004<\/td><\/tr> Germany<\/strong>GlaxoSmithKline GmbH & Co. KGTel .: + 49 (0) 89 36044 8701produkt.info@gsk.com<\/td> The Netherlands<\/strong>GlaxoSmithKline BVTel: + 31 (0) 33 2081100<\/td><\/tr> Eesti<\/strong>O\u00dc Berlin-Chemie Menarini EestiTel: + 372 667 5001ee@berlin-chemie.com<\/td> Norway<\/strong>GlaxoSmithKline ASTel: + 47 22 70 20 00<\/td><\/tr> Greece<\/strong>GlaxoSmithKline A\u03bf\u03bd\u03bf\u03c0\u03c1\u03cc\u03c3\u03c9\u03c0\u03b7 AEBE:\u0397\u03bb: + 30 210 68 82 100<\/td> Austria<\/strong>GlaxoSmithKline Pharma GmbHTel: + 43 (0) 1 97075 0at.info@gsk.com<\/td><\/tr> Spain<\/strong>GlaxoSmithKline, SATel: + 34 900 202 700es-ci@gsk.com<\/td> Poland<\/strong>GSK Services Sp. z ooTel .: + 48 (0) 22 576 9000<\/td><\/tr> France<\/strong>GlaxoSmithKline LaboratoryTel: + 33 (0) 1 39 17 84 44diam@gsk.com<\/td> Portugal<\/strong>GlaxoSmithKline – Pharmaceutical Products, Lda.Tel: + 351 21 412 95 00FI.PT@gsk.com <\/td><\/tr> Croatia<\/strong>Berlin-Chemie Menarini Hrvatska dooTel: +385 1 4821 361office-croatia@berlin-chemie.com<\/td> Romania<\/strong>GlaxoSmithKlineTrading Services Ltd.Tel: + 40 800672524<\/td><\/tr> Ireland<\/strong>GlaxoSmithKline (Ireland) LimitedTel: + 353 (0) 1 4955000<\/td> Slovenia<\/strong>Berlin-Chemie \/ A. Menarini Distribution Ljubljana dooTel: + 386 (0) 1 300 2160slovenia@berlin-chemie.com<\/td><\/tr> Iceland<\/strong>Vistor hf.Phone: + 354 535 7000<\/td> Slovak Republic<\/strong>Berlin-Chemie \/ A. Menarini Distribution Slovakia sroTel: + 421 2 544 30 730slovakia@berlin-chemie.com<\/td><\/tr> Italy<\/strong>GlaxoSmithKline SpATel: + 39 (0) 45 7741111<\/td> Finland \/ Finland<\/strong>GlaxoSmithKline OyPuh \/ Tel: + 358 (0) 10 30 30 30<\/td><\/tr> .\u03a0\u03c1\u03bf\u03c2<\/strong>GlaxoSmithKline Trading ServicesLtd.:\u0397\u03bb: + 357 80070017<\/td> Sweden<\/strong>GlaxoSmithKline ABTel: + 46 (0) 8 638 93 00info.produkt@gsk.com<\/td><\/tr> Latvia<\/strong>SIA Berlin-Chemie \/ Menarini BalticTel: + 371 67103210lv@berlin-chemie.com<\/td> United Kingdom (Northern Ireland)<\/strong>GlaxoSmithKline Trading ServicesLtd.Tel: + 44 (0) 800 221441customercontactuk@gsk.com<\/td><\/tr><\/tbody><\/table><\/figure>\n","protected":false},"excerpt":{"rendered":"