200 mg injection, in pre-filled pen
belimumab<\/p>\n\n\n\n
Bone marrow <\/strong>as a subcutaneous injection <\/strong>is a drug used to treat lupus<\/strong>(systemic lupus erythematosus, SLE ) in adults (18 years and older), whose disease is still<\/p>\n\n\n\n highly active despite standard treatment. Lupus is a disease in which the immune system (the system that fights infection s) attacks your own cells and tissues you, and cause inflammation and tissue damage. It can affect almost any organ in the body and is believed to involve a type of white blood cell called a B cell s<\/em> . Benlysta contains belimumab<\/strong> ( a monoclonal antibody<\/em> ). It reduces the number of B cells in the blood by blocking the function of BLyS, a protein that helps B cells live longer and is found in high levels in people with lupus. You will receive Benlysta in addition to your usual treatment for lupus. Talk to a doctor before using Benlysta:<\/p>\n\n\n\n Depression and suicide<\/strong><\/p>\n\n\n\n Depression, suicidal ideation and suicide attempts including suicide have been reported during treatment with Benlysta. Tell your doctor if you have had any of these conditions before. If at any time you experience new or worsening symptoms: If you feel depressed or have thoughts of hurting yourself or committing suicide, it may help to tell a relative or close friend and ask them to read this leaflet. You can ask them to tell you if they are worried about any changes in your mood or behavior. Pay attention to important symptoms<\/strong><\/p>\n\n\n\n People taking drugs that affect the immune system may be at greater risk of developing infections , including a rare but serious brain infection called progressive multifocal leukoencephalopathy (PML). To improve the traceability of this medicine, you and your healthcare provider should register Benlyst’s batch number. You should record this information in the event that you are asked about it in the future.<\/p>\n\n\n\n Do not give Benlysta as a subcutaneous injection to children or adolescents under 18 years of age.<\/p>\n\n\n\n Tell<\/strong> your doctor<\/strong> if you are taking, have recently taken, or might take any other medicines.<\/p>\n\n\n\n In particular, you should tell your doctor if you are being treated with medicines that affect the immune system:<\/p>\n\n\n\n Birth control in fertile women<\/strong> Pregnancy<\/strong> Legs are usually not recommended if you are pregnant.<\/strong><\/p>\n\n\n\n Breast-feeding<\/strong><\/p>\n\n\n\n Benlysta can cause side effects that impair the ability to drive or use machines.<\/p>\n\n\n\n This medicine contains less than 1 mmol sodium (23 mg) per dose and is therefore essentially ‘sodium-free’. How much to use<\/strong> Adults (18 years and older)<\/strong><\/p>\n\n\n\n The recommended dose <\/strong>is 200 mg (the entire contents of a pen ) once a week, injected under the skin on the same day each week. If you want to change the dosing day<\/p>\n\n\n\n Take one dose on the new day (even if it is less than a week since the last dose ). Continue with the new weekly schedule from that day. Injection of Benlysta<\/strong><\/p>\n\n\n\n The doctor or nurse will show you or your caregiver how Benlysta is injected. Your doctor or nurse will be present when you inject the first dose of Benlysta with the pre-filled pen. Once you have learned to use the pen, your doctor or nurse may decide that you can give your injections yourself or that your caregiver can give them. Your doctor or nurse will also tell you what signs and symptoms you should be aware of when using Benlysta as severe allergic reactions may occur (see \u201c Allergic reactions<\/i>\u201d in section 4). Bone marrow is injected under the skin of the abdomen or thighs. Bone subcutaneous injection must not be given into a vein ( intravenously<\/em> ). Instructions on how to use the pre-filled pen are provided at the end of this leaflet.<\/p>\n\n\n\n If this happens, contact a doctor or nurse immediately who will monitor you for signs or symptoms of side effects and treat them if necessary. If possible, take the package or this leaflet with you.<\/p>\n\n\n\n Inject the missed dose as soon as you remember. Then continue according to your usual weekly schedule or start a new weekly schedule from the day you injected the missed dose . If you do not notice that you have missed a dose until it is time for your next dose , only inject the next dose according to plan. It is not necessary to inject two doses on the same day.<\/p>\n\n\n\n Your doctor will decide if you need to stop using Benlysta.<\/p>\n\n\n\n Like all medicines, this medicine can cause side effects, although not everybody gets them. Allergic reactions – seek medical attention immediately<\/strong><\/p>\n\n\n\n Bone marrow can cause a reaction to injection or an allergic reaction ( hypersensitivity reaction<\/em> ). Such side effects are common (may affect up to 1 in 10 people). They can sometimes be serious (uncommon, occurring in up to 1 in 100 users) and can be life-threatening. Such severe reactions are more likely to occur on the day of the first or second treatment with Benlysta but may be delayed and occur several days later. Tell your doctor or nurse immediately or go to the nearest hospital emergency department <\/strong>if <\/strong>you experience any of the following symptoms of an allergic or injection-related reaction:<\/strong><\/p>\n\n\n\n In rare cases, less severe, delayed reactions to Benlysta may occur, usually 5 to 10 days after an injection . Such reactions may include a combination of symptoms such as rash, malaise, fatigue, muscle aches, headache and \/ or swelling of the face. If you experience these symptoms,<\/strong> especially if you experience a combination of those symptoms:<\/p>\n\n\n\n Infection is<\/strong><\/p>\n\n\n\n Leg ulcers can increase the risk of infection , including infection of the urinary tract and respiratory tract. These are very common and may occur in more than 1 in 10 users. Some infections can be serious and can cause death in rare cases. If you get any of the following symptoms of infection:<\/strong><\/p>\n\n\n\n Depression and suicide<\/strong><\/p>\n\n\n\n Depression, suicidal ideation and suicide attempts have been reported during treatment with Benlysta. Depression can occur in up to 1 in 10 users. Suicidal ideation and suicide attempts can occur in up to 1 in 100 users. If you feel depressed, have thoughts of harming yourself or other anxious thoughts, or if you are depressed and notice that you are feeling worse or developing new symptoms:<\/p>\n\n\n\n Increased risk of brain infection<\/strong> Drugs that weaken the immune system, such as Benlysta, can increase the risk of developing a rare but serious brain infection called progressive multifocal leukoencephalopathy (PML). Symptoms<\/strong> of PML are:<\/p>\n\n\n\n If you already had these symptoms before starting treatment with Benlysta:<\/p>\n\n\n\n Other possible side effects:<\/strong> Very common side effects are<\/strong><\/p>\n\n\n\n These can occur in more than 1 in 10<\/strong> users:<\/p>\n\n\n\n Common side effects are<\/strong><\/p>\n\n\n\n These can occur in up to 1 in 10<\/strong> users:<\/p>\n\n\n\n Uncommon side effects are<\/strong><\/p>\n\n\n\n These can occur in up to 1 in 100<\/strong> users:<\/p>\n\n\n\n Reporting of side effects<\/em><\/p>\n\n\n\n If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. <\/p>\n\n\n\n Keep this medicine out of the sight and reach of children. 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. Store in a refrigerator (2 \u00b0 C to 8 \u00b0 C). Do not freeze. Store in the original package. Sensitive to light. A Benlysta prefilled injection pen can be stored at room temperature (up to 25 \u00b0 C) for more than 12 hours – so long as it is protected from light. After being removed from the refrigerator , the<\/strong> pen must be used within 12 hours or discarded.<\/strong> Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.<\/p>\n\n\n\n The active substance is belimumab. Each 1 ml pre-filled pen contains 200 mg belimumab. The other ingredients are: arginine hydrochloride, histidine, histidine monohydrochloride, polysorbate 80, sodium chloride, water for injections. See ‘Important information about the contents of Benlysta’ in section 2 for more information.<\/p>\n\n\n\n Benlysta supplied as 1 ml colorless to pale yellow solution in a pre-filled pen disposable. Available in packs of 1 or 4 pre-filled pens in each pack and in multi-packs of 12 pre-filled pens (3 packs of 4 pre-filled pens). Not all pack sizes may be marketed.<\/p>\n\n\n\n Marketing Authorisation Holder<\/strong><\/p>\n\n\n\n GlaxoSmithKline (Ireland) 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 Manufacturer<\/strong><\/p>\n\n\n\n Glaxo Operations UK Ltd<\/p>\n\n\n\n Harmire Road<\/p>\n\n\n\n Barnard Castle<\/p>\n\n\n\n Durham County, DL12 8DT<\/p>\n\n\n\n UK OR GlaxoSmithKline Manufacturing SPA<\/p>\n\n\n\n Strada Provinciale Asolana, 90<\/p>\n\n\n\n 43056 San Polo di Torrile<\/p>\n\n\n\n Parma<\/p>\n\n\n\n Italy Contact the representative of the marketing authorization holder to find out more about this medicine:<\/p>\n\n\n\n Bone marrow as a subcutaneous injection is a drug used to treat lupus(systemic lupus erythematosus, SLE ) in adults (18 years and older), whose disease is still<\/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":[2202,2200],"tags":[9103,9105,9108,9107,9110,9106,9111,9104,9109],"class_list":["post-5966","post","type-post","status-publish","format-standard","hentry","category-b","category-medicines","tag-belimumab","tag-belimumab-injection","tag-benlysta","tag-side-effects-of-belimumab","tag-side-effects-of-benlysta","tag-what-belimumab-is-used-for","tag-what-benlysta-is-used-for","tag-what-is-belimumab","tag-what-is-benlysta"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/5966","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=5966"}],"version-history":[{"count":5,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/5966\/revisions"}],"predecessor-version":[{"id":12092,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/5966\/revisions\/12092"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=5966"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=5966"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=5966"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
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<\/p>\n\n\n\n2. What you need to know before using Benlysta<\/h2>\n\n\n\n
Do not use Benlysta<\/h2>\n\n\n\n
Warnings and cautions<\/h2>\n\n\n\n
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Other medicines and Benlysta<\/h2>\n\n\n\n
Pregnancy, breastfeeding, and fertility<\/h2>\n\n\n\n
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<\/p>\n\n\n\nDriving and using machines<\/h2>\n\n\n\n
Important information about the contents of Benlysta<\/h2>\n\n\n\n
<\/p>\n\n\n\n3. How to use Benlysta<\/h2>\n\n\n\n
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<\/p>\n\n\n\nIf you use too much Benlysta <\/h2>\n\n\n\n
If you forget to use Benlysta<\/h2>\n\n\n\n
Discontinue treatment with Benlysta<\/h2>\n\n\n\n
4. Possible side effects<\/h2>\n\n\n\n
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<\/p>\n\n\n\n5. How to store Benlysta<\/h2>\n\n\n\n
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<\/p>\n\n\n\n6. Contents of the packaging and other information<\/h2>\n\n\n\n
Content declaration<\/h2>\n\n\n\n
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<\/p>\n\n\n\nWhat the medicine looks like and contents of the pack<\/h2>\n\n\n\n
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<\/p>\n\n\n\nBelgium \/ Belgique \/ Belgien<\/strong>GlaxoSmithKline Pharmaceuticals sa \/ nvTel: + 32 (0) 10 85 52 00<\/td> Luxembourg \/ Luxemburg<\/strong>GlaxoSmithKline Pharmaceuticals sa \/ nvBelgium \/ BelgiumTel: + 32 (0) 10 85 52 00<\/td><\/tr> Bulgaria<\/strong>The GlaxoSmithKlein \u0415\u041e\u041e\u0414Tel .: + 359 2 953 10 34<\/td> Hungary<\/strong>GlaxoSmithKline Kft.Tel .: + 36 1 225 5300<\/td><\/tr> Czech Republic<\/strong>GlaxoSmithKline sroTel: + 420 222 001 111cz.info@gsk.com<\/td> Malta<\/strong>GlaxoSmithKline (Malta) LimitedTel: + 356 21 238131<\/td><\/tr> Denmark<\/strong>GlaxoSmithKline Pharma A \/ STel: + 45 36 35 91 00dk-info@gsk.com<\/td> The Netherlands<\/strong>GlaxoSmithKline BVTel: + 31 (0) 33 2081100<\/td><\/tr> Germany<\/strong>GlaxoSmithKline GmbH & Co. KGTel .: + 49 (0) 89 36044 8701produkt.info@gsk.com<\/td> Norway<\/strong>GlaxoSmithKline ASTel: + 47 22 70 20 00firmapost@gsk.no<\/td><\/tr> Eesti<\/strong>GlaxoSmithKline Eesti O\u00dcTel: + 372 6676 900estonia@gsk.com<\/td> Austria<\/strong>GlaxoSmithKline Pharma GmbHTel: + 43 (0) 1 97075 0at.info@gsk.com<\/td><\/tr> Greece<\/strong>GlaxoSmithKline AEBE Converter:\u0397\u03bb: + 30 210 68 82 100<\/td> Poland<\/strong>GSK Services Sp. z ooTel .: + 48 (0) 22 576 9000<\/td><\/tr> Spain<\/strong>GlaxoSmithKline, SATel: + 34 900 202 700es-ci@gsk.com<\/td> Portugal<\/strong>GlaxoSmithKline – Pharmaceutical Products, Lda. Tel: + 351 21 412 95 00FI.PT@gsk.com <\/td><\/tr> France<\/strong>GlaxoSmithKline LaboratoryTel .: + 33 (0) 1 39 17 84 44diam@gsk.com<\/td> Romania<\/strong>GlaxoSmithKline (GSK) SRLTel: + 4021 3028 208<\/td><\/tr> Croatia<\/strong>GlaxoSmithKline dooTel: + 385 1 6051 999<\/td> Slovenia<\/strong>GlaxoSmithKline dooTel: + 386 (0) 1 280 25 00medical.x.si@gsk.com<\/td><\/tr> Ireland<\/strong>GlaxoSmithKline (Ireland) LimitedTel: + 353 (0) 1 4955000<\/td> Slovak Republic<\/strong>GlaxoSmithKline Slovakia sroTel: + 421 (0) 2 48 26 11 11recepcia.sk@gsk.com<\/td><\/tr> Iceland<\/strong>Vistor hf. Phone: + 354 535 7000<\/td> Finland \/ Finland<\/strong>GlaxoSmithKline OyPuh \/ Tel: + 358 (0) 10 30 30 30Finland.tuoteinfo@gsk.com<\/td><\/tr> Italy<\/strong>GlaxoSmithKline SpATel: + 39 (0) 45 9218 111<\/td> <\/td><\/tr> \u039a\u03cd\u03c0\u03c1\u03bf\u03c2<\/strong>GlaxoSmithKline (Cyprus) Ltd:\u0397\u03bb: + 357 22 39 70 00gskcyprus@gsk.com<\/td> United Kingdom<\/strong>GlaxoSmithKline UK LtdTel: + 44 (0) 800 221441customercontactuk@gsk.com<\/td><\/tr> Latvia<\/strong>GlaxoSmithKline Latvia SIATel: + 371 67312687lv-epasts@gsk.com<\/td>
<\/td><\/tr>Lithuania<\/strong>GlaxoSmithKline Lithuania UABTel: + 370 5 264 90 00info.lt@gsk.com<\/td><\/tr><\/tbody><\/table><\/figure>\n","protected":false},"excerpt":{"rendered":"