50 mg powder for concentrate for infusion solution
brentuximab vedotin<\/p>\n\n\n\n
Adcetris contains the active substance brentuximab vedotin<\/strong> , an anti-cancer agent consisting of monoclonal antibodies bound to a substance which is intended to kill cancer cells. This substance is delivered to cancer cells by the monoclonal antibody . A monoclonal antibody is a protein that recognizes certain cancer cells.<\/p>\n\n\n\n Hodgkin’s lymphoma, systemic large cell anaplastic lymphoma, and cutaneous T cell lymphoma are types of cancers in the white blood cells.<\/p>\n\n\n\n Classical Hodgkin’s lymphoma has specific proteins on the cell surface that are different from non-classical Hodgkin’s lymphoma .<\/p>\n\n\n\n Adcetris is used to treat advanced classic Hodgkin’s lymphoma that has not been treated before. Adcetris is co-administered with doxorubicin, vinblastine, and dacarbazine, other chemotherapy drugs used to treat Hodgkin’s lymphoma.<\/p>\n\n\n\n Adcetris is also used as the only drug to reduce the likelihood of classic Hodgkin’s lymphoma returning after an infusion of your own healthy stem cells into your body ( autologous stem cell transplantation ) in patients with certain risk factors.<\/p>\n\n\n\n Adcetris is also used as the sole drug to treat classic Hodgkin’s lymphoma which has:<\/p>\n\n\n\n Systemic large-cell anaplastic lymphoma is a type of non\u2011 Hodgkin’s lymphoma found in the lymph nodes and \/ or other parts of the body.<\/p>\n\n\n\n Adcetris is used to treat systemic large-cell anaplastic lymphoma that has not been previously treated. Adcetris is given together with cyclophosphamide, doxorubicin, and prednisone, which are other chemotherapy drugs used to treat these conditions.<\/p>\n\n\n\n Adcetris is also used to treat large-cell anaplastic lymphoma such as:<\/p>\n\n\n\n Cutaneous T cell lymphoma is a cancer of a certain type of white blood cell called T cell that mainly affects the skin. Adcetris is used to treat cutaneous T cell lymphoma when a specific type of protein is present on the cell surface.<\/p>\n\n\n\n Adcetris is used to treat cutaneous T-cell lymphoma in patients who have previously been treated with at least one blood cancer drug.<\/p>\n\n\n\n When you first receive this medicine or during treatment, tell your doctor about:<\/p>\n\n\n\n To check that it is safe for you to receive this medicine, your doctor will take regular blood tests on you.<\/p>\n\n\n\n Tell your doctor if you are taking, have recently taken, or might take any other medicines. This also applies to herbal preparations and other over-the-counter medicines.<\/p>\n\n\n\n You and your partner must use two effective methods of contraception during your treatment with this medicine. Women must continue to use contraception for 6 months after the last dose of Adcetris.<\/p>\n\n\n\n You should not use this medicine if you are pregnant unless you and your doctor decide that the benefit to you outweighs the potential risk to the unborn baby.<\/p>\n\n\n\n It is important to tell your doctor before and during treatment, if you are pregnant, think you may be pregnant or are planning to have a baby.<\/p>\n\n\n\n If you are breast-feeding, you should discuss with your doctor whether you should receive this medicine.<\/p>\n\n\n\n Men treated with this medicine are advised to freeze semen samples for storage before treatment. Men are advised not to become fathers during treatment with this medicine or for the following six months after the last dose.<\/p>\n\n\n\n Your treatment may affect your ability to drive or use machines. If you do not feel well during the treatment, do not drive or use machines.<\/p>\n\n\n\n This medicine contains 13.2 mg of sodium (the main component of common table salt) in each vial. This corresponds to 0.7% of the recommended maximum daily intake of sodium via the diet of an adult.<\/p>\n\n\n\n If you have any further questions on the use of this product, ask your doctor or nurse who is giving you an infusion.<\/p>\n\n\n\n Dose and frequency<\/strong> The dose of this medicine depends on your body weight.<\/p>\n\n\n\n See the package leaflet for these medicines given in combination with Adcetris for more information on their use and efficacy. After the first dose of Adcetris in combination with chemotherapy, your doctor may also give you a medicine to prevent or alleviate neutropenia (reduced white blood cell count ), as neutropenia may increase the risk of infection. Tell your doctor if you have kidney or liver problems as your doctor may reduce your starting dose or may not recommend Adcetris<\/p>\n\n\n\n The usual dose of Adcetris when given as a single drug is 1.8 mg \/ kg once every 3 weeks for a maximum of one year. If you have liver or kidney problems, your doctor may reduce the starting dose to 1.2 mg \/ kg. Adcetris should only be given to adults. It is not intended for use in children.<\/p>\n\n\n\n How Adcetris is given<\/strong> This medicine is given to you in a vein ( intravenously ) as an infusion. It is given by your doctor or nurse for 30 minutes. Your doctor or nurse will also monitor you during and after the infusion.<\/p>\n\n\n\n If you have any further questions on the use of this product, ask your doctor.<\/p>\n\n\n\n Like all medicines, this medicine can cause side effects , although not everybody gets them. Infusion reactions<\/strong><\/p>\n\n\n\n Drugs of this type (monoclonal antibodies ) can lead to infusion reactions such as:<\/p>\n\n\n\n Infusion reactions of this medicine may occur in more than 1 in 10 people. In general, these types of reactions occur within minutes to several hours after the infusion is completed. However, they may develop more than several hours after infusion one, but this is unusual. These infusion reactions can be severe or even fatal (so-called anaphylactic reaction ). The extent to which infusion-related reactions of this drug are severe or fatal is not known. You can get other medicines, e.g.<\/p>\n\n\n\n to alleviate some of the above reactions if you have already experienced them when you received this type of medicine. If you think you may have had a similar reaction in the past, tell your doctor BEFORE you receive this medicine.<\/p>\n\n\n\n If you develop infusion reactions (as above), your doctor may stop giving you this medicine and start supportive treatment.<\/p>\n\n\n\n If infusion is started again, your doctor may increase the time during which your infusion is given so that you can tolerate it better. Tell your doctor immediately if you notice any of the following symptoms as some of them may be signs of a serious or potentially fatal condition:<\/strong><\/p>\n\n\n\n You may experience the following side effects:<\/p>\n\n\n\n The following side effects have been reported when Adcetris is the only drug: A very common side effect is<\/strong> (can occur in more than 1 in 10)<\/p>\n\n\n\n Common side effects are<\/strong> (may affect up to 1 in 10 people)<\/p>\n\n\n\n Less common side effects are<\/strong> (may affect up to 1 in 100 people)<\/p>\n\n\n\n The following side effects have been reported when Adcetris is given in combination with chemotherapy: Very common side effects (may affect more than 1 in 10 people)<\/strong><\/p>\n\n\n\n Common side effects are<\/strong> (may affect up to 1 in 10 people)<\/p>\n\n\n\n Less common side effects are<\/strong> (may affect up to 1 in 100 people)<\/p>\n\n\n\n If you are an elderly patient (65 years or older), you may be more likely to have serious side effects . 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 vial label and outer carton after EXP. The expiration date is the last day of the specified month. Unopened vial:<\/strong> Store in a refrigerator (2 \u00b0 C – 8 \u00b0 C). Do not freeze.<\/p>\n\n\n\n Keep the vial in the outer carton. Sensitive to light. Reconstituted\/diluted solution:<\/strong> Use immediately or refrigerate (2 \u00b0 C-8 \u00b0 C) and use within 24 hours. Do not use this medicine if you notice any particles or discoloration before administering one.<\/p>\n\n\n\n Medicines should not be disposed of via wastewater or household waste. Your doctor or nurse will discard this medicine. These measures will help to protect the environment.<\/p>\n\n\n\n Adcetris is a white to off-white cake or powder for concentrate for solution for infusion, supplied in a glass vial.<\/p>\n\n\n\n Each pack of Adcetris contains one vial.<\/p>\n\n\n\n Takeda Pharma A \/ S<\/p>\n\n\n\n Delta Park 45 <\/p>\n\n\n\n 2665 Vallensbaek Strand<\/p>\n\n\n\n Denmark Manufacturer<\/strong><\/p>\n\n\n\n Takeda Austria GmbH<\/p>\n\n\n\n St. Peter-Stra\u03b2e 25<\/p>\n\n\n\n A4020 Linz<\/p>\n\n\n\n Austria Delpharm Novara Srl<\/p>\n\n\n\n Via Crosa, 86<\/p>\n\n\n\n 28065 Cerano (NO)<\/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 This leaflet was last modified on 15\/09\/2020<\/p>\n\n\n\n This medicine has received a “conditional marketing authorization”. This means that more information about the drug is expected.<\/p>\n\n\n\n The European Medicines Agency reviews new information on this medicine at least every year and updates this leaflet as needed. Further information on this medicine is available on the European Medicines Agency web site: http:\/\/www.ema.europa.eu\/.<\/p>\n\n\n\n Traceability<\/strong><\/p>\n\n\n\n To facilitate the traceability of biological drugs, the name and manufacturing batch number of the drug must be documented.<\/p>\n\n\n\n Disposal<\/strong><\/p>\n\n\n\n Adcetris is for single use only.<\/p>\n\n\n\n Any unused product or waste material should be disposed of in accordance with local requirements. Instructions for reconstitution<\/strong> Each single-use vial must be reconstituted with 10.5 ml of water for injections to a final concentration of 5 mg \/ ml. Each vial contains 10% overfill, which means 55 mg of Adcetris per vial and a total volume after reconstitution of 11 ml.<\/p>\n\n\n\n Completion of infusion solution<\/strong> Appropriate reconstituted Adcetris must be withdrawn from the vial (s) and injected into an infusion bag containing sodium chloride 9 mg\/ml (0.9%) solution for injection to achieve a final concentration of 0.4-1.2 mg\/ml Adcetris.<\/p>\n\n\n\n The recommended dilution volume is 150 ml.<\/p>\n\n\n\n Reconstituted Adcetris can also be diluted in glucose 50 mg\/ml (5%) solution for injection or Ringer-lactate solution for injection.<\/p>\n\n\n\n Carefully turn the bag upside down to mix the solution containing Adcetris. DO NOT SHAKE.<\/p>\n\n\n\n Any remaining solution in the vial, after the solution has been withdrawn for dilution, must be discarded in accordance with local regulations.<\/p>\n\n\n\n Do not add any other medicines to the reconstituted Adcetris infusion solution or the intravenous infusion set. The infusion line should be flushed after administration with sodium chloride 9 mg\/ml (0.9%) solution for injection, glucose 50 mg\/ml (5%) solution for injection, or Ringer-lactate solution for injection.<\/p>\n\n\n\n After dilution, the Adcetris solution is infused immediately at the recommended infusion rate.<\/p>\n\n\n\n The total storage time of the solution from reconstitution to infusion should not exceed 24 hours.<\/p>\n","protected":false},"excerpt":{"rendered":" Adcetris contains the active substance brentuximab vedotin , an anti-cancer agent consisting of monoclonal antibodies bound to a substance which is intended to kill cancer cells. This substance is delivered to cancer cells by the monoclonal antibody . A monoclonal antibody is a protein that recognizes certain cancer cells.<\/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":[2201,2200],"tags":[11690,11693,11695,11688,11684,11687,11694,11689,11692,11686,11691,11685],"class_list":["post-4759","post","type-post","status-publish","format-standard","hentry","category-a","category-medicines","tag-adcetris","tag-adcetris-powder","tag-benefits-of-adcetris","tag-benefits-of-brentuximab-vedotin","tag-brentuximab-vedotin","tag-brentuximab-vedotin-powder","tag-side-effects-of-adcetris","tag-side-effects-of-brentuximab-vedotin","tag-what-adcetris-is-used-for","tag-what-brentuximab-vedotin-is-used-for","tag-what-is-adcetris","tag-what-is-brentuximab-vedotin"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/4759","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=4759"}],"version-history":[{"count":5,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/4759\/revisions"}],"predecessor-version":[{"id":13125,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/4759\/revisions\/13125"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=4759"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=4759"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=4759"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}2. What you need to know before you receive Adcetris<\/h2>\n\n\n\n
Do not use Adcetris<\/h2>\n\n\n\n
Warnings and cautions<\/h2>\n\n\n\n
Other medicines and Adcetris<\/h2>\n\n\n\n
Pregnancy, breastfeeding, and fertility<\/h2>\n\n\n\n
Driving and using machines<\/h2>\n\n\n\n
Adcetris contains sodium<\/h2>\n\n\n\n
How Adcetris will be given<\/h2>\n\n\n\n
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<\/p>\n\n\n\n4. Possible side effects<\/h2>\n\n\n\n
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<\/p>\n\n\n\n5. How to store Adcetris<\/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
What the medicine looks like and the contents of the pack<\/h2>\n\n\n\n
Marketing Authorization Holder and Manufacturer<\/h2>\n\n\n\n
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<\/p>\n\n\n\nBelgium \/ Belgique \/ Belgien<\/strong>Takeda BelgiumTel \/ Tel: +32 2 464 06 11takeda\u2011belgium@takeda.com<\/td> Lithuania<\/strong>Takeda, UABTel: +370 521 09 070lt\u2011info@takeda.com<\/td><\/tr> Bulgaria<\/strong>Takade BulgariaTel .: + 359 2 958 27 36<\/td> Luxembourg \/ <\/strong>Luxemburg<\/strong>Takeda BelgiumTel \/ Tel: +32 2 464 06 11takeda\u2011belgium@takeda.com<\/td><\/tr> Czech Republic<\/strong>Takeda PharmaceuticalsCzech Republic sroTel: + 420 234722722<\/td> Hungary<\/strong>Takeda Pharma Kft.Tel: +361 2707030<\/td><\/tr> Denmark<\/strong>Takeda Pharma A \/ STel: +45 46 77 11 11<\/td> Malta<\/strong>Takeda Italia SpATel: +39 06 502601<\/td><\/tr> Germany<\/strong>Takeda GmbHTel: +49 (0) 800 825 3325medinfoEMEA@takeda.com<\/td> The Netherlands<\/strong>Takeda Nederland bvTel: +31 23 56 68 777nl.medical.info@takeda.com<\/td><\/tr> Eesti<\/strong>Takeda Pharma ASTel: +372 6177 669<\/td> Norway<\/strong>Takeda Nycomed ASTel: +47 6676 3030infonorge@takeda.com<\/td><\/tr> Greece<\/strong>TAKEDA \u0395\u039b\u039b\u0391\u03a3 \u0391.\u0395T\u03b7\u03bb: +30 210 6387800gr.info@takeda.com<\/td> Austria<\/strong>Takeda Pharma Ges.mbHTel: +43 (0) 800\u201120 80 50<\/td><\/tr> Spain<\/strong>Takeda Pharmac\u00e9utica Espa\u00f1a SATel: +34 917 90 42 22spain@takeda.com<\/td> Poland<\/strong>Takeda Pharma sp. z ooTel .: + 48 22 608 13 00<\/td><\/tr> France<\/strong>Takeda France SASTel .: + 33 1 40 67 33 00medinfoEMEA@takeda.com<\/td> Portugal<\/strong>Takeda Pharmaceuticals Portugal, Lda.Tel: + 351 21 120 1457<\/td><\/tr> Croatia<\/strong>Takeda Pharmaceuticals Croatia dooTel: +385 1 377 88 96<\/td> Romania<\/strong>Takeda Pharmaceuticals SRLTel: +40 21 335 03 91<\/td><\/tr> Ireland<\/strong>Takeda Products Ireland LimitedTel: +44 (0) 1628 537 900<\/td> Slovenia<\/strong>Takeda GmbH, Podru\u017enica SlovenijaTel: + 386 (0) 59 082 480<\/td><\/tr> Iceland<\/strong>Vistor hf.Phone: +354 535 7000vistor@vistor.is<\/td> Slovak Republic<\/strong>Takeda Pharmaceuticals Slovakia sroTel: +421 (2) 20 602 600<\/td><\/tr> Italy<\/strong>Takeda Italia SpATel: +39 06 502601<\/td> Finland \/ Finland<\/strong>Takeda OyPuh \/ Tel: +358 20 746 5000infoposti@takeda.com<\/td><\/tr> \u039a\u03cd\u03c0\u03c1\u03bf\u03c2<\/strong>A. POTAMITIS MEDICARE LTDT\u03b7\u03bb: +357 22583333info@potamitismedicare.com<\/td> Sweden<\/strong>Takeda Pharma ABTel: +46 8 731 28 00infosweden@takeda.com<\/td><\/tr> Latvia<\/strong>Takeda Latvia SIATel: +371 67840082<\/td> United Kingdom<\/strong>Takeda UK LtdTel: +44 (0) 1628 537 900<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n Other sources of information<\/h2>\n\n\n\n
<\/p>\n\n\n\nThe following information is intended for healthcare professionals only:<\/h2>\n\n\n\n
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