10 mg \/ ml concentrate for solution for infusion
nivolumab<\/p>\n\n\n\n
OPDIVO is a medicine used to treat:<\/p>\n\n\n\n
It contains the active substance nivolumab which is a\u00a0human\u00a0monoclonal\u00a0antibody, a kind of\u00a0protein\u00a0designed to recognize and bind to specific target substances in the body.<\/p>\n\n\n\n
Nivolumab binds to a target protein called the programmed-dead-1\u00a0receptor\u00a0(PD-1) and PD-1 can block the activity of\u00a0T cells\u00a0(a type of\u00a0white blood cell\u00a0that forms part of the immune system, the body’s natural defenses).\u00a0By binding to PD-1, nivolumab blocks its activity and prevents it from shutting down your\u00a0T cells.\u00a0This increases the activity of T cells against\u00a0melanoma, lung, kidney,\u00a0lymph node, head, and neck, bladder, colon, rectum, stomach,<\/p>\n\n\n\n
esophageal cancer cells or against cancer cells in the transition between the esophagus and stomach.<\/p>\n\n\n\n
OPDIVO can be given in combination with other anticancer medicines. It is important that you also read the package leaflet for these medicines. Ask your doctor if you have any questions about these medicines.<\/p>\n\n\n\n
Talk to your doctor before using OPDIVO as it may cause:<\/p>\n\n\n\n
Note that these signs and symptoms\u00a0may be delayed<\/strong>\u00a0and may develop weeks or months after your last\u00a0dose.\u00a0Before treatment, your doctor will check your general health.\u00a0You will also be able to take\u00a0blood samples<\/strong>\u00a0during your treatment.<\/p>\n\n\n\n Talk to your doctor or nurse before receiving OPDIVO if:<\/strong><\/p>\n\n\n\n Complications of\u00a0stem cell transplantation\u00a0with donor stem cells (\u00a0allogeneic\u00a0stem cell transplantation\u00a0) after treatment with OPDIVO.\u00a0<\/strong>These complications can be serious and lead to death.\u00a0If you have had\u00a0an allogeneic\u00a0stem cell transplant, your healthcare provider will monitor you for signs of complications.<\/p>\n\n\n\n OPDIVO should not be used by children and adolescents under 18 years of age.<\/p>\n\n\n\n Before you receive OPDIVO, tell your doctor<\/strong>\u00a0if you are taking any medicines that lower your immune system, such as\u00a0corticosteroids, as these medicines may affect the effect of OPDIVO.\u00a0However, once you have started treatment with OPDIVO, your doctor may give you\u00a0corticosteroids\u00a0to reduce the possible\u00a0side effects\u00a0that you may experience during your treatment and this will not affect the effectiveness of the medicine.<\/p>\n\n\n\n Tell your doctor<\/strong> if you are taking or have recently taken any other medicines. Do not take any other medicines<\/strong> during your treatment without first talking to a doctor.<\/p>\n\n\n\n Tell your doctor<\/strong> if you are or think you may be pregnant, if you are planning to have a baby or if you are breast-feeding.<\/p>\n\n\n\n Do not use OPDIVO if you are pregnant<\/strong> unless your doctor specifically tells you to. The effects of OPDIVO in pregnant women are not known, but it is possible that the active substance, nivolumab, may harm an unborn baby.<\/p>\n\n\n\n OPDIVO or OPDIVO in combination with ipilimumab may have a minor effect on the ability to drive and use machines. Be careful until you are sure that OPDIVO does not affect you negatively.<\/p>\n\n\n\n Tell your doctor<\/strong>\u00a0if you have been prescribed a low-salt diet (low in sodium) before receiving OPDIVO.\u00a0This medicine contains 2.5 mg\u00a0sodium\u00a0(the main ingredient in table salt\/table salt) per ml concentrate.\u00a0OPDIVO contains 10 mg\u00a0sodium\u00a0per 4 ml\u00a0vial\u00a0, 25 mg\u00a0sodium\u00a0per 10 ml\u00a0vial\u00a0, 30 mg\u00a0sodium\u00a0per 12 ml<\/p>\n\n\n\n vial\u00a0or 60 mg\u00a0sodium\u00a0per 24 ml\u00a0vial, which corresponds to 0.5%, 1.25%, 1.5%, and 3% respectively of the maximum recommended daily intake of\u00a0sodium\u00a0for an adult.<\/p>\n\n\n\n You will also find the main messages from this leaflet in the patient care that you have received from your doctor.\u00a0You must carry the patient card with you and show it to your partner or caregiver.<\/p>\n\n\n\n How much OPDIVO is given<\/strong><\/p>\n\n\n\n When OPDIVO alone is given, the recommended dose is either 240 mg every two weeks or 480 mg every four weeks, depending on what it is used for.<\/p>\n\n\n\n When OPDIVO is given in combination with ipilimumab for the treatment of\u00a0melanoma, the recommended\u00a0dose\u00a0is one of OPDIVO 1 mg nivolumab per kg body weight for the first four\u00a0doses\u00a0(combination phase).\u00a0Thereafter, the recommended\u00a0dose\u00a0is one of OPDIVO 240 mg every two weeks or 480 mg every four weeks (monotherapy phase).<\/p>\n\n\n\n When OPDIVO is given in combination with ipilimumab for the treatment of advanced kidney cancer, the recommended dose is one of OPDIVO 3 mg nivolumab per kg body weight for the first four doses (combination phase). Thereafter, the recommended dose is one of OPDIVO 240 mg every two weeks or 480 mg every four weeks (monotherapy phase).<\/p>\n\n\n\n When OPDIVO is given in combination with ipilimumab for the treatment of advanced colon or rectal cancer, the recommended dose is one of OPDIVO 3 mg nivolumab per kg body weight for the first four doses (combination phase). Thereafter, the recommended dose is one of OPDIVO 240 mg every two weeks (monotherapy phase).<\/p>\n\n\n\n When OPDIVO is given in combination with ipilimumab for the treatment of lung cancer, the recommended dose is one of OPDIVO 360 mg every three weeks.<\/p>\n\n\n\n When OPDIVO is given in combination with\u00a0chemotherapy\u00a0for the treatment of advanced gastric cancer, cancer of the esophagus, gastric cancer, or esophageal cancer, the recommended\u00a0dose\u00a0is one of OPDIVO 360 mg every three weeks or 240 mg every two weeks.<\/p>\n\n\n\n When OPDIVO is given in combination with ipilimumab and\u00a0chemotherapy\u00a0for the treatment of advanced non-small-cell lung cancer, the recommended\u00a0dose\u00a0is one of OPDIVO 360 mg every three weeks.<\/p>\n\n\n\n After two cycles of\u00a0chemotherapy, OPDIVO is given in combination with ipilimumab; the recommended\u00a0dose\u00a0of OPDIVO is 360 mg every three weeks.<\/p>\n\n\n\n When OPDIVO is given in combination with cabozantinib for the treatment of advanced renal cell carcinoma, the recommended\u00a0dose\u00a0is one of OPDIVO 240 mg every two weeks or 480 mg every four weeks.<\/p>\n\n\n\n Based on your\u00a0dose, the correct amount of OPDIVO will be diluted with 9 mg\/ml (0.9%) sodium chloride solution for\u00a0injection\u00a0or 50 mg\/ml (5%) glucose solution for\u00a0injection\u00a0before use.\u00a0More than one\u00a0vial\u00a0of OPDIVO may be required to obtain the correct\u00a0dose.<\/p>\n\n\n\n How OPDIVO is given<\/strong><\/p>\n\n\n\n You will receive treatment with OPDIVO in a hospital or clinic, under the supervision of an experienced doctor.<\/p>\n\n\n\n OPDIVO will be given to you by infusion (drip) into a vein ( intravenously ) for 30 or 60 minutes every two weeks or every four weeks, depending on the dose you receive. Your doctor will continue to give you OPDIVO for as long as you benefit from it or until you no longer tolerate the treatment.<\/p>\n\n\n\n When OPDIVO is given in combination with ipilimumab for the treatment of\u00a0melanoma, advanced renal cell carcinoma, or advanced colon or rectal cancer, you will receive an\u00a0infusion\u00a0for 30 minutes, every three weeks for the first 4\u00a0doses\u00a0(combination phase).\u00a0You will then receive an\u00a0infusion\u00a0for 30 or 60 minutes, every two weeks, or every four weeks, depending on the\u00a0dose\u00a0you receive (the monotherapy phase).<\/p>\n\n\n\n When OPDIVO is given in combination with ipilimumab for the treatment of lung cancer, you will receive an infusion for 30 minutes every three weeks.<\/p>\n\n\n\n When OPDIVO is given in combination with\u00a0chemotherapy\u00a0for the treatment of advanced gastric cancer, cancer of the esophagus, and gastric cancer or esophageal cancer, you will receive an\u00a0infusion\u00a0for 30 minutes every three weeks or every two weeks depending on the\u00a0dose\u00a0you receive.<\/p>\n\n\n\n When OPDIVO is given in combination with ipilimumab and\u00a0chemotherapy\u00a0for the treatment of advanced non-small-cell lung cancer, you will receive an\u00a0infusion\u00a0for 30 minutes every three weeks.<\/p>\n\n\n\n When OPDIVO is given in combination with cabozantinib, you will receive an\u00a0infusion\u00a0for 30 minutes or 60 minutes, every two or four weeks, depending on the\u00a0dose\u00a0you receive.<\/p>\n\n\n\n It is very important for you that you come to your booked visits to get OPDIVO.\u00a0If you miss a visit, ask your doctor when to schedule your next\u00a0dose.<\/p>\n\n\n\n If you stop your treatment, the effect of the medicine may not be there. Do not end treatment with OPDIVO without discussing it with your doctor.<\/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 When OPDIVO is given in combination with other anticancer medicines, you will first be given OPDIVO followed by another medicine.<\/p>\n\n\n\n See the package leaflet for the other medicines to understand how they are to be used. If you have any further questions, ask your doctor.<\/p>\n\n\n\n Like all medicines, this medicine can cause\u00a0side effects, although not everybody gets them.\u00a0Your doctor will discuss these with you and explain the risks and benefits of your treatment.<\/p>\n\n\n\n Pay attention to important symptoms of\u00a0inflammation.\u00a0<\/strong>OPDIVO affects your immune system and can cause\u00a0inflammation\u00a0in parts of the body.\u00a0Inflammation\u00a0can cause serious damage to the body and certain inflammatory conditions can be life-threatening and need treatment or the use of OPDIVO is discontinued.<\/p>\n\n\n\n The following side effects have been reported with OPDIVO alone:<\/strong><\/p>\n\n\n\n Very common (may affect more than 1 in 10 people)<\/strong><\/p>\n\n\n\n Common (can affect up to 1 in 10 people)<\/strong><\/p>\n\n\n\n Uncommon (may affect up to 1 in 100 people)<\/strong><\/p>\n\n\n\n Rare (may affect up to 1 in 1000 people)<\/strong><\/p>\n\n\n\n Other side effects reported without known frequency (can not be calculated from the available data):<\/strong><\/p>\n\n\n\n The following side effects have been reported with OPDIVO in combination with other anticancer medicines<\/strong> (the frequency and severity of the side effects may vary with the combination of the anticancer medicines you get)<\/p>\n\n\n\n Very common (may affect more than 1 in 10 people)<\/strong><\/p>\n\n\n\n Other side effects reported <\/strong>without known frequency <\/strong>(can not be calculated from the available data)<\/strong><\/p>\n\n\n\n Changes in test results<\/strong><\/p>\n\n\n\n OPDIVO alone or in combination may cause changes in the results of certain tests performed by your doctor. These include:<\/p>\n\n\n\n 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 carton and label on the vial 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 – 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 The unopened vial can be stored at controlled room temperature (up to 25 \u00b0 C) and room lighting for up to 48 hours.<\/p>\n\n\n\n Do not save unused\u00a0infusion fluid\u00a0for reuse.\u00a0Any unused product or waste material should be disposed of by local requirements.<\/p>\n\n\n\n OPDIVO concentrate for solution for infusion (sterile concentrate), is a clear to opalescent, colorless to light yellow liquid that may contain a few light particles.<\/p>\n\n\n\n It is available in pack sizes of 1\u00a0vial\u00a0with 4 ml, 1\u00a0vial\u00a0with 10 ml, 1 vial with 12 ml, or 1 vial with 24 ml.<\/p>\n\n\n\n Not all pack sizes may be marketed.<\/p>\n\n\n\n Bristol-Myers Squibb Pharma EEIG<\/p>\n\n\n\n Plaza 254 Ireland<\/p>\n\n\n\n Manufacturer<\/strong><\/p>\n\n\n\n Swords Laboratories Unlimited Company to Bristol-Myers Squibb Cruiserath Biologics 10 mg \/ ml concentrate for solution for infusion
Tell your doctor immediately if<\/strong> you have any of these signs or symptoms, or if they get worse. Do not try to treat your symptoms with other medicines on your own. <\/strong>Your doctor may:<\/p>\n\n\n\nChildren and young people<\/h2>\n\n\n\n
Other medicines and OPDIVO<\/h2>\n\n\n\n
Pregnancy and breastfeeding<\/h2>\n\n\n\n
It is not known if OPDIVO passes into breast milk. A risk to the breastfed baby can not be ruled out. Ask your doctor<\/strong> if you can breast-feed during or after treatment with OPDIVO.<\/p>\n\n\n\nDriving and using machines<\/h2>\n\n\n\n
OPDIVO contains sodium<\/h2>\n\n\n\n
How to use OPDIVO<\/h2>\n\n\n\n
If you miss a dose of OPDIVO<\/h2>\n\n\n\n
If you stop using OPDIVO<\/h2>\n\n\n\n
Possible side effects<\/h2>\n\n\n\n
Common (can affect up to 1 in 10 people)<\/strong><\/p>\n\n\n\n
Uncommon (may affect up to 1 in 100 people)<\/strong><\/p>\n\n\n\n
Rare (may affect up to 1 in 1000 people<\/strong> )<\/p>\n\n\n\n
Tell your doctor immediately if<\/strong>\u00a0you get any of the above\u00a0side effects.\u00a0Do not try to treat the symptoms with other medicines on your own.<\/p>\n\n\n\nHow to store OPDIVO<\/h2>\n\n\n\n
Contents of the pack 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
Blanchardstown Corporate Park 2
Dublin 15, D15 T867<\/p>\n\n\n\n
Cruiserath Road, Mulhuddart
Dublin 15, D15 H6EF
Ireland<\/p>\n","protected":false},"excerpt":{"rendered":"
\nnivolumab<\/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":[2200,18526],"tags":[20170,20175,20166,20169,20171,20174,20167,20172,20168,20173],"class_list":["post-19862","post","type-post","status-publish","format-standard","hentry","category-medicines","category-o","tag-benefits-of-nivolumab","tag-benefits-of-opdivo","tag-nivolumab","tag-nivolumab-side-effects","tag-opdivo","tag-opdivo-side-effects","tag-what-is-nivolumab","tag-what-is-opdivo","tag-what-nivolumab-is-used-for","tag-what-opdivo-is-used-for"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/19862","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=19862"}],"version-history":[{"count":5,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/19862\/revisions"}],"predecessor-version":[{"id":19915,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/19862\/revisions\/19915"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=19862"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=19862"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=19862"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}