{"id":337,"date":"2025-05-15T09:38:36","date_gmt":"2025-05-15T09:38:36","guid":{"rendered":"https:\/\/www.udenyca.com\/cms\/?page_id=337"},"modified":"2025-10-06T09:19:28","modified_gmt":"2025-10-06T09:19:28","slug":"important-safety-information-isi","status":"publish","type":"page","link":"https:\/\/www.udenyca.com\/cms\/important-safety-information-isi\/","title":{"rendered":"IMPORTANT SAFETY INFORMATION (ISI)"},"content":{"rendered":"","protected":false},"excerpt":{"rendered":"","protected":false},"author":2,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-337","page","type-page","status-publish","hentry"],"acf":{"what_is_udenyca_title":"What is UDENYCA?","what_is_udenyca_description_short":"<p><strong>UDENYCA <span class=\"no-wrap\">(pegfilgrastim-cbqv)<\/span> is a prescription medicine<\/strong> used to help reduce the chance of infection due to a low white blood cell count, in people with certain types of cancer <span class=\"no-wrap\">(non-myeloid),<\/span> who receive <span class=\"no-wrap\">anti-cancer<\/span> medicines (chemotherapy) that can cause fever and low <\/p>","what_is_udenyca_description_full":"<p><strong>UDENYCA <span class=\"no-wrap\">(pegfilgrastim-cbqv)<\/span> is a prescription medicine<\/strong> used to help reduce the chance of infection due to a low white blood cell count, in people with certain types of cancer <span class=\"no-wrap\">(non-myeloid),<\/span> who receive <span class=\"no-wrap\">anti-cancer<\/span> medicines (chemotherapy) that can cause fever and low white blood cell count.<\/p>","important_safety_information_title":"IMPORTANT SAFETY INFORMATION","important_safety_information_description_short":"<p><strong>Do not take UDENYCA<\/strong> if you have had a serious allergic reaction to pegfilgrastim or filgrastim products.<\/p>\r\n<p><strong>Before taking UDENYCA, tell your healthcare provider about all of your medical conditions, including if you:<\/strong><\/p>\r\n","important_safety_information_description_full":"<h4 class=\"green-title\">IMPORTANT SAFETY INFORMATION<\/h4>\r\n<p><strong>Do not take UDENYCA<\/strong> if you have had a serious allergic reaction to pegfilgrastim or filgrastim products.<\/p>\r\n<p><strong>Before taking UDENYCA, tell your healthcare provider about all of your medical conditions, including if you:<\/strong><\/p>\r\n<ul>\r\n <li>Have a sickle cell disorder<\/li>\r\n<li>Have had severe skin reactions to acrylic adhesives<\/li>\r\n<li>Have kidney problems<\/li> \r\n<li>Are pregnant or plan to become pregnant. It is not known if UDENYCA will harm your unborn baby<\/li>\r\n<li>Are breastfeeding or plan to breastfeed. It is not known if UDENYCA passes into your breast milk<\/li>\r\n<\/ul>\r\n<p><strong>Tell your healthcare provider<\/strong> about all the medicines you take, including prescription and <span class=\"no-wrap\">over-the-counter<\/span> medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.<\/p>\r\n<h4 class=\"green-title mar-b-g\">What are the possible side effects of UDENYCA?<\/h4>\r\n<p><strong>UDENYCA can cause serious side effects, including:<\/strong><\/p>\r\n<p><strong>Spleen rupture:<\/strong> Your spleen may become enlarged and can rupture. A ruptured spleen can cause death. Call your healthcare provider right away if you have pain in the left upper stomach (abdomen) area or your left shoulder.<\/p>\r\n<p><strong>A serious lung problem called acute respiratory distress syndrome (ARDS):<\/strong> Call your healthcare provider or get emergency medical help right away if you have shortness of breath with or without a fever, trouble breathing, or a fast rate of breathing.<\/p>\r\n<p><strong>Serious allergic reactions:<\/strong> UDENYCA can cause serious allergic reactions. These reactions can cause a rash over your whole body, shortness of breath, wheezing, dizziness, swelling around your mouth or eyes, fast heart rate, and sweating. <strong>If you have any of these symptoms, stop using UDENYCA and call your healthcare provider or get emergency medical help right away.<\/strong><\/p>\r\n<p><strong>Sickle cell crisis: <\/strong>You may have a serious sickle cell crisis, which could lead to death, if you have a sickle cell disorder and receive UDENYCA. Call your healthcare provider right away if you have symptoms of sickle cell crisis such as pain or difficulty breathing.<\/p>\r\n<p><strong>Kidney injury (glomerulonephritis): <\/strong>UDENYCA can cause kidney injury. Call your healthcare provider right away if you experience swelling of your face or ankles, blood in your urine (or <span class=\"no-wrap\">dark-colored<\/span> urine), or you urinate less than usual.<\/p>\r\n<p><strong>Increased white blood cell count (leukocytosis):<\/strong> Your healthcare provider will check your blood during treatment with UDENYCA.<\/p>\r\n<p><strong>Decreased platelet count (thrombocytopenia): <\/strong>Your healthcare provider will check your blood during treatment with UDENYCA. Tell your healthcare provider if you have unusual bleeding or bruising during treatment with UDENYCA. This could be a sign of decreased platelet counts, which may reduce your blood\u2019s ability to clot.<\/p>\r\n<p><strong>Capillary leak syndrome: <\/strong>Pegfilgrastim products can cause fluid to leak from blood vessels into your body\u2019s tissues. This condition is called \u201cCapillary Leak Syndrome\u201d (CLS). CLS can quickly cause you to have symptoms that may become <span class=\"no-wrap\">life-threatening.<\/span> Get emergency medical help right away if you develop any of the following\r\nsymptoms:<\/p>\r\n<ul>\r\n<li>Swelling or puffiness and urinating less than usual<\/li>\r\n<li>Trouble breathing<\/li>\r\n<li>Swelling of your stomach area (abdomen) and feeling of fullness<\/li>\r\n<li>Dizziness or feeling faint<\/li>\r\n<li>A general feeling of tiredness<\/li>\r\n<\/ul>\r\n<p><strong>Myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML):<\/strong> If you have breast cancer or lung cancer and are receiving UDENYCA in combination with chemotherapy and radiation therapy, or radiation therapy alone, you may have an increased risk of developing a precancerous blood condition called MDS or a blood cancer called AML. Symptoms of MDS and AML may include tiredness, fever, and easy bruising or bleeding. Call your healthcare provider if you develop these symptoms during treatment with UDENYCA.<\/p>\r\n<p><strong>Inflammation of the aorta (aortitis):<\/strong> Inflammation of the aorta (the large blood vessel that transports blood from the heart to the body) has been reported in patients who received pegfilgrastim products. Symptoms may include fever, abdominal pain, feeling tired, and back pain. Call your healthcare provider if you experience these\r\nsymptoms.<\/p>\r\n<p><strong>Allergies to acrylics (UDENYCA ONBODY\u00ae only): <\/strong>The <span class=\"no-wrap\">on-body<\/span> injector (OBI) for UDENYCA uses acrylic adhesive. If you have had reactions to acrylic adhesives, use of this product may result in a significant reaction.<\/p>\r\n<p><strong>The most common side effects of UDENYCA<\/strong> are pain in the bones, arms, and legs.<\/p>\r\n<p>These are not all the possible side effects of UDENYCA. Tell your healthcare provider about any side effect you experience. For additional information, see the full Prescribing Information or ask your healthcare provider or pharmacist.<\/p>  \r\n<p><strong>You are encouraged to report side effects of prescription drugs to the FDA. Visit <a class=\"text-decoration-underline\" href=\"https:\/\/www.fda.gov\/safety\/medwatch-fda-safety-information-and-adverse-event-reporting-program\" target=\"_blank\" rel=\"noopener\" >www.fda.gov\/medwatch<\/a> or call <span class=\"no-wrap\">1-800-FDA-1088.<\/span><\/strong><\/p>  \r\n<p class=\"mar-bottom-0\">UDENYCA is supplied as:<\/p>  \r\n<ul>\r\n<li>Prefilled syringe: 6 mg\/0.6 mL in a <span class=\"no-wrap\">single-dose<\/span> prefilled syringe for manual use only.<\/li>\r\n<li>Autoinjector: 6 mg\/0.6 mL in a <span class=\"no-wrap\">single-dose<\/span> prefilled autoinjector.<\/li>\r\n<li>UDENYCA ONBODY\u00ae: 6 mg\/0.6 mL in a <span class=\"no-wrap\">single-dose<\/span> prefilled syringe <span class=\"no-wrap\">co-packaged<\/span> with the <span class=\"no-wrap\">on-body<\/span> injector for UDENYCA\u00ae.<\/li>\r\n<\/ul>\r\n<p><strong>For more information, please see the <a class=\"text-decoration-underline\" href=\"https:\/\/www.udenyca.com\/pdf\/udenyca-pi.pdf\"  target=\"_blank\" rel=\"noopener\">full Prescribing Information<\/a> and <a class=\"text-decoration-underline\" href=\"https:\/\/www.udenyca.com\/pdf\/udenyca-patient-information.pdf\" target=\"_blank\" rel=\"noopener\"> Patient Information<\/a>.<\/strong><\/p>"},"banners":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.2 - 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