{"id":3769,"date":"2019-12-03T23:25:29","date_gmt":"2019-12-03T23:25:29","guid":{"rendered":"https:\/\/www.sicklecelldisease.org\/?p=3769"},"modified":"2019-12-03T23:25:29","modified_gmt":"2019-12-03T23:25:29","slug":"gbts-oxbryta-voxelotor-tablets-is-approved-for-the-treatment-of-sickle-cell-disease","status":"publish","type":"post","link":"https:\/\/www.sicklecelldisease.org\/2019\/12\/03\/gbts-oxbryta-voxelotor-tablets-is-approved-for-the-treatment-of-sickle-cell-disease\/","title":{"rendered":"GBT\u2019s Oxbryta\u2122 (voxelotor) tablets is approved for the treatment of sickle cell disease"},"content":{"rendered":"

Oxbryta\u2122 (voxelotor) tablets Now Approved<\/strong><\/p>\n

On behalf of GBT, we are happy to share that Oxbryta (pronounced ox-brye-ta) is now approved by the U.S. Food and Drug Administration (FDA). Oxbryta is a prescription medicine used for the treatment of sickle cell disease in adults and children 12 years of age and older.1 It is not known if Oxbryta is safe and effective in children below 12 years of age.1
\nThis indication is approved under accelerated approval based on increase in hemoglobin (Hb). Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).2
\nThis approval has been the result of years of collaboration with the community, and we are so grateful for your role in helping GBT get this to patients quickly!
\n1) Oxbryta is the brand name for voxelotor. This approval represents a historic one, as Oxbryta is the first sickle cell disease drug approved under both the Breakthrough Therapy and Accelerated Approval designations by the FDA.
\n\u00b7 Voxelotor is a hemoglobin S (HbS) polymerization inhibitor.2
\n\u00b7 Nonclinical studies suggest that voxelotor may inhibit red blood cell (RBC) sickling, improve RBC deformability, and reduce whole blood viscosity.2
\n\u00b7 It is a prescription medicine (tablet) taken by mouth once daily, every day.1
\n2) Oxbryta should not be taken if a patient has had an allergic reaction to voxelotor or any of the ingredients in Oxbryta. Oxbryta can cause side effects including: headache, diarrhea, stomach (abdominal) pain, nausea, tiredness, rash and fever.1
\nPatient Support: GBT Source Solutions\u2122<\/strong>
\nAs part of GBT\u2019s commitment to supporting access to care for patients, we have launched GBT Source Solutions, a resource center for patients who have been prescribed Oxbryta by their healthcare provider. GBT Source Solutions will provide support by:
\n\u00b7 Reviewing insurance coverage options and explaining benefits.
\n\u00b7 Coordinating shipment of Oxbryta and explaining Specialty Pharmacy benefits.
\n\u00b7 Helping to pay for treatment with financial and co-pay assistance for eligible patients.
\n\u00b7 Helping to stay on treatment with a nurse support team. The nurse support team is there to support product adherence, and not to replace a patient\u2019s treatment plan. They do not provide medical advice or case management services.
\nYour role<\/strong>
\nYour organization plays a critical role in supporting patients, and we are very thankful for everything you do for people living with SCD. Your collaboration is critical to helping inform patients about Oxbryta and GBT\u2019s patient support services for patients prescribed Oxbryta.
\nIf a patient is interested in learning more about Oxbryta, they should consult their healthcare professional or visit www.Oxbryta.com<\/a>.
\nWe have attached in this email several resources. You may share these with patients, caregivers, and other members of your community.
\n\u2026 Oxbryta fact sheet<\/a>
\n\u2026 Oxbryta patient education brochure<\/a>
\n\u2026 GBT Source Solutions brochure<\/a>
\nPlease feel free to reach out with any questions. We look forward to continuing our collaboration to help improve the lives of SCD patients and provide hope to our community.
\nWarmest regards,
\nJung
\nINDICATION AND IMPORTANT SAFETY INFORMATION<\/strong>
\nINDICATION<\/strong>
\nWhat is OXBRYTA?<\/strong>
\nOXBRYTA is a prescription medicine used for the treatment of sickle cell disease in adults and children 12 years of age and older.
\nIt is not known if OXBRYTA is safe and effective in children below 12 years of age.
\nThis indication is approved under accelerated approval based on increase in hemoglobin (Hb). Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
\nIMPORTANT SAFETY INFORMATION<\/strong>
\nDo not take OXBRYTA if you have had an allergic reaction to voxelotor or any of the ingredients in OXBRYTA. See the end of the patient leaflet for a list of the ingredients in OXBRYTA.
\nIf you are receiving exchange transfusions<\/strong>, talk to your healthcare provider about possible difficulties with the interpretation of certain blood tests when taking OXBRYTA.
\nBefore taking OXBRYTA, tell your healthcare provider about all of your medical conditions, including if you:<\/strong>
\n\u00b7 have liver problems
\n\u00b7 are pregnant or plan to become pregnant. It is not known if OXBRYTA can harm your unborn baby.
\n\u00b7 are breastfeeding or plan to breastfeed. It is not known if OXBRYTA can pass into your breastmilk and if it can harm your baby. Do not breastfeed during treatment with OXBRYTA and for at least 2 weeks after the last dose.
\nTell your healthcare provider about all the medicines you take<\/strong>, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines may affect how OXBRYTA works. OXBRYTA may also affect how other medicines work.
\nWhat are the possible side effects of OXBRYTA?<\/strong>
\nOXBRYTA can cause serious side effects, including:<\/strong>
\nSerious allergic reactions.<\/strong> Tell your healthcare provider or get emergency medical help right away if you get:
\n\u00b7 rash
\n\u00b7 hives
\n\u00b7 shortness of breath
\n\u00b7 swelling of the face
\nThe most common side effects of OXBRYTA include:<\/strong>
\n\u00b7 headache
\n\u00b7 diarrhea
\n\u00b7 stomach (abdominal) pain
\n\u00b7 nausea
\n\u00b7 tiredness
\n\u00b7 rash
\n\u00b7 fever
\nThese are not all the possible side effects of OXBRYTA.
\nCall your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
\nYou may also report side effects to Global Blood Therapeutics at 1-833-428-4968 (1-833-GBT-4YOU).
\nKeep OXBRYTA and all medicines out of the reach of children.<\/strong>
\n1 Patient Information Leaflet 11 2019
\n2 USPI 11 2019<\/p>\n","protected":false},"excerpt":{"rendered":"

Oxbryta\u2122 (voxelotor) tablets Now Approved On behalf of GBT, we are happy to share that Oxbryta (pronounced ox-brye-ta) is now approved by the U.S. Food and Drug Administration (FDA). Oxbryta is a prescription medicine used for the treatment of sickle cell disease in adults and children 12 years of age and older.1 It is not […]<\/p>\n","protected":false},"author":1,"featured_media":3776,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[2],"tags":[],"class_list":["post-3769","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news"],"yoast_head":"\nGBT\u2019s Oxbryta\u2122 (voxelotor) tablets is approved for the treatment of sickle cell disease - Sickle Cell Disease Association of America Inc.<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.sicklecelldisease.org\/2019\/12\/03\/gbts-oxbryta-voxelotor-tablets-is-approved-for-the-treatment-of-sickle-cell-disease\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"GBT\u2019s Oxbryta\u2122 (voxelotor) tablets is approved for the treatment of sickle cell disease - Sickle Cell Disease Association of America Inc.\" \/>\n<meta property=\"og:description\" content=\"Oxbryta\u2122 (voxelotor) tablets Now Approved On behalf of GBT, we are happy to share that Oxbryta (pronounced ox-brye-ta) is now approved by the U.S. Food and Drug Administration (FDA). 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