{"id":61072,"date":"2023-10-30T10:59:07","date_gmt":"2023-10-30T14:59:07","guid":{"rendered":"https:\/\/www.singlecare.com\/blog\/?p=61072"},"modified":"2024-03-18T18:35:34","modified_gmt":"2024-03-18T22:35:34","slug":"zituvio-fda-approval","status":"publish","type":"post","link":"https:\/\/www.singlecare.com\/blog\/news\/zituvio-fda-approval\/","title":{"rendered":"FDA approves Zituvio for Type 2 diabetes"},"content":{"rendered":"<p><span style=\"font-weight: 400;\">People with Type 2 diabetes now have another option to help manage blood sugar. The U.S. Food and Drug Administration (FDA) approved Zituvio (sitagliptin) for adults with Type 2 diabetes. Manufactured by Zydus Pharmaceuticals, this medication joins other diabetes medications with the same active ingredient that are already on the market, namely <\/span><a href=\"https:\/\/www.singlecare.com\/prescription\/januvia\"><span style=\"font-weight: 400;\">Januvia<\/span><\/a><span style=\"font-weight: 400;\"> (sitagliptin) and <\/span><a href=\"https:\/\/www.singlecare.com\/prescription\/janumet\"><span style=\"font-weight: 400;\">Janumet<\/span><\/a><span style=\"font-weight: 400;\">, a metformin-sitagliptin combination medication.\u00a0\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">This approval is noteworthy because in 2022 the <\/span><a href=\"https:\/\/www.fda.gov\/drugs\/drug-safety-and-availability\/fda-works-avoid-shortage-sitagliptin-following-detection-nitrosamine-impurity\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">FDA found nitrosamine impurities in certain samples of sitagliptin<\/span><\/a><span style=\"font-weight: 400;\">, raising concerns about potential shortages of these two drugs. Merck is still working to resolve the <\/span><a href=\"https:\/\/www.reuters.com\/business\/healthcare-pharmaceuticals\/merck-set-remove-cancer-causing-chemical-top-diabetes-drugs-bloomberg-news-2023-01-17\/\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">cause of the contamination<\/span><\/a><span style=\"font-weight: 400;\">. Prior to the approval, Zituvio underwent quality testing to ensure it was not contaminated with these potential carcinogens.<\/span><\/p>\n<h2><span style=\"font-weight: 400;\">What is Zituvio (sitagliptin)?<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Zituvio (<\/span><a href=\"https:\/\/medlineplus.gov\/druginfo\/meds\/a606023.html\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">sitagliptin<\/span><\/a><span style=\"font-weight: 400;\">) is an oral diabetes medication, taken by mouth once a day in 25 mg, 50 mg, or 100 mg dosages. Sitagliptin is used alone and also in combination with <\/span><a href=\"https:\/\/www.ncbi.nlm.nih.gov\/books\/NBK518983\/\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">metformin<\/span><\/a><span style=\"font-weight: 400;\">. <\/span><a href=\"https:\/\/www.singlecare.com\/prescription\/metformin-hcl\"><span style=\"font-weight: 400;\">Metformin<\/span><\/a><span style=\"font-weight: 400;\">, sold under the brand names Fortamet and Glumetza, is still considered the first-line treatment for Type 2 diabetes. However, <\/span><a href=\"https:\/\/www.frontiersin.org\/articles\/10.3389\/fendo.2019.00389\/full\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">research<\/span><\/a><span style=\"font-weight: 400;\"> shows sitagliptin is an effective second-line therapy when metformin alone fails. Zituvio is most effective as an adjunct to exercise and diet to improve glycemic (blood sugar) control in adults with Type 2 diabetes. Zituvio is not indicated for people with Type 1 diabetes.\u00a0<\/span><\/p>\n<h2><span style=\"font-weight: 400;\">How does Zituvio work?<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Zituvio (<\/span><a href=\"https:\/\/medlineplus.gov\/druginfo\/meds\/a606023.html\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">sitagliptin<\/span><\/a><span style=\"font-weight: 400;\">) is in a class of medications called dipeptidyl peptidase-4 (DPP-4) inhibitors. Also known as gliptins, these medications work by spurring the pancreas to produce more insulin to allow your body to lower your blood sugar levels. <\/span><a href=\"https:\/\/www.ncbi.nlm.nih.gov\/books\/NBK542331\/\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">Other DPP-4 inhibitors<\/span><\/a><span style=\"font-weight: 400;\"> approved for Type 2 diabetes include <\/span><a href=\"https:\/\/www.singlecare.com\/prescription\/saxagliptin-hcl\"><span style=\"font-weight: 400;\">Onglyza (saxagliptin)<\/span><\/a><span style=\"font-weight: 400;\">, <\/span><a href=\"https:\/\/www.singlecare.com\/prescription\/tradjenta\"><span style=\"font-weight: 400;\">Tradjenta (linagliptin)<\/span><\/a><span style=\"font-weight: 400;\">, and <\/span><a href=\"https:\/\/www.singlecare.com\/prescription\/nesina\"><span style=\"font-weight: 400;\">Nesina (alogliptin)<\/span><\/a><span style=\"font-weight: 400;\">.\u00a0<\/span><\/p>\n<h2><span style=\"font-weight: 400;\">What are the possible side effects of Zituvio?<\/span><\/h2>\n<p><a href=\"https:\/\/www.ncbi.nlm.nih.gov\/books\/NBK542331\/\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">Research<\/span><\/a><span style=\"font-weight: 400;\"> suggests that gliptins are generally not associated with a high incidence of adverse events. The most <\/span><a href=\"https:\/\/my.clevelandclinic.org\/health\/drugs\/20653-sitagliptin-tablets\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">common side effects<\/span><\/a><span style=\"font-weight: 400;\"> of sitagliptin include:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Headache<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Stuffy or runny nose<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Sore throat<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Hypoglycemia (low blood sugar)<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">Hypoglycemia is more common when taking sitagliptin in addition to a sulfonylurea drug (such as glimepiride, glipizide, or glyburide) or insulin. <\/span><a href=\"https:\/\/www.mayoclinic.org\/drugs.\/sitagliptin.\/drg-20069730?p=1\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">Less common<\/span><\/a><span style=\"font-weight: 400;\">, <\/span><a href=\"https:\/\/medlineplus.gov\/druginfo\/meds\/a606023.html\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">more serious side effects<\/span><\/a><span style=\"font-weight: 400;\"> are also possible, and require an immediate call to your healthcare provider, or emergency medical attention, such as:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Stomach pain<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Diarrhea<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Fever<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Nausea and vomiting<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Symptoms of heart failure, such as shortness of breath, swelling of feet or ankles, or rapid weight gain<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Joint pain<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Pancreatitis (severe pain in the upper stomach, with or without vomiting)<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">If you experience symptoms of an allergic reaction (hives, trouble breathing or swallowing, or swelling of the face, lips, tongue, or throat) or skin reaction (blistering\/peeling skin, rash, fever, sore throat, burning eyes), get emergency medical help right away.<\/span><span style=\"font-weight: 400;\"><br \/>\n<\/span><span style=\"font-weight: 400;\"><br \/>\n<\/span><b>RELATED: <\/b><a href=\"https:\/\/www.singlecare.com\/blog\/januvia-side-effects\/\"><b>Januvia side effects<\/b><\/a><b> | <\/b><a href=\"https:\/\/www.singlecare.com\/blog\/janumet-side-effects\/\"><b>Janumet side effects<\/b><\/a><span style=\"font-weight: 400;\">\u00a0<\/span><\/p>\n<h2><span style=\"font-weight: 400;\">When will Zituvio be available?<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Zydus has not announced when Zituvio will be available for purchase.<\/span><\/p>\n<h2><span style=\"font-weight: 400;\">How much will Zituvio cost?<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Zydus has not announced pricing for Zituvio. \u201cThrough our industry-leading capabilities, we pride ourselves in finding innovative ways to bring value to the healthcare systems by providing affordable medicines for our patients,\u201d said Dr. Punit Patel, CEO of Zydus Pharmaceuticals, Americas in a <\/span><a href=\"https:\/\/www.prnewswire.com\/news-releases\/zydus-receives-usfda-approval-for-zituvio-to-treat-adult-patients-with-type-2-diabetes-mellitus-301963298.html\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">statement<\/span><\/a><span style=\"font-weight: 400;\">. \u201cWe look forward to bringing additional innovative products in the future that align with our purpose to empower patients to live healthier and more fulfilled lives.\u201d<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>People with Type 2 diabetes now have another option to help manage blood sugar. The U.S. Food and Drug Administration (FDA) approved Zituvio (sitagliptin) for adults with Type 2 diabetes. Manufactured by Zydus Pharmaceuticals, this medication joins other diabetes medications with the same active ingredient that are already on the market, namely Januvia (sitagliptin) and [&hellip;]<\/p>\n","protected":false},"author":135,"featured_media":61074,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[4589,4114],"tags":[10298,4141,8905],"coauthors":[9482],"class_list":["post-61072","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-drug-info","category-news","tag-diabetes","tag-fda-approvals","tag-seasonal","wpautop"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.4 (Yoast SEO v27.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>FDA approves Zituvio, a Januvia alternative | SingleCare<\/title>\n<meta name=\"description\" content=\"Zituvio, with the same active ingredient as Januvia, is approved by the FDA. 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