{"id":8689,"date":"2020-02-04T13:57:29","date_gmt":"2020-02-04T18:57:29","guid":{"rendered":"https:\/\/www.singlecare.com\/blog\/?p=8689"},"modified":"2021-04-16T15:06:33","modified_gmt":"2021-04-16T19:06:33","slug":"fda-approves-trijardy-xr","status":"publish","type":"post","link":"https:\/\/www.singlecare.com\/blog\/news\/fda-approves-trijardy-xr\/","title":{"rendered":"FDA approves Trijardy XR for type 2 diabetes"},"content":{"rendered":"<p><span style=\"font-weight: 400;\">Good news for adults with type 2 diabetes: You have a new treatment option available to lower blood sugar. The U.S. Food and Drug Administration (FDA) announced approval for Trijardy XR. The new triple-combination pill incorporates three <\/span><a href=\"https:\/\/www.singlecare.com\/conditions\/diabetes-medications-treatments\/\"><span style=\"font-weight: 400;\">diabetes medications<\/span><\/a><span style=\"font-weight: 400;\"> in a once-daily prescription:<\/span><\/p>\n<ul>\n<li><a href=\"https:\/\/singlecare.com\/prescription\/glucophage\"><span style=\"font-weight: 400;\">Glucophage<\/span><\/a><span style=\"font-weight: 400;\"> (<\/span><a href=\"https:\/\/www.singlecare.com\/prescription\/metformin-hcl\"><span style=\"font-weight: 400;\">metformin HCl<\/span><\/a><span style=\"font-weight: 400;\">), a biguanide<\/span><\/li>\n<li><a href=\"https:\/\/www.singlecare.com\/prescription\/tradjenta\"><span style=\"font-weight: 400;\">Tradjenta<\/span><\/a><span style=\"font-weight: 400;\"> (linagliptin), a dipeptidyl peptidase-4 (DPP-4) inhibitor<\/span><\/li>\n<li><a href=\"https:\/\/www.singlecare.com\/prescription\/jardiance\"><span style=\"font-weight: 400;\">Jardiance<\/span><\/a><span style=\"font-weight: 400;\"> (empagliflozin), a sodium-glucose co-transporter 2 (SGLT2) inhibitor<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">This pill is not actually a new medication\u2014it\u2019s just a repackaging of three existing therapies, notes Dr. Marie Bellantoni, a board-certified endocrinologist in The Center for Endocrinology at Mercy Medical Center in Baltimore, Maryland.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">However, the convenience factor could be very appealing.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u201cTo the extent that anything improves patient adherence to medications is good\u2014the pills don\u2019t work if they don\u2019t get into the patient\u2014then this is helpful,\u201d says Dr. Bellantoni. \u201cSome people feel less overwhelmed if they are taking fewer pills.\u201d<\/span><\/p>\n<h2><span style=\"font-weight: 400;\">What is Trijardy XR?<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Some of the medications contained in Trijardy XR may sound familiar to you, if you or a loved one have type 2 diabetes. You may have taken one or all of these at some point.<\/span><\/p>\n<p><a href=\"https:\/\/medlineplus.gov\/druginfo\/meds\/a696005.html\" target=\"_blank\" rel=\"noopener noreferrer\"><span style=\"font-weight: 400;\">Metformin<\/span><\/a><span style=\"font-weight: 400;\"> is typically prescribed as a first-line treatment for people with type 2 diabetes. It helps lower blood sugar levels by decreasing your body\u2019s insulin resistance. It also reduces the amount of glucose produced by your liver and your body\u2019s absorption of sugar. Some people take metformin alone, but others must take it along with other diabetes medications.<\/span><\/p>\n<p><a href=\"https:\/\/www.tradjenta.com\/\" target=\"_blank\" rel=\"noopener noreferrer\"><span style=\"font-weight: 400;\">Tradjenta<\/span><\/a><span style=\"font-weight: 400;\"> is designed to help people with type 2 diabetes manage blood sugar levels, along with exercise and diet. It helps to lower blood sugar levels by decreasing the amount of glucose released by the liver and increasing the amount of insulin produced by the pancreas. It\u2019s often prescribed for people who are already taking diabetes medications and making lifestyle changes but still need help to achieve their target A1C. (A1C measures a person\u2019s average blood sugar levels over a three-month span.) It\u2019s also available in a once-daily tablet.<\/span><\/p>\n<p><a href=\"https:\/\/www.jardiance.com\/\" target=\"_blank\" rel=\"noopener noreferrer\"><span style=\"font-weight: 400;\">Jardiance<\/span><\/a><span style=\"font-weight: 400;\"> is another drug that can help people lower their blood sugar levels along with diet and exercise, but it can also reduce the risk of cardiovascular death in people with type 2 diabetes and heart disease. It\u2019s a once-daily tablet that comes in two formulations (10 mg and 25 mg) and can be taken along with many other medications, including metformin, insulin, beta blockers, ACE inhibitors, and statins.<\/span><\/p>\n<h2><span style=\"font-weight: 400;\">Trijardy XR dosages<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Trijardy XR, marketed by Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company, will be available in four dosages:<\/span><\/p>\n<ul>\n<li><span style=\"font-weight: 400;\">5 mg empagliflozin, 2.5 mg linagliptin, 1000 mg metformin HCl extended-release<\/span><\/li>\n<li><span style=\"font-weight: 400;\">10 mg empagliflozin, 5 mg linagliptin, 1000 mg metformin HCl extended-release<\/span><\/li>\n<li><span style=\"font-weight: 400;\">12.5 mg empagliflozin, 2.5 mg linagliptin, 1000 mg metformin HCl extended-release<\/span><\/li>\n<li><span style=\"font-weight: 400;\">25 mg empagliflozin, 5 mg linagliptin, 1000 mg metformin HCl extended-release<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">According to the manufacturers, Trijardy XR is the first triple-combination pill to incorporate Jardiance. Jardiance was originally approved by the FDA in 2014, but its approval was<\/span><a href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-approves-jardiance-reduce-cardiovascular-death-adults-type-2-diabetes\" target=\"_blank\" rel=\"noopener noreferrer\"> <span style=\"font-weight: 400;\">expanded in late 2016<\/span><\/a><span style=\"font-weight: 400;\"> to acknowledge its use to reduce the risk of cardiovascular death.<\/span><\/p>\n<h2><span style=\"font-weight: 400;\">Trijardy XR warnings<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Trijardy XR is not intended for people with type 1 diabetes or for people with diabetic ketoacidosis. The manufacturer warns that the<\/span><a href=\"https:\/\/docs.boehringer-ingelheim.com\/Prescribing%20Information\/PIs\/Trijardy%20XR\/Trijardy%20XR.pdf?DMW_FORMAT=pdf\" target=\"_blank\" rel=\"noopener noreferrer\"> <span style=\"font-weight: 400;\">drug was not studied in people with pancreatitis<\/span><\/a><span style=\"font-weight: 400;\">, so it\u2019s not recommended for people with that condition.<\/span><a href=\"https:\/\/docs.boehringer-ingelheim.com\/Prescribing%20Information\/PIs\/Trijardy%20XR\/Trijardy%20XR.pdf?DMW_FORMAT=pdf\" target=\"_blank\" rel=\"noopener noreferrer\"> <span style=\"font-weight: 400;\">The manufacturer also cautions people who develop signs of metformin-associated lactic acidosis<\/span><\/a><span style=\"font-weight: 400;\"> to stop taking the drug immediately. It should also not be used in those with severe kidney issues, end-stage renal disease, or those who are on dialysis.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u00a0<\/span><span style=\"font-weight: 400;\">One potential downside of a triple-combination med is it may be more difficult to determine which medication is responsible if you experience an adverse reaction, says Dr. Bellantoni.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u201cThe rational use of a three-drug combination would be after the patient shows efficacy and toleration of the drugs given separately,\u201d she says, \u201cthen they really appreciate decreasing the number of prescription refill copays that they have to make.\u201d\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Still, it\u2019s a promising new treatment option. \u201cWe believe Trijardy XR has the potential to help adults with type 2 diabetes conveniently manage their treatment, especially those who are taking other medications and working on the necessary lifestyle changes,\u201d Dr. Mohamed Eid, vice president for Clinical Development and Medical Affairs, Cardio-Metabolism and Respiratory Medicine for Boehringer Ingelheim Pharmaceuticals, Inc. said in a statement announcing the approval.<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Good news for adults with type 2 diabetes: You have a new treatment option available to lower blood sugar. The U.S. Food and Drug Administration (FDA) announced approval for Trijardy XR. The new triple-combination pill incorporates three diabetes medications in a once-daily prescription: Glucophage (metformin HCl), a biguanide Tradjenta (linagliptin), a dipeptidyl peptidase-4 (DPP-4) inhibitor [&hellip;]<\/p>\n","protected":false},"author":85,"featured_media":6927,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[4114],"tags":[10298,4141],"coauthors":[9482],"class_list":["post-8689","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","tag-diabetes","tag-fda-approvals","wpautop"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.8 (Yoast SEO v27.8) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>FDA approves new type 2 diabetes medication: Trijardy XR<\/title>\n<meta name=\"description\" content=\"Tridjardy XR is a combination of 3 diabetes medications (metformin, linagliptin, empagliflozin). 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