When BYETTA® (exenatide) injection was approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes by the U.S. Food and Drug Administration (FDA) in 2005, headlines over the following few days highlighted its unique origin:
“FDA OKs Lizard-Derived Shot for Diabetes” – Associated Press
“Lizard Is Source of Newest Diabetes Drug” – Los Angeles Times
“Lizard-Derived Diabetes Drug Is Approved by the F.D.A.” – The New York Times
“FDA OKs Lizard Spit Drug for Diabetes” – WebMD
Though the Gila monster may have led the news, the real story was that with the approval of BYETTA, adult patients with type 2 diabetes (T2D) and prescribers had a new class of diabetes treatment – called glucagon-like peptide-1 receptor agonists, or GLP-1 RAs. The GLP-1 RA class was a new therapeutic option that worked differently from other diabetes medications available at that time.
“As the first GLP-1 receptor agonist approved to treat type 2 diabetes, BYETTA offered a new treatment approach for adult patients who were struggling to meet their A1C goals,” said Dr. Ralph DeFronzo, Deputy Director of the Texas Diabetes Institute and an early clinical researcher of exenatide. “BYETTA helped kick off an era of development that changed the diabetes treatment landscape dramatically over the past decade.”
“At the time of its launch, BYETTA was considered the most innovative new type 2 diabetes products since the early 1990s,” said Curtis Carter, Director of Advocacy, AstraZeneca, who was Manager of Professional Education during the BYETTA approval. “The response from the physician and advocacy community was tremendous. Everyone was excited about the approval, because they knew BYETTA offered another critical treatment option that could help a large number of adults with type 2 diabetes manage the condition.”
Exenatide is the synthetic version of a protein called exendin-4, which comes from the saliva of the Gila monster. Since the launch of BYETTA, AstraZeneca has developed a new formulation and delivery methods for exenatide. In 2012, the FDA approved BYDUREON® (exenatide extended-release) for injectable suspension, the first once-weekly treatment, indicated as an adjunct to diet and exercise, to improve glycemic control in adults with type 2 diabetes. Originally packaged as a single-dose tray, in 2014 AstraZeneca additionally launched the BYDUREON Pen, a pre-filled, single-use pen.The extensive exenatide clinic trial program has helped to inform changes in medical guidelines for treating adults with type 2 diabetes, such as the American Diabetes Association’s recommendations for managing diabetes.
Dr. Ralph DeFronzo was an early investigator and adopter of exenatide.
Exenatide-based products are now marketed in more than 80 countries worldwide, and it is estimated that more than 2 million people have used exenatide products since the launch of BYETTA. Over the past 10 years, the GLP-1 receptor agonist class has grown to include five marketed products in the U.S.
Diabetes is projected to affect more than 592 million people by 2035. To help address the treatment needs of people with diabetes, AstraZeneca will continue to push the boundaries of science in an effort to create life-changing medicines. Additionally, AstraZeneca offers market-leading resources such as SteadySTART, a robust program that connects adults with type 2 diabetes with a live clinical educator, as well as Fit2Me™, a comprehensive, online, personalized diet and lifestyle support program.
WHAT IS BYETTA?
BYETTA is an injectable prescription medicine that may improve blood sugar (glucose) control in adults with type 2 diabetes, when used with diet and exercise. BYETTA is not insulin and should not be taken instead of insulin. BYETTA can be used with Lantus® (insulin glargine), which is a long-acting insulin, but should not be taken with short- and/or rapid-acting insulin.
BYETTA should not be used in people with type 1 diabetes or people with diabetic ketoacidosis (a condition caused by very high blood sugar). BYETTA is not recommended for use in children. BYETTA has not been studied in people who have pancreatitis. BYETTA should not be used in people who have severe kidney problems.
IMPORTANT SAFETY INFORMATION for BYETTA
- Do not take BYETTA if you have had an allergic reaction to exenatide or any of the other ingredients in BYETTA. Severe allergic reactions can happen with BYETTA. Symptoms of a severe allergic reaction include severe rash or itching, swelling of your face, lips, and throat that may cause difficulty breathing or swallowing, feeling faint or dizzy and very rapid heartbeat. If you have any symptoms of a severe allergic reaction, stop taking BYETTA and get medical help right away.
- Do not share your BYETTA Pen with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.
- Inflammation of the pancreas (pancreatitis) may happen, which may be severe and lead to death. Before taking BYETTA, tell your healthcare provider if you have had pancreatitis, stones in your gallbladder (gallstones), a history of alcoholism, or high blood triglyceride levels. Stop taking BYETTA and call your healthcare provider right away if you have pain in your stomach area (abdomen) that is severe, and will not go away, occurs with or without vomiting or is felt going from your abdomen through to your back. These may be symptoms of pancreatitis.
- Your risk for getting low blood sugar (hypoglycemia) is higher if you take BYETTA with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. The dose of your sulfonylurea or insulin medicine may need to be lowered while you use BYETTA. Signs and symptoms of low blood sugar may include headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heartbeat, sweating, and feeling jittery.
- Tell your healthcare provider if you have or had kidney problems or a kidney transplant. BYETTA may cause new or worse problems with the way your kidneys work. Call your healthcare provider right away if you have nausea, vomiting, or diarrhea that will not go away, or if you cannot take liquids by mouth.
- Tell your healthcare provider if you have severe problems with your stomach, such as delayed emptying of your stomach (gastroparesis) or problems with digesting food.
- The most common side effects with BYETTA include nausea, vomiting, diarrhea, feeling jittery, dizziness, headache, acid stomach, constipation, and weakness. Nausea most commonly happens when first starting BYETTA, but may become less over time.
- Before using BYETTA, tell your doctor about all the medicines you take, as taking them with BYETTA may affect how each medicine works. Tell your healthcare provider if you take other diabetes medicines, especially insulin or a sulfonylurea, or birth control pills, an antibiotic, warfarin sodium (Coumadin® or Jantoven®), a blood pressure medicine, water pill, pain medicine, or lovastatin (Altoprev®, Mevacor®, or Advicor®). Take your birth control pills or antibiotics at least one hour before injecting BYETTA.
- Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known if BYETTA will harm your unborn baby. Talk to your healthcare provider first if you are breastfeeding or plan to breastfeed.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
BYDUREON® (exenatide extended-release) for injectable suspension was approved by the U.S. Food and Drug Administration (FDA) in 2012 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. BYDUREON should not be used for treatment of patients with type 1 diabetes or diabetic ketoacidosis. BYDUREON is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise. BYDUREON is not a substitute for insulin. The concurrent use of BYDUREON with insulin has not been studied and is not recommended.
IMPORTANT SAFETY INFORMATION for BYDUREON® (exenatide extended-release) for injectable suspension
- POSSIBLE THYROID TUMORS, INCLUDING CANCER: Tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In animal studies, BYDUREON and medicines that work like it caused thyroid tumors, including thyroid cancer. It is not known if BYDUREON will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people.
- Do not use BYDUREON if you or any of your family members have ever had MTC or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
- Do not use BYDUREON if you have had an allergic reaction to exenatide or any of the other ingredients in BYDUREON.
BYDUREON may cause serious side effects, including:
- Inflammation of the pancreas (pancreatitis).Stop using BYDUREON and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back
- Low blood sugar (hypoglycemia).Your risk for getting low blood sugar may be higher if you use BYDUREON with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may include dizziness or lightheadedness, sweating, confusion or drowsiness, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, mood changes, hunger, weakness, or feeling jittery
- Kidney problems (kidney failure).Tell your healthcare provider if you have or had kidney problems. In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration) which may cause kidney problems to get worse
- Stomach problems.Tell your healthcare provider if you have severe problems with your stomach, such as delayed emptying of your stomach (gastroparesis) or problems digesting food. Other medicines like BYDUREON may cause severe stomach problems. It is not known if BYDUREON causes or worsens stomach problems
- Serious allergic reactions.Stop using BYDUREON and get medical help right away if you have any symptoms of a serious allergic reaction, including itching, rash, or difficulty breathing
- Injection-site reactions.Serious injection-site reactions, with or without bumps (nodules), have happened in some people who use BYDUREON. Some of these injection-site reactions have required surgery. Call your healthcare provider if you have any symptoms of injection-site reactions, including severe pain, swelling, blisters, an open wound, or a dark scab
The most common side effects with BYDUREON may include nausea, diarrhea, headache, vomiting, constipation, itching at the injection site, a small bump (nodule) at the injection site, and indigestion. Nausea is most common when you first start using BYDUREON, but decreases over time in most people as their body gets used to the medicine.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements, as taking them with BYDUREON may affect how each medicine works.
Before using BYDUREON, talk to your healthcare provider about low blood sugar and how to manage it. Tell your healthcare provider if you are taking other diabetes medicines, including insulin or sulfonylureas.
Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known if BYDUREON will harm your unborn baby. Talk to your healthcare provider first if you are breastfeeding or plan to breastfeed.
APPROVED USES for BYDUREON
BYDUREON is an injectable prescription medicine that may improve blood sugar (glucose) in adults with type 2 diabetes mellitus, and should be used along with diet and exercise.
BYDUREON is not recommended as the first choice of medicine for treating diabetes.
BYDUREON is not a substitute for insulin and is not for people with type 1 diabetes or people with diabetic ketoacidosis.
BYDUREON is a long-acting form of the medication in BYETTA® (exenatide) injection so both drugs should not be used at the same time.
It is not known if BYDUREON can be used in people with a history of pancreatitis or if BYDUREON is safe and effective for use in children.
3156200 Last Updated 8/15