(Exenatide Extended-release) For Injectable Suspension Fact Sheet

Transcription

BYDUREON (EXENATIDE EXTENDED-RELEASE)FOR INJECTABLE SUSPENSIONFACT SHEETINDICATION AND FORMSBYDUREON (exenatide extended-release) for injectable suspension was approved by the US Food and DrugAdministration (FDA) in 2012 as an adjunct to diet and exercise to improve glycemic control in adults with type 2diabetes. BYDUREON comes in two forms: a Single-dose Pen or a Single-dose Tray. Individuals should discuss withtheir healthcare provider which form of BYDUREON is best for them. BYDUREON should not be used for treatmentof patients with type 1 diabetes or diabetic ketoacidosis. BYDUREON is not recommended as first-line therapy forpatients who have inadequate glycemic control on diet and exercise. BYDUREON is not a substitute for insulin. Theconcurrent use of BYDUREON with insulin has not been studied and is not recommended.1, 2OVERVIEWBYDUREON was the first once-weekly treatment option FDA-approved for adults with type 2 diabetes. A twice-dailyversion of exenatide is also available. Today, BYDUREON is available in more than 40 countries worldwide, includingEuropean (EU) countries. Exenatide is used in nearly 80 countries worldwide, and more than 2 million people havetaken exenatide.3BYDUREON is an injectable prescription medication that belongs to the glucagon-like peptide-1 (GLP-1) receptoragonist class of anti-diabetic therapies.1 An agonist is a molecule, such as a drug or a hormone, that binds to areceptor of a cell and triggers a response by that cell.4 A GLP-1 receptor agonist binds to and activates the GLP-1receptor, which exhibits multiple anti-hyperglycemic actions.5 BYDUREON works with the body to help the pancreasrelease insulin when needed; prevent the release of GLP-1, which triggers the liver to make sugar, when it’s notneeded; slow down how quickly the stomach empties, to send sugar into the blood more slowly; and help reducethe amount of food eaten.1BYDUREON WAS THE FIRST ONCE-WEEKLY TREATMENT OPTION FORADULTS WITH TYPE 2 DIABETES.GLP-1 receptor agonists provide important benefits for patients with type 2 diabetes working to control their bloodsugar. GLP-1 receptor agonists have a strong record of effectiveness in lowering A1C levels in people with type 2diabetes.6 They help lower blood sugar, as measured by A1C levels: according to the DURATION-5 trial, patientstreated with BYDUREON achieved a mean A1C of 7.1% starting at 8.5% compared with a mean A1C of 7.7% starting 2016 AstraZeneca. All rights reserved. BYDUREON, BYETTA, SteadySTART and Fit2Me are registered trademarks of the AstraZeneca group of companies.3216701 2/16

at 8.4% in those treated with exenatide 10 mcg twice daily [10 MCG BID] at 24 weeks.7 GLP-1 receptor agonistsalso have the potential to contribute to weight loss: as a secondary endpoint in the DURATION-5 clinical trial,patients taking BYDUREON achieved weight loss at 24 weeks, with an average loss of 5.1 lbs when starting at214 lbs. BYDUREON and exenatide 10 MCG BID are not approved as weight loss medications.7One dose of BYDUREON lasts a full seven days. Each weekly dose of BYDUREON is made up of tiny microspheresthat hold the medicine. After an injection of BYDUREON and the initial release of medicine, the microspheresslowly break down and gradually release more medicine into the body. By breaking down slowly over time, themicrospheres allow BYDUREON to be released all week long.1The Prescribing Information for BYDUREON includes a Boxed WARNING regarding the risk of thyroid C-celltumors. It is unknown whether BYDUREON causes thyroid C-cell tumors, including medullary thyroid carcinoma(MTC), in humans, as human relevance could not be determined by clinical or nonclinical studies. BYDUREON iscontraindicated in patients with a personal or family history of MTC, in patients with Multiple Endocrine Neoplasiasyndrome type 2 (MEN 2), or history of a serious hypersensitivity reaction to exenatide or any of the productcomponents.1Based on post-marketing data, exenatide has been associated with acute pancreatitis, including fatal and non-fatalhemorrhagic or necrotizing pancreatitis. If pancreatitis is suspected, BYDUREON should be discontinued promptlyand not restarted if pancreatitis is confirmed. Other antidiabetic therapies should be considered in patients with ahistory of pancreatitis.1ASTRAZENECA IS COMMITTED TO SUPPORTING PATIENT ACCESS TOBYDUREON AND CONNECTING PATIENTS WITH THE SUPPORT THEY NEED.AstraZeneca is committed to supporting patient access to BYDUREON and connecting patients with the supportthey need. To help patients get started on BYDUREON, AstraZeneca offers the SteadySTART program, in whicha clinical educator teaches patients how to prepare and administer BYDUREON and provides diabetes educationfocused on healthy eating and being active. SteadySTART educators facilitate face-to-face meetings or providesupport over the phone, focused on incorporating healthy habits into everyday life. The program also offers groupeducational sessions, where educators provide resources, and lead discussions and activities. Another supportprogram by AstraZeneca is Fit2Me , a free online diet and lifestyle support program that covers four key areas ofdiabetes care—food, activity, treatment information and support—and allows people with diabetes to pick theirfavorite ingredients, cuisines and fitness activities to build a customized lifestyle plan. It also provides a personalizeddigital health coach to help guide their journey and track their progress.DOSING AND ADMINISTRATIONBYDUREON has two dosage forms: BYDUREON single-dose tray containing 2-mg vial and BYDUREON Pen singledose 2-mg pen. BYDUREON 2 mg is administered via subcutaneous injection once every seven days (weekly).BYDUREON can be administered any time of day, with or without meals, and should be administered immediatelyafter the dose is prepared.1To see the full BYDUREON Prescribing Information, visit http://www.azpicentral.com/bydureon/pi bydureon.pdf. 2016 AstraZeneca. All rights reserved. BYDUREON, BYETTA, SteadySTART and Fit2Me are registered trademarks of the AstraZeneca group of companies.3216701 2/16

KEY CLINICAL DATAThe FDA approval of BYDUREON was based on the safety and efficacy data from the pivotal DURATION-5 clinicaltrial, in which treatment with BYDUREON resulted in improvements in glycemic control. The DURATION-5 trialwas a randomized open-label clinical study of 252 adult patients with type 2 diabetes and inadequate glycemiccontrol with diet and exercise alone or with oral antidiabetic therapy, including metformin, a sulfonylurea, athiazolidinedione, or a combination of two of these oral type 2 diabetes medications comparing BYDUREON 2 mgonce weekly to exenatide 10 MCG BID (n 129 and n 123, respectively). After 24 weeks of treatment, patientstaking once-weekly BYDUREON experienced a statistically significant mean reduction in HbA1c of 1.6 percentagepoints (8.5% baseline), compared to a reduction of 0.9 percentage points (8.4% baseline) for patients takingexenatide 10 MCG BID. HbA1c is a measure of average blood sugar over three months. Both treatment groupsachieved a reduction in weight by the end of the study, with an average loss of 5.1 lbs or 2.3 kg (213.8 lbs or 97kg baseline) for patients taking BYDUREON and 3.1 lbs or 1.4 kg (207.2 lbs or 94 kg baseline) for patients takingexenatide 10 MCG BID (change in weight was a secondary endpoint and exenatide is not indicated for weight loss).The most frequently reported adverse event in both groups was nausea, reported less frequently by BYDUREONusers (14%) than by exenatide 10 MCG BID users (35%). Other common treatment-emergent adverse events in theBYDUREON group included diarrhea (9.3% vs 4.1%) and injection-site erythema (5.4% vs 2.4%, respectively). Therewere no major hypoglycemic events in either treatment arm. Minor episodes of hypoglycemia occurred in BYDUREON2 mg and exenatide 10 MCG BID patients with concomitant sulfonylurea use (12.5% vs 11.8%, respectively).7The ongoing global clinical development program also includes a cardiovascular outcomes trial, EXSCEL, which aims toenroll more than 14,000 patients.8 For information on ongoing BYDUREON clinical trials, visit www.clinicaltrials.gov.IMPORTANT SAFETY INFORMATION FOR BYDUREON (EXENATIDE EXTENDED-RELEASE) FORINJECTABLE SUSPENSION P OSSIBLE THYROID TUMORS, INCLUDING CANCER: Tell your healthcare provider if you get a lump orswelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptomsof 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 thyroidcancer 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 anendocrine 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 ingredientsin BYDUREON. 2016 AstraZeneca. All rights reserved. BYDUREON, BYETTA, SteadySTART and Fit2Me are registered trademarks of the AstraZeneca group of companies.3216701 2/16

BYDUREON MAY CAUSE SERIOUS SIDE EFFECTS, INCLUDING: Inflammation of the pancreas (pancreatitis). Stop using BYDUREON and call your healthcare provider rightaway 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 BYDUREONwith another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. Signs andsymptoms 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. Inpeople 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, suchas delayed emptying of your stomach (gastroparesis) or problems digesting food. Other medicines likeBYDUREON may cause severe stomach problems. It is not known if BYDUREON causes or worsens stomachproblems Serious allergic reactions. Stop using BYDUREON and get medical help right away if you have any symptomsof a serious allergic reaction, including itching, rash, or difficulty breathing Injection-site reactions. Serious injection-site reactions, with or without bumps (nodules), have happenedin some people who use BYDUREON. Some of these injection-site reactions have required surgery. Call yourhealthcare provider if you have any symptoms of injection-site reactions, including severe pain, swelling,blisters, an open wound, or a dark scabThe 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 whenyou 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-countermedicines, 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 willharm your unborn baby. Talk to your healthcare provider first if you are breastfeeding or plan to breastfeed. 2016 AstraZeneca. All rights reserved. BYDUREON, BYETTA, SteadySTART and Fit2Me are registered trademarks of the AstraZeneca group of companies.3216701 2/16

APPROVED USES FOR BYDUREONBYDUREON is an injectable prescription medicine that may improve blood sugar (glucose) in adults with type 2diabetes 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 beused 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 andeffective for use in children.Please see the enclosed Medication Guide and Full Prescribing Information for BYDUREON 2 mg, includingBoxed WARNING about possible thyroid tumors including thyroid cancer.You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call1-800-FDA-1088.MEDIA INQUIRIESFor media inquiries, contact the U.S. Media Team at 302-885-2677.ADDITIONAL INFORMATIONFor further information, visit ations or www.astrazeneca.com.REFERENCES1.BYDUREON (exenatide extended-release) for injectable suspension [package insert]. Wilmington, DE: AstraZenecaPharmaceuticals LP; March 2015.2.BYDUREON.com. Your Prescription. November 2015. ription.html.Accessed January 19, 2016.3.Data on file, 3223910. IMS (SDI) Total Patient Tracker Database as of February 16, 2016.4.Medline Plus Medical Dictionary. . Accessed February 2016.5.Liu Z and Habener J. Glucagon-like Peptide-1 Activation of TCF7L2-dependent Wnt Signaling Enhances Pancreatic Beta CellProliferation. J. Biol. Chem. 2008;283:8723-8735.6.Garber AJ. Long-Acting Glucagon-Like Peptide 1 Receptor Agonists. Diabetes Care. 2011, 34(2):S279-S284.7.Blevins T, et al. DURATION-5: exenatide once weekly resulted in greater improvements in glycemic control compared withexenatide twice daily in patients with type 2 diabetes. J Clin Endocrinol Metab. 2011;96:1301–10.8.Clinicaltrials.gov. Exenatide Study of Cardiovascular Event Lowering Trial (EXSCEL): A Trial To Evaluate CardiovascularOutcomes After Treatment With Exenatide Once Weekly In Patients With Type 2 Diabetes Mellitus. http://clinicaltrials.gov/ct2/show/NCT01144338. Accessed February 2016. 2016 AstraZeneca. All rights reserved. BYDUREON, BYETTA, SteadySTART and Fit2Me are registered trademarks of the AstraZeneca group of companies.3216701 2/16

BYDUREON has two dosage forms: BYDUREON single-dose tray containing 2-mg vial and BYDUREON Pen single-dose 2-mg pen. BYDUREON 2 mg is administered via subcutaneous injection once every seven days (weekly). BYDUREON can be administered any time of day, with or without meals, and should be administered immediately after the dose is prepared.1 To .