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If you have questions about BYETTA (exenatide) injection, please contact the Customer Support Center toll-free at 1-800-868-1190.

*BYETTA is not indicated for the management of obesity, and weight change was a secondary endpoint in clinical trials.

Important Safety Information for BYETTA (exenatide) injection

Contraindications

BYETTA is contraindicated in patients with prior severe hypersensitivity reactions to exenatide or to any of the product components.

Warnings and Precautions

Never Share a BYETTA Pen Between Patients: Pen-sharing poses a risk for transmission of blood-borne pathogens, even if the needle is changed.
Pancreatitis: Based on postmarketing data BYETTA has been associated with acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. After initiation and dose increases of BYETTA, observe patients carefully for pancreatitis (including persistent severe abdominal pain, sometimes radiating to the back, with or without vomiting). If pancreatitis is suspected, BYETTA should be discontinued promptly and should not be restarted if pancreatitis is confirmed.
Hypoglycemia: Increased risk of hypoglycemia when used in combination with a sulfonylurea (SU) or when used with a glucose-independent insulin secretagogues (eg, meglitinides). Clinicians may consider reducing the SU dose in patients receiving BYETTA to reduce the risk of hypoglycemia. When used with insulin, evaluate and consider reducing the insulin dose in patients at increased risk of hypoglycemia.
Renal Impairment: Should not be used in patients with severe renal impairment or end-stage renal disease. Use with caution in patients with renal transplantation or when initiating or escalating the dose in patients with moderate renal failure. Postmarketing reports of altered renal function, including increased serum creatinine, renal impairment, worsened chronic renal failure, and acute renal failure, sometimes requiring hemodialysis and kidney transplantation.
Gastrointestinal Disease: Because exenatide is commonly associated with gastrointestinal adverse reactions, BYETTA is not recommended in patients with severe gastrointestinal disease (eg gastroparesis).
Immunogenicity: Patients may develop antibodies to exenatide. In 3 registration trials, antibody levels were measured in 90% of patients, with up to 4% of patients having high-titer antibodies and attenuated glycemic response. If worsening of or failure to achieve adequate glycemic control occurs, consider alternative antidiabetic therapy.
Hypersensitivity: Postmarketing reports of serious hypersensitivity reactions (eg anaphylaxis and angioedema). If this occurs, patients should discontinue BYETTA and other suspect medications and promptly seek medical advice.
Macrovascular Outcomes: No clinical studies establishing conclusive evidence of macrovascular risk reduction with BYETTA or any other antidiabetic drug.

Most Common Adverse Reactions (=5%)

24-week monotherapy trial vs placebo (PBO): nausea (8% vs 0%).
Three 30-week combination trials of BYETTA added to metformin (MET) and/or SU vs PBO: nausea (44% vs 18%), vomiting (13% vs 4%), and diarrhea (13% vs 6%), feeling jittery (9% vs 4%), dizziness (9% vs 6%), headache (9% vs 6%), dyspepsia (6% vs 3%).
16-week trial of BYETTA added to thiazolidinedione (TZD) ± MET vs PBO: nausea (40% vs 15%), vomiting (13% vs 1%), dyspepsia (7% vs 1%), diarrhea (6% vs 3%).
30-week trial of BYETTA added to insulin glargine ± MET and/or TZD vs PBO: nausea (41% vs 8%), vomiting (18% vs 4%), diarrhea (18% vs 8%), headache (14% vs 4%), constipation (10% vs 2%), dyspepsia (7% vs 2%), asthenia (5% vs 1%).
Hypoglycemia: BYETTA as monotherapy vs PBO, 3.8% (10 mcg) and 5.2% (5 mcg) vs 1.3%; BYETTA vs PBO, with metformin (MET): 5.3% (10 mcg) and 4.5% (5 mcg) vs 5.3%; with SU, 35.7% (10 mcg) and 14.4% (5 mcg) vs 3.3%; with MET + SU, 27.8% (10 mcg) and 19.2% (5 mcg) vs 12.6%; with TZD, 10.7% (10 mcg) vs 7.1%; with insulin glargine, 24.8% (10 mcg) vs 29.5%.
Withdrawals: monotherapy trial: 2 of 155 BYETTA patients withdrew due to headache and nausea vs 0 PBO-treated patients. Three 30-week combination trials of BYETTA added to MET and/or SU vs PBO: nausea (3% vs <1%), vomiting (1% vs 0). 16-week trial of BYETTA added to TZD ± MET vs PBO: nausea (9%) and vomiting (5%), with <1% PBO patients withdrawing due to nausea. 30-week trial of BYETTA added to insulin glargine ± MET and/or TZD vs PBO: nausea (5.1% vs 0), vomiting (2.9% vs 0).

Drug Interactions

Oral Medications: BYETTA slows gastric emptying and can reduce the extent and rate of absorption of orally administered drugs. Use with caution with medications that have a narrow therapeutic index or require rapid gastrointestinal absorption. Oral medications dependent on threshold concentrations for efficacy, such as contraceptives or antibiotics, should be taken at least 1 hour before BYETTA.
Warfarin: Postmarketing reports of increased international normalized ratio (INR) sometimes associated with bleeding with concomitant use of warfarin. Monitor INR frequently until stable upon initiation or alteration of BYETTA.

Use in Specific Populations

Pregnant and Nursing Women: Based on animal data, BYETTA may cause fetal harm and should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. To report drug exposure during pregnancy call 1-800-633-9081. When administered to a nursing woman, a decision should be made whether to discontinue nursing or discontinue BYETTA.
Pediatric Patients: Use in pediatric patients is not recommended as safety and effectiveness have not been established.

Indication and Important Limitations of Use for BYETTA

BYETTA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Not a substitute for insulin and should not be used in patients with type 1 diabetes or diabetic ketoacidosis.
Concurrent use with prandial insulin has not been studied and cannot be recommended.
BYETTA has been associated with acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, based on postmarketing data. It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using BYETTA; consider other antidiabetic therapies for these patients.

Please see full Prescribing Information and Medication Guide for BYETTA (exenatide) injection 5 mcg and 10 mcg.

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.

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References: 1. Buse JB, Bergenstal RM, Glass LC, et al. Use of twice-daily exenatide in basal insulin–treated patients with type 2 diabetes: a randomized, controlled trial.Ann Intern Med. 2011;154:103-112.

2. Riddle MC, Rosenstock J, Gerich J; Insulin Glargine 4002 Study Investigators. The treat-to-target trial: randomized addition of glargine or human NPH insulin to oral therapy of type 2 diabetic patients. Diabetes Care. 2003;26(11):3080-3086.

Reference: 1. Diamant M, Nauck MA, Shaginian R, et al; for the 4B Study Group. Glucagon-like peptide-1 receptor agonist or bolus insulin with optimized basal insulin in type 2 diabetes. Diabetes Care. 2014;37(10):2763-2773.

References: 1. Diamant M, Nauck MA, Shaginian R, et al; for the 4B Study Group. Glucagon-like peptide-1 receptor agonist or bolus insulin with optimized basal insulin in type 2 diabetes. Diabetes Care. 2014;37(10):2763-2773.
2. Yki-Jarvinen H, Juurinen L, Alvarsson M, et al. Initiate Insulin by Aggressive Titration and Education (INITIATE): a randomized study to compare initiation of insulin combination therapy in type 2 diabetic patients individually and in groups. Diabetes Care. 2007;30(6):1364-1369.

References: 1. Diamant M, Nauck MA, Shaginian R, et al; for the 4B Study Group. Glucagon-like peptide-1 receptor agonist or bolus insulin with optimized basal insulin in type 2 diabetes. Diabetes Care. 2014;37(10):2763-2773.

IMPORTANT SAFETY INFORMATION

This product information is intended for US Healthcare Professionals only.

BYETTA, the BYETTA logo, and BYETTA By Your Side are registered trademarks of the AstraZeneca group of companies. The Double B logo is a trademark of the AstraZeneca group of companies. All other trademarks are property of their respective owners.

Indication and Important Limitations of Use for BYETTA

BYETTA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Not a substitute for insulin and should not be used in patients with type 1 diabetes or diabetic ketoacidosis.
Concurrent use with prandial insulin has not been studied and cannot be recommended.
BYETTA has been associated with acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, based on postmarketing data. It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using BYETTA; consider other antidiabetic therapies for these patients.

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3109503 Last Updated 4/15

Adults with type 2 diabetes on insulin glargine alone or in combination with metformin and/or a TZD were enrolled in a 30-week, randomized, double-blind, placebo-controlled clinical study to receive either BYETTA (n=137) or placebo (n=122) in addition to titrated insulin glargine. In both arms, under investigator guidance, insulin was titrated to achieve a targeted fasting glucose level of <100 mg/dL using the Treat-to-Target algorithm. Upon adding BYETTA to insulin glargine, patients with an A1C ≤8% were instructed to decrease their insulin glargine dose by 20%; patients with an A1C >8% maintained their current insulin dose. Patients receiving BYETTA were titrated from the 5-mcg dose to the 10-mcg dose after the first 4 weeks.¹ Please see full Prescribing Information for full dosing algorithm.

30-week trial of BYETTA added to insulin glargine ± MET and/or TZD vs PBO: nausea (41% vs 8%), vomiting (18% vs 4%), diarrhea (18% vs 8%), headache (14% vs 4%), constipation (10% vs 2%), dyspepsia (7% vs 2%), asthenia (5% vs 1%).
The most frequently reported adverse reactions leading to withdrawal for Byetta-treated patients were nausea (5.1%) and vomiting (2.9%). No placebo-treated patients withdrew due to nausea or vomiting.