Free Resources to Help With Starting BYETTA

BYETTA is a treatment option that can help patients with type 2 diabetes reach their A1C goals. A variety of patient support resources that help lead to success are available at no cost to your patients:

BYETTA By Your Side^® is a free support program that provides information and motivation that helps patients start therapy, stay on therapy, and manage their type 2 diabetes.

• Provides patients with support, as well as tips and advice from a team of diabetes experts.
• 90% of BYETTA By Your Side members were taking BYETTA as prescribed by their doctors.¹
• Have your patients visit www.BYETTA.com/ByYourSide to enroll in the program.

Learn more about the BYETTA By Your Side program.

BYETTA Easy Start Line (1-800-868-1190)

If your patients ever have questions about BYETTA or the BYETTA Pen, answers are just a toll-free call away during normal business hours. The BYETTA Easy Start Line is staffed by trained BYETTA specialists who can walk patients through setting up and using the BYETTA Pen.

BYETTA Patient Starter Kit

• Patient-friendly design organized to help patients successfully start BYETTA and know what to expect.
• Comprehensive training DVD featuring a certified diabetes educator.
• Patient education brochure with information about BYETTA and managing type 2 diabetes.

www.BYETTA.com

A variety of patient resources are available 24/7:

• BYETTA Pen Tutorial shows patients how to use the BYETTA Pen to reinforce the training patients receive in their physician's office.
• Patient Education Materials, including brochures and BYETTA Pen user manuals, are available for download.
• Frequently Asked Questions about BYETTA basics, dosing, using the pen, and safety.

Formulary Access Tool

This online formulary tool enables you to download PDF files listing formulary access information of insurance providers covering BYETTA in your state.

We hope these tools and resources provide you with the information you need to help your patients get started on BYETTA.

Indication and Usage

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 cannot be recommended.
• Has not been studied in patients with a history of pancreatitis. 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.

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

• 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 (persistent severe abdominal pain, sometimes radiating to the back, with or without vomiting). If pancreatitis is suspected, BYETTA should be discontinued promptly. BYETTA should not be restarted if pancreatitis is confirmed.
• Increased risk of hypoglycemia when used in combination with glucose-independent insulin secretagogues (eg, sulfonylureas); reduction of the sulfonylurea dose may be needed. When used with insulin, evaluate and consider reducing the insulin dose in patients at increased risk of hypoglycemia.
• 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. BYETTA 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.
• Not recommended in patients with severe gastrointestinal disease (eg, gastroparesis).
• 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.
• 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.
• No clinical studies establishing conclusive evidence of macrovascular risk reduction with BYETTA or any other antidiabetic drug.

Adverse Reactions

• Most common adverse reactions in registration trials associated with BYETTA vs placebo (PBO): nausea (44% vs 18%), vomiting (13% vs 4%), and diarrhea (13% vs 6%). Other adverse reactions ≥5% and more than PBO: feeling jittery, dizziness, headache, and dyspepsia. With a thiazolidinedione (TZD), adverse reactions were similar; as monotherapy, most common was nausea (8% vs 0%). With insulin glargine: 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 incidence, BYETTA vs PBO, with metformin (MET): 5.3% (10 mcg) and 4.5% (5 mcg) vs 5.3%; with SFU, 35.7% (10 mcg) and 14.4% (5 mcg) vs 3.3%; with MET + SFU, 27.8% (10 mcg) and 19.2% (5 mcg) vs 12.6%; with TZD, 10.7% (10 mcg) vs 7.1%; as monotherapy, 3.8% (10 mcg) and 5.2% (5 mcg) vs 1.3%; with insulin glargine, 24.8% (10 mcg) vs 29.5%.
• Withdrawals: as monotherapy, 2 of 155 BYETTA patients withdrew due to headache and nausea vs 0 PBO; with MET and/or SFU vs PBO, nausea (3% vs <1%) and vomiting (1% vs 0); with TZD ± MET, nausea (9%) and vomiting (5%), with <1% of PBO patients withdrawing due to nausea; with insulin glargine vs PBO, nausea (5.1% vs 0), vomiting (2.9% vs 0).

Drug Interactions

• 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. Medications dependent on threshold concentrations for efficacy should be taken at least 1 hour before BYETTA.
• 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

• 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.
• Caution should be exercised when administered to a nursing woman.
• Safety and effectiveness have not been established in pediatric patients.

For complete safety profile and other important prescribing considerations, see the Prescribing Information and Medication Guide.

Reference

1. Data on file, Amylin Pharmaceuticals, Inc.