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BYDUREON BCISE- exenatide injection, suspension, extended release

  1. Patient Information
  2. Manufactured For:

Patient Information 

Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).

Risk of Thyroid C-cell Tumors

Inform patients that exenatide extended-release causes benign and malignant thyroid C-cell tumors in rats and that the human relevance of this finding has not been determined. Counsel patients to report symptoms of thyroid tumors (e.g., a lump in the neck, hoarseness, dysphagia, or dyspnea) to their physician[seeBoxed WarningandWarnings and Precautions (5.1)].

Risk of Pancreatitis

Inform patients treated with BYDUREON BCISE of the potential risk for pancreatitis. Explain that persistent severe abdominal pain that may radiate to the back, and which may or may not be accompanied by vomiting, is the hallmark symptom of acute pancreatitis. Instruct patients to discontinue BYDUREON BCISE promptly and contact their healthcare provider if persistent severe abdominal pain occurs[seeWarnings and Precautions (5.2)].

Risk of Hypoglycemia

Inform patients that the risk of hypoglycemia is increased when BYDUREON BCISE is used in combination with an agent that induces hypoglycemia, such as a sulfonylurea or insulin[seeWarnings and Precautions (5.3)]. Explain the symptoms, treatment, and conditions that predispose to the development of hypoglycemia. Review and reinforce instructions for hypoglycemia management when initiating BYDUREON BCISE therapy, particularly when concomitantly administered with a sulfonylurea or insulin[seeWarnings and Precautions (5.3)].

Risk of Acute Kidney Injury

Inform patients treated with BYDUREON BCISE of the potential risk for worsening kidney function and explain the associated signs and symptoms of renal impairment, as well as the possibility of dialysis as a medical intervention if renal failure occurs[seeWarnings and Precautions (5.4)].

Risk of Hypersensitivity Reactions

Inform patients that serious hypersensitivity reactions have been reported during postmarketing use of exenatide. Inform patients that if symptoms of hypersensitivity reaction occur, stop taking BYDUREON BCISE and seek medical advice promptly[seeWarnings and Precautions (5.7)].

Risk of Injection-Site Reactions

Inform patients that there have been postmarketing reports of serious injection-site reactions with or without subcutaneous nodules, with the use of BYDUREON. Isolated cases of injection-site reactions required surgical intervention. Advise patients to seek medical advice if symptomatic nodules occur, or for any signs or symptoms of abscess, cellulitis, or necrosis[seeWarnings and Precautions (5.8)].

Acute Gallbladder Disease

Inform patients of the potential risk for cholelithiasis or cholecystitis. Instruct patients to contact their physician if cholelithiasis or cholecystitis is suspected for appropriate clinical follow-up[seeWarnings and Precautions (5.9)].


Train patients on how to use BYDUREON BCISE properly prior to self-administration. Instruct patients on proper mixing and injection technique to ensure the product is adequately mixed and a full dose is delivered. Refer patients to the accompanying Instructions for Use for complete administration instructions with illustrations.

Inform patients formerly on BYETTA who start BYDUREON BCISE may experience transient elevations in blood glucose concentrations, which generally improve within the first 4 weeks after initiation of therapy[seeDosage and Administration (2.4)].

Treatment with BYDUREON BCISE may also result in nausea, particularly upon initiation of therapy[seeAdverse Reactions (6)].

Inform patients about the importance of proper storage of BYDUREON BCISE[seeHow Supplied/Storage and Handling (16)].

Instruct the patient to review the BYDUREON BCISE Medication Guide and the Instructions for Use each time the prescription is refilled.

Manufactured For: 

AstraZeneca Pharmaceuticals LP

Wilmington, DE 19850


Amylin Ohio LLC

West Chester, OH 45071


Vetter Pharma-Fertigung GmbH & Co. KG

88214 Ravensburg


BYDUREON, BCISE and BYETTA are trademarks of the AstraZeneca group of companies.

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