Bydureon BCise Risks, Warnings, and Complications

RISK OF THYROID TUMORS: Studies in rats have shown that extended-release exenatide (Bydureon BCise) can cause thyroid C-cell tumors. The risk is higher at larger doses and with a longer treatment duration. Other drugs in the same class, glucagon-like peptide-1 (GLP-1) receptor agonists, have also been linked to an increased risk of thyroid tumors in mice and rats. It is unknown if Bydureon BCise can cause thyroid tumors in humans, including thyroid C cell tumors and medullary thyroid carcinoma (MTC). There are postmarketing reports of medullary thyroid carcinoma in patients who received liraglutide, another GLP-1 RA. 

Exenatide extended release (Bydureon BCise) is contraindicated in people who have a personal or family history of medullary thyroid carcinoma and in patients who have multiple endocrine neoplasia type 2 (MEN 2). 

Screening for thyroid tumors with lab tests like serum calcitonin or imaging tests like thyroid ultrasound is of unclear benefit in the early detection of thyroid cancer in patients treated with exenatide extended release. 

Seek immediate medical attention for signs of thyroid tumors, such as a mass in the neck, difficulty swallowing, difficulty breathing, or persistent hoarseness.

ACUTE PANCREATITIS: Acute pancreatitis (inflammation of the pancreas) has been reported in people receiving GLP-1 RA drugs, including Bydureon BCise. Both fatal and non-fatal hemorrhagic or necrotizing pancreatitis have been reported. Seek immediate medical attention for symptoms of pancreatitis, such as severe abdominal pain that may radiate to the back and may or may not be accompanied by vomiting. You will need to stop taking the medicine if you develop suspected or confirmed pancreatitis.

HYPOGLYCEMIA: Treatment with Bydureon BCise in combination with insulin or insulin secretagogues (for example, sulfonylureas) can increase the risk of hypoglycemia (low blood sugar), including severe hypoglycemia which is a medical emergency. For example, in insulin glargine treated patients. Your doctor may adjust the doses of your other diabetes medications to lower the risk. Make sure you know how to recognize hypoglycemia (low blood sugar) and what to do if it occurs (such as drinking some fruit juice or taking glucose tablets).

ACUTE KIDNEY INJURY FROM VOLUME DEPLETION: There are reports of acute kidney injury, including severe cases requiring hemodialysis, in people treated with exenatide and other GLP-1 drugs. The majority of these adverse events have occurred in people who developed gastrointestinal side effects to the drug, such as severe nausea, vomiting, and diarrhea, which led to dehydration. Your doctor will monitor kidney function if you develop side effects that can cause volume depletion, especially when first starting treatment with Bydureon BCise. This drug is not recommended for people with moderate renal impairment (eGFR below 45) due to a risk of worsened chronic renal failure or end-stage renal disease. Patients with mild renal impairment need to be monitored regularly while on this drug.

SEVERE GASTROINTESTINAL ADVERSE REACTIONS: GLP-1 receptor agonists, including exenatide extended release (Bydureon BCise) are linked to potentially serious gastrointestinal adverse reactions. These drugs are not recommended for patients with severe gastroparesis (stomach paralysis).

IMMUNOGENICITY AND DECREASED GLYCEMIC CONTROL: Continued treatment with Bydureon BCise can lead to the formation of anti-exenatide antibodies and decreased glycemic control in both adults and children. If you have worsening glycemic control or failure to achieve the target hemoglobin A1c, your doctor will consider stopping treatment with this drug and starting you on alternative antidiabetic medications. 

HYPERSENSITIVITY REACTIONS: There are reports of serious hypersensitivity reactions, including anaphylaxis (throat closing) and angioedema (swelling) in people who received exenatide, the active ingredient in Bydureon BCise. Stop taking the drug and seek emergency medical attention at the first sign of an allergic reaction. Before starting treatment, tell your doctor if you have had a severe allergic reaction to other similar drugs (GLP-1 RAs). 

DRUG-INDUCED THROMBOCYTOPENIA: Use of exenatide (Bydureon BCise) can lead to immune-mediated thrombocytopenia (low platelets), which can cause serious bleeding. This is an immune-mediated reaction, and it leads to the formation of exenatide-dependent anti-platelet antibodies that cause platelet destruction. Contact your doctor immediately if you develop any unusual bruising or bleeding while taking Bydureon BCise. If your doctor diagnoses drug-induced thrombocytopenia, you should not take this drug again. The immune-mediated thrombocytopenia can persist for up to 10 weeks even after stopping treatment.

SERIOUS INJECTION SITE REACTIONS: There are postmarketing reports of serious injection site reactions, including cellulitis, abscess, and necrosis, with or without subcutaneous nodules (lumps in the skin), in patients using Bydureon BCise, with some patients requiring surgical interventions.

ACUTE GALLBLADDER DISEASE: Patients receiving extended-release exenatide (Bydureon BCise) can develop acute gallbladder disease, including cholelithiasis (gallstones) or cholecystitis (inflammation). 

PULMONARY ASPIRATION: Bydureon BCise and other GLP-1 RAs delay gastric emptying. This can lead to residual food in the stomach even after appropriate fasting before a surgery. There are reports of pulmonary aspiration (swallowing food into the lungs) in patients who were on GLP-1 receptor agonists and underwent elective surgeries requiring general anesthesia or deep sedation. Tell your surgeon if you are on Bydureon BCise before any planned surgeries. They may modify fasting recommendations or temporarily stop Bydureon BCise before your surgery.