Bydureon (Exenatide) Pens

Bydureon carries a risk of thyroid C-cell tumors, including medullary thyroid carcinoma (MTC). Patients with a personal or family history of MTC or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) should not use this medication. Regular monitoring for symptoms of thyroid tumors, such as a lump in the neck or hoarseness, is recommended.

Bydureon can be used by itself or if you cannot take metformin. It also can be used in combination with the drugs listed below. The mixture is used when these drugs no longer provide enough control of blood sugar levels on their own.

– Metformin
– A sulfonylurea (SU)
– Metformin and an SU
– Basal insulin
– Basal insulin and metformin

Do Not Use Bydureon If You:

– Are allergic to exenatide or any of the ingredients in this drug.
– Have severe kidney disease or are on dialysis.
– Have diabetic ketoacidosis (accumulation of ketones in blood and urine)
– Have type 1 diabetes.
– Are under 18 years old.

To help avoid side effects and ensure proper use, talk to your healthcare professional before taking Bydureon. Talk about any health conditions or problems you may have, including if you:

– Are taking other drugs to control blood sugar.
– Are taking a blood thinner such as warfarin.
– Have a high heart rate (fast pulse).
– Have a condition called heart block.
– Have any heart disease, such as angina, history of a heart attack, or heart rhythm disturbances.
– Have severe problems with your stomach (gastroparesis).
– Have severe vomiting and diarrhea, and dehydration.
– Have a history of problems with your pancreas, stones in your gallbladder.
– Are breastfeeding or plan to breastfeed.
– Are over 65 years old.

Common side effects of Bydureon include:

– Diarrhea
– Constipation
– Nausea
– Injection site reactions
– Low blood sugar
– Headache
– Injection site nodule
– Indigestion

Seek emergency medical attention immediately or call the Poison Help line at 1-800-222-1222.

Overdose can cause severe nausea and vomiting, or signs of low blood sugar (headache, hunger, irritability, dizziness, feeling shaky).

Do not use it if you are pregnant or planning to have a baby. It is not known if Bydureon will harm your unborn baby. Women who can have children should use effective means of birth control while they are taking Bydureon. Stop Bydureon at least three months before planning to become pregnant.

Thyroid C-Cell Tumors

Bydureon has been shown to cause thyroid C-cell tumors in rats. Other GLP-1 receptor agonists have been known to cause thyroid C-cell adenomas and carcinomas as well. Liraglutide, for example, has demonstrated medullary thyroid carcinoma (MTC) in post-marketing data, though causality cannot be determined at this time.

Currently, it is not known if Bydureon can induce thyroid C-cell tumors, but those with a history of MTC should avoid using Bydureon. Patients should look out for MTC symptoms, such as a neck mass, dysphagia, hoarseness, or dyspnea. If these signs are present, patients should be evaluated for thyroid disease.

Acute Pancreatitis

Both fatal and non-fatal hemorrhagic or necrotizing acute pancreatitis cases have been reported in post-marketing data. Patients should be monitored for pancreatitis signs, such as abdominal pain or vomiting. If these symptoms occur, Bydureon should be stopped immediately, and pancreatitis should be managed appropriately. Therapy with Bydureon should not be reinitiated in the presence of actual pancreatitis.

Hypoglycemia with Concomitant Use of Insulin Products

Bydureon can cause hypoglycemia when combined with other products that lower blood glucose, such as insulin. Dose adjustments to insulin may be required to prevent the development of hypoglycemia. Patients should be made aware of other drugs that can potentiate the glycemic effects of Bydureon and cause hypoglycemia. Patients should also be counseled on typical signs and symptoms of low blood sugar.

Acute Kidney Injury

Bydureon runs the risk of causing nausea and vomiting with transient hypovolemia, potentially impairing renal function. Bydureon has been reported to potentially cause elevated serum creatinine or worsen chronic and acute renal failure, resulting in the need for a kidney transplant or hemodialysis. In some cases, other drugs with renal effects such as angiotensin-converting enzyme inhibitors and diuretics were being used concomitantly. Multiple cases of altered renal function have been reversed with supportive care and halting of causative agents. Because of these occurrences, Bydureon should not be used in those with an eGFR of less than 45 mL/min/1.73 m².

Gastrointestinal Disease

Bydureon has been shown to cause gastrointestinal (GI) side effects such as nausea, vomiting, and diarrhea. Because Bydureon has not been analyzed in pre-existing GI diseases like gastroparesis, it is not recommended for use in patients with severe GI disease.

Immunogenicity

Patients can have anti-exenatide antibodies following treatment with Bydureon. The presence of antibodies has been associated with an attenuated glycemic response. If glucose control worsens or glycemic targets are not reached, providers should switch patients to another therapy.

Hypersensitivity Reactions

Bydureon has been shown to cause severe hypersensitivity reactions, including anaphylaxis and angioedema. Patients with a history of hypersensitivity reactions with other GLP-1 receptor agonists should be closely observed for allergic reactions. If anaphylaxis or angioedema occurs, Bydureon should be stopped, and the patient should seek medical attention.

Drug-Induced Thrombocytopenia

Drug-induced thrombocytopenia involves the immune system’s development of exenatide-dependent antibodies against platelets. When Bydureon is used, these antibodies can damage platelets and cause severe bleeding. Drug-induced thrombocytopenia can be fatal, and thus Bydureon should be stopped instantly if suspected. If confirmed, Bydureon should not be initiated.

Injection Site Reactions

Bydureon has been reported to cause severe injection-site reactions. These reactions include necrosis, abscess, and cellulitis, potentially with the presence of subcutaneous nodules. Isolated cases will necessitate intervention with surgery.

Acute Gallbladder Disease

Other GLP-1 receptor agonists have been shown to cause acute occurrences of gallbladder disease, such as cholelithiasis or cholecystitis. If gallbladder disease is suspected, providers should provide appropriate clinical interventions and monitoring.

For more information on Bydureon, visit AstraZeneca’s product monograph.

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