Bydureon Bcise Vs. Ozempic®: Drug Comparison

Bydureon BCise^® (exenatide extended-release) is a glucagon-like peptide-1 (GLP-1) receptor agonist used to improve blood sugar control in adults and pediatric patients (10 years or older) with type 2 diabetes. It works by enhancing insulin secretion, slowing stomach emptying, and reducing the release of glucagon, helping to lower blood sugar levels. The FDA-approved indication for Bydureon BCise is the management of type 2 diabetes, typically in combination with diet and exercise. It is not indicated for type 1 diabetes. It is available as a once-weekly injectable suspension in a pre-filled autoinjector. Common side effects include nausea, injection site reactions, and diarrhea, while serious warnings include a boxed warning for the risk of thyroid C-cell tumors.

Ozempic^® (semaglutide) is an injectable medication used to improve blood sugar control in adults with type 2 diabetes, to reduce the risk of major cardiovascular events in individuals with established heart disease, and to reduce the risk of kdiney problems in certain populations. It works by mimicking the hormone glucagon-like peptide-1 (GLP-1), which increases insulin secretion, decreases glucagon release, and slows gastric emptying. Administered once weekly, Ozempic is often part of a comprehensive treatment plan that includes diet and exercise. Common side effects include nausea, vomiting, diarrhea, and abdominal pain, and it should be used with caution in patients with a history of pancreatitis​.

Glucagon-like peptide-1 (GLP-1) receptor agonist

Glucagon-like peptide-1 (GLP-1) receptor agonist

Bydureon BCise (exenatide) is indicated:

• As an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus

Ozempic (semaglutide) is indicated:

• As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus

• To reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease

• To reduce the risk of sustained eGFR decline, end-stage kidney disease and cardiovascular death in adults with type 2 diabetes mellitus and chronic kidney disease

• Typically taken as an injection once weekly

• Comes in an extended-release injectable suspension: 2 mg of exenatide in a 0.85 mL single-dose autoinjector

• Typically taken as an injection once weekly

• Comes in single-patient-use pens that deliver 0.25 mg, 0.5 mg, 1 mg, or 2 mg per injection

Most common (≥5%) in clinical trials:

• Injection-site nodule

• Nausea

The most common adverse reactions, reported in ≥5% of patients are:

• Nausea

• Vomiting

• Diarrhea

• Abdominal pain

• Constipation

• Personal or family history of medullary thyroid carcinoma or in patients with multiple endocrine neoplasia syndrome type 2

• Prior serious hypersensitivity reaction to exenatide or any of the product components

• History of drug-induced immune-mediated thrombocytopenia from exenatide products

• Drug interactions: orally administered medication, warfarin

• Personal or family history of medullary thyroid carcinoma or in patients with multiple endocrine neoplasia syndrome type 2

• Serious hypersensitivity reaction to semaglutide or any of the excipients in Ozempic

• Drug interactions: Ozempic delays gastric emptying and may impact the absorption of concomitantly administered oral medications

• Acute pancreatitis

• Low blood sugar with concomitant use of insulin secretagogues or insulin

• Acute kidney injury

• Gastrointestinal disease

• Immunogenicity-associated decreased glycemic control

• Hypersensitivity reactions

• Drug-induced immune-mediated thrombocytopenia

• Serious injection-site reactions

• Acute gallbladder disease

• Pancreatitis

• Diabetic retinopathy complications

• Never share an Ozempic pen between patients, even if the needle is changed

• Low blood sugar: Concomitant use with an insulin secretagogue or insulin may increase the risk of low blood sugar, including severe low blood sugar

• Acute kidney injury

• Hypersensitivity reactions

• Acute gallbladder disease

• Females and males of reproductive potential: Discontinue Ozempic in women at least 2 months before a planned pregnancy due to the long washout period for semaglutide

WARNING: RISK OF THYROID C-CELL TUMORS

Exenatide extended-release causes thyroid C-cell tumors at clinically relevant exposures in rats. It is unknown whether Bydureon BCise causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC) in humans, as the human relevance of exenatide extended-release-induced rodent thyroid C-cell tumors has not been determined.

Bydureon BCise is contraindicated in patients with a personal or family history of MTC or in patients with multiple endocrine neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC and the symptoms of thyroid tumors.

WARNING: RISK OF THYROID C-CELL TUMORS

In rodents, semaglutide causes thyroid C-cell tumors. It is unknown whether Ozempic causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as the human relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined.

Ozempic is contraindicated in patients with a personal or family history of MTC or in patients with multiple endocrine neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC and symptoms of thyroid tumors.

*This information is from the label for brand name Bydureon BCise^®. See the Full Prescribing Information for more complete information. Exenatide, the active ingredient in Bydureon BCise, may also be the active ingredient in other medications, and this information may not be accurate for all medications that include the active ingredient exenatide.

*This information is from the label for brand name Ozempic^®. See the Full Prescribing Information for more complete information. Semaglutide, the active ingredient in Ozempic, may also be the active ingredient in other medications, and this information may not be accurate for all medications that include the active ingredient semaglutide.