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July 23, 2021 – The U.S. FDA has approved an expanded indication for Bydureon BCise (exenatide extended release), manufactured by AstraZeneca. Initially FDA approved for use in adults in 2017, Bydureon BCise is now also indicated as an adjunct to diet and exercise to improve glycemic control in pediatric patients who are 10-17 years old and have type 2 diabetes mellitus.
Diabetes can cause dangerously high blood sugar levels due to a lack of insulin. Although most children who have diabetes have type 1, a growing number in the United States are developing type 2 diabetes. Bydureon BCise works by helping the body release and use its own insulin to lower blood sugar.
In a clinical trial, individuals from 10 to less than 18 years of age received either exenatide extended release, the active pharmaceutical ingredient in Bydureon BCise, or a placebo. They also received standard of care for type 2 diabetes. Patients who received the exenatide extended-release experienced significant improvement in glycemic control compared to those on placebo.
Recommended dosing is 2mg administered by subcutaneous injection once every seven days, at any time of the day, with or without a meal. Bydureon BCise can be administered at home after proper training in preparation and injection technique from a qualified healthcare provider.
A black box warning cautions that use of exenatide extended-release may carry a risk of thyroid C-cell tumors, including medullary thyroid carcinoma (MTC). The drug’s use is contraindicated in individuals who have a personal or family history of MTC or in individuals who have multiple endocrine neoplasia syndrome type 2 (MEN 2). Individuals taking Bydureon BCise should be counseled on the potential risk of MTC and the symptoms of thyroid tumor.