AstraZeneca today announced that BYDUREON® BCise™ (exenatide extended-release) injectable suspension 2mg is now available in pharmacies across the United States. BYDUREON BCise was recently approved by the U.S. Food and Drug Administration for adults with type-2 diabetes whose blood sugar remains uncontrolled on one or more oral antidiabetic medicines in addition to diet and exercise, to improve glycemic control.
BYDUREON BCise is a new formulation of BYDUREON® (exenatide extended-release) injectable suspension 2mg in an improved once-weekly, single-dose autoinjector device. It is designed for patient ease and convenience in a pre-filled device with a pre-attached hidden needle. The new formulation of BYDUREON BCise is proven to reduce blood sugar levels and may have the added benefit of weight loss, although not a weight loss medicine. The medication is administered in three simple steps - mix, unlock, inject.
Rod Wooten, Vice President, Cardiovascular and Metabolic Diseases, AstraZeneca, said: "We're pleased that BYDUREON BCise, a new once-weekly treatment option in an easy-to-use device, is now available for adults with type 2 diabetes. This new formulation helps to provide consistent glycemic control, in addition to the powerful HbA1c reductions and added benefit of weight loss, now in a simply improved device."
Across two clinical trials, average HbA1c reductions of up to 1.4% and average weight loss of up to 3.1 pounds were achieved when used as monotherapy or as an add-on to metformin, a sulfonylurea, a thiazolidinedione, or any combination of two of these oral antidiabetic medicines at 28 weeks. The most common adverse reactions reported in ≥5% of patients in clinical trials were nausea (8.2%) and adverse events associated with injection-site nodules (10.5%).
Virginia Valentine APRN, BC-ADM, CDE, FAADE, said: "Managing type 2 diabetes is complicated and requires daily attention to meal planning, exercise and medications. A once-weekly prescription option in an easy-to-use device, like BYDUREON BCise, can help simplify a patient's regimen and help them achieve diabetes control goals."
AstraZeneca is committed to supporting patient access to BYDUREON BCise. Eligible commercially insured patients may pay as low as $0 for BYDUREON BCise every month. For more information visit www.BydureonBCise.com.
INDICATION AND LIMITATIONS OF USE
BYDUREON and BYDUREON BCise are both indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
- Not recommended as first-line therapy for patients inadequately controlled on diet and exercise
- Not a substitute for insulin. Should not be used to treat type 1 diabetes or diabetic ketoacidosis
- Not recommended for use with insulin
- Do not coadminister with other exenatide-containing products
- Not studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis
IMPORTANT SAFETY INFORMATION ABOUT BYDUREON AND BYDUREON BCISE, INCLUDING BOXED WARNING
WARNING: RISK OF THYROID C-CELL TUMORS
- Exenatide extended-release causes an increased incidence in thyroid C-cell tumors at clinically relevant exposures in rats compared to controls. It is unknown whether BYDUREON or BYDUREON BCise cause 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 and BYDUREON BCise are 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 with the use of BYDUREON or BYDUREON BCise and inform them of symptoms of thyroid tumors (eg, mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for detection of MTC in patients treated with BYDUREON or BYDUREON BCiseRead More
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