Bydureon Prescribing Information
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- 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 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 [see Warnings and Precautions (5.1) and Nonclinical Toxicology (13.1)].
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- BYDUREON BCISE is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk for MTC with the use of BYDUREON BCISE and inform them of symptoms of thyroid tumors (e.g., 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 BCISE [see Contraindications (4) and Warnings and Precautions (5.1)].
BYDUREON BCISE 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 [see Clinical Studies (14)].
Limitations of Use
BYDUREON BCISE:
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- Is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise because of the uncertain relevance of the rat thyroid C-cell tumor findings to humans [see Warnings and Precautions (5.1)].
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- Is not indicated for use in patients with type 1 diabetes mellitus.
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- Is an extended-release formulation of exenatide and should not be used with other products containing the active ingredient exenatide.
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- Has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis [see Warnings and Precautions (5.2) and Adverse Reactions (6.2)].
Recommended Dosage
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- The recommended dosage of BYDUREON BCISE is 2 mg subcutaneously once every 7 days (weekly). The dose can be administered at any time of day, with or without meals.
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- Discontinue an immediate- or extended-release exenatide product prior to initiation of BYDUREON BCISE. Patients changing from another extended-release exenatide product to BYDUREON BCISE may do so at the next regularly scheduled dose. Patients changing from immediate-release exenatide to BYDUREON BCISE may experience transient (approximately 2 to 4 weeks) elevations in blood glucose concentrations.
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- The day of weekly administration can be changed if necessary, as long as the last dose was administered 3 or more days before the new day of administration.
Recommendations Regarding Missed Dose
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- If a dose is missed, administer the dose as soon as noticed, provided the next regularly scheduled dose is due at least 3 days later. Thereafter, administer subsequent doses once every 7 days (weekly).
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- If a dose is missed and the next regularly scheduled dose is due 1 or 2 days later, do not administer the missed dose and instead resume BYDUREON BCISE with the next regularly scheduled dose.
Administration Instructions
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- Prior to initiation, train patients and caregivers on proper mixing and injection [see Instructions for Use]. Instruct caregivers to assist pediatric patients with mixing and administration.
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- Remove the autoinjector from the refrigerator 15 minutes prior to mixing the injection, in order to reach room temperature.
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- Mix by shaking vigorously for at least 15 seconds.
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- Inspect BYDUREON BCISE visually before use. After mixing, BYDUREON BCISE should appear as an opaque, cloudy, white to off-white suspension, evenly mixed with no residual medicine along the side, bottom or top of the inspection window. Do not use if particulate matter is present or if discoloration is observed.
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- Administer BYDUREON BCISE immediately after the autoinjector is prepared as a subcutaneous injection in the abdomen, thigh, or upper arm region. Advise patients to use a different injection site each week when injecting in the same region.
Extended-release injectable suspension: 2 mg of exenatide per 0.85 mL suspension, in a pre-filled single-dose autoinjector. Redispersion by mixing provides a white to off-white, opaque, suspension.
Renal Impairment
Pharmacokinetic studies of adult patients with renal impairment who received BYDUREON BCISE indicate that there is an increase in exenatide exposure in those with mild and moderate renal impairment as compared to patients with normal kidney function. BYDUREON BCISE may induce nausea and vomiting with transient hypovolemia and may worsen kidney function in patients with renal impairment.
Monitor patients with mild renal impairment for adverse reactions that may lead to hypovolemia. BYDUREON BCISE is not recommended for use in patients with eGFR below 45 mL/min/1.73 m2 or end-stage renal disease. If BYDUREON BCISE is used in patients with renal transplantation, closely monitor for adverse reactions that may lead to hypovolemia [see Warnings and Precautions (5.4) and Clinical Pharmacology (12.3)].
BYDUREON BCISE is contraindicated in patients with a:
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- Personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
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- Prior serious hypersensitivity reaction to exenatide or to any of the excipients of BYDUREON BCISE. Serious hypersensitivity reactions including anaphylactic reactions and angioedema have been reported with exenatide [see Warnings and Precautions (5.7)].
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- History of drug-induced immune-mediated thrombocytopenia from exenatide products. Serious bleeding, which may be fatal, from drug-induced immune-mediated thrombocytopenia has been reported with exenatide use [see Warnings and Precautions (5.8)].