WARNING: RISK OF THYROID C-CELL TUMORS
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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 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
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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 BCise
CONTRAINDICATIONS
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Personal or family history of MTC, patients with MEN 2
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Prior serious hypersensitivity reactions to exenatide or product components
WARNINGS AND PRECAUTIONS
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Acute Pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been reported. After initiation, observe patients carefully for symptoms of pancreatitis. If suspected, discontinue promptly and do not restart if confirmed. Consider other antidiabetic therapies in patients with a history of pancreatitis
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Hypoglycemia Risk of hypoglycemia is increased when exenatide is coadministered with insulin or insulin secretagogues. Consider lowering the dose of these agents when coadministered with BYDUREON or BYDUREON BCise
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Acute Kidney Injury May induce nausea and vomiting with transient hypovolemia and may worsen renal function. Increased serum creatinine, renal impairment, worsened chronic renal failure, and acute renal failure, sometimes requiring hemodialysis and kidney transplantation have been reported. Not recommended in patients with eGFR <45 mL/min/1.73 m2
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Gastrointestinal Disease Because exenatide is commonly associated with gastrointestinal adverse reactions, not recommended in patients with severe gastrointestinal disease (eg, gastroparesis)
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Immunogenicity Patients may develop antibodies to exenatide. Patients with higher titer antibodies may have an attenuated HbA1c response. In clinical trials, attenuated glycemic response was associated with BYDUREON- or BYDUREON BCise-treated patients. If worsening of or failure to achieve adequate glycemic control occurs, consider alternative antidiabetic therapy
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Hypersensitivity Reports of serious hypersensitivity reactions (eg, anaphylaxis and angioedema). If this occurs, patients should discontinue BYDUREON or BYDUREON BCise and promptly seek medical advice
-
Injection-Site Reactions Serious reactions (eg, abscess, cellulitis, and necrosis), with or without subcutaneous nodules, have been reported
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Acute Gallbladder Disease has been reported in GLP-1 receptor agonist trials, including exenatide. If cholelithiasis or cholecystitis are suspected, gallbladder studies are indicated
ADVERSE REACTIONS
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Most common (≥5%) and occurring more frequently than comparator in BYDUREON clinical trials: nausea (16.9%), diarrhea (12.7%), headache (8.0%), vomiting (6.8%), constipation (5.9%), injection-site pruritus (5.9%), injection-site nodule (5.3%), dyspepsia (5.1%)
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Most common (≥5%) in BYDUREON BCise clinical trials: injection-site nodule (10.5%), nausea (8.2%)
DRUG INTERACTIONS
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Oral Medications BYDUREON and BYDUREON BCise slow gastric emptying and may reduce the rate of absorption of orally administered drugs
-
Warfarin Increased international normalized ratio (INR) sometimes associated with bleeding has been reported with concomitant use of exenatide with warfarin. Monitor INR frequently until stable upon initiation of BYDUREON or BYDUREON BCise
PREGNANCY
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.
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 studied with prandial 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
You may report side effects related to AstraZeneca products by clicking here.
Please see full Prescribing Information, including Boxed WARNINGS, for BYDUREON, and BYDUREON BCise.
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 BCise
CONTRAINDICATIONS
-
For BYDUREON and BYDUREON BCise: Personal or family history of MTC, patients with MEN 2
-
Prior serious hypersensitivity reactions to exenatide or product components
WARNINGS AND PRECAUTIONS
-
Acute Pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been reported. After initiation, observe patients carefully for symptoms of pancreatitis. If suspected, discontinue promptly and do not restart if confirmed. Consider other antidiabetic therapies in patients with a history of pancreatitis
-
Never Share Injection Device or Needle Between Patients Sharing poses a risk for transmission of blood-borne pathogens, even if the needle is changed
-
Hypoglycemia Risk of hypoglycemia is increased when exenatide is coadministered with insulin or insulin secretagogues. Consider lowering the dose of these agents when coadministered with BYDUREON, BYDUREON BCise or BYETTA
-
Acute Kidney Injury and Impairment of Renal Function May induce nausea and vomiting with transient hypovolemia and may worsen renal function. Altered renal function, including increased serum creatinine, renal impairment, worsened chronic renal failure, and acute renal failure, sometimes requiring hemodialysis and kidney transplantation have been reported. BYDUREON or BYDUREON BCise are not recommended in patients with eGFR <45 mL/min/1.73 m2. BYETTA should not be used in patients with severe renal impairment or end-stage renal disease and should be used with caution in patients with moderate renal impairment or renal transplantation
-
Gastrointestinal Disease Because exenatide is commonly associated with gastrointestinal adverse reactions, not recommended in patients with severe gastrointestinal disease (eg, gastroparesis)
-
Immunogenicity Patients may develop antibodies to exenatide. Patients with higher titer antibodies may have an attenuated HbA1c response. In clinical trials, attenuated glycemic response was associated with BYDUREON-, BYDUREON BCise-, or BYETTA-treated patients. If worsening of or failure to achieve adequate glycemic control occurs, consider alternative antidiabetic therapy
-
Hypersensitivity Reports of serious hypersensitivity reactions (eg, anaphylaxis and angioedema). If this occurs, patients should discontinue BYDUREON, BYDUREON BCise or BYETTA and promptly seek medical advice
-
Injection-Site Reactions Serious reactions (eg, abscess, cellulitis, and necrosis), with or without subcutaneous nodules, have been reported with extended-release exenatide
-
Acute Gallbladder Disease has been reported in GLP-1 receptor agonist trials, including exenatide. If cholelithiasis or cholecystitis are suspected, gallbladder studies are indicated
-
Macrovascular Outcomes No clinical studies establishing conclusive evidence of macrovascular risk reduction with BYETTA
ADVERSE REACTIONS
-
Most common (≥5%) and occurring more frequently than comparator in BYDUREON clinical trials: nausea (16.9%), diarrhea (12.7%), headache (8.0%), vomiting (6.8%), constipation (5.9%), injection-site pruritus (5.9%), injection-site nodule (5.3%), dyspepsia (5.1%)
-
Most common (≥5%) in BYDUREON BCise clinical trials: injection-site nodule (10.5%), nausea (8.2%)
-
Most common (≥5%) and occurring more frequently than placebo in BYETTA clinical trials: nausea (8%-44%), hypoglycemia (3.8%-35.7%), vomiting (4%-18%), diarrhea (6%-18%), feeling jittery (9%), dizziness (9%), headache (9%-14%), dyspepsia (3%-7%), constipation (10%), asthenia (4%-5%)
DRUG INTERACTIONS
-
Oral Medications BYDUREON, BYDUREON BCise and BYETTA slow gastric emptying and may reduce the rate of absorption of orally administered drugs
-
Warfarin Increased international normalized ratio (INR) sometimes associated with bleeding has been reported with concomitant use of exenatide with warfarin. Monitor INR frequently until stable upon initiation of BYDUREON, BYDUREON BCise, or BYETTA
PREGNANCY
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.
INDICATION AND LIMITATIONS OF USE
BYDUREON, BYDUREON BCise and BYETTA are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
-
BYDUREON or BYDUREON BCise is not recommended as first-line therapy for patients inadequately controlled on diet and exercise
-
BYDUREON, BYDUREON BCise or BYETTA is not a substitute for insulin. Should not be used to treat type 1 diabetes or diabetic ketoacidosis
-
Not studied with prandial 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
You may report side effects related to AstraZeneca products by clicking here.
Please see full Prescribing Information, including Boxed WARNINGS, for BYDUREON and BYDUREON BCise, and full Prescribing Information for BYETTA.