isease 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
BYDUREON and BYETTA have not been studied with prandial insulin. BYDUREON BCise is 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
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