Exenatide Injectable Solution

Exenatide injectable solution (Rx)

• Classes: Antidiabetics, Glucagon-like Peptide-1 Agonists

Exenatide injectable suspension (Rx)

Brand and Other Names: Bydureon BCise

• Classes: Antidiabetics, Glucagon-like Peptide-1 Agonists

Hypersensitivity

ESRD, severe renal impairment (CrCl <30 mL/min)

History of drug-induced immune-mediated thrombocytopenia from drug or related products

Family or current history of medullary thyroid carcinoma

Hypersensitivity to exenatide or to any of the product components

Personal or family history of medullary thyroid carcinoma or in patients with multiple endocrine neoplasia syndrome type 2

• Injection-site nodule (6-77%)
• Injection-site reactions (2-18%)
• Nausea (8-11%)
• Vomiting (4-11%)
• Diarrhea (2-11%)
• Constipation (6-10%)
• Headache (5-9%)
• Dyspepsia (3-7%)
• Hyperhidrosis (3%)
• Jitteriness (<3%)
• Dizziness (<2%)
• Asthenia
• Alopecia
• Anaphylactic reaction
• Angioedema
• Pancreatitis
• Rash
• Renal impairment
• Upper respiratory infection
• Severe hypoglycemia with concomitant use of sulfonylurea or insulin
• Dysgeusia
• Somnolence
• Cholecystitis, cholelithiasis requiring cholecystectomy

Never share a pen between patients even if the needle is changed

Not a substitute for insulin

Not a first-line therapy for patients inadequately controlled on diet and exercise alone

Evaluate insulin dose when added on to long-acting insulin (ie, insulin glargine); in patients with increased risk of hypoglycemia, consider decreasing insulin dose

Not recommended for patients experiencing severe gastrointestinal disease, including gastroparesis

Not recommended for type 1 diabetes

Do not take with short- and/or rapid-acting insulins

Animal studies show association of extended-release dosage form with the formation of thyroid tumors (effects in humans unknown)

Always administer before a meal and never after a meal

Weight loss resulting from reduced intake reported

Avoid concurrent use of extended release (Bydureon BCise) and immediate release xenatide (Byetta) formulations

Serious injection-site reactions (eg, abscess, cellulitis, and necrosis) reported, with or without SC nodules; some required surgical intervention

Thyroid C-cell tumors in animals observed; human relevance unknown

Limited data in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage

There is no information regarding presence of drug, in human milk, effects on breastfed infant, or on milk production