Byetta (exenatide)
BYETTA (exenatide) – a glucagon-like peptide-1 (GLP-1) receptor agonist commonly used to treat type 2 adult diabetes mellitus.
FDA approved uses: Byetta is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Available dosage forms: Solution for subcutaneous injection, prefilled multi-dose pen delivering doses of 0.6, 1.2, or 1.8 mg.
Usual dosage: Administer subcutaneously once daily at any time of the day, independent of meals. Initiate at 0.6 mg per day for one week. This dose is intended to reduce gastrointestinal symptoms during initial titration, and is not effective for glycemic control. After one week, increase the dose to 1.2 mg. If the 1.2 mg dose does not result in acceptable glycemic control, the dose can be increased to 1.8 mg.
Contraindications: Do not use BYETTA if patient has history of serious hypersensitivity to Byetta or any product components. Not recommended for use in patients with severe gastrointestinal disease, such as in patients with gastroparesis.
Special Warnings: Pancreatitis – Postmarketing reports with exenatide, including fatal and nonfatal hemorrhagic or necrotizing pancreatitis. Discontinue BYETTA promptly. BYETTA should not be restarted. Consider other antidiabetic therapies in patients with a history of pancreatitis. Serious hypoglycemia (low blood sugar) can occur when used in combination with an insulin secretagogue (like sulfonylureas) or with insulin.
Adverse reactions (side effects) of these medications: The most common side effects seen in clinical trial include nausea, hypoglycemia, vomiting, diarrhea, feeling jittery, dizziness, headache, dyspepsia, constipation, and asthenia. Nausea usually decreases over time. Other adverse reactions seen in clinical trials or post-marketing include: increased INR (international normalized ratio) when used with warfarin, immunogenicity with antibody formation, hyperhidrosis, somnolence, taste disturbances, abdominal distention, decreased appetite, flatulence and gastroesophageal reflux disease (GERD).
Common drug interactions: Byetta causes a delay of gastric emptying, and thereby has the potential to impact the absorption of concomitantly administered oral medications. Caution should be used when patients used Byetta concomitantly with drugs that have a narrow therapeutic index or require rapid gastrointestinal absorption. May cause increased INR (sometimes associated with bleeding) when used with warfarin. Prothrombin time should be more frequently when initiating Byetta in warfarin patients.
Special instructions for patients: Use this medication exactly as directed by physician. Consult patient medication guide before starting treatment, and with each refill. Stop taking Byetta and notify doctor if you have severe pain in the abdomen, sometimes radiating to the back with or without vomiting, that will not go away.
Full prescribing information may be found at the manufacturer‘s official website Byetta.com or at the U.S. Food and Drug Administration’s website at Byetta Info at Drugs@FDA
Tags: byetta, exenatide, exenatide adverse effects, side effects of byetta, side effects of exenatide