Bydureon (Exenatide) - Drug Interactions, Contraindications, Overdosage, etc

DRUG INTERACTIONS

Orally Administered Drugs

Exenatide slows gastric emptying. Therefore, BYDUREON has the potential to reduce the rate of absorption of orally administered drugs. Use caution when administering oral medications with BYDUREON [see Clinical Pharmacology ].

In patients with type 2 diabetes, BYDUREON did not affect the absorption of orally administered acetaminophen to any clinically relevant degree.

Warfarin

BYDUREON has not been studied with warfarin. However, in a drug interaction study, BYETTA did not have a significant effect on INR [see Clinical Pharmacology ]. There have been postmarketing reports for BYETTA of increased INR with concomitant use of warfarin, sometimes associated with bleeding [see Adverse Reactions ]. In patients taking warfarin, the INR should be monitored more frequently after initiating BYDUREON. Once a stable INR has been documented, the INR can be monitored at the intervals usually recommended for patients on warfarin.

OVERDOSAGE

There were no reports of overdose in the five comparator-controlled 24-30 week trials of BYDUREON. Effects of overdoses with BYETTA in clinical studies included severe nausea, severe vomiting, and rapidly declining blood glucose concentrations, including severe hypoglycemia requiring parenteral glucose administration. In the event of overdose, appropriate supportive treatment should be initiated according to the patient's clinical signs and symptoms.

CONTRAINDICATIONS

Medullary Thyroid Carcinoma

BYDUREON is contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

Hypersensitivity

BYDUREON is contraindicated in patients with a prior serious hypersensitivity reaction to exenatide or to any of the product components.