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Bydureon (Exenatide) - Summary

 
 



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 causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as human relevance could not be determined by clinical or nonclinical studies. BYDUREON is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Routine serum calcitonin or thyroid ultrasound monitoring is of uncertain value in patients treated with BYDUREON. Patients should be counseled regarding the risk and symptoms of thyroid tumors [see Contraindications, Warnings and Precautions (5.1) and Nonclinical Toxicology ].

 

BYDUREON SUMMARY

BYDUREON (exenatide extended-release for injectable suspension) is supplied as a sterile powder to be suspended in the diluent included in the single-dose tray and administered by subcutaneous injection. Exenatide is a 39-amino acid synthetic peptide amide.

BYDUREON is an extended-release formulation of exenatide, administered as an injection once every seven days (weekly).

Type 2 Diabetes Mellitus

BYDUREON is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see Clinical Studies].

Important Limitations of Use

Because of the uncertain relevance of the rat thyroid C-cell tumor findings to humans, prescribe BYDUREON only to patients for whom the potential benefits are considered to outweigh the potential risk.

BYDUREON is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise.

BYDUREON is not a substitute for insulin. BYDUREON should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings.

The concurrent use of BYDUREON with insulin has not been studied and cannot be recommended.

BYDUREON and BYETTA (exenatide) injection both contain the same active ingredient, exenatide, and therefore should not be used together.

Based on postmarketing data, exenatide has been associated with acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. BYDUREON has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using BYDUREON. Other antidiabetic therapies should be considered in patients with a history of pancreatitis.


See all Bydureon indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Bydureon (Exenatide)

Efficacy and tolerability of exenatide once weekly versus sitagliptin in patients with type 2 diabetes mellitus: a retrospective analysis of pooled clinical trial data. [2013]
and American College of Endocrinology treatment algorithm... CONCLUSION: Significantly greater improvements in HbA1c and FBG levels were

Exenatide and the treatment of patients with Parkinson's disease. [2013]
BACKGROUND.

Effects of HbA1c and weight reduction on blood pressure in patients with type 2 diabetes mellitus treated with exenatide*. [2012]
with either exenatide twice daily (BID) or once weekly (QW)... CONCLUSION: Although the mechanism of BP-lowering effect of exenatide is not

Investigation of the haemodynamic effects of exenatide in healthy male subjects. [2012]
male volunteers... CONCLUSIONS: Exenatide has significant haemodynamic effects in healthy

Safety, tolerability, pharmacokinetics, and pharmacodynamics of exenatide once weekly in Japanese patients with type 2 diabetes. [2009]
This randomized, placebo-controlled, double-blind, parallel study assessed the safety, tolerability, pharmacokinetics, and pharmacodynamics of exenatide once weekly (QW) in 30 Japanese patients with type 2 diabetes (T2D) suboptimally controlled by diet and exercise alone or combined with biguanide, sulfonylurea, thiazolidinedione, or combinations of these agents (58.6% male; 58+/-9 years; body mass index 26.3+/-2.9 kg/m(2); hemoglobin A(1c) [HbA(1c)] 7.4+/-0.8%; fasting plasma glucose [FPG] 156.1+/-29.1 mg/dL; duration of T2D 6+/-5 years; means +/- SD)...

more studies >>

Clinical Trials Related to Bydureon (Exenatide)

Effects of Exenatide Long-Acting Release on Glucose Control and Safety in Subjects With Type 2 Diabetes Mellitus(DURATION - 1) [Completed]
This is a Pharmacokinetic (PK) sub-study to determine the relative bioavailability of exenatide when administered using the once weekly dual chambered pen and the once weekly single dose tray.

Trial of Exenatide for Parkinson's Disease [Active, not recruiting]
This study is a clinical trial in patients with Parkinson's disease, of a drug called Exenatide which is already licensed for the treatment of patients with Type 2 Diabetes. There have been several groups that have confirmed that Exenatide has beneficial effects on nerve cells when tested in the laboratory, that raises the possibility that Exenatide may slow down or stop the degenerative process of Parkinson's disease. In an open label trial in patients with Parkinson's disease who self administered the drug for 1 year, we have previously shown that the drug is well tolerated and shows encouraging effects on the movement and non-movement aspects of the disease, even 2 months after patients stopped administering the drug. The next step is therefore to formally evaluate whether Exenatide really is a potential "neuroprotective" drug, i. e. stops the nerve cells dying in Parkinson's disease, by conducting a double blind, placebo controlled trial.

The Effects of Exenatide on Oral Contraceptive Pharmacokinetics in Healthy Females [Completed]

Study Examining Exenatide Long-Acting Release in Subjects With Type 2 Diabetes [Completed]
Exenatide LAR is a long-acting release formulation of exenatide, which is a twice-daily dosage form currently under investigation as a potential treatment for people with type 2 diabetes mellitus. This study will assess the safety, tolerability, and pharmacokinetics of Exenatide LAR administered weekly by subcutaneous injection in people with type 2 diabetes mellitus.

Study to Evaluate the Effect of BYDUREON on 24-hour Glucose Control in Metformin Treated Patients With Type 2 Diabetes [Active, not recruiting]
A Randomized, Double-blind, Parallel-group Study to Evaluate the Effect of Bydureon Compared with Placebo on 24-hour Glucose Control in Metformin-treated Patients with Type 2 Diabetes.

more trials >>

Reports of Suspected Bydureon (Exenatide) Side Effects

Blood Glucose Increased (38)Nausea (24)Weight Decreased (23)Injection Site Nodule (23)OFF Label USE (22)Dizziness (19)Urticaria (17)Injection Site Erythema (16)Diarrhoea (14)Injection Site Haemorrhage (13)more >>


Page last updated: 2014-11-30

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