How a Once-Weekly Injection Can Help Manage Type 2 Diabetes

As recently as 2015, over 30 million people in the US had diabetes—a rate equivalent to 9.4% of the US population.¹ Of these cases, a rate of 90%-95% are type 2 diabetes (T2D).¹ The prevalence of T2D has been on the rise.²

Patients are advised to work closely with their physicians to set and achieve long-term strategies, including diet modifications and improvements to exercise routines. Lifestyle management is a fundamental aspect of diabetes care and healthcare providers may recommend pharmacotherapy for patients when target blood sugar levels have not been achieved with diet and exercise alone.^3,4 Diabetes care should be individualized for each patient, which may include determining the appropriate pharmacologic treatment.³

A significant milestone in the area of T2D therapies was the approval of the first glucagon-like peptide-1 receptor agonist (GLP-1 RA), in the U.S., in 2005.⁵ In 2017, the FDA approved the GLP-1 RA BYDUREON BCise^® (exenatide extended-release)‎ injectable suspension 2 mg.⁶ Indicated for the lowering of glycated hemoglobin (HbA1c) as an adjunct to diet and exercise in adults with T2D who are uncontrolled on antidiabetic agent(s), BYDUREON BCise features convenient once-weekly dosing and an easy to use device for patients working to manage their T2D.⁷

Individualizing, Simplifying T2D Care

Medication adherence plays an essential role in overall glycemic control. Unfortunately, the adherence rate among patients with T2D is as low as 45%, with nearly one-third of patients with T2D failing to fill even their first prescription of a glucose-lowering agent.^8,9

But more convenient options and advances in formulations and delivery devices may help improve adherence.¹⁰

One option for healthcare providers to consider is the single-dose autoinjector BYDUREON BCise. This once-weekly autoinjector device was deemed “easy” or “very easy” to use by 86% of patients in a clinical study.¹¹ The non-insulin therapy was designed to be simple to use, being administered subcutaneously in 4 steps following preparation: mix, unlock, unscrew and inject. The injection contains a unique continuous-release microsphere technology that releases the medicine into the body over time, reaching a steady state at 10 weeks with continued once-weekly dosing.¹² In turn, BYDUREON BCise helps the body release its own insulin to help lower blood sugar specifically when the body needs it.⁷

BYDUREON BCise is not recommended as a first therapy for type 2 diabetes and should not be used to treat type 1 diabetes. It causes an increased incidence in thyroid C-cell tumors at clinically relevant exposures in rats compared to controls. It is unknown whether BYDUREON BCise causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC) in humans, as the human relevance of exenatide extended-release-induced rodent thyroid C-cell tumors has not been determined. It is contraindicated in patients with a personal or family history of medullary thyroid cancer, or in patients with Multiple Endocrine Neoplasia syndrome type 2, or with a prior serious hypersensitivity reaction to any of the product components.⁷

The most common adverse reactions are injection site reaction (10.5%) and nausea (8.2%).⁷ Please refer to the IMPORTANT SAFETY INFORMATION below for more details.

Looking at the Future of T2D Care

Effective T2D medication therapy delivers the right drug at the right dose, through the right route, at the right time, for the right patient. Though the sheer breadth of available antihyperglycemic therapies—available across different drug classes, in combination or as lone therapy—is overwhelming, the base of knowledge informing treatment decisions is still growing.

Some decisions may be simplified by a proven, easy-to-use device such as BYDUREON BCise.

IMPORTANT SAFETY INFORMATION

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 BCise causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC) in humans, as the human relevance of exenatide extended-release-induced rodent thyroid C-cell tumors has not been determined
• BYDUREON BCise is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC with the use of BYDUREON BCise and inform them of symptoms of thyroid tumors (eg, mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for detection of MTC in patients treated with BYDUREON BCise

CONTRAINDICATIONS

• Personal or family history of MTC, patients with MEN 2
• Patients with prior serious hypersensitivity reactions to exenatide or product components

WARNINGS AND PRECAUTIONS

• Acute Pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been reported. After initiation, observe patients carefully for symptoms of pancreatitis. If suspected, discontinue promptly and do not restart if confirmed. Consider other antidiabetic therapies in patients with a history of pancreatitis
• Hypoglycemia Risk of hypoglycemia is increased when exenatide is coadministered with insulin or insulin secretagogues. Consider lowering the dose of these agents when coadministered with BYDUREON BCise
• Acute Kidney Injury May induce nausea and vomiting with transient hypovolemia and may worsen renal function. Increased serum creatinine, renal impairment, worsened chronic renal failure, and acute renal failure, sometimes requiring hemodialysis and kidney transplantation have been reported. Not recommended in patients with eGFR <45 mL/min/1.73 m²
• 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 BCise-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 BCise and promptly seek medical advice
• Injection-Site Reactions Serious reactions (eg, abscess, cellulitis, and necrosis), with or without subcutaneous nodules, have been reported
• Acute Gallbladder Disease has been reported in GLP-1 receptor agonist trials, including exenatide. If cholelithiasis or cholecystitis are suspected, gallbladder studies are indicated

ADVERSE REACTIONS

Most common (≥5%) in clinical trials: injection-site nodule (10.5%), nausea (8.2%).

DRUG INTERACTIONS

• Oral Medications BYDUREON BCise slows 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 BCise

PREGNANCY

Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.

INDICATION AND LIMITATIONS OF USE

BYDUREON BCise is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus

• Not recommended as first-line therapy for patients inadequately controlled on diet and exercise
• Not a substitute for insulin. Should not be used to treat type 1 diabetes or diabetic ketoacidosis
• Use with prandial insulin has not been studied
• 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

Please click here for Full Prescribing Information and click here for Medication Guide for BYDUREON BCise 2 mg, including Boxed WARNING.

References

1. Centers for Disease Control. National Diabetes Statistics Report, 2017. Atlanta, GA: Centers for Disease Control and Prevention, US Department of Health and Human Services; 2017.

https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf Last accessed July 25, 2019.

2. Centers for Disease Control. Long-Term Trends in Diabetes, April 2017.

https://www.cdc.gov/diabetes/statistics/slides/long_term_trends.pdf. Last accessed July 25, 2019.

3. American Diabetes Association. Standards of Medical Care in Diabetes — 2019. Diabetes Care. 2019;42(Suppl 1):S1-S55.

https://care.diabetesjournals.org/content/42/Supplement_1. Last accessed July 25, 2019.

4. Mayo Clinic. Type 2 Diabetes-Diagnosis & treatment.

https://www.mayoclinic.org/diseases-conditions/type-2-diabetes/diagnosis-treatment/drc-20351199. Last accessed July 25, 2019.

5. Trujillo JM, Nuffer W, Ellis SL. GLP-1 receptor agonists: a review of head-to-head clinical studies. Ther Adv Endocrinol Metab. 2015;6(1):19-28.

6. AstraZeneca US press release. US FDA approves new easy-to-use, once-weekly BYDUREON® BCise^TM injectable medicine for patients with type-2 diabetes.

https://www.astrazeneca-us.com/content/az-us/media/press-releases/2017/us-fda-approves-new-easy-to-use-once-weekly-bydureon-bcise-injectable-medicine-for-patients-with-type-2-diabetes-10232017.html. Last accessed July 25, 2019.

7. BYDUREON BCise^® ([exenatide extended-release] injectable suspension) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2019.

8. Curkendall SM, Thomas N, Bell KF, Juneau PL, Weiss AJ. Predictors of medication adherence in patients with type 2 diabetes mellitus. Curr Med Res Opin. 2013; 29:1275-1286.

9. Fischer MA, Stedman MR, Lii J, et al. Primary medication non-adherence: analysis of 195,930 electronic prescriptions. J Gen Intern Med. 2010;25: 284-290.

10. Giorgino F, Penfornis A, Pechtner V, Gentilella R, Corcos A. Adherence to antihyperglycemic medications and glucagon-like peptide-1 receptor agonists in type 2 diabetes: clinical consequences and strategies for improvement. Patient Prefer Adherence. 2018;12:707-719.

11. Data on File, REF-14053, AstraZeneca Pharmaceuticals.

12. BYDUREON BCise HCP site. https://www.bydureonhcp.com/bydureon-bcise/pk-profile.html. Last accessed July 25, 2019.