Australian Doctor Australia Doctor 18th August 2017 | Page 7

PBS LISTED
BYDUREON :
The first once-weekly treatment for
type 2 diabetes approved in Australia
®
1
Powerful HbA 1c reduction – significantly improved
HbA 1c with BYDUREON vs. exenatide bd, sitagliptin,
pioglitazone or insulin glargine *
*BYDUREON did not meet primary endpoint of non-inferiority
vs. liraglutide 1.8mg.
†1–5
Significant weight loss with BYDUREON vs.
sitagliptin, pioglitazone or insulin glargine
‡ B  YDUREON is not indicated for weight loss.
‡ #1, 3, 4
#Study duration 26 weeks. Weight loss was statistically significant, p<0.05.
6
†Study duration 24–30 weeks. Patients were administered study drug with background therapy. HbA 1c reductions
were statistically significant, p<0.05. 1–5 Studies vs. exenatide bd were designed to demonstrate non-inferiority. 2,5
6 years of sustained HbA 1c reduction vs. baseline ^
^In patients receiving BYDUREON with background therapy.
¶1, 2, 7–10
¶ Open-label, uncontrolled extension study in patients administered BYDUREON with background therapy.
46% of patients remained in the study at Year 6.
Find out more about once-weekly BYDUREON Pen at
www.azhealth.com.au/medicines/BYDUREON
AZHealth is a website provided by AstraZeneca Pty Ltd
for Australian healthcare professionals.
PBS Information: Authority Required (STREAMLINED). Type 2 diabetes. Criteria Apply. Refer to PBS Schedule for full Authority Required Information.
BEFORE PRESCRIBING PLEASE REVIEW FULL PRODUCT INFORMATION AVAILABLE ON REQUEST
FROM ASTRAZENECA ON 1800 805 342 OR www.astrazeneca.com.au/PI
MINIMUM PRODUCT INFORMATION. BYDUREON ® (exenatide) powder for injection vial with diluent syringe. BYDUREON (exenatide) powder and solvent for injection pre-filled pen. BYDUREON is an extended release microspheres formulation
of exenatide. INDICATIONS: Treatment of type 2 diabetes in combination with metformin, a sulfonylurea, or a combination of metformin and a sulfonylurea, in patients who have not achieved adequate glycaemic control. CONTRAINDICATIONS: Hypersensitivity to
exenatide and compo nents of BYDUREON, end-stage renal disease, severe renal impairment (creatinine clearance <30ml/min). PRECAUTIONS: Subcutaneous use only; severe gastrointestinal disease including gastroparesis and dumping syndrome; concurrent use
with insulin, d-phenylalanine derivatives, meglitinides, alpha-glucosidase inhibitors, gliptins, orlistat, opioids, and anticholinergics have not been studied; concomitant use with Byetta (exenatide) not recommended; increased risk of hypoglycaemia with sulfonylurea
especially in renally impaired, consider decrease sulfonylurea dose; altered renal function especially with medicines that affect renal function or hydration status (ACE inhibitors, NSAIDs, diuretics); concomitant use of warfarin; acute pancreatitis (persistent, severe
abdominal pain); haemorrhagic or necrotising pancreatitis; risk factors for pancreatitis (gallstones, alcoholism, severe hypertriglyceridaemia); rapid weight loss >1.5 kg per week; not to be used for type 1 diabetes or diabetic ketoacidosis; safety and effectiveness not
established in patients <18 years of age; avoid hypoglycaemia while driving or using machinery if used with sulfonylurea; not recommended during pregnancy (Category C); excretion in breast milk is unknown; post-market reports of serious injection site reactions
including abscesses, cellulitis, ulcers and necrosis. ADVERSE EFFECTS (very common and common): Nausea, vomiting, diarrhoea, constipation, dyspepsia, GORD; abdominal discomfort, pain; toothache; injection site reactions including pruritis, erythema,
haematoma, induration, nodule and pain; asymptomatic nodule formation; fatigue; nasopharyngitis; URTI; UTI; sinusitis; gastroenteritis (inc viral); influenza; joint pain; back pain, arthralgia; pain in extremity; musculoskeletal pain; muscle spasms; hypoglycaemia;
decreased appetite; anorexia; hypokalaemia; headache; dizziness; depression; insomnia; anxiety; cough; oropharyngeal pain; hypertension; antibody development. Refer to full PI for complete list. INTERACTION WITH OTHER MEDICINES: Warfarin (monitor INR
during initiation of exenatide); HMG CoA reductase inhibitors (monitor lipid profile). DOSAGE AND ADMINISTRATION: 2 mg once weekly subcutaneously in the abdomen anytime during the day. BYDUREON is not for intramuscular or intravenous use. BYDUREON is for
use by 1 person only and must be injected immediately after suspension of the powder in the diluent. Two injections should not be given on the same day (Refer to full PI and User Manual for dosing instructions). If added to sulfonylurea therapy, reduction in sulfonylurea
dose should be considered to reduce hypoglycaemic risk. Following discontinuation, consider prolonged release of exenatide. No dose adjustment for elderly (limited experience >75 years), mild or moderate renal impairment, hepatic impairment. BYDUREON that has
been frozen must not be used. PRESENTATIONS: BYDUREON single dose kit (vial with diluent syringe): exenatide powder for injection is packaged in a 3 mL type 1 glass vial. The diluent is packaged in a 1.5 mL type 1 glass syringe. Each single-dose kit contains
1 vial of exenatide powder, one pre-filled syringe of diluent for injection, one vial connector and 2 needles (one spare). BYDUREON single dose pen (pre-filled pen): each pre-filled pen contains exenatide powder and solvent for suspension for injection; one needle
supplied per pen (one spare). Storage: 2º to 8º C; refrigerate; do not freeze; may be kept for up to 4 weeks below 30º during the shelf life. Protect from light. Date of first inclusion in the ARTG 20 December 2012. Date of most recent amendment 14 March 2017.
HbA 1c = haemoglobin A 1c . References: 1. BYDUREON ® (exenatide) Approved Product Information. 2. Drucker DJ et al. Lancet 2008; 372:1240–1250. 3. Bergenstal RM et al. Lancet 2010; 376:431–439. 4. Diamant M et al. Lancet
2010; 375:2234–2243. 5. Blevins T et al. J Clin Endocrin Metab 2011; 96:1301–1310. 6. Buse JB et al. Lancet 2013; 381:117–124. 7. Buse JB et al. Diabetes Care 2010; 33:1255–1261. 8. MacConnell L et al. Diabetes Metab Syndr
Obes 2013; 6:31–41. 9. Wysham CH et al. Mayo Clin Proc 2015; 90(3):356–365. 10. Henry RR et al. Diabetes Technol Ther 2016; 18(11):677–686. ® BYDUREON is a registered trademark of the AstraZeneca group of companies.
Registered user AstraZeneca Pty Ltd. ABN 54 009 682 311. 66 Talavera Road, Macquarie Park, NSW 2113. AstraZeneca Medical Information or to report an adverse event: 1800 805 342. AU-3119. July 2017. 14434-MR.