Australian adults living with type 2 diabetes mellitus can now access a new treatment option, following the announcement that AstraZeneca’s SIDAPVIA® 10/100, a combination medicine containing dapagliflozin and sitagliptin, will be listed on the Pharmaceutical Benefits Scheme (PBS) from 1 November 2024.
SIDAPVIA® is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both dapagliflozin and sitagliptin is appropriate. SIDAPVIA® should be used in combination with metformin unless contraindicated or not tolerated.1
This PBS listing provides another treatment option for people living with type 2 diabetes mellitus.
· Type 2 diabetes is a condition when the body becomes resistant to the normal effects of insulin and gradually loses capacity to produce enough insulin in the pancreas.2
· Almost 1.2 million people were living with type 2 diabetes in Australia in 20213, and up to 500,000 people are estimated to have undiagnosed type 2 diabetes.4
Ben McDonald, Country President of AstraZeneca Australia and New Zealand, which has delivered innovative medicines for chronic diseases to Australian patients for more than 60 years, said:
“Australians living with type 2 diabetes mellitus can now access SIDAPVIA® on the PBS.
“Thousands of adults with type 2 diabetes may now benefit from reimbursed access to SIDAPVIA®.
“The PBS listing of SIDAPVIA® is another example of the contribution AstraZeneca makes to cardiorenal and metabolic disease research in Australia.” Mr McDonald said.
Dr Ted Wu, Senior Specialist Endocrinologist and Director of the Royal Prince Alfred Hospital Diabetes Centre said:
“Improving diabetes management is an urgent health priority in primary and tertiary care especially for people who do not respond to existing therapy.
“Type 2 diabetes patients can experience a high pill burden. SIDAPVIA® combines two tablets - dapagliflozin and sitagliptin - into one.
“The listing of SIDAPVIA® on the PBS provides people with type 2 diabetes access to another option in the treatment of diabetes when they take metformin and do not have an adequate response to existing dual therapy.” Dr Wu said.
About SIDAPVIA® 10/100
SIDAPVIA® 10/100 contains two active ingredients, dapagliflozin and sitagliptin. Dapagliflozin belongs to a class of medicines called sodium glucose co-transporter-2 (SGLT2) inhibitors, and sitagliptin belongs to a class of medicines called dipeptidyl peptidase-4 inhibitors (DPP-4). SIDAPVIA® is used with diet and exercise to control the level of blood sugar (glucose) in adults with type 2 diabetes mellitus.
Precautions: SIDAPVIA® should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. It should not be used in patients with an eGFR <45 mL/min/1.73 m2. Renal function should be evaluated prior to initiation of SIDAPVIA® and periodically thereafter. Treatment with SIDAPVIA® should be ceased prior to major surgery.
Interactions: The lack of pharmacokinetic interaction between dapagliflozin and sitagliptin was demonstrated in a drug-drug interaction study between dapagliflozin and sitagliptin. No dose adjustment of either dapagliflozin or sitagliptin is needed when the two drugs are co-administered.
Side Effects: All medicines can have side effects. Some side effects may need medical attention. Serious side effects can include allergic reaction, low blood sugar (hypoglycaemia), skin conditions, dehydration and volume depletion, genital infections, urinary tract infections, diabetic ketoacidosis, pancreatitis, and kidney-related problems.
More information can be found in the SIDAPVIA® Consumer Medicine Information.
Patients should discuss their treatment options with their clinician.
| PBS Information: SIDAPVIA® 10/100: Authority Required (STREAMLINED): Diabetes mellitus type 2. Clinical criteria: the treatment must be in combination with at least metformin, AND the condition must be inadequately responsive to dual therapy consisting of metformin with either: a DPP-4 inhibitor, an SGLT2 inhibitor. Refer to PBS Schedule for full Authority Required Information. |
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Dr Wu has been involved in medical education and speaker activities sponsored by AstraZeneca for which compensation was received. In relation to this AstraZeneca media announcement, no compensation was provided to Dr Wu, and the opinions expressed are his own. Dr Wu was briefed by AstraZeneca on the approved use of this product.
Media Contacts
AstraZeneca Australia
SIDAPVIA® is a registered trademark of AstraZeneca. ABN 54 009 682 311. 66 Talavera Road, Macquarie Park, NSW 2113. www.astrazeneca.com.au.
For Medical Information enquiries or to report an adverse event or product quality complaint: Telephone 1800 805 342 or via https://contactazmedical.astrazeneca.com or email Medical Information enquiries to medinfo.australia@astrazeneca.com
About AstraZeneca
AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas – Oncology; Cardiovascular, Renal & Metabolism; and Respiratory & Immunology. Headquartered in Cambridge, United Kingdom, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.
For more information, please visit www.astrazeneca.com.au
References
1. SIDAPVIA Product Information. Available at www.astrazeneca.com.au/PI
2. Diabetes Australia, Type 2 Diabetes, https://www.diabetesaustralia.com.au/about-diabetes/type-2-diabetes/, viewed 21 October 2024
3. Australian Institute of Health and Welfare, ‘Diabetes Australian Facts’, https://www.aihw.gov.au/reports/diabetes/diabetes/contents/how-common-is-diabetes/type-2-diabetes, viewed 21 October 2024
4. Diabetes Australia, Facts about Diabetes, https://www.diabetesaustralia.com.au/about-diabetes/, viewed 21 October 2024
AstraZeneca Pty. Ltd. ABN 54 009 682 311. 66 Talavera Road, Macquarie Park, NSW 2113. www.astrazeneca.com.au. For Medical Information enquiries or to report an adverse event or product quality complaint: Telephone 1800 805 342 or via https://contactazmedical.astrazeneca.com