Dapagliflozin/saxagliptin/metformin explained
| Type: | combo |
| Component1: | Dapagliflozin |
| Class1: | SGLT-2 inhibitor |
| Component2: | Saxagliptin |
| Class2: | DPP‑4 inhibitor |
| Component3: | Metformin |
| Class3: | Anti-diabetic biguanide |
| Tradename: | Qternmet XR, Qtrilmet |
| Dailymedid: | Qternmet |
| Routes Of Administration: | By mouth |
| Atc Prefix: | A10 |
| Atc Suffix: | BD25 |
| Legal Us: | Rx-only |
| Legal Eu: | Rx-only |
| Cas Number: | 2447636-43-1 |
| Kegg: | D11711 |
Dapagliflozin/saxagliptin/metformin, sold under the brand name Qternmet XR among others, is a fixed-dose combination anti-diabetic medication used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.[1] [2] It is a combination of dapagliflozin, saxagliptin, and metformin. It is taken by mouth. The drug is marketed by AstraZeneca.[3]
The most common side effects include infections of the nose and throat, hypoglycaemia (low blood sugar) when used with a sulphonylurea and effects on the gut such as nausea (feeling sick), vomiting, diarrhoea, abdominal (tummy) pain and loss of appetite.
Dapagliflozin/saxagliptin/metformin was approved for medical use in the United States in May 2019, and in the European Union in November 2019.[4] [5] Its marketing authorisation was withdrawn in the European Union in August 2020, and its approval was withdrawn in the US in April 2021, in both cases at the request of AstraZeneca.[6] [7]
Medical uses
In the United States, dapagliflozin/saxagliptin/metformin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.
In the European Union it is indicated in adults aged 18 years and older with type 2 diabetes:
- to improve glycemic control when metformin with or without sulphonylurea (SU) and either saxagliptin or dapagliflozin does not provide adequate glycemic control.
- when already being treated with metformin and saxagliptin and dapagliflozin.
Notes and References
- Web site: Qternmet XR- dapagliflozin saxagliptin and metformin hydrochloride tablet, film coated . DailyMed . 24 January 2020 . 14 July 2020 . 14 July 2020 . https://web.archive.org/web/20200714200256/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cfffcbfe-dcd9-4001-963e-a99e67390116 . live .
- Web site: Qtrilmet EPAR . European Medicines Agency (EMA) . 16 September 2019 . 14 July 2020 . 29 December 2019 . https://web.archive.org/web/20191229223247/https://www.ema.europa.eu/en/medicines/human/EPAR/qtrilmet . live . Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- Web site: AstraZeneca Medications . AstraZeneca US . Apr 2020 . 30 March 2020 . 4 May 2020 . https://web.archive.org/web/20200504172946/https://www.astrazeneca-us.com/medicines/astrazeneca-medications.html . live .
- Web site: Drug Approval Package: Qternmet XR . U.S. Food and Drug Administration (FDA) . 27 January 2020 . 14 July 2020 . 17 February 2020 . https://web.archive.org/web/20200217083231/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/210874Orig1s000TOC.cfm . live .
- Qternmet XR approved in the US for the treatment of type-2 diabetes . AstraZeneca . 3 May 2019 . 14 July 2020 . 16 July 2020 . https://web.archive.org/web/20200716055330/https://www.astrazeneca.com/media-centre/press-releases/2019/qternmet-xr-approved-in-the-us-for-the-treatment-of-type-2-diabetes-03052019.html . live .
- Web site: Qtrilment . European Medicines Agency . 9 October 2020 . 30 March 2021 . 30 March 2021 . https://web.archive.org/web/20210330075512/https://www.ema.europa.eu/en/documents/public-statement/public-statement-qtrilmet-withdrawal-marketing-authorisation-european-union_en.pdf . live .
- Web site: Bristol-Meyers Squibb Company, et al.; Withdrawal of Approval of 19 New Drug Applications . Federal Register . 16 March 2021 . 30 March 2021 . 30 March 2021 . https://web.archive.org/web/20210330075529/https://www.federalregister.gov/documents/2021/03/16/2021-05368/bristol-meyers-squibb-company-et-al-withdrawal-of-approval-of-19-new-drug-applications . live .
