Ertugliflozin
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Trade names | Steglatro |
Other names | PF-04971729, ertugliflozin l-pyroglutamic acid |
AHFS/Drugs.com | Monograph |
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Antidiabetic agent | |
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faeces , 50% urine | |
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Ertugliflozin, sold under the brand name Steglatro, is a medication for the treatment of type 2 diabetes.[3][4]
The most common side effects include fungal infections of the vagina and other infections of the female reproductive system.[4]
Ertugliflozin is a
In the United States, it was approved by the Food and Drug Administration for use as a monotherapy and as a fixed dose combination with either sitagliptin or with metformin.[6] In the European Union, it was approved in March 2018, for use as a monotherapy or combination therapy.[7] In September 2020, The New England Journal of Medicine reported that ertugliflozin was shown to be essentially non-inferior to placebo with respect to cardiovascular events.[8]
A combination with metformin is marketed as Segluromet and a combination with sitagliptin is marketed as Steglujan.[1][9][10][11][12]
It is available as a generic in the US.[13]
Medical uses
Steglatro is indicated for the treatment of adults with insufficiently controlled type 2 diabetes as an adjunct to diet and exercise as monotherapy when metformin is considered inappropriate due to intolerance or contraindications or in addition to other medicinal products for the treatment of diabetes.[4]
Contraindications
Under the US approval, ertugliflozin is contraindicated for patients with severe
Adverse effects
Adverse effects in studies that were significantly more common under ertugliflozin than under
To lessen the risk of developing ketoacidosis (a serious condition in which the body produces high levels of blood acids called ketones) after surgery, the FDA has approved changes to the prescribing information for SGLT2 inhibitor diabetes medicines to recommend they be stopped temporarily before scheduled surgery. Ertugliflozin should be stopped at least four days before scheduled surgery.[14]
Symptoms of ketoacidosis include nausea, vomiting, abdominal pain, tiredness, and trouble breathing.[14]
Overdose
Up to sixfold clinical doses over two weeks, or 20-fold single doses, are tolerated by patients without any toxic effects.[7]
Interactions
As with many diabetes drugs, combining ertugliflozin with
Pharmacology
Mechanism of action
Pharmacokinetics
After oral intake, ertugliflozin is practically completely absorbed from the gut and undergoes no relevant
The
Society and culture
Legal status
Ertugliflozin, ertugliflozin/metformin, and ertugliflozin/sitagliptin were approved for medical use in the United States in December 2019, and in the European Union in March 2018.[3][9][11][4][10][12]
References
- ^ a b Australian Public Assessment Report for Ertugliflozin, Ertugliflozin / Sitagliptin, Ertugliflozin / Metformin (PDF) (Report).
- ^ "Drug and medical device highlights 2018: Helping you maintain and improve your health". Health Canada. 14 October 2020. Retrieved 17 April 2024.
- ^ a b c d e f g h i "Steglatro- ertugliflozin tablet, film coated". DailyMed. 30 January 2020. Retrieved 24 September 2020.
- ^ a b c d e f "Steglatro EPAR". European Medicines Agency (EMA). 17 September 2018. Retrieved 24 September 2020. Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- S2CID 211159566.
- ^ "FDA Approves SGLT2 Inhibitor Ertugliflozin for Type 2 Diabetes". MedScape.
- ^ a b c d e f "Steglatro: EPAR – Product Information" (PDF). European Medicines Agency. 4 June 2018. Archived from the original (PDF) on 18 June 2018. Retrieved 18 June 2018.
- PMID 32966714.
- ^ a b "Segluromet- ertugliflozin and metformin hydrochloride tablet, film coated". DailyMed. 11 August 2020. Retrieved 24 September 2020.
- ^ a b "Segluromet EPAR". European Medicines Agency (EMA). 17 September 2018. Retrieved 24 September 2020.
- ^ a b "Steglujan- ertugliflozin and sitagliptin tablet, film coated". DailyMed. U.S. National Library of Medicine. 31 January 2020. Retrieved 24 September 2020.
- ^ a b "Steglujan EPAR". European Medicines Agency (EMA). 17 September 2018. Retrieved 24 September 2020.
- ^ Research, Center for Drug Evaluation and (15 December 2023). "First Generic Drug Approvals". FDA. Retrieved 10 January 2024.
- ^ a b "FDA revises labels of SGLT2 inhibitors for diabetes to include warning". U.S. Food and Drug Administration. 19 March 2020. Retrieved 6 June 2020. This article incorporates text from this source, which is in the public domain.