saxagliptin (Onglyza)
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Introduction
FDA approved 2009. Generic FDA-approved 2023[6]
Indications
- treatment of type 2 diabetes in adults
Contraindications
- no benefit in reduced risk of cardiovascular events[3]
Dosage
- 2.5 mg or 5 mg once daily, without regards to meals
Dosage adjustment in renal failure
Pharmacokinetics
Adverse effects
- upper respiratory tract infection
- urinary tract infection
- headache
- allergic-like reactions
- increases risk of hypoglycemia when used with a sulfonylurea (relative to sulfonylurea alone)
- may increase risk of may increase the risk of heart failure, particularly in patients with heart disease or kidney disease[3][4]
- not associated with increased risk for hospitalization due to heart failure relative to other diabetes medications[5]
Drug interactions
- drugs that inhibit CYP3A4 may increase saxagliptin levels
- drugs that induce CYP3A4 may decrease saxagliptin levels
- rifampin is a strong inducer of CYP3A4 but does not seem to affect saxagliptin levels
- drug interaction(s) of gliptins with sulfonylureas
- drug interaction(s) of fluoroquinolones with hypoglycemic agents
Mechanism of action
- dipeptidyl peptidase-4 inhibitor which stimulates the pancreas to make more insulin after eating
- no evidence that saxagliptin can reduce microvascular or macrovascular complications associated with diabetes
Notes
- manufactured by Bristol-Myers Squibb Co
- marketed by Bristol-Myers & AstraZeneca Pharmaceuticals LP
- $206.00 per 30 tablets (2009)
More general terms
Component of
References
- ↑ FDA NEWS RELEASE, July 31, 2009 FDA Approves New Drug Treatment for Type 2 Diabetes http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm174780.htm
- ↑ Prescriber's Letter 16(9): 2009 COMMENTARY: New Drug: Onglyza (Saxagliptin) CHART: Stepwise Approach to Selecting Treatments for Type 2 Diabetes GUIDELINES: Consensus Statement on Management of Hyperglycemia in Type 2 Diabetes (ADA, 2008) Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=250905&pb=PRL (subscription needed) http://www.prescribersletter.com
- ↑ 3.0 3.1 3.2 Scirica BM et al. for the SAVOR-TIMI 53 Steering Committee and Investigators. Saxagliptin and cardiovascular outcomes in patients with type 2 diabetes mellitus. N Engl J Med. 2013 Oct 3;369(14):1317-26 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/23992601 <Internet> http://www.nejm.org/doi/full/10.1056/NEJMoa1307684
- ↑ 4.0 4.1 FDA MedWatch. Feb 11, 2014 Saxagliptin (marketed as Onglyza and Kombiglyze XR): Drug Safety Communication - FDA to Review Heart Failure Risk. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm385471.htm
FDA Safety Alert. April 5, 2015 Diabetes Medications Containing Saxagliptin and Alogliptin: Drug Safety Communication - Risk of Heart Failure. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm494252.htm - ↑ 5.0 5.1 Toh S, Hampp C, Reichman ME et al Risk for Hospitalized Heart Failure Among New Users of Saxagliptin, Sitagliptin, and Other Antihyperglycemic Drugs: A Retrospective Cohort Study. Ann Intern Med. Published online 26 April 2016 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/27110660 <Internet> http://annals.org/article.aspx?articleid=2517404
Selby JV Complementary Efforts Make for Efficient Research. Ann Intern Med. Published online 26 April 2016 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/27110867 <Internet> http://annals.org/article.aspx?articleid=2517405 - ↑ 6.0 6.1 ACP Diabetes Monthly Newsletter. November 10, 2023
- ↑ Medscape. saxagliptin (Rx) https://reference.medscape.com/drug/onglyza-saxagliptin-999211