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saxagliptin (Onglyza)

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: - eGFR < 50 mL/min 2.5 mg once daily Pharmacokinetics: - metabolized by CYP3A4 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 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)

Interactions

drug adverse effects of hypoglycemic agents

General

gliptin; dipeptidyl peptidase-4 inhibitor; DPP-4 inhibitor

References

  1. FDA NEWS RELEASE, July 31, 2009 FDA Approves New Drug Treatment for Type 2 Diabetes http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm174780.htm
  2. 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#: 250905 (subscription needed) http://www.prescribersletter.com
  3. 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 PMID: 23992601 http://www.nejm.org/doi/full/10.1056/NEJMoa1307684
  4. 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. 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 PMID: 27110660 http://annals.org/article.aspx?articleid=2517404 - Selby JV Complementary Efforts Make for Efficient Research. Ann Intern Med. Published online 26 April 2016 PMID: 27110867 http://annals.org/article.aspx?articleid=2517405
  6. ACP Diabetes Monthly Newsletter. November 10, 2023
  7. Medscape. saxagliptin (Rx) https://reference.medscape.com/drug/onglyza-saxagliptin-999211

Component-of

metformin/saxagliptin (Kombiglyze XR)