Onglyza
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Side Effects & Adverse Reactions
Saxagliptin & Concerns of Heart Failure
Post-marketing drug trials of the diabetes drug Saxagliptin have recently led an FDA panel to vote to require new labeling information, warning of the concerns about heart failure, according to Medpage Today. The decision was based on post-marketing trial involving 16,000 patients.
Saxagliptin is currently marketed under two names, Onglyza and Kombiglyze XR.
The FDA announced last year that the agency was involved in an investigation into the connection between incidents of heart failure and the use of Saxagliptin and other type 2 diabetes drugs. One member of the FDA’s review committee, a consumer representative, voted to completely withdraw Saxalgliptin from the market due to the associated risk of heart failure for patients, according to the same article in Medpage Today.
The FDA now requires drug manufacturers applying for FDA approval to prove that their product will not lead to an “unacceptable increase of cardiovascular risk.” Drug manufacturers are now required to engage in post-marketing evaluations of their products, such as the study data recently released in the New England Journal of Medicine (NEJM).
Broad Evaluation of Diabetes Drug TreatmentsThe FDA reports that they are involved in a broad evaluation of all types of type 2 diabetes drug treatments with regard to cardiovascular risks. A safety notice issued by the agency asks health care providers, as well as diabetes patients currently on the drug, to provide reports of side effects associated with Saxagliptin.
The FDA initiated the investigation into Saxagliptin following the release of a study published in 2013 in the NEJM. This study concluded that there were increased rates of hospitalization for heart failure. The FDA says that the information in this report is considered to be preliminary, and part of a wider investigation into all diabetes drugs with regard to cardiovascular risks.
The manufacturer, AstraZeneca, has already warned patients of various potential side effects, prior to the decision by the FDA. Some of these side effects include pancreatitis, which is potentially fatal, as well as low blood sugar and fluid retention. The FDA panel has voted that this new concern about the risk of heart failure warrants a change in labeling.
Sources:- MedPage Today: FDA Panel Wants New DPP-4 Inhibitor Labels
- FDA: FDA to Review Heart Failure Risk With Diabetes Drug Saxagliptin
- FDA: Saxagliptin – FDA to Review Heart Failure Risk
- New England Journal of Medicine: Saxagliptin and Cardiovascular Outcomes in Patients with Type 2 Diabetes Mellitus
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
ONGLYZA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings. [See Clinical Studies (14).]
ONGLYZA should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.
ONGLYZA has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using ONGLYZA. [See Warnings and Precautions (5.1).]ONGLYZA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings. [See Clinical Studies (14).]
History
There is currently no drug history available for this drug.
Other Information
Saxagliptin is an orally-active inhibitor of the DPP4 enzyme.
Saxagliptin monohydrate is described chemically as (1S,3S,5S)-2-[(2S)-2-Amino-2-(3-hydroxytricyclo[3.3.1.13,7]dec-1-yl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile, monohydrate or (1S,3S,5S)-2-[(2S)-2-Amino-2-(3-hydroxyadamantan-1-yl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile hydrate. The empirical formula is C18H25N3O2•H2O and the molecular weight is 333.43. The structural formula is:
Sources
Onglyza Manufacturers
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Cardinal Health
![Onglyza (Saxagliptin) Tablet, Film Coated [Cardinal Health]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Onglyza | Cardinal Health
2.1 Recommended DosageThe recommended dosage of ONGLYZA is 2.5 mg or 5 mg once daily taken regardless of meals. ONGLYZA tablets must not be split or cut.
2.2 Dosage in Patients with Renal ImpairmentNo dosage adjustment for ONGLYZA is recommended for patients with mild renal impairment (creatinine clearance [CrCl] >50 mL/min).
The dosage of ONGLYZA is 2.5 mg once daily (regardless of meals) for patients with moderate or severe renal impairment, or with end-stage renal disease (ESRD) requiring hemodialysis (creatinine clearance [CrCl] ≤50 mL/min) [see Clinical Pharmacology (12.3) and Clinical Studies (14.3)]. ONGLYZA should be administered following hemodialysis. ONGLYZA has not been studied in patients undergoing peritoneal dialysis. Because the dosage of ONGLYZA should be limited to 2.5 mg based upon renal function, assessment of renal function is recommended prior to initiation of ONGLYZA and periodically thereafter. Renal function can be estimated from serum creatinine using the Cockcroft-Gault formula or Modification of Diet in Renal Disease formula. [See Clinical Pharmacology (12.3).] 2.3 Dosage Adjustment with Concomitant Use of Strong CYP3A4/5 InhibitorsThe dosage of ONGLYZA is 2.5 mg once daily when coadministered with strong cytochrome P450 3A4/5 (CYP3A4/5) inhibitors (e.g., ketoconazole, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, and telithromycin). [See Drug Interactions (7.1) and Clinical Pharmacology (12.3).]
2.4 Concomitant Use with an Insulin Secretagogue (e.g., Sulfonylurea) or with InsulinWhen ONGLYZA is used in combination with an insulin secretagogue (e.g., sulfonylurea) or with insulin, a lower dose of the insulin secretagogue or insulin may be required to minimize the risk of hypoglycemia. [See Warnings and Precautions (5.2).]
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Astrazeneca Pharmaceuticals Lp
Onglyza | Virbac Ah, Inc.
There is currently no dosage information available for this product. We apologize for any inconvenience.
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Physicians Total Care, Inc.
Onglyza | Physicians Total Care, Inc.
2.1 Recommended DosingThe recommended dose of ONGLYZA is 2.5 mg or 5 mg once daily taken regardless of meals.
ONGLYZA tablets must not be split or cut.
2.2 Patients with Renal ImpairmentNo dosage adjustment for ONGLYZA is recommended for patients with mild renal impairment (creatinine clearance [CrCl] >50 mL/min).
The dose of ONGLYZA is 2.5 mg once daily for patients with moderate or severe renal impairment, or with end-stage renal disease (ESRD) requiring hemodialysis (creatinine clearance [CrCl] ≤50 mL/min) [see Clinical Pharmacology (12.3) and Clinical Studies (14.3)]. ONGLYZA should be administered following hemodialysis. ONGLYZA has not been studied in patients undergoing peritoneal dialysis.
Because the dose of ONGLYZA should be limited to 2.5 mg based upon renal function, assessment of renal function is recommended prior to initiation of ONGLYZA and periodically thereafter. Renal function can be estimated from serum creatinine using the Cockcroft-Gault formula or Modification of Diet in Renal Disease formula. [See Clinical Pharmacology (12.3).]
2.3 Strong CYP3A4/5 InhibitorsThe dose of ONGLYZA is 2.5 mg once daily when coadministered with strong cytochrome P450 3A4/5 (CYP3A4/5) inhibitors (e.g., ketoconazole, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, and telithromycin). [See Drug Interactions (7.1) and Clinical Pharmacology (12.3).]
2.4 Concomitant Use with an Insulin Secretagogue (e.g., Sulfonylurea) or with InsulinWhen ONGLYZA is used in combination with an insulin secretagogue (e.g., sulfonylurea) or with insulin, a lower dose of the insulin secretagogue or insulin may be required to minimize the risk of hypoglycemia. [See Warnings and Precautions (5.1).]
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E.r. Squibb & Sons, L.l.c.
Onglyza | E.r. Squibb & Sons, L.l.c.
2.1 Recommended DosageThe recommended dosage of ONGLYZA is 2.5 mg or 5 mg once daily taken regardless of meals. ONGLYZA tablets must not be split or cut.
2.2 Dosage in Patients with Renal ImpairmentNo dosage adjustment for ONGLYZA is recommended for patients with mild renal impairment (creatinine clearance [CrCl] >50 mL/min).
The dosage of ONGLYZA is 2.5 mg once daily (regardless of meals) for patients with moderate or severe renal impairment, or with end-stage renal disease (ESRD) requiring hemodialysis (creatinine clearance [CrCl] ≤50 mL/min) [see Clinical Pharmacology (12.3) and Clinical Studies (14.3)]. ONGLYZA should be administered following hemodialysis. ONGLYZA has not been studied in patients undergoing peritoneal dialysis.
Because the dosage of ONGLYZA should be limited to 2.5 mg based upon renal function, assessment of renal function is recommended prior to initiation of ONGLYZA and periodically thereafter. Renal function can be estimated from serum creatinine using the Cockcroft-Gault formula or Modification of Diet in Renal Disease formula. [See Clinical Pharmacology (12.3).]
2.3 Dosage Adjustment with Concomitant Use of Strong CYP3A4/5 InhibitorsThe dosage of ONGLYZA is 2.5 mg once daily when coadministered with strong cytochrome P450 3A4/5 (CYP3A4/5) inhibitors (e.g., ketoconazole, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, and telithromycin). [See Drug Interactions (7.1) and Clinical Pharmacology (12.3).]
2.4 Concomitant Use with an Insulin Secretagogue (e.g., Sulfonylurea) or with InsulinWhen ONGLYZA is used in combination with an insulin secretagogue (e.g., sulfonylurea) or with insulin, a lower dose of the insulin secretagogue or insulin may be required to minimize the risk of hypoglycemia. [See Warnings and Precautions (5.2).]
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Cardinal Health
Onglyza | Cardinal Health
2.1 Recommended DosageThe recommended dosage of ONGLYZA is 2.5 mg or 5 mg once daily taken regardless of meals.
ONGLYZA tablets must not be split or cut.
2.2 Dosage in Patients with Renal ImpairmentNo dosage adjustment for ONGLYZA is recommended for patients with mild renal impairment (creatinine clearance [CrCl] >50 mL/min).
The dosage of ONGLYZA is 2.5 mg once daily (regardless of meals) for patients with moderate or severe renal impairment, or with end-stage renal disease (ESRD) requiring hemodialysis (creatinine clearance [CrCl] ≤50 mL/min) [see Clinical Pharmacology (12.3) and Clinical Studies (14.3)]. ONGLYZA should be administered following hemodialysis. ONGLYZA has not been studied in patients undergoing peritoneal dialysis.
Because the dosage of ONGLYZA should be limited to 2.5 mg based upon renal function, assessment of renal function is recommended prior to initiation of ONGLYZA and periodically thereafter. Renal function can be estimated from serum creatinine using the Cockcroft-Gault formula or Modification of Diet in Renal Disease formula. [See Clinical Pharmacology (12.3).]
2.3 Dosage Adjustment with Concomitant Use of Strong CYP3A4/5 InhibitorsThe dosage of ONGLYZA is 2.5 mg once daily when coadministered with strong cytochrome P450 3A4/5 (CYP3A4/5) inhibitors (e.g., ketoconazole, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, and telithromycin). [See Drug Interactions (7.1) and Clinical Pharmacology (12.3).]
2.4 Concomitant Use with an Insulin Secretagogue (e.g., Sulfonylurea) or with InsulinWhen ONGLYZA is used in combination with an insulin secretagogue (e.g., sulfonylurea) or with insulin, a lower dose of the insulin secretagogue or insulin may be required to minimize the risk of hypoglycemia. [See Warnings and Precautions (5.2).]
![Onglyza (Saxagliptin) Tablet, Film Coated [Astrazeneca Pharmaceuticals Lp]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=1334b4ed-6c76-4108-9b29-1e61d3fc9cbe&name=KetoChlor.jpg)
![Onglyza (Saxagliptin) Tablet, Film Coated [Physicians Total Care, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d45fc842-2563-4421-86af-a55b3191e19b&name=6309.jpg)
![Onglyza (Saxagliptin) Tablet, Film Coated [E.r. Squibb & Sons, L.l.c.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=ba48ac4b-9503-4006-f6e2-3b8a83059c03&name=onglyza-2-5mg-lbl.jpg)
![Onglyza (Saxagliptin) Tablet, Film Coated [Cardinal Health]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=97b7f4d7-43a0-4e31-b8bc-cb52f2bb31f4&name=image-01.jpg)
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