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Onglyza
Generic Name: Saxagliptin
Drug Category: DPP-4 Inhibitor
Litigation Alert Level: High
This drug has been approved for use by males and females over the age of 18 years old for a maximum duration of 2 years.
| Approved Uses |
|
Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ONGLYZA should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with ONGLYZA or any other antidiabetic drug. There have been postmarketing reports of acute pancreatitis in patients taking ONGLYZA. Subjects with a prior history of heart failure and subjects with renal impairment had a higher risk for hospitalization for heart failure, irrespective of treatment assignment. Consider the risks and benefits of ONGLYZA prior to initiating treatment in patients at a higher risk for heart failure. There have been postmarketing reports of severe and disabling arthralgia in patients taking DPP-4 inhibitors. Postmarketing cases of bullous pemphigoid requiring hospitalization have been reported with DPP-4 inhibitor use. Saxagliptin and its active metabolite are eliminated in part by the kidney. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection in the elderly based on renal function. The dosage of ONGLYZA is 2.5 mg once daily (regardless of meals) for patients with eGFR <45mL/min/1.73 m2 (which includes a subset of moderate or severe renal impairment, or with end-stage renal disease (ESRD) requiring hemodialysis). ONGLYZA has not been studied in patients undergoing peritoneal dialysis. The dosage of ONGLYZA is 2.5 mg once daily when co-administered with strong cytochrome P450 3A4/5 (CYP3A4/5) inhibitors (e.g., ketoconazole, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, and telithromycin). When 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. Ketoconazole significantly increased saxagliptin exposure.Similar significant increases in plasma concentrations of saxagliptin are anticipated with other strong CYP3A4/5 inhibitors (e.g., atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, and telithromycin). Limited data with ONGLYZA in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriages. There is no information regarding the presence of ONGLYZA in human milk, the effects on the breastfed infant, or the effects on milk production. Saxagliptin is present in the milk of lactating rats. |
| Off-label Uses |
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• Use in patients under the age of 18. GoToSource • Type 1 diabetes mellitus. GoToSource |
| Adverse Events |
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Pancreatitis (inflammation of the pancreas). GoToSource Potential risk of pre-cancerous findings of the pancreas. GoToSource Weight gain, urticaria (hives) and facial edema. GoToSource Bullous pemphigoid (blistering skin disorder) and hypersensitivity reactions. GoToSource Upper respiratory tract infections and urinary tract infections. GoToSource Increased risk of heart failure. GoToSource Hypoglycemia (low blood sugar). GoToSource Increase in blood creatinine or creatine phosphokinase and lymphopenia (low number of lymphocytes, a type of white blood cell). GoToSource Pulmonary edema (excess fluid in the lungs). GoToSource Severe and disabling joint pain. GoToSource |
| Litigation |
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Lawsuits filed for pancreatic cancer and heart failure. |
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