Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Not for treatment of type 1 diabetes or diabetic ketoacidosis. NESINA has not been studied in patients undergoing peritoneal dialysis.

The dose of NESINA is 12.5 mg once daily for patients with moderate renal impairment (CrCl ≥30 to <60 mL/min).

The dose of NESINA is 6.25 mg once daily for patients with severe renal impairment (CrCl ≥15 to <30 mL/min) or with end-stage renal disease (ESRD) (CrCl <15 mL/min or requiring hemodialysis). NESINA may be administered without regard to the timing of dialysis. NESINA has not been studied in patients undergoing peritoneal dialysis.

Acute pancreatitis has been reported in the postmarketing setting and in randomized clinical trials.

Postmarketing reports of hepatic failure, sometimes fatal. Causality cannot be excluded. If liver injury is detected, promptly interrupt NESINA and assess patient for probable cause, then treat cause if possible, to resolution or stabilization. Do not restart NESINA if liver injury is confirmed and no alternative etiology can be found.

There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with NESINA or any other antidiabetic drug. 

Consider the risks and benefits of NESINA prior to initiating treatment in patients at risk for heart failure. If heart failure develops, evaluate and manage according to current standards of care and consider discontinuation of NESINA.

There have been postmarketing reports of severe and disabling arthralgia in patients taking DPP-4 inhibitors.

There have been postmarketing reports of serious hypersensitivity reactions in patients treated with NESINA. These reactions include anaphylaxis, angioedema and severe cutaneous adverse reactions, including Stevens-Johnson syndrome. Postmarketing cases of bullous pemphigoid requiring hospitalization have been reported with DPP-4 inhibitor use.

Insulin and insulin secretagogues, such as sulfonylureas, are known to cause hypoglycemia. Therefore, a lower dose of insulin or insulin secretagogue may be required to minimize the risk of hypoglycemia when used in combination with NESINA.

Limited data with NESINA in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage.

There is no information regarding the presence of alogliptin in human milk, the effects on the breastfed infant, or the effects on milk production. Alogliptin is present in rat milk: however, due to species specific differences in lactation physiology, animal lactation data may not reliably predict levels in human milk.

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• Dosage greater than 6.25 mg once daily in patients with severe renal impairment or with end-stage renal disease or requiring hemodialysis. GoToSource

• Dosage greater than 25 mg once daily in patients with normal renal function or mild renal impairment. GoToSource

• Use in patients under the age of 18. GoToSource

• Use for type 1 diabetes. GoToSource

Acute pancreatitis (inflammation of the pancreas). GoToSource  

Pancreatic and thyroid cancer. GoToSource

Anaphylaxis (life-threatening allergic reaction), angioedema (swelling in the deep layers of the skin),   stevens-johnson syndrome (serious disorder of the skin), hypoglycemia (low blood sugar) and upper respiratory tract infection. GoToSource 

Severe and disabling joint pain. GoToSource 

Liver failure. GoToSource

Upper respiratory tract infection. GoToSource

Bullous pemphigoid (blistering skin condition). GoToSource

Heart failure. GoToSource

Lawsuits filed for pancreatic cancer and thyroid cancer.