nd II may increase risk. Consider the risks and benefits of OSENI prior to initiating treatment in patients at risk for heart failure. Monitor patients at risk for heart failure for signs and symptoms. If heart failure develops, eva luate and manage according to current standards of care and consider discontinuation of OSENI. (5.1)
Acute pancreatitis: There have been postmarketing reports of acute pancreatitis. If pancreatitis is suspected, promptly discontinue OSENI. (5.2)
Hypersensitivity: There have been postmarketing reports of serious hypersensitivity reactions in patients treated with alogliptin such as anaphylaxis, angioedema and severe cutaneous adverse reactions, including Stevens-Johnson syndrome. In such cases, promptly discontinue OSENI, assess for other potential causes, institute appropriate monitoring and treatment and initiate alternative treatment for diabetes. (5.3)
Hepatic effects: Postmarketing reports of hepatic failure, sometimes fatal. Causality cannot be excluded. If liver injury is detected, promptly interrupt OSENI and assess patient for probable cause, then treat cause if possible, to resolution or stabilization. Do not restart OSENI if liver injury is confirmed and no alternative etiology can be found. Use with caution in patients with liver disease. (5.4)
Edema: Dose-related edema may occur. (5.5)
Fractures: Increased incidence in female patients. Apply current standards of care for assessing and maintaining bone health. (5.6)
Bladder cancer: May increase the risk of bladder cancer. Do not use in patients with active bladder cancer. Use caution when using in patients with a prior history of bladder cancer. (5.7)
Hypoglycemia: When an insulin secretagogue (e.g., sulfonylurea) or insulin is used in combination with OSENI, a lower dose of insulin secretagogue or insulin may be required to minimize the risk of hypoglycemia. (5.8)
Macular edema: Postmarketing reports. Recommend regular eye exams in all patients with diabetes according to current standards of care with prompt eva luation for acute visual changes. (5.9)
Arthralgia: Severe and disabling arthralgia has been reported in patients taking DPP-4 inhibitors. Consider as a possible cause for severe joint pain and discontinue if appropriate. (5.10)
Bullous pemphigoid: There have been postmarketing reports of bullous pemphigoid requiring hospitalization in patients taking DPP-4 inhibitors. Tell patients to report development of blisters or erosions. If bullous pemphigoid is suspected, discontinue OSENI. (5.11)
Macrovascular outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with OSENI or any other antidiabetic drug. (5.12)
ADVERSE REACTIONS
The most common adverse reactions (4% or greater incidence) are nasopharyngitis, back pain and upper respiratory tract infection. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals at 1-877-TAKEDA-7 (1-877-825-3327) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Strong CYP2C8 inhibitors (e.g., gemfibrozil) increase pioglitazone concentrations. Limit the pioglitazone dose to 15 mg daily. (2.3, 7.1)
CYP2C8 inducers (e.g., rifampin) may decrease pioglitazone concentrations. (7.2)
USE IN SPECIFIC POPULATIONS
Females and Males of Reproductive Potential: Advise premenopausal females of the potential for an unintended pregnancy. (8
