HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use OSENI safely and effectively. See full prescribing information for OSENI.
OSENI(alogliptin and pioglitazone) tablets, for oral use
Initial U.S. Approval: 2013
WARNING: CONGESTIVE HEART FAILURE SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING
Thiazolidinediones, including pioglitazone, cause or exacerbate congestive heart failure in some patients. (5.1)
After initiation of OSENI and after dose increases, monitor patients carefully for signs and symptoms of heart failure (e.g., excessive, rapid weight gain, dyspnea and/or edema). If heart failure develops, it should be managed according to current standards of care and discontinuation or dose reduction of pioglitazone in OSENI must be considered. (5.1)
OSENI is not recommended in patients with symptomatic heart failure. (5.1)
Initiation of OSENI in patients with established New York Heart Association (NYHA) Class III or IV heart failure is contraindicated. (4, 5.1)
RECENT MAJOR CHANGES

Indications and Usage (1.1) 4/2016
Warnings and Precautions
  Congestive Heart Failure (5.1) 4/2016
  Pancreatitis (5.2) 4/2016
  Hepatic Effects (5.4) 4/2016
  Urinary Bladder Tumors (5.7) 12/2016
  Bullous pemphigoid (5.11) 12/2016
INDICATIONS AND USAGE

OSENI is a dipeptidyl peptidase-4 inhibitor and thiazolidinedione combination product indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (1.1)

Important Limitations of Use: Not for treatment of type 1 diabetes or diabetic ketoacidosis. (1.1)

DOSAGE AND ADMINISTRATION

Individualize the starting dose of OSENI based on the patient's current regimen and concurrent medical condition but do not exceed a daily dose of alogliptin 25 mg and pioglitazone 45 mg. (2.1)
Can be taken with or without food. (2.1)
Limit initial dose of pioglitazone to 15 mg once daily in patients with NYHA Class I or II heart failure. (2.1)
Adjust dose if moderate renal impairment. (2.2)
Degree of Renal Impairment Creatinine Clearance (mL/min) Recommended Dosing
Moderate ≥30 to <60 12.5 mg/15 mg, 12.5 mg/30 mg or 12.5 mg/45 mg once daily
OSENI is not recommended for patients with severe renal impairment or end-stage renal disease (ESRD) requiring dialysis. (2.2)
The maximum recommended dose of pioglitazone is 15 mg once daily in patients taking strong CYP2C8 inhibitors (e.g., gemfibrozil). (2.3, 7.1)
DOSAGE FORMS AND STRENGTHS

Tablets:

25 mg alogliptin and 15 mg pioglitazone, 25 mg alogliptin and 30 mg pioglitazone, 25 mg alogliptin and 45 mg pioglitazone. (3)

12.5 mg alogliptin and 15 mg pioglitazone, 12.5 mg alogliptin and 30 mg pioglitazone, 12.5 mg alogliptin and 45 mg pioglitazone. (3)

CONTRAINDICATIONS

History of a serious hypersensitivity reaction to alogliptin or pioglitazone, components of OSENI, such as anaphylaxis, angioedema or severe cutaneous adverse reactions. (4)
Do not initiate OSENI in patients with established NYHA Class III or IV heart failure. (4)
WARNINGS AND PRECAUTIONS

Congestive heart failure: Fluid retention may occur and can exacerbate or lead to congestive heart failure. Combination use with insulin and use in congestive heart failure NYHA Class I a