2.2 Patients with Renal Impairment
No dose adjustment of OSENI is necessary for patients with mild renal impairment (creatinine clearance [CrCl] ≥60 mL/min).

The dose of OSENI is 12.5 mg/15 mg, 12.5 mg/30 mg or 12.5 mg/45 mg once daily for patients with moderate renal impairment (CrCl ≥30 to <60 mL/min).

OSENI is not recommended for patients with severe renal impairment or ESRD [see USE IN SPECIFIC POPULATIONS (8.6), CLINICAL PHARMACOLOGY (12.3)]. Coadministration of pioglitazone and alogliptin 6.25 mg once daily based on individual requirements may be considered in these patients.

Because there is a need for dose adjustment based upon renal function, assessment of renal function is recommended prior to initiation of OSENI therapy and periodically thereafter.

2.3 Coadministration with Strong CYP2C8 Inhibitors
Coadministration of pioglitazone and gemfibrozil, a strong CYP2C8 inhibitor, increases pioglitazone exposure approximately three-fold. Therefore, the maximum recommended dose of OSENI is 25 mg/15 mg daily when used in combination with gemfibrozil or other strong CYP2C8 inhibitors [see DRUG INTERACTIONS (7.1) and CLINICAL PHARMACOLOGY (12.3)].

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3 DOSAGE FORMS AND STRENGTHS
25 mg/15 mg tablets are yellow, round, biconvex, and film-coated, with both "A/P" and "25/15" printed on one side.
25 mg/30 mg tablets are peach, round, biconvex, and film-coated, with both "A/P" and "25/30" printed on one side.
25 mg/45 mg tablets are red, round, biconvex, and film-coated, with both "A/P" and "25/45" printed on one side.
12.5 mg/15 mg tablets are pale yellow, round, biconvex, and film-coated, with both "A/P" and "12.5/15" printed on one side.
12.5 mg/30 mg tablets are pale peach, round, biconvex, and film-coated, with both "A/P" and "12.5/30" printed on one side.
12.5 mg/45 mg tablets are pale red, round, biconvex, and film-coated, with both "A/P" and "12.5/45" printed on one side.
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4 CONTRAINDICATIONS
History of a serious hypersensitivity reaction to alogliptin or pioglitazone, components of OSENI, such as anaphylaxis, angioedema or severe cutaneous adverse reactions.

Do not initiate in patients with NYHA Class III or IV heart failure [see BOXED WARNING].

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5 WARNINGS AND PRECAUTIONS
5.1 Congestive Heart Failure
Consider the risks and benefits of OSENI prior to initiating treatment in patients at risk for heart failure, such as those with a prior history of heart failure and a history of renal impairment, and observe these patients for signs and symptoms of congestive heart failure. Patients should be advised of the characteristic symptoms of congestive heart failure and should be instructed to immediately report such symptoms. If congestive heart failure develops, it should be managed according to current standards of care and consider discontinuation of OSENI.

Alogliptin

In the EXAMINE trial which enrolled patients with type 2 diabetes and recent acute coronary syndrome, 106 (3.9%) of patients treated with alogliptin and 89 (3.3%) of patients treated with placebo were hospitalized for congestive heart failure.

Pioglitazone

Pioglitazone, like other t