OSENI- alogliptin benzoate and pioglitazone hydrochloride tablet, film coated
Takeda Pharmaceuticals America, Inc.
WARNING: CONGESTIVE HEART FAILURE•
Thiazolidinediones, including pioglitazone, which is a component of OSENI, cause or exacerbate congestive heart failure in some patients [see Warnings and Precautions (5.1)].
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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.
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OSENI is not recommended in patients with symptomatic heart failure.
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Initiation of OSENI in patients with established New York Heart Association (NYHA) Class III or IV heart failure is contraindicated [see Contraindications (4) and Warnings and Precautions (5.1)].
1 INDICATIONS AND USAGE1.1 Monotherapy and Combination Therapy
OSENI is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings when treatment with both alogliptin and pioglitazone is appropriate [see Clinical Studies (14)].

1.2 Limitation of UseOSENI should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings.

Use with caution in patients with liver disease [see Warnings and Precautions (5.4)].

2 DOSAGE AND ADMINISTRATION2.1 Recommendations for All PatientsOSENI should be taken once daily and can be taken with or without food. The tablets must not be split before swallowing.

The recommended starting dose for OSENI (alogliptin and pioglitazone):

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for patients inadequately controlled on diet and exercise is 25 mg/15 mg or 25 mg/30 mg,
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for patients inadequately controlled on metformin monotherapy is 25 mg/15 mg or 25 mg/30 mg,
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for patients on alogliptin who require additional glycemic control is 25 mg/15 mg or 25 mg/30 mg,
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for patients on pioglitazone who require additional glycemic control is 25 mg/15 mg, 25 mg/30 mg or 25 mg/45 mg as appropriate based upon current therapy,
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for patients switching from alogliptin coadministered with pioglitazone, OSENI may be initiated at the dose of alogliptin and pioglitazone based upon current therapy,
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for patients with congestive heart failure (NYHA Class I or II) is 25 mg/15 mg.
The OSENI dose can be titrated up to a maximum of 25 mg/45 mg once daily based on glycemic response as determined by hemoglobin A1c (A1C).

After initiation of OSENI or with dose increase, monitor patients carefully for adverse reactions related to fluid retention as has been seen with pioglitazone (e.g., weight gain, edema and signs and symptoms of congestive heart failure) [see Boxed Warning and Warnings and Precautions (5.1)].

2.2 Patients with Renal ImpairmentNo 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 Clinical Pharmacology (12.3)]. Coadministratio