Recommendations for All Patients

OSENI should be taken once daily and can be taken with or without food. Do not spilt tablets.

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

• for patients inadequately controlled on diet and exercise is 25 mg/15 mg or 25 mg/30 mg,
• for patients inadequately controlled on metformin monotherapy is 25 mg/15 mg or 25 mg/30 mg,
• for patients on alogliptin who require additional glycemic control is 25 mg/15 mg or 25 mg/30 mg,
• 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,
• for patients switching from alogliptin coadministered with pioglitazone, OSENI may be initiated at the dose of alogliptin and pioglitazone based upon current therapy,
• 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)].

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) and 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.

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)].