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 InhibitorsCoadministration 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)].

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.
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25 mg/30 mg tablets are peach, round, biconvex, and film-coated, with both "A/P" and "25/30" printed on one side.
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25 mg/45 mg tablets are red, round, biconvex, and film-coated, with both "A/P" and "25/45" printed on one side.
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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.
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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.
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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.
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].
5 WARNINGS AND PRECAUTIONS5.1 Congestive Heart FailurePioglitazone

Pioglitazone, like other thiazolidinediones, can cause dose-related fluid retention when used alone or in combination with other antidiabetic medications and is most common when pioglitazone is used in combination with insulin. Fluid retention may lead to or exacerbate congestive heart failure. Patients should be observed for signs and symptoms of congestive heart failure. If congestive heart failure develops, it should be managed according to current standards of care and discontinuation or dose reduction of pioglitazone must be considered [see Boxed Warning, Contraindications (4) and Adverse Reactions (6.1)].

5.2 PancreatitisThere have been postmarketing reports of acute pancreatitis in patients taking alogliptin. After initiation of OSENI, patients should be observed carefully for signs and symptoms of pancreatitis. If pancreatitis is suspected, OSENI should promptly be discontinued and appropriate management should be initiated. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using OSENI.

5.3 Hypersensitivity ReactionsThere have been postmarketing reports of serious hypersensitivity reactions in patients treated with alogliptin. These reactions include anaphylaxis, angioedema and severe cutaneous adverse reactions, including Stevens-Johnson syndrome. If a serious hypersensitivity reaction is suspected, discontinue OSENI, assess for other p