Revised: 12/2016

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FULL PRESCRIBING INFORMATION: CONTENTS*
WARNING: CONGESTIVE HEART FAILURE
1 INDICATIONS AND USAGE
1.1 Monotherapy and Combination Therapy
2 DOSAGE AND ADMINISTRATION
2.1 Recommendations for All Patients
2.2 Patients with Renal Impairment
2.3 Coadministration with Strong CYP2C8 Inhibitors
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Congestive Heart Failure
5.2 Pancreatitis
5.3 Hypersensitivity Reactions
5.4 Hepatic Effects
5.5 Edema
5.6 Fractures
5.7 Urinary Bladder Tumors
5.8 Use with Medications Known to Cause Hypoglycemia
5.9 Macular Edema
5.10 Severe and Disabling Arthralgia
5.11 Bullous Pemphigoid
5.12 Macrovascular Outcomes
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Laboratory Abnormalities
6.3 Postmarketing Experience
7 DRUG INTERACTIONS
7.1 Strong CYP2C8 Inhibitors
7.2 CYP2C8 Inducers
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.3 Females and Males of Reproductive Potential
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Renal Impairment
8.7 Hepatic Impairment
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
13.2 Animal Toxicology and/or Pharmacology
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
* Sections or subsections omitted from the full prescribing information are not listed. CLOSE
1 INDICATIONS AND USAGE
1.1 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 when treatment with both alogliptin and pioglitazone is appropriate [see CLINICAL STUDIES (14)].

Important Limitations of Use

OSENI is not indicated for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.

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2 DOSAGE AND ADMINISTRATION
2.1 Recommendations for All Patients
OSENI 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):

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 p