Bottles of 90 tablets

NDC 64764-124-05

Bottles of 500 tablets

Storage

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep container tightly closed and protect from moisture and humidity.

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17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide)

Inform patients of the potential risks and benefits of OSENI.

Patients should be informed of the signs and symptoms of heart failure. Patients who experience an unusually rapid increase in weight or edema or who develop shortness of breath or other symptoms of heart failure while on OSENI should immediately report these symptoms to their physician. Before initiating OSENI, patients should be asked about a history of heart failure or other risk factors for heart failure including moderate to severe renal impairment.

Patients should be informed that acute pancreatitis has been reported during use of alogliptin. Patients should be informed that persistent, severe abdominal pain, sometimes radiating to the back, which may or may not be accompanied by vomiting, is the hallmark symptom of acute pancreatitis. Patients should be instructed to promptly discontinue OSENI and contact their physician if persistent severe abdominal pain occurs.

Patients should be informed that allergic reactions have been reported during use of alogliptin and pioglitazone. If symptoms of allergic reactions (including skin rash, hives and swelling of the face, lips, tongue and throat that may cause difficulty in breathing or swallowing) occur, patients should be instructed to discontinue OSENI and seek medical advice promptly.

Patients should be informed that postmarketing reports of liver injury, sometimes fatal, have been reported during use of alogliptin and pioglitazone. If signs or symptoms of liver injury occur (e.g., unexplained nausea, vomiting, abdominal pain, fatigue, anorexia or dark urine), patients should be instructed to discontinue OSENI and seek medical advice promptly.

Tell patients to promptly report any sign of macroscopic hematuria or other symptoms such as dysuria or urinary urgency that develop or increase during treatment, as these may be due to bladder cancer.

Inform patients that hypoglycemia can occur, particularly when an insulin secretagogue or insulin is used in combination with OSENI. Explain the risks, symptoms and appropriate management of hypoglycemia.

Inform female patients that treatment with pioglitazone, like other thiazolidinediones, may result in an unintended pregnancy in some premenopausal anovulatory females due to its effect on ovulation [see USE IN SPECIFIC POPULATIONS (8.3)].

Inform patients that severe and disabling joint pain may occur with this class of drugs. The time to onset of symptoms can range from one day to years. Instruct patients to seek medical advice if severe joint pain occurs.

Inform patients that bullous pemphigoid may occur with this class of drugs. Instruct patients to seek medical advice if blisters or erosions occur [see WARNINGS AND PRECAUTIONS (5.11)].

Instruct patients to take OSENI only as prescribed daily. OSENI can be taken with or without meals. If a dose is missed, advise patients not to double their next dose.

Patients should be informed that the tablets must never be split.

Instruct patients to read the Medica