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.

Therapy with thiazolidinediones, including pioglitazone, which is one of the active components of OSENI, may result in ovulation in some premenopausal anovulatory women. As a result, these patients may be at an increased risk for pregnancy while taking OSENI. Therefore, adequate contraception should be recommended for all premenopausal women who are prescribed OSENI.

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 Medication Guide before starting OSENI therapy and to reread each time the prescription is refilled. Instruct patients to inform their healthcare provider if an unusual symptom develops or if a symptom persists or worsens.

Revised: June 2013

ALP008 R3

MEDICATION GUIDE

OSENI (OH-senn-ee) (alogliptin and pioglitazone)tablets

Read this Medication Guide carefully before you start taking OSENI and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment. If you have any questions about OSENI, ask your doctor or pharmacist.

What is the most important information I should know about OSENI?

OSENI can cause serious side effects, including:

1.
New or worse heart failure: Pioglitazone, one of the medicines in OSENI, can cause your body to keep extra fluid (fluid retention), which leads to swelling (edema) and weight gain. Extra body fluid can make some heart problems worse or lead to heart failure. Heart failure means your heart does not pump blood well enough.
•
Do not take OSENI if you have severe heart failure.
•
If you have heart failure with symptoms (such as shortness of breath or swelling), even if these symptoms are not severe, OSENI may not be right for you.
Call your doctor right away if you have any of the following:
•
swelling or fluid retention, especially in the ankles or legs
•
shortness of breath or trouble breathing, especially when you lie down
•
an unusually fast i