Oseni contains a combination of alogliptin and pioglitazone. Alogliptin and pioglitazone are oral diabetes medicines that helps control blood sugar levels.

Oseni is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.

Oseni is not for treating type 1 diabetes.

You should not use Oseni if you have severe or uncontrolled heart failure, active bladder cancer, or diabetic ketoacidosis (call your doctor for treatment).

This medicine can cause or worsen congestive heart failure. Call your doctor at once if you have shortness of breath (even with mild exertion), swelling, or rapid weight gain.

Stop taking Oseni and call your doctor right away if you have symptoms of pancreatitis: nausea or vomiting, and upper stomach pain (that may spread to your back).

Before taking this medicine

You should not use Oseni if you are allergic to alogliptin and pioglitazone, or if you have:

• severe or uncontrolled heart failure;

• active bladder cancer; or

• diabetic ketoacidosis (call your doctor for treatment).

Pioglitazone may increase your risk of serious heart problems. However, not treating your diabetes can damage your heart and other organs. Talk to your doctor about the risks and benefits of taking Oseni.

Tell your doctor if you have ever had:

• heart failure;

• liver disease;

• kidney disease (or if you are on dialysis);

• eye problems caused by diabetes;

• pancreatitis; or

• bladder cancer.

Oseni may increase your risk of developing bladder cancer. Talk with your doctor about your specific risk.

Women may be more likely to have a broken bone while taking Oseni. Talk with your doctor about ways to keep your bones healthy.

Follow your doctor's instructions about using this medicine if you are pregnant. Blood sugar control is very important during pregnancy, and your dose needs may be different during each trimester of pregnancy. Having high blood sugar may cause complications in both the mother and the baby.

Pioglitazone may cause you to ovulate and get pregnant, even if you are premenopausal or do not have regular periods. Talk with your doctor about the need for birth control.

It may not be safe to breast-feed a baby while you are using this medicine. Ask your doctor about any risks.

Oseni is not approved for use by anyone younger than 18 years old.

Take Oseni exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You may take this medicine with or without food.

Do not break an Oseni tablet. Swallow the tablet whole.

Low blood sugar (hypoglycemia) can happen to everyone who has diabetes. Symptoms include headache, hunger, sweating, irritability, dizziness, nausea, fast heart rate, and feeling anxious or shaky. To quickly treat low blood sugar, always keep a fast-acting source of sugar with you such as fruit juice, hard candy, crackers, raisins, or non-diet soda.

Your doctor can prescribe a glucagon emergency injection kit to use in case you have severe hypoglycemia and cannot eat or drink. Be sure your family and close friends know how to give you this injection in an emergency.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.

Oseni is only part of a complete treatment program that may also include diet, exercise, weight control, regular blood sugar testing, and special medical care. Follow your doctor's instructions very closely.

Store at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.

Usual Adult Dose for Diabetes Type 2:

Individualize dose based on current regimen and concurrent medical condition:

For patients inadequately controlled on diet and exercise or metformin monotherapy:
-Initial dose: alogliptin-pioglitazone 25 mg/15 mg or 25 mg/30 mg orally once a day
-For patients on alogliptin requiring additional glycemic control:
-Initial dose: alogliptin-pioglitazone 25 mg/15 mg or 25 mg/30 mg orally once a day
For patients on pioglitazone requiring additional glycemic control:
-Initial dose: alogliptin-pioglitazone 25 mg/15 mg, 25 mg/30 mg, or 25 mg/45 mg orally once a day
For patients with congestive heart failure (NYHA Class I or II):
-Initial dose: alogliptin-pioglitazone 25 mg/15 mg orally once a day
For patients switching from individual components:
-Initial dose: Switch to combination product based on current therapy.

Titrate dose based on glycemic response as determined by hemoglobin A1c (HbA1c).
Maximum dose: Alogliptin 25 mg per day; Pioglitazone 45 mg per day.

Comments: When used in combination with insulin or insulin secretagogues such as sulfonylureas, a lower dose of insulin or the insulin secretagogue may be required to minimize the risk of hypoglycemia.

Use: As an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetess when treatment with both alogliptin and pioglitazone is appropriate.

You should not use Oseni if you are allergic to alogliptin and pioglitazone, or if you have:

• severe or uncontrolled heart failure;

• active bladder cancer; or

• diabetic ketoacidosis (call your doctor for treatment).

Pioglitazone may increase your risk of serious heart problems. However, not treating your diabetes can damage your heart and other organs. Talk to your doctor about the risks and benefits of taking Oseni.

Tell your doctor if you have ever had:

• heart failure;

• liver disease;

• kidney disease (or if you are on dialysis);

• eye problems caused by diabetes;

• pancreatitis; or

• bladder cancer.

Oseni may increase your risk of developing bladder cancer. Talk with your doctor about your specific risk.

Women may be more likely to have a broken bone while taking Oseni. Talk with your doctor about ways to keep your bones healthy.

Follow your doctor's instructions about using this medicine if you are pregnant. Blood sugar control is very important during pregnancy, and your dose needs may be different during each trimester of pregnancy. Having high blood sugar may cause complications in both the mother and the baby.

Pioglitazone may cause you to ovulate and get pregnant, even if you are premenopausal or do not have regular periods. Talk with your doctor about the need for birth control.

It may not be safe to breast-feed a baby while you are using this medicine. Ask your doctor about any risks.

Oseni is not approved for use by anyone younger than 18 years old.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction to Oseni (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Stop taking Oseni and call your doctor right away if you have symptoms of pancreatitis: nausea or vomiting, and upper stomach pain (that may spread to your back).

Call your doctor at once if you have:

• a severe autoimmune reaction - itching, blisters, breakdown of the outer layer of skin;

• severe or ongoing pain in your joints;

• pink or red urine, burning when you urinate, new or worsening urge to urinate;

• changes in your vision;

• liver problems - upper stomach pain, vomiting, tiredness, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes); or

• symptoms of heart failure - shortness of breath (even while lying down), swelling in your legs or feet, rapid weight gain.

Common Oseni side effects may include:

• back pain; or

• cold symptoms such as stuffy nose, sinus pain, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor if you use insulin. Taking Oseni while you are using insulin may increase your risk of serious heart problems.

Other drugs may increase or decrease the effects of Oseni on lowering your blood sugar. Tell your doctor about all medications you use. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.