Oseni

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You may take this medicine with or without food. Follow your doctor's instructions.

Do not break an alogliptin and pioglitazone tablet. Swallow it whole.

Your blood sugar will need to be checked often, and you may need other blood tests at your doctor's office.

Low blood sugar (hypoglycemia) can happen to everyone who has diabetes. Symptoms include headache, hunger, sweating, pale skin, irritability, dizziness, feeling shaky, or trouble concentrating.

Keep a source of sugar with you in case you have low blood sugar. Sugar sources include fruit juice, hard candy, crackers, raisins, and non-diet soda. Be sure your family and close friends know how to help you in an emergency. If you have severe hypoglycemia and cannot eat or drink, use a glucagon injection. Your doctor can prescribe a glucagon emergency injection kit and tell you how to use it.

Check your blood sugar carefully during times of stress, travel, illness, surgery or medical emergency, vigorous exercise, or if you drink alcohol or skip meals. These things can affect your glucose levels and your dose needs may also change. Do not change your medication dose or schedule without your doctor's advice.

Alogliptin and pioglitazone is only part of a treatment program that may also include diet, exercise, weight control, blood sugar testing, vision exams, 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.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. You may have signs of low blood sugar, such as extreme weakness, blurred vision, sweating, trouble speaking, tremors, stomach pain, confusion, and seizure (convulsions).

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

>10% (pioglitazone)

Worsening CHF (9.9-13.4%)

Edema when used in combination with sulfonylurea or insulin

1-10%

Hypoglycemia (0.8-4.5%)

Nasopharyngitis (4%)

Back pain (4.2%)

Upper respiratory tract infection (4.1%)

<1% (alogliptin)

Hypersensitivity (0.6%)

Pancreatitis (0.2%)

Postmarketing reports (alogliptin)

Severe and disabling arthralgia

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Oseni is a prescription medication used with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes. It is a combination of two prescription medications, alogliptin and pioglitazone. Alogliptin belongs to a group of drugs called dipeptidyl peptidase-4 (DPP-4) inhibitors. It works by stopping the DPP-4 enzyme from removing a hormone that is responsible for telling your body to release insulin after you eat. This allows insulin to be released, which lowers blood sugar. Pioglitazone belongs to a group of drugs called thiazolidinediones. It lowers blood sugar by helping your body use its natural insulin better.

Oseni comes in tablet form and is usually taken once daily, with or without food. Do not break or cut Oseni tablets before swallowing.

Some of the common side effects of Oseni include stuffy or runny nose and sore throat, back pain, and cold-like symptoms.

• Takeda Pharmaceuticals America, Inc.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known whether Oseni passes into your breast milk and if it can harm your baby. You should not take alogliptin/pioglitazone if you breastfeed your baby. Talk with your doctor about the best way to feed your baby if you are taking Oseni.

• Take Oseni exactly as your doctor tells you to take it.
• Take Oseni 1 time each day with or without food.
• Do not break or cut Oseni tablets before swallowing.
• Your doctor may need to change your dose of Oseni to control your blood glucose. Do not change your dose unless told to do so by your doctor.
• If you miss a dose, take it as soon as you remember. If you do not remember until it is time for your next dose, skip the missed dose, and take the next dose at your regular time. Do not take 2 doses of Oseni at the same time.
• If you take too much Oseni, call your doctor or go to the nearest hospital emergency room right away.
• If your body is under stress, such as from fever, infection, accident, or surgery, the dose of your diabetes medicines may need to be changed. Call your doctor right away.
• Stay on your diet and exercise programs and check your blood sugar as your doctor tells you to.
• Your doctor may do certain blood tests before you start Oseni and during treatment as needed. Your doctor may change your dose of Oseni based on the results of your blood tests due to how well your kidneys are working.
• Your doctor will check your diabetes with regular blood tests, including your blood sugar levels and your hemoglobin A1C.
• Your doctor should check your eyes regularly while you take Oseni.

Alogliptin and pioglitazone are oral diabetes medicines that helps control blood sugar levels.

Alogliptin and pioglitazone is a combination medicine for people with type 2 diabetes. This medicine is sometimes used in combination with other diabetes medications, but is not for treating type 1 diabetes.

Alogliptin and pioglitazone may also be used for purposes not listed in this medication guide.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
• Pain when passing urine or blood in urine.
• Passing urine more often.
• Bone pain.
• Feeling very tired or weak.
• Chest pain or pressure.
• Change in eyesight.
• Very bad and sometimes deadly pancreas problems (pancreatitis) have happened with Oseni (alogliptin and pioglitazone). This could happen at any time during care. Signs of pancreatitis include very bad stomach pain, very bad back pain, or very upset stomach or throwing up. Call your doctor right away if you have any of these signs.
• Very bad and sometimes deadly liver problems have happened with this medicine. Call your doctor right away if you have signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
• Drugs like this one may cause joint pain that can be very bad and disabling. Call your doctor right away if you have very bad joint pain or any joint pain that does not go away.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Stuffy nose.
• Runny nose.
• Sore throat.
• Back pain.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Take Oseni exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You may take Oseni with or without food. Follow your doctor's instructions.

Do not break an Oseni tablet. Swallow it whole.

Your blood sugar will need to be checked often, and you may need other blood tests at your doctor's office.

Low blood sugar (hypoglycemia) can happen to everyone who has diabetes. Symptoms include headache, hunger, sweating, pale skin, irritability, dizziness, feeling shaky, or trouble concentrating.

Keep a source of sugar with you in case you have low blood sugar. Sugar sources include fruit juice, hard candy, crackers, raisins, and non-diet soda. Be sure your family and close friends know how to help you in an emergency. If you have severe hypoglycemia and cannot eat or drink, use a glucagon injection. Your doctor can prescribe a glucagon emergency injection kit and tell you how to use it.

Check your blood sugar carefully during times of stress, travel, illness, surgery or medical emergency, vigorous exercise, or if you drink alcohol or skip meals. These things can affect your glucose levels and your dose needs may also change. Do not change your medication dose or schedule without your doctor's advice.

Oseni is only part of a treatment program that may also include diet, exercise, weight control, blood sugar testing, vision exams, 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.

Applies to alogliptin / pioglitazone: oral tablet

Along with its needed effects, alogliptin / pioglitazone may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking alogliptin / pioglitazone:

• Anxiety
• blurred vision
• chest pain
• chills
• cold sweats
• confusion
• cool, pale skin
• decreased urine output
• depression
• dilated neck veins
• dizziness
• extreme fatigue
• fast heartbeat
• headache
• increased hunger
• irregular breathing
• irregular heartbeat
• nausea
• nightmares
• seizures
• shakiness
• slurred speech
• swelling of the face, fingers, feet, or lower legs
• tightness in the chest
• troubled breathing
• unusual tiredness or weakness
• weight gain

• Blistering, peeling, or loosening of the skin
• bloating
• blood in the urine
• constipation
• cough
• darkened urine
• diarrhea
• difficulty with swallowing
• feeling of discomfort
• fever
• frequent, strong, or increased urge to urinate
• hives, itching, or rash
• indigestion
• inflammation of the joints
• joint or muscle pain
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• loss of appetite
• muscle aches
• pain in the back, lower abdomen, or stomach
• painful urination
• pains in the stomach, side, or abdomen, possibly radiating to the back
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• red skin lesions, often with a purple center
• red, irritated eyes
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• swollen lymph glands
• vomiting
• yellow eyes or skin

• Change in vision
• general feeling of tiredness or weakness
• light-colored stools
• severe joint pain
• stomach pain, continuing

Some side effects of alogliptin / pioglitazone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Back pain
• body aches or pain
• ear congestion
• loss of voice
• sneezing
• stuffy or runny nose