Important Safety Information
WARNING for OSENI (alogliptin and pioglitazone): RISK OF HEART FAILURE
OSENI can cause heart failure and 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. Before you start taking OSENI, tell your doctor if you have ever had heart failure or have problems with your kidneys. Call your doctor right away if you experience shortness of breath or trouble breathing (especially when you lie down), an unusually fast increase in weight or swelling or fluid retention (especially in the feet, ankles or legs). These may be symptoms of heart failure.
WARNING for KAZANO (alogliptin and metformin HCl): RISK OF LACTIC ACIDOSIS
Metformin, one of the medicines in KAZANO, can cause a rare but serious condition called lactic acidosis (a buildup of an acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in a hospital. Stop taking KAZANO and call your doctor right away if you feel very weak or tired, have unusual (not normal) muscle pain, have trouble breathing, feel sleepy or drowsy, have stomach pains, nausea or vomiting, feel cold in your hands or feet, feel dizzy or lightheaded, or have a slow or irregular heartbeat, as these could be symptoms of lactic acidosis.
You have a higher chance of getting lactic acidosis if you have severe kidney problems or your kidneys are affected by certain x-ray tests that use injectable dye, have liver problems, have congestive heart failure that requires treatment with medicines, drink a lot of alcohol (very often or short-term “binge” drinking), get dehydrated (lose a large amount of body fluids, which can happen if you are sick with a fever, vomiting, or diarrhea, or when you sweat a lot with activity or exercise and do not drink enough fluids), have surgery, have a heart attack, severe infection, or stroke. The best way to keep from having a problem with lactic acidosis from metformin is to tell your doctor if you have any of the problems listed above. Your doctor may decide to stop KAZANO for a while if you have any of these things.
NESINA, KAZANO, or OSENI may not be right for everyone. NESINA, KAZANO, and OSENI can cause serious side effects.
Do not take KAZANO if you have severe kidney problems, have a condition called metabolic acidosis or have had diabetic ketoacidosis (increased ketones in the blood or urine). If you are going to get an injection of dye or contrast agents for an x-ray procedure, KAZANO may need to be stopped for a short time. Talk to your doctor about when you should stop KAZANO and when you should start KAZANO again.
Do not take NESINA, KAZANO, or OSENI if you are allergic to any of their ingredients.
Stop taking NESINA, KAZANO, or OSENI and contact your doctor or go to the nearest hospital emergency room right away if you experience swelling of your face, lips, throat, or other areas on your skin, difficulty swallowing or breathing, raised red areas on your skin (hives), skin rash, itching, flaking, or peeling, as these may be symptoms of a serious allergic reaction.
Warnings and Precautions—for NESINA, KAZANO, and OSENI
Inflammation of the pancreas (pancreatitis), which may be severe, can happen to people taking NESINA, KAZANO, or OSENI. Tell your doctor if you have ever had pancreatitis, kidney problems, or liver problems. Stop taking NESINA, KAZANO, or OSENI and call your doctor right away if you have pain in your stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your abdomen through to your back. The pain may happen with or without vomiting. These may be symptoms of pancreatitis.
Before taking NESINA, KAZANO, or OSENI tell your doctor if you have ever had heart failure or have problems with your kidneys. Contact your doctor right away if you have any of the following symptoms: increasing shortness of breath or trouble breathing especially when lying down, an unusually fast increase in weight, or swelling of feet, ankles, or legs. These may be symptoms of heart failure.
NESINA, KAZANO, or OSENI may cause liver problems. Call your doctor right away if you experience nausea, vomiting, stomach pain, unusual or unexplained tiredness, loss of appetite, dark urine, or yellowing of your skin or eyes.
If you take NESINA, KAZANO, or OSENI with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea medicine or insulin may need to be lowered while you take NESINA, KAZANO, or OSENI. If you have symptoms of low blood sugar, you should check your blood sugar and treat if low, and then call your doctor. Signs and symptoms of low blood sugar include shaking or feeling jittery, sweating, fast heartbeat, change in vision, hunger, headache, change in mood, confusion, or dizziness.
Some people who take medicines called DPP-4 inhibitors like NESINA, or one of the medicines in KAZANO, or OSENI may develop joint pain that can be severe. Call your doctor if you have severe joint pain.
Some people who take medicines called DPP-4 inhibitors, like NESINA, or one of the medicines in KAZANO or OSENI, may develop a skin reaction called bullous pemphigoid that can require treatment in a hospital. Tell your doctor right away if you develop blisters or the breakdown of the outer layer of your skin (erosion). Your doctor may tell you to stop taking NESINA, KAZANO, or OSENI.
Before taking NESINA, KAZANO, or OSENI, you should tell your doctor if you are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed. It is not known if NESINA, KAZANO, or OSENI can harm an unborn baby, or if it passes into breast milk.
Warnings and Precautions—for OSENI
Women are at a higher risk of having broken bones (fractures) while taking OSENI.
There may be an increased chance of having bladder cancer when you take OSENI. You should not take OSENI if you are receiving treatment for bladder cancer. Tell your doctor right away if you have blood or a red color in your urine, an increased need to urinate, or pain while you urinate as these may be symptoms of bladder cancer.
Tell your doctor right away if you have any changes in your vision. Your doctor should check your eyes regularly.
Ovulation may happen when premenopausal women who do not have regular monthly periods take OSENI. This can increase your chance of getting pregnant.
The most common side effects of NESINA were stuffy or runny nose and sore throat (4.8%), cold-like symptoms (upper respiratory tract infection; 4.5%), and headache (4.3%).
The most common side effects of KAZANO were cold-like symptoms (upper respiratory tract infection) (8.0%), stuffy or runny nose and sore throat (6.8%), diarrhea (5.5%), increase in blood pressure (5.5%), headache (5.3%), back pain (4.3%), and urinary tract infection (4.2%).
The most common side effects of OSENI were stuffy or runny nose and sore throat (4.9%), back pain (4.2%), and cold-like symptoms (upper respiratory tract infection; 4.1%).
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Medicines can affect each other. You should contact your doctor before you start or stop other medicines. You may need to have your dose of KAZANO or OSENI, or certain other medicines, changed.
Talk to your doctor or healthcare professional.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Indication for NESINA (alogliptin) 6.25 mg, 12.5 mg, and 25 mg Tablets; OSENI (alogliptin and pioglitazone) 25 mg/15 mg, 25 mg/30 mg, 25 mg/45 mg, 12.5 mg/15 mg, 12.5 mg/30 mg, and 12.5 mg/45 mg Tablets; and KAZANO (alogliptin and metformin HCl) 12.5 mg/500 mg and 12.5 mg/1000 mg Tablets
NESINA, KAZANO, and OSENI are prescription medicines used with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes. NESINA, KAZANO, and OSENI are not for patients with type 1 diabetes or diabetic ketoacidosis (increased ketones in blood or urine).