United States Food and Drug Administration approves NESINA (alogliptin), OSENI (alogliptin and pioglitazone) and KAZANO (alogliptin and metformin HCl)
(BPT) – The number of people living with type 2 diabetes continues to grow. In the United States, it is estimated that approximately 23 million Americans are currently living with the disease. Type 2 diabetes is the most common form of the disease and is a progressive and chronic condition. Patients should work with a health care professional to manage and monitor their disease.
In addition to maintaining a healthy diet and engaging in physical activity, the use of medications may be required for managing type 2 diabetes. Diabetes is an increasingly complex disease and all patients require treatment to be individualized to their needs. As each patient responds differently to medications, the availability of multiple treatment options helps make it possible for health care professionals to create personalized treatment plans for their patients.
Three new treatments, NESINA (alogliptin), OSENI (alogliptin and pioglitazone) and KAZANO (alogliptin and metformin HCl) have recently been approved by the U.S. Food and Drug Administration for use, along with diet and exercise, in adults with type 2 diabetes to improve blood sugar (glucose) control. OSENI is the first and only fixed-dose combination therapy in the U.S. that combines NESINA with a thiazolidinedione (TZD), another class of anti-diabetes treatments, in a single tablet. KAZANO combines NESINA with metformin, a widely used anti-diabetes medication, in a single tablet. The two medicines in OSENI and KAZANO work in complementary ways to help improve blood sugar levels.
“Many people with type 2 diabetes live with the disease for many years and require disease management over time, while working with their health care provider, to help them control their blood sugar levels,” said Robert Busch, M.D., Managing Partner, Endocrine Group, Albany, NY. “NESINA, OSENI and KAZANO provide health care professionals with new treatment options for managing type 2 diabetes. For appropriate patients who need to take more than one diabetes medication at the same time, OSENI and KAZANO each combine two different medicines in one pill.”
NESINA, OSENI and KAZANO by Takeda Pharmaceuticals U.S.A., Inc. will be available in pharmacies in the summer of 2013. More information about these products can be found on: www.Takeda.us/NESINA, www.Takeda.us/OSENI and www.Takeda.us/KAZANO.
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; 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).
Important Safety Information
WARNING FOR OSENI: RISK OF HEART FAILURE
OSENI can cause new or worsen heart failure. Pioglitazone, one of the medicines in OSENI, can cause the 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 the heart does not pump blood well enough. Patients should call their doctor right away if they experience swelling or fluid retention (especially in the ankles or legs), shortness of breath or trouble breathing (especially when they lie down), an unusually fast increase in weight, or unusual tiredness. Patients should not take OSENI if they have severe heart failure. If patients 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 them.
WARNING FOR KAZANO: RISK OF LACTIC ACIDOSIS
Metformin, one of the medicines in KAZANO, can cause a rare but serious condition called lactic acidosis (a build-up of an acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in a hospital. Patients should stop taking KAZANO and call their doctor right away if they feel very weak or tired, have unusual (not normal) muscle pain, have trouble breathing, have unusual sleepiness or sleep longer than usual, have unexplained stomach or intestinal problems with nausea and vomiting or diarrhea, feel cold, especially in the arms or legs, feel dizzy or lightheaded, or have a slow or irregular heartbeat, as these could be symptoms of lactic acidosis. Patients have a higher chance of getting lactic acidosis if they have kidney problems (people whose kidneys are not working properly should not take KAZANO), 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 patients are sick with a fever, vomiting, or diarrhea, or when they sweat a lot with activity or exercise and do not drink enough fluids), have certain x-ray tests with injectable dyes or contrast agents that are injected into their body, have surgery, have a heart attack, severe infection, or stroke.
NESINA, KAZANO or OSENI may not be right for everyone. NESINA, KAZANO and OSENI can cause serious side effects.
Patients should not take KAZANO if they have kidney problems, have a condition called metabolic acidosis, or have had diabetic ketoacidosis (increased ketones in the blood or urine), or are going to get an injection of dye or contrast agents for an x-ray procedure. Patients older than 80 years should not take KAZANO unless their kidneys have been checked and they are normal.
Patients should not take NESINA, KAZANO, or OSENI if they are allergic to any of their ingredients.
Patients should stop taking NESINA, KAZANO, or OSENI and contact their doctor or go to the nearest hospital emergency room right away if they experience swelling of the face, lips, throat, or other areas on the skin, difficulty swallowing or breathing, raised red areas on 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 patients taking NESINA, KAZANO or OSENI. Before patients take NESINA, KAZANO, or OSENI, they should tell their doctor if they have or have had pancreatitis, stones in their gallbladder (gallstones), a history of alcoholism, or if they have kidney or liver problems. Patients should stop taking NESINA, KAZANO, or OSENI and call their doctor right away if they have pain in the stomach area (abdomen) that is severe and will not go away. The pain may be felt going from the abdomen through to the back. The pain may happen with or without vomiting. These may be symptoms of pancreatitis.
NESINA, KAZANO, or OSENI may cause liver problems. Patients should call their doctor right away if they experience nausea, vomiting, stomach pain, unusual or unexplained tiredness, loss of appetite, dark urine, or yellowing of the skin or eyes.
If patients take NESINA, KAZANO or OSENI with another medicine that can cause low blood sugar, such as sulfonylurea or insulin, their risk of getting low blood sugar is higher. The dose of sulfonylurea medicine or insulin may need to be lowered while patients use NESINA, KAZANO, or OSENI. If patients have symptoms of low blood sugar, they should check their blood sugar and treat if low, and then call their 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.
Before taking NESINA, KAZANO, or OSENI, patients should tell their doctor if they 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 patients take OSENI. Patients should not take OSENI if they are receiving treatment for bladder cancer. Patients should tell their doctor right away if they have blood or a red color in their urine, an increased need to urinate, or pain while they urinate as these may be symptoms of bladder cancer.
Patients should tell their doctor right away if they have any changes in their vision. Doctors should check their patients’ eyes regularly.
If a patient is a woman of childbearing age, but does not have monthly periods, she should talk to her doctor before taking OSENI, as it could increase her chance of becoming pregnant.
The most common side effects of NESINA were stuffy or runny nose and sore throat (4.4%), headache (4.2%), and cold-like symptoms (upper respiratory tract infection) (4.2%).
The most common side effects of KAZANO were cold-like symptoms (upper respiratory tract infection) (8%), 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%).
Patients should tell their doctor about all the medicines, vitamins, and supplements they take. Medicines can affect each other, and patients should contact their doctor before they start or stop other medicines. Patients may need to have their dose of KAZANO or OSENI or certain other medicines changed.
Patients should talk to their doctor or healthcare professional. Please see the accompanying Prescribing Information, including Medication Guide, for NESINA, KAZANO, and OSENI.
Patients are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.